101027163744_bbc_tae_288_unplugged_media
DYANAVEL XR(amphetamine)延长释放型口服悬液药液说明指南说明书
MEDICATION GUIDEMEDICATION GUIDE®DYANAVEL XR (dī-an-uh-vel)(amphetamine)extended-release oral suspension, CIIRead this Medication Guide that comes with DYANAVEL XR before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with DYANAVEL XR.What is the most important information I should know about DYANAVEL XR?DYANAVEL XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL XR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL XR may harm others and is against the law.Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.DYANAVEL XR is a stimulant medicine. Some patients have had the following problems when taking stimulant medicines such as DYANAVEL XR.The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.1. Heart-related problems:•sudden death in patients who have heart problems or heart defects•sudden death, stroke and heart attack in adults•increased blood pressure and heart rateTell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.Your doctor should check you or your child carefully for heart problems before starting DYANAVEL XR.Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with DYANAVEL XR.Call your doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking DYANAVEL XR.2. Mental (Psychiatric) problems:All Patients•new or worse behavior and thought problems•new or worse bipolar illness•new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptomsTell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.Call your doctor right away if you have or your child has any new or worsening mental symptoms or problems while taking DYANAVEL XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:•fingers or toes may feel numb, cool, painful•fingers or toes may change color from pale, to blue, to redTell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking DYANAVEL XR.What is DYANAVEL XR?DYANAVEL XR is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.Who should not take DYANAVEL XR?DYANAVEL XR should not be taken if you or your child:•are allergic to amphetamine, or any of the ingredients in DYANAVEL XR. See the end of this Medication Guide for a complete list of ingredients in DYANAVEL XR.•are taking or have taken within the past 14 days an anti-depression medicine called monoamine oxidase inhibitor or MAOI.What should I tell my doctor before taking DYANAVEL XR?DYANAVEL XR may not be right for you or your child. Before starting DYANAVEL XR tell your or your child’s doctor about all health conditions (or a family history of) including:•heart problems, heart defects, or high blood pressure•mental problems including psychosis, mania, bipolar illness, or depression•circulation problems in fingers and toesTell your doctor:•if you or your child have any kidney problems. Your doctor may lower the dose.•if you are or your child is pregnant, or plan to become pregnant. It is not known if DYANAVEL XR will harm your unborn baby.•if you are or your child is breastfeeding or plan to breastfeed. DYANAVEL XR passes into breast milk.Discuss with your doctor before you breastfeed while you are taking DYANAVEL XR.Tell your doctor about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements. DYANAVEL XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking DYANAVEL XR.Your doctor will decide whether DYANAVEL XR can be taken with other medicines.Especially tell your doctor if you or your child take:•anti-depression medicines including MAOIsKnow the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.Do not start any new medicine while taking DYANAVEL XR without talking to your doctor first.How should DYANAVEL XR be taken?•Take DYANAVEL XR exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.•Take DYANAVEL XR oral suspension 1 time each day in the morning.•DYANAVEL XR can be taken with or without food.•Shake the DYANAVEL XR bottle well before you use it.•Use an oral dosing syringe or other measuring device to help you measure the right amount of DYANAVEL XR.•Your doctor may sometimes stop DYANAVEL XR treatment for a while to check your ADHD symptoms. •Your doctor may do regular checks of your or your child’s blood, heart, and blood pressure while taking DYANAVEL XR.•Children should have their height and weight checked often while taking DYANAVEL XR. DYANAVEL XR treatment may be stopped if a problem is found during these check-ups.•If you or your child take(s) too much DYANAVEL XR, call your doctor or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.What should I avoid while taking DYANAVEL XR?•drinking alcoholWhat are possible side effects of DYANAVEL XR?DYANAVEL XRcan cause serious side effects, including:•See “What is the most important information I should know about DYANAVEL XR?” for information on reported heart and mental problems.•slowing of growth (height and weight) in childrenCommon side effects of amphetamine products include:•dry mouth •decreased appetite •weight loss •stomach pain•nausea•trouble sleeping•restlessness•extreme mood changes•dizziness•increased heart rateTalk to your doctor if you or your child have any side effects that bother you or do not go away.These are not all the possible side effects of DYANAVEL XR. Ask your doctor or pharmacist for more information.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store DYANAVEL XR?•Store DYANAVEL XR at room temperature between 68°F to 77°F (20°C to 25°C).•Store DYANAVEL XR in a safe place, like a locked cabinet.•Dispose of remaining, unused, or expired DYANAVEL XR by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix DYANAVEL XR with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away DYANAVEL XR in the household trash. Keep DYANAVEL XR and all medicines out of the reach of children.General information about the safe and effective use of DYANAVEL XRMedicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use DYANAVEL XR for a condition for which it has not been prescribed. Do not give DYANAVEL XR to other people, even if they have the same condition. It may harm them and it is against the law.This Medication Guide summarizes the most important information about DYANAVEL XR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DYANAVEL XR that was written for healthcare professionals.For more information about DYANAVEL XR please contact Tris Pharma at 1-732-940-0358 or.What are the ingredients in DYANAVEL XR?Active Ingredient: amphetamine.Inactive Ingredients: anhydrous citric acid, bubblegum flavor, glycerin, methylparaben, modified food starch, polysorbate 80, povidone, polyvinyl acetate, propylparaben, sodium lauryl sulfate, sodium polystyrene sulfonate, sucralose, triacetin and xanthan gum.Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852 LB8417 Rev. This Medication Guide has been approved by the U.S. Food and Drug Administration.03 01/17。
约翰斯·霍普金斯指南:抗生素指南说明书
Nursing Central™Your complete mobile andweb solution for nursing!The Johns Hopkins Guides are a series of comprehensivereferences, created by the experts at Johns HopkinsMedicine. Each of the resources can be downloadedas a mobile app to tablets and smartphones and containfrequently updated, evidence-based recommendationsthat help raise the standard of care.Johns Hopkins ABX Guide is the#1 Ranked Infectious Disease App– Clinical Infectious DiseasesJohns Hopkins ABX GuideThe official ABX (Antibiotic) Guide contains quick-to-read,detailed coverage of infectious diseases including drugs,vaccines, specific infections, pathogens, and more.NEW! Johns Hopkins Psychiatry GuideConsult the Psychiatry Guide for disease, drug, and treatmentdetails. Review recommendations from the renowned PHIPPSClinic consistent with the latest diagnostic criteria.From the Johns Hopkins POC-IT Center. For more information go to .© 2014 Unbound Medicine, Inc. All rights reserved.Subscriptions to any of the mobile guides include web access, allowing you to find the answers you need using any web browser.The official Johns Hopkins Guides website features the same evidence-based information contained in the apps along with access to selected MEDLINEJournals, the Johns Hopkins CME program, medical news, and more.Experience the official Johns Hopkins Guides at: The Johns Hopkins POC-IT ABX GuideEditor In Chief: John G. Bartlett, MD Managing Editor: Paul G. Auwaerter, MD Pharmacology Editor: Paul Pham, PharmD, BCPSThe Johns HopkinsPOC-IT Psychiatry GuideEditors In Chief:J. Raymond DePaulo, Jr., MD O. Joseph Bienvenu, MD, PhD Managing Editors: Paul Kim, MD, PhD Paul Nestadt, MD Matthew Peters, MD Traci Speed, MD, PhDPharmacology Editor:Sujin Lee Weinstein, PharmD, BCPPThe Johns Hopkins POC-IT Diabetes GuideEditor In Chief:Rita Rastogi Kalyani, MD, MHS Co-Editor: Thomas Donner, MDThe Johns Hopkins POC-IT HIV GuideEditor In Chief: Joel E. Gallant, MD, MPH Pharmacology Editor: Paul Pham, PharmD, BCPSGroup discounts and site licenses are available.For more information: *************************1.800.230.2423。
(2024年详解)国家慢性疾病编码指南英文版
(2024年详解)国家慢性疾病编码指南英文版(2024 Explained) National Chronic Disease Coding GuidelinesIn 2024, the National Chronic Disease Coding Guidelines were introduced to provide a standardized system for classifying and coding chronic diseases. These guidelines aim to streamline the process of recording and categorizing chronic health conditions, making it easierfor healthcare providers to track and manage patient information effectively.Chronic diseases, such as diabetes, heart disease, and cancer, are long-lasting conditions that require ongoing medical attention. By following the National Chronic Disease Coding Guidelines, healthcare professionals can accurately document these conditions in medical records, ensuring that patients receive the appropriate care and treatment.The coding guidelines include a comprehensive list of codes for different chronic diseases, each corresponding to a specific diagnosis. These codes help healthcare providers accurately identify and classify a patient's condition, enabling them to provide tailored treatment plans and monitor the progression of the disease over time.In addition to standardizing the coding process, the National Chronic Disease Coding Guidelines also promote consistency and accuracy in healthcare documentation. By using the prescribed codes, healthcare providers can communicate effectively with other professionals, insurance companies, and government agencies, ensuring that all relevant parties have access to the necessary information.Overall, the National Chronic Disease Coding Guidelines play a crucial role in improving the quality of care for patients with chronic conditions. By adhering to these guidelines, healthcare providers can better manage and monitor chronic diseases, ultimately leading to better health outcomes for individuals with long-term health issues.。
SUBLOCADE 说明书
MEDICATION GUIDESUBLOCADE(SUB-lo-kade) (buprenorphine extended-release) injection, for subcutaneous use, (CIII)What is the most important information I should know about SUBLOCADE?•Because of the serious risk of potential harm or death from self-injecting SUBLOCADE into a vein (intravenously), it is only available through a restricted program called the SUBLOCADE REMS Program.•SUBLOCADE is not available in retail pharmacies.•Your SUBLOCADE injection will only be given to you by a certified healthcare provider.•SUBLOCADE contains a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs.•Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose. If naloxone is given, you must call 911 or get emergency medical help right away to treat overdose or accidental use of an opioid.•SUBLOCADE may cause serious and life-threatening breathing problems. Get emergency help right away if you:•feel faint•feel dizzy•are confused•Feel sleepy or uncoordinated •have blurred vision•have slurred speech•are breathing slower than normal •cannot think well or clearlyDo not take certain medicines during treatment with SUBLOCADE. Taking other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) while on SUBLOCADE can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.•In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with SUBLOCADE.•You may have detectable levels of SUBLOCADE in your body for a long period after stopping treatment with SUBLOCADE.What is SUBLOCADE?SUBLOCADE is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who:•have received treatment with an oral transmucosal (used under the tongue or inside the cheek) buprenorphine-containing medicine for 7 days and•are taking a dose that controls withdrawal symptoms for at least seven days.•SUBLOCADE is part of a complete treatment plan that should include counseling.Who should not take SUBLOCADE?Do not use SUBLOCADE if you are allergic to buprenorphine or any ingredient in the prefilled syringe (ATRIGEL® delivery system). See the end of this Medication Guide for a list of ingredients in SUBLOCADE.Before starting SUBLOCADE, tell your healthcare provider about all your medical conditions, including if you have:•trouble breathing or lung problems• a curve in your spine that affects your breathing •Addison’s disease •an enlarged prostate (men)•problems urinating•liver, kidney, or gallbladderproblems•alcoholism• a head injury or brainproblem•mental health problems•adrenal gland or thyroidgland problemsTell your healthcare provider if you are:•pregnant or plan to become pregnant. If you receive SUBLOCADE while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life-threatening if not recognized and treated. Talk to your healthcare provider if you are pregnant or plan to become pregnant.•breastfeeding or plan to breastfeed. SUBLOCADE can pass into your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with SUBLOCADE. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with SUBLOCADE.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.How will I receive SUBLOCADE?•You will receive SUBLOCADE by your healthcare provider as an injection just under the skin (subcutaneous) of your stomach (abdomen). You will receive SUBLOCADE monthly (with at least 26 days between doses). •SUBLOCADE is injected as a liquid. After the injection, SUBLOCADE changes to a solid form called a depot. The depot may be seen or felt as a small bump under your skin at the injection site on your abdomen for several weeks. The depot will get smaller over time.•Do not try to remove the depot.•Do not rub or massage the injection site.•Try not to let belts or clothing waistbands rub against the injection site.•If you miss a dose of SUBLOCADE, see your healthcare provider to get your SUBLOCADE injection as soon as possible.What should I avoid while being treated with SUBLOCADE?•Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBLOCADE affects you. Buprenorphine can cause drowsiness and slow reaction times. SUBLOCADE can make you sleepy, dizzy, or lightheaded. This may happen more often in the first few days after your injection and when your dose is changed.•You should not drink alcohol or take prescription or over-the-counter medicines that contain alcohol during treatment with SUBLOCADE, because this can lead to loss of consciousness or even death.What are the possible side effects of SUBLOCADE?SUBLOCADE can cause serious side effects, including:•Trouble breathing. Taking other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants during treatment with SUBLOCADE can cause breathing problems that can lead to coma and death. •Sleepiness, dizziness, and problems with coordination.•Physical dependence.•Liver problems. Call your healthcare provider right away if you notice any of these symptoms:•your skin or the white part of your eyes turns yellow (jaundice)•dark or “tea-colored” urine•light colored stools (bowel movements) •loss of appetite•pain, aching, or tenderness on the right side of your stomach area•nausea•Your healthcare provider should do blood tests to check your liver before you start and during treatment with SUBLOCADE.•Allergic reaction. You may have a rash, hives, swelling of your face, wheezing, low blood pressure, or loss of consciousness. Call your healthcare provider or get emergency help right away.•Opioid withdrawal. Call your healthcare provider right away if you get any of these symptoms:•shaking•sweating more than normal •feeling hot or cold more than normal •runny nose•watery eyes •goose bumps •diarrhea •vomiting •muscle aches•Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down. •The most common side effects of SUBLOCADE include:•constipation •headache •vomiting•increase in liver enzymes•nausea •injection site itching •tiredness •injection site pain•SUBLOCADE may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you. These are not all the possible side effects of SUBLOCADE.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. General information about SUBLOCADEMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your doctor or pharmacist for information that is written for healthcare professionals.What are the ingredients in SUBLOCADE?Active ingredient: buprenorphineATRIGEL® delivery system: biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP).© 2022, Indivior UK Limited. All Rights Reserved.SUBLOCADE® is a registered trademark of Indivior UK Limited.Manufactured by Curia Global Inc. Albany, NY 12203For more information, go to or call 1-877-782-6966.This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 08/2022。
Zulresso(Brexanolone)商品说明书
UnitedHealthcare ® Community PlanZulresso ® (Brexanolone)Policy Number : CS2023D0080J Effective Date : November 1, 2023 Instructions for UseTable of Contents Page Application ..................................................................................... 1 Coverage Rationale ....................................................................... 1 Applicable Codes .......................................................................... 2 Background .................................................................................... 2 Clinical Evidence ........................................................................... 2 U.S. Food and Drug Administration ............................................. 3 References ..................................................................................... 3 Policy History/Revision Information ............................................. 3 Instructions for Use ....................................................................... 3 This Medical Benefit Drug Policy does not apply to the states listed below; refer to the state-specific policy/guideline, if noted: StatePolicy/GuidelineFloridaRefer to the state’s Medicaid clinical policyIndiana Zulresso ® (Brexanolone) (for Indiana Only)Kansas None LouisianaRefer to the state’s Medicaid clinical policy North CarolinaNone OhioZulresso ® (Brexanolone) (for Ohio Only)TexasRefer to the drug specific criteria found within the Texas Medicaid Provider Procedures ManualZulresso (brexanolone) is proven and medically necessary for the treatment of postpartum depression in patients who meet all of the following criteria :Diagnosis of major depressive disorder (MDD) according to the current DSM (i.e., DSM-5), by a mental health professional; andOnset of current depressive episode was during the third trimester or within 4 weeks postpartum; andCurrent depressive episode is considered moderate to severe based on a standardized, validated tool; andPatient has not previously received Zulresso (brexanolone) for the current postpartum depressive episode from the most recent pregnancy (within 6 months); andPatient has not previously received Zurzuvae (zuranolone) for the current postpartum depressive episode from the most recent pregnancy (within 6 months); andThe provider and/or the provider’s healthcare setting is certified in the Zulresso REMS program, with ability to support onsite continuous monitoring; andBrexanolone is dosed in accordance with the United States Food and Drug Administration (FDA)-approved labeling; and Commercial Policy • Zulresso ® (Brexanolone)Approval is for a single 60-hour infusionThe following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.HCPCS Code DescriptionJ1632 Injection, brexanolone, 1 mgDiagnosis Code DescriptionF53.0 Postpartum depressionBrexanolone is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator, that is chemically identical to endogenous allopregnanolone.Meltzer-Brody et al. assessed brexanolone as a treatment for moderate to severe postpartum depression (PPD) in two double-blind, randomized, placebo-controlled, phase 3 trials.2 Women in the trial were 18-45 years of age, 6 months post-partum or less at screening, and diagnosed with PPD with a Hamilton Rating Scale for Depression (HAM-D) score of ≥ 26 and 20-25 for study 1 and study 2, respectively. Study participants were randomly assigned to receive either brexanolone 90 μg/kg per hr. (BRX90), brexanolone 60 μg/kg per hr. (BRX60), or matching placebo for a single 60-hour infusion in study 1. In study 2, BRX90 or placebo was infused as a single 60-hour infusion. The primary efficacy endpoint was the change from baseline in the 17-item HAM-D total score at 60 hours. This was assessed in all patients who started infusion of brexanolone or placebo, had a valid HAM-D baseline assessment, and had at least one post-baseline HAM-D assessment. The trials are NCT02942004 (study 1) and NCT02942017 (study 2). In study 1, at 60 hours, the least-squares (LS) mean reduction in HAM-D total score from baseline was 19.5 points (SE 1.2) in the BRX60 group and 17.7 points (1.2) in the BRX90 group compared with 14.0 points (1.1) in the placebo group [difference -5.5 (95% CI -8.8 to -2.2), p = 0.0013 for the BRX60 group; -3.7 (95% CI -6.9 to -0.5), p = 0.0252 for the BRX90 group]. In study 2, at 60 hours, the LS mean reduction in HAM-D total score from baseline was 14.6 points (SE 0.8) in the BRX90 group compared with 12.1 points (SE 0.8) for the placebo group [difference -2.5 (95% CI -4.5 to -0.5), p = 0·0160]. The authors conclude that brexanolone for PPD resulted in significant and clinically meaningful reductions in HAM-D total score at 60 hours compared with placebo, with rapid onset of action and durable treatment response during the study period. The authors conclude that results suggest that brexanolone injection is a novel therapeutic drug for PPD that has the potential to improve treatment options for women with this disorder.Brexanolone safety, tolerability, and pharmacokinetics were evaluated in a multicenter, open-label study in 20 patients aged 15 to 17 years diagnosed with PPD and were comparable to those in adult patients with PPD.1Professional SocietiesThe American College of Obstetricians and Gynecologists (ACOG) has published a clinical practice guideline with recommendations on treatment and management of perinatal mental health conditions including depression. ACOG recommends consideration of brexanolone administration in the postpartum period for moderate-to-severe perinatal depression with onset in the third trimester or within 4 weeks postpartum. The decision to use brexanolone should balance the benefits (e.g., rapid onset of action) with the risks and challenges (e.g., limited access, high cost, lack of data supporting safety with breastfeeding, requirement for inpatient monitoring during the infusion, lack of efficacy data beyond 30 days).(STRONG RECOMMENDATION, MODERATE-QUALITY EVIDENCE)This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.Zulresso is indicated for the treatment of postpartum depression (PPD) in patients 15 years and older.Zulresso is only available through a restricted program under a REMS called the Zulresso REMS due to the risk of excessive sedation or sudden loss of consciousness that can result in serious harm.Important requirements of the Zulresso REMS include the following:Healthcare facilities must enroll in the program and ensure that Zulresso is only administered to patients who are enrolled in the Zulresso REMSPharmacies must be certified with the program and must only dispense Zulresso to healthcare facilities who are certified inthe Zulresso REMSPatients must be enrolled in the Zulresso REMS prior to administration of ZulressoWholesalers and distributors must be registered with the program and must only distribute to certified healthcare facilities and pharmacies1.Zulresso [package insert]. Cambridge, MA: Sage Therapeutics; June 2022.2.Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, Li H, Sankoh AJ, Clemson C,Schacterle A, Jonas J, Kanes S. Brexanolone injection in post-partum depression: two multicentre, double-blind,randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070.3.AAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 2013. Washington,DC. Pages 451-459.4.Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum: ACOG Clinical PracticeGuideline No. 5. Obstet Gynecol. 2023;141(6):1262-1288. doi:10.1097/AOG.0000000000005202.Date Summary of Changes11/01/2023 Coverage Rationale•Replaced references to “brexanolone” with “Zulresso (brexanolone)”•Revised coverage criteria:o Added criterion requiring the patient has not previously received Zurzuvae (zuranolone) for thecurrent postpartum depressive episode from the most recent pregnancy (within 6 months)o Replaced criterion requiring “onset of current depressive episode was during the third trimester and 4 weeks postpartum” with “onset of current depressive episode was during the thirdtrimester or within 4 weeks postpartum”Supporting Information•Updated Clinical Evidence and References sections to reflect the most current information•Archived previous policy version CS2022D0080IThis Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare standard benefit plans. When deciding coverage, the federal, state, or contractual requirements for benefit plan coverage must be referenced as the terms of the federal, state, or contractual requirements for benefit plan coverage may differ from the standard benefit plan. In the event of a conflict, the federal, state, or contractual requirements for benefit plan coverage govern. Before using this policy, please check the federal, state, or contractual requirements for benefit plan coverage. UnitedHealthcare reserves the right to modify itsPolicies and Guidelines as necessary. This Medical Benefit Drug Policy is provided for informational purposes. It does not constitute medical advice.UnitedHealthcare may also use tools developed by third parties, such as the InterQual® criteria, to assist us in administering health benefits. The UnitedHealthcare Medical Benefit Drug Policies are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.。
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
Unit-Dose Repackaged Solid Oral Dosage Form Drug ProductsGuidance for IndustryDRAFT GUIDANCEThis guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.For questions regarding this draft document, contact (CDER) Bill Harvey at 240-402-4180.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)August 2017Pharmaceutical Quality/Manufacturing Standards (CGMP)Revision 1Unit-Dose Repackaged Solid Oral Dosage Form Drug ProductsGuidance for IndustryAdditional copies are available from:Office of Communications,Division of Drug InformationCenter for Drug Evaluation and ResearchFood and Drug Administration10001 New Hampshire Ave., Hillandale Bldg., 4th FloorSilver Spring, MD 20993-0002Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353Email: druginfo@https:///Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)August 2017Pharmaceutical Quality/Manufacturing Standards (CGMP)Revision 1TABLE OF CONTENTSI.INTRODUCTION (1)II.BACKGROUND (2)III.POLICY (2)Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage1Form Drug Products2Guidance for Industry13456This draft guidance, when finalized, will represent the current thinking of the Food and Drug7Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10for this guidance as listed on the title page.11121314I. INTRODUCTION1516The last few decades have seen an increasing demand in various health care settings for solid17oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of 18drug for administration as a single dose. The increase in unit-dose repackaging has led to19questions regarding stability studies and appropriate expiration dates for these repackaged20products. This guidance describes the conditions under which FDA does not intend to take action 21regarding required stability studies for these repackaged products and the expiration date to22assign under those conditions.22324This guidance addresses repackaging of prescription and over-the-counter solid oral dosage form 25drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are26required to register with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act 27(FD&C Act) and to comply with current good manufacturing practice (CGMP) regulations in 21 28CFR parts 210 and 211.32930The guidance does not address repackaging involving the following:31•Other dosage forms (e.g., sterile, liquid, topical).32331 This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation andResearch at the Food and Drug Administration.2 This draft guidance replaces the draft guidance for industry Expiration Dating of Unit-Dose Repackaged Drugs:Compliance Policy Guide (2005). In addition, this draft guidance, once final, will supersede Compliance PolicyGuide 480.200 Expiration Dating of Unit-Dose Repackaged Drugs (1995).3 As described in 21 CFR 207.3(a)(8), manufacturing or processing includes repackaging or otherwise changing thecontainer, wrapper, or labeling of any drug package to further the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.3435•Products repackaged by State-licensed pharmacies, Federal facilities, and outsourcing 36facilities as defined under section 503B of the FD&C Act.43738In general, FDA’s guidance documents do not establish legally enforceable responsibilities.39Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 40as recommendations, unless specific regulatory or statutory requirements are cited. The use of 41the word should in Agency guidances means that something is suggested or recommended, but 42not required.4344II. BACKGROUND4546FDA’s CGMP regulations for finished pharmaceuticals require that each drug product bear an 47expiration date determined by appropriate stability testing and that the date must be related to any storage conditions stated on the labeling, as determined by stability studies (§§ 211.137(a)4849and (b)).5 The expiration date for a drug product packaged in a single-dose container should be 50placed on the primary container unless it is not feasible to do so.65152Samples used for stability testing must be in the same container-closure system as that in which 53the drug product is marketed (§ 211.166(a)(4)). This is to ensure the drug product’s safety and 54efficacy over its intended shelf life and to ensure that data representing the marketed product are 55available in case quality issues arise during the drug product’s intended shelf life.5657United States Pharmacopeia (USP) General Chapter <7> Labeling states that “the label of an official drug product … shall bear an expiration date.”7 For unit-dose repackaged products, USP5859General Chapter <1178> Good Repackaging Practices recommends that the expiration date “not 60exceed (1) 6 months from the date of repackaging; or (2) the manufacturer’s expiration date; or 61(3) 25% of the time between the date of repackaging and the expiration date shown on the62manufacturer’s bulk article container of the drug being repackaged, whichever is earlier.”6364III. POLICY6566For solid oral dosage form drugs repackaged into unit-dose containers, FDA does not intend to 67take action regarding the requirements of §§ 211.137 and 211.166 (i.e., expiration dating68determined by stability studies) if these products are assigned an expiration date that does not 69exceed (1) 6 months from the date of repackaging, or (2) 25 percent of the time between the date4 Repackaging by state-licensed pharmacies, Federal facilities, and outsourcing facilities is addressed by separateguidance. See, for example, guidance for industry Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page athttps:///Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.5 Stability testing and stability studies are described in § 211.166.6 Under 21 CFR 201.17, when single-dose containers are packed in individual cartons, the expiration date mayproperly appear on the individual carton instead of the immediate product container.7 Here and elsewhere in this guidance, the USP version referenced is USP 39, 8/1/2016.70of repackaging and the expiration date on the container of the original manufacturer’s product, 71whichever time period is shorter, and if the following conditions are met:7273(1)The unit-dose container complies with Class A or Class B standards as described in USP 74General Chapter <671> Containers—Performance Testing, “Packaging System75Classification for Single-Unit Containers and Unit-Dose Containers for Solid Oral76Dosage Forms.”7778Under this condition, containers complying with the Class B standard are used only if (a) 79appropriate data on the moisture permeability of the Class B material and the moisture 80sensitivity of the drug product are available, and (b) a risk assessment of these data81provides a high level of confidence that use of such containers will not compromise the 82quality of the product throughout the assigned expiration dating.88384(2)If the drug product is sensitive to light as indicated by the manufacturer (e.g., “Protect 85from light” on its labeling), the unit-dose repackaging container-closure system provides 86light protection equal to or greater than that of the drug product’s original container-87closure system.8889(3)The drug product’s original container has not been opened previously and the entire90contents are repackaged in one operation.9192(4)Repackaging and storage occur in an environment that is consistent with the conditions 93described in the original drug product’s labeling. If temperature and humidity are notspecified in the original labeling, the product should be maintained at “controlled room9495temperature” and in a “dry place” (as defined in USP <659> Packaging and StorageRequirements) during the repackaging process, including storage.9697(5)The drug product’s labeling does not caution against repackaging.99899100In addition, FDA does not intend to take action regarding the requirements of §§ 211.137 and 101211.166 for an expiration date exceeding the ones described above (i.e., (1) 6 months from the 102date of repackaging, or (2) 25 percent of the time between the date of repackaging and the103expiration date on the container of the original manufacturer’s product, whichever time period is shorter), provided the following:104105106(1)The above five conditions are met.107108(2)Supportive data from appropriate studies, using an adequate number of samples,109demonstrate that the container-closure system used for repackaging is at least as110protective of the drug product as is the original packaging. Appropriate studies should8 Containers meeting USP <671> Class C and Class D standards do not meet condition (1).9 Directions in the package insert such as “Keep these tablets in the original container” and “Do not repackage” areexamples of a caution against repackaging in the product’s labeling.be based on sound science and a risk-based assessment to ensure that product quality is 111112maintained up to the expiration date.10113114(3)The expiration date of the repackaged product does not exceed the original115manufacturer’s expiration date.10 Satisfactory comparison of container-closure systems is possible through several methods, e.g., testing forprotection from moisture, oxygen, and light, as appropriate; comparing the properties of the original container-closure system to a new system by stress testing, which refers to product testing after storage under exaggerated conditions (e.g., high temperature and high humidity); degradation testing after storage under long-term oraccelerated conditions.。
药学网站1
国内相关网站药品标准目录:/standard/index.htm 中国药典、部颁标准、地方标准目录,既可浏览也可按汉字或拼音搜索。
中文医网-药品检索:/doctor/pharma/index.htm提供5000余种药物的药物参数,药代动力学检索,不良反应,药物相互作用等检索。
中国金药网:/ 可提供科研信息检索等服务。
药联盟:/,药学交流最好的平台。
中国传统医药信息网:/ 包括政策法规、中医药专业杂志等,可进行药材市场、药品制剂等的数据库查询。
由国家药品监督管理局信息中心、全国中药信息工作委员会主办。
中国医药信息网:/ 包括医药数据库查询、医药信息服务等。
由国家药品监督管理局信息中心主办。
药品快速查询:/nhi/Medicine.htm 可依台湾药品编号,名称,剂型和制造商查询。
国外相关网站Pharminfo:http://www.santel.lu/SANTEL/diseases/diabet.html 是反映药学领域最新信息的网站,信息量大,更新快,内容包括药物信息、出版物、重要会议及讨论组等。
两个数据库分别是:Drug database 和 Disease database。
Drug database 用于检索具体药物信息的资料库,可以按照通用名和商品名两种方式检索。
Pharmacy:/ 内有众多的药学数据库。
美国药典数据库USP:/chi/resource/pharmacy开设网上药刊,发表研究成果,促进药学科研。
/药学信息相关网站Pharmweb:/ 1994年在Internet上第一个提供药学信息服务的机构,是目前药学方面的重要网站。
列出有关药学、化学、世界各国的药学网、出版物、药学院校等167个与药学有关的网站,按字顺索引。
美国药学会:/ 介绍美国药学会的新闻、会议、出版物。
加拿大药学会:http://www.ualberta.ca/ 发布学会活动消息及出版物等。
虚拟药学图书馆:/pharmacy/pharminfo.html 内容包括全世界有关药学机构、团体、期刊、书籍、会议资料、讨论组等。
2023年开放英语形成性考核册及答案
开放英语形成性考核册及答案作.1第一部分.交际用.(每题2分.共10分)一、阅读下面的小对话, 从A.B.C.D四个选项中选出一个能填入空白处的最佳选项。
1.Ma..hel.you.madam?_________D____________.A.....Sorry..hav.n.ideaB.....Yes..kno.wha.t.buyC.....You’.bette.giv.m..handD.....Yes..‘.lik..kilo.o.oranges2.Ma..kno.you.address?________A______________.A.....Sure.Her.yo.are.B......hav.n.ideaC.....It’.fa.fro.hereD.....Sorry.I’v.forgotten3.Well.Mary.ho.ar.you?_________C______________.A.....I’.goodB.....I’.pleasedC.....I’.fineD.....I’.nice4..don’.lik.th.sport.program.o.Sundays.__B______A.S.d.IB.Neithe.d.IC.S.a.ID.Neithe.a.I5.Wil.yo.g.o..picni.wit.u.tomorrow?_________B___________________.A.....Yes.bu.I’l.hav.Englis.classes.B.....Sorry..hav.a.appointmen.wit.Dr.Brown.C.....I’.afrai..hav.n.idea.D.....Neithe.a.I第二部分: 英语知识运用(40分)二、选择填空阅读下面的句子和对话, 从A.B.C.D四个选项中选出一个能填入空白处的最佳选项。
(每小题2分, 共20分)6.I.happened___D____..winte.night...kno.i.isn’.importan.bu..can’.help__B_______.abou.it.A.bu.t.think............B.thinking............C.to............D.think8.That’.al.settled.It____D______.talke.about.A.shouldn’t................B.mustn’.be........C.can’t............D.needn’.be9.He.parent.die.whe.sh.wa.ver.young.s.sh.was___A_______.b.he.aunt.A.brough.up............B.brough.out........C.grow.up........D.grown10._____B__________.h.sai.i.quit.right.A.That....................B.What................C.How............D.Why11.Don’.worry.Ther.is___C_______.roo.fo.al.you.book.here.A.more....................B.much................C.enough........D.some12.What’.happene.t.Tom?____D__________.t.hospital.A.He’.taken............B.He’l.b.taken........C.He’l.take........D.He’.bee.taken13..don’.suppos.h.wil.atten.th.meeting.___B__________?A.won’.he................B.wil.he............C.d..............D.don’.I14._______A_________.fin.weathe.i.is!A.What....................B.Wha..............C.How............D.Ho..1.No.onl..bu.als.Jan.an.Mar.____B_______.tire.o.havin.on.examinatio.afte.another.A.is....................B.are................C.am........D.be三、完型填空阅读下面的短文, 从短文后所给的A.B.C.D四个选项中选出能填入相应空白处的最佳选项, 并在答题纸上写出所选的字母符号。
E14 Guideline (R3) - questions and answers说明书
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 555525 January 2016EMA/CHMP/ICH/310133/2008Committee for Human Medicinal ProductsICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) - questions and answersStep 5E14 Q&As (R3) Document HistoryICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) - questions and answersICH guideline E14 (R3) - questions and answersTable of contents1E lectrocardiograms methodology (4)2G ender (9)3P ositive control (10)4S tudy design (12)5U se of concentration response modeling of QTc data (13)6S pecial cases (16)7E lectrocardiograms monitoring in late stage clinical trials (17)ICH guideline E14 (R3) - questions and answers1Electrocardiograms methodologyICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 4/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 5/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 6/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 7/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 8/202GenderICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 9/203Positive controlICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 10/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 11/204Study designICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 12/205Use of concentration response modeling of QTc dataICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 13/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 14/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 15/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 16/20 6 Special cases6.1 March2014 The ICH E14 Guideline states that in certain cases a conventional thoroughQT study might not be feasible. In suchcases what other methods should beused for evaluation of QT/QTc andproarrhythmic potential? In certain cases the conventional “thorough QT/QTc” study design (a crossover study in healthy volunteers with short-term administration of the usual maximum dose and one higher dose with placebo and positive control) might need to be modified for a drug or active metabolite with a long half-life or delayed QT effect, or because of safety, tolerability or practical issues that preclude use in healthy subjects. In most cases alternative designs can be used that may affect power considerations, but do notcompromise study interpretation. For example, multiple doses can be studied in aparallel design trial or can use patients with the disease for which the drug is intendedrather than healthy volunteers.Where a placebo-controlled comparison using appropriate doses is not possible,alternative study d esigns should incorporate as many of the usual “thorough QT/QTc”design features as possible, and the quality and extent of the pre-clinical evaluation (ICHS7B Guideline) is particularly critical. Other useful supplementary data might includeintensive ECG data acquisition in early phase single or multiple ascending dose studies,utilisation of concentration-response analysis, and evaluation of exposures that aregreater than are anticipated with the intended marketed dose.A single dose of a positive control is generally sufficient, even if it precedes theinvestigational drug treatment. In the absence of a positive control, there is reluctanceto draw conclusions of lack of an effect; however, if the upper bound of the two-sided90% confidence interval around the estimated maximal effect on QTc is less than 10 ms,it is unlikely to have an actual mean effect as large as 20 ms.When a thorough QTc study of usual or modified design is not feasible, the intensity oflate phase ECG monitoring will be dependent upon the quality and extent of the non-clinical and clinical evaluation. In situations where it is not possible to study higherexposures than are anticipated with the intended marketed dose, more intensive ECGmonitoring might be necessary during Phase 3 trials. When the non-clinical and early7Electrocardiograms monitoring in late stage clinical trialsICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 17/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 18/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 19/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 20/20。
修改白血球分类异常警示讯号
修改白血球分類異常警示訊號修改Sysmex XE-2100分析儀中白血球分類異常警示訊號的條件以降低臨床人工閱片的比例林宏澤1鄧金堂1張永達1高振強1翁志昇1郭明宗1,2甯孝真1林口長庚紀念醫院1臨床病理科2血液科背景:自動化血液分析儀不僅有白血球分類的功能,當偵測到不正常血球時還能產生警示訊號。
當檢體分析結果出現警示訊號,操作者就必須進行人工閱片以確認血球是否異常。
本科血液檢驗室所使用的Sysmex XE-2100有三種警示訊號,包括形態異常訊號(Morph flag)、分類異常訊號(Diff flag)和計數異常訊號(Count flag),這些警示訊號條件可依使用者需求來做適當調整。
目前有許多評估血液分析儀的文獻,但是針對警示訊號的評估卻很少。
目的:本研究是評估XE-2100中分類異常訊號的條件,在不影響檢驗品質下,希望降低警示訊號的偽陽性以提高特異性,來改善人工閱片的比例。
材料與方法:861件需白血球分類的血液檢體經儀器分析,單獨出現分類異常訊號與同時出現分類和計數異常訊號的有105件。
這些血片由兩位經驗豐富的醫檢師獨立看片,統計偽陽性檢體的分類結果並與原廠設定值做比較,將分類異常訊號的設定條件作適度調整。
更改設定值後持續追蹤,檢體結果落在儀器分類異常訊號條件更改前後之間的檢體。
結果:分類異常訊號的條件經過調整後,偽陽性檢體由原先102件降到28件,人工閱片量約可減少8.6%。
結論:每間檢驗室由於病人族群的差異,應該評估適合自己的警示訊號條件,以提升臨床血液檢驗效率與品質。
關鍵詞:白血球分類計數、白血球分類警示訊號、Sysmex XE-2100前 言自動化血液分析儀廣泛使用在血球計數與白血球分類計數上,目前市面上有許多公司的血液分析儀,Abbott [1-2]、ABX [3]、Bayer [4-5]、Beckman Coulter [6-8]和Sysmex [9]等。
每個公司都一直設計出新的血液分析儀,處理大量檢體、節省人力與時間並提供更快速更準確的分析。
奇怪的疾病英语作文
奇怪的疾病英语作文I woke up one morning feeling like my skin was on fire. It was as if I had been sunburned all over, but I hadn't been out in the sun for days. The doctors were baffled by my symptoms, unable to explain why my body was reactingthis way.My hair started falling out in clumps, leaving me with bald patches all over my scalp. I tried wearing hats and scarves to cover it up, but nothing could hide the factthat something was seriously wrong with me.I developed a strange rash that covered my entire body, causing intense itching and discomfort. The doctors prescribed creams and medications, but nothing seemed to make it go away. I felt like a walking, talking medical mystery that no one could solve.My joints began to swell and ache, making it difficult to move or even hold a pen. I was diagnosed with a rareautoimmune disease that was attacking my body from the inside out. It was a terrifying realization that my own immune system was turning against me.As if things couldn't get any worse, I started experiencing hallucinations and delusions. I would see things that weren't there and hear voices whispering in my ear. The doctors attributed it to the stress of my illness, but I couldn't shake the feeling that something more sinister was at play.Despite all the tests, treatments, and consultations, no one could give me a definitive answer about what was happening to me. I felt like a guinea pig in a lab experiment, poked and prodded with no real understanding of my condition.In the end, I learned to live with my strange and mysterious illness, accepting that sometimes the answers we seek are beyond our grasp. I may never know why my body rebelled against me, but I have come to appreciate thefragility and resilience of the human spirit in the face of the unknown.。
特殊感染患者处理流程
特殊感染患者处理流程英文回答:Special Pathogen Infection Management Protocol.Introduction.Special pathogens are highly infectious and potentially life-threatening agents that require specialized management protocols to prevent their spread and to ensure the safety of healthcare workers and the community. These protocols are designed to provide guidance for healthcare facilities in the identification, diagnosis, treatment, and prevention of infections caused by special pathogens.Identification and Diagnosis.The first step in managing special pathogen infections is to identify and diagnose the infection. This is done through a combination of clinical symptoms, laboratorytesting, and epidemiological investigations. Healthcare workers should be aware of the signs and symptoms associated with special pathogen infections and should immediately notify infection control personnel if they suspect a case.Laboratory Testing.Laboratory testing is essential for confirming the diagnosis of a special pathogen infection. Specimens should be collected from the patient and sent to a laboratory for testing. The type of testing performed will depend on the suspected pathogen.Treatment.The treatment of special pathogen infections depends on the specific pathogen involved. In some cases, antibiotics or antiviral medications may be effective. In other cases, supportive care may be necessary.Prevention.Prevention of special pathogen infections is essential to protect healthcare workers and the community. Infection control measures should be implemented to prevent the spread of infection, including:Hand hygiene.Personal protective equipment (PPE)。
解除医学保护医嘱范文
解除医学保护医嘱范文英文回答:To lift a medical protection order, there are a few important steps that need to be followed. First, it is crucial to consult with the attending physician or medical team responsible for the protection order. They will have the necessary information and expertise to guide you through the process.The first step is to understand the reasons for the medical protection order. This could be due to a patient's specific medical condition, such as a contagious disease or a risk of harm to themselves or others. It is important to have a clear understanding of the underlying reasons in order to proceed with the necessary steps.Once the reasons are understood, it is important to gather any relevant medical documents or reports that support the request for lifting the protection order. Thiscould include recent medical tests, evaluations, or reports from specialists. These documents will provide evidence to support the request and help the medical team make an informed decision.Next, it is important to have a discussion with the attending physician or medical team. This could be done through a scheduled appointment or a written request, depending on the hospital's protocols. During this discussion, it is important to express the reasons for wanting to lift the protection order and provide any supporting evidence. The medical team will evaluate the request based on the patient's current medical conditionand any potential risks involved.If the medical team agrees to lift the protection order, they will provide the necessary instructions and documentation. This could include a written statement or a revised treatment plan. It is important to follow these instructions carefully to ensure the smooth transition and continuity of care.In some cases, the medical team may not agree to lift the protection order. If this happens, it is important to understand their reasoning and discuss any alternative options. It may be necessary to seek a second opinion from another medical professional or consult with a patient advocate or legal counsel.Overall, the process of lifting a medical protection order involves understanding the reasons for the order, gathering relevant medical documents, discussing the request with the medical team, and following their instructions. It is important to approach this process with patience, clear communication, and a focus on the best interests of the patient.中文回答:解除医学保护医嘱需要遵循一些重要的步骤。
福利院孤残成年人看病流程
福利院孤残成年人看病流程英文回答:Health Care Process for Foster Care Adults with Disabilities.Adults with disabilities who have been in the foster care system may face unique challenges when it comes to accessing health care. They may not have a regular doctor or clinic, and they may not know how to navigate the complex health care system. The following steps can help ensure that foster care adults with disabilities receive the health care they need:1. Identify a Primary Care Provider (PCP). A PCP is a doctor or other health care provider who can provide ongoing care for a patient. They can help manage chronic conditions, order tests, and refer patients to specialists when necessary. To find a PCP, contact your local health department or visit the website of the National Associationof Community Health Centers (NACHC).2. Establish a Relationship with Your PCP. Once you have found a PCP, it is important to establish a relationship with them. This means seeing them for regular checkups and appointments, and communicating any health concerns you have. Your PCP should be able to provide you with information about your health, answer your questions, and help you develop a treatment plan.3. Keep Track of Your Medical Records. It is important to keep track of your medical records, including doctor's visits, test results, and prescriptions. This information can be helpful in case you need to see a new doctor or if you are applying for disability benefits.4. Understand Your Health Insurance. If you have health insurance, it is important to understand your coverage. This includes knowing what types of services are covered, what your deductible is, and how to file a claim. You can contact your health insurance provider to get more information about your coverage.5. Advocate for Yourself. It is important to advocate for yourself when it comes to your health care. This means speaking up about your needs, asking questions, and making sure that you are getting the care you need. If you are not satisfied with the care you are receiving, you can contact your PCP, your health insurance provider, or a patient advocate.中文回答:福利院孤残成年人看病流程。
“重大医疗事故”英语怎么说
“重大医疗事故”英语怎么说摘要:台湾大学医院发生一起重大医疗事故。
院方误将一名艾滋病感染者的器官移植给5名病患,导致这5人均有感染艾滋病毒之虞。
你知道怎么用英语表达吗?Taiwan's health authorities say they are investigating a case of "critical medical negligence" that led to five patients receiving organs from an HIV-positive donor."The National Taiwan University Hospital is required to come up with a detailed report before the end of Tuesday," Wang Je-chau, a spokesman for the department of health, told Agence France-Presse on Sunday, referring to the hospital where four of the five transplant operations were performed on Thursday.The department said it was the first-ever known case of recipients being exposed to the risk of contracting AIDS because of organ transplants.台湾卫生部门称正在调查一起“重大医疗事故”,该事故中五名患者接受了艾滋感染者的器官捐献。
周日卫生部门的发言人王瑞周(音译)告诉法新社,五个移植手术中的四个于周四在台湾大学医院进行的,“台湾大学医院被要求在周二结束之前拿出一份详细的报告。
Allegheny County Tenant Resource Guide
Housing & Community Environment Program3190 Sassafras Way Pittsburgh PA 15201412-350-4046Find us online at /housing034-HCE-0522https:///Human-Services/Programs-Ser-vices/Basic-Needs/Housing-and-Homeless/Homeless-Services.Women’s Center and Shelter of Greater PittsburghAllegheny County District Attorney(412) 350-4406Room 303 Courthouse, 436 Grant St. Pittsburgh, PA 15219The Allegheny County District Attorney’s Office Domestic Violence Prosecution Unit, prosecutes cases involving current or former sexual or intimate partners who engage in criminal conduct of a threatening, intimidating or physically violent nature. The District Attorney of Allegheny County is committed to prosecuting domestic violence crimes vigorously, with the safety of domestic violence victims as our primary concern.National Coalition Against Domestic Violence/NCADV’s mission is to lead, mobilize and raise their voices to support efforts that demand a change of conditions that lead to domestic violence such as patriarchy, privilege, racism, sexism, and classism. They are dedicated to supporting survivors and holding offenders accountable and supporting advocates. (Hosts an expansive resource list for victims and survivors)Rape, Abuse & Incest National Network (RAINN)https:///https:///es (Spanish)1-800-656-HOPE (4673)RAINN is the nation’s largest anti-sexual violence organization. RAINN created and operates the National Sexual Assault Hotline (800.656.HOPE, /online ) partnership with more than 1,000 local sexual assault service providers across the country and operates the DoD Safe Helpline for the Department of Defense. RAINN also carries out programs to prevent sexual violence, help survivors, and ensure that perpetrators are brought to justice.Drug and Alcohol Assistance:Pathways to Care and Recovery412-325-7550326 Third Ave, Pittsburgh, PA 15222Pathway to Care and Recovery offersAllegheny County residents who are ready to begin their recovery from drug or alcohol addiction the support they need to succeed.PA Get Help Now1-800-662-HELP (4357)Resolve1-888-796-8226333 North Braddock Ave, Point Breeze, PA 15208Other Free or Low-Cost Health Resources:For a comprehensive guide to other free or low-cost health resources in Allegheny County, also check out ACHD’s Guide to Health Care Services for Underinsured or Uninsured (https:///uploadedFiles/Allegheny_Home/Health_Department/Programs/Chronic_Disease_Prevention/Condensed-Guide-to-Low-Cost-or-Free-Health-Resources.pdf ) or scan this QR Code to download the Guide .Lead Paint Resources:Allegheny County EconomicDevelopment Lead Safe Homes Program: https:///leadsafeprogram 412-227-5700Free lead-based paint testing and repairsfor qualifying homeowners and renters to make homes lead safe. Income based assistance for families with children under 6 years old.Get the Lead Out Pittsburgh:https:///faq-and-resourcesEnvironmental Protection Agency Lead Information/Find a Lead Safe Certified Firm:https:///leadAllegheny County Conservation District:412-291-8017Testing of soil samples from your yard or garden for lead.Parent Resource Toolkit for Children with Elevated Blood Lead Levels-This Parent Resource Toolkit from the Pennsylvania Lead-Free Promise Project is a way for parents of children who have tested with elevated blood lead levels to find ways to get help in their County. https:///prthousing and supportive services; street outreach, engagement and case management; and prevention strategies. Over 30 agencies provide Allegheny County Tenant https:///Health-Department/Health-Ser-Energy Assistance Programs like the Low-Income Home。
医院监察建议书
医院监察建议书[Your Name][Your Address][City, Province, Postal Code][Email Address][Phone Number][Date][Name of Hospital][Address of Hospital][City, Province, Postal Code]Subject: Suggestions for Hospital MonitoringDear [Hospital Administration],I hope this letter finds you in good health. As a concerned citizen and a frequent visitor to your esteemed institution, I am writing to provide you with some suggestions for improving the monitoring system at [Name of Hospital].I have always been impressed with the quality of care provided by your medical staff and the advanced facilities available in your hospital. However, there have been instances where I have observed certain areas where vigilance could be increased to ensure the well-being of patients and the smooth operation of the hospital.1. Implementation of CCTV Surveillance:Installing closed-circuit television (CCTV) cameras throughout the hospital premises, particularly in key areas such as entrances, waiting areas, corridors, and emergency zones, can greatly enhance security and monitoring. This would not only deter potential criminal activities but also help ensure the safety of patients, staff, and visitors.2. Regular Monitoring of Staff:Implementing a system to monitor staff conduct and efficiency is crucial for maintaining a high standard of patient care. Regular evaluations and performance assessments can identify areas for improvement, provide constructive feedback, and help motivate staff to excel in their duties. Implementing a feedback mechanism, such as anonymous surveys or helplines, can enable patients and their families to report any concerns or grievances regarding staff behavior.3. Improving Patient Documentation:Ensuring accurate and up-to-date documentation is vital for proper patient care and for protecting the hospital from potential legal issues. Implementing an electronic medical records system that is accessible to authorized personnel can significantly reduce errors caused by manual paperwork and enhance data security. Moreover, regular audits of patient records can help identify any inconsistencies and improve the overall quality of healthcare delivery.4. Strengthening Drug Inventory Management:Efficient management of the hospital's drug inventory is essential for patient safety and preventing drug misuse. Implementing a barcode system can streamline the tracking and monitoring of drugs. Regular audits can help identify any discrepancies, prevent expired drugs from being administered, and safeguard against drug theft or unauthorized use.5. Enhancing Emergency Preparedness:Developing and regularly updating a comprehensive emergency preparedness plan can ensure the hospital is well-equipped to handle various crisis situations. Conducting frequent drills and exercises, such as simulated evacuations and response to natural disasters, can improve staff readiness and coordination during emergencies. Additionally, providing regular training on life-saving techniques, such as cardiopulmonary resuscitation (CPR) and first aid, to both medical and non-medical staff can significantly enhance patient outcomes in critical situations.6. Streamlining Discharge Procedures:Efficient and timely discharge procedures can greatly improve the overall patient experience. Implementing a standardized process for discharge, including clear instructions for continued care at home, medication schedules, and follow-up appointments, can minimize patient confusion and improve continuity of care. Regular audits of the discharge process can help identify any bottlenecks and ensure a smooth transition for patients from hospital to home.In conclusion, I believe that implementing the above suggestions will contribute to the overall enhancement of monitoring systems at [Name of Hospital]. The well-being and safety of patients should be of paramountimportance to the hospital administration, and these measures can further consolidate your commitment to providing exceptional healthcare.Thank you for considering my suggestions. I would appreciate if you could acknowledge the receipt of this letter and keep me informed about any actions taken to implement these recommendations.Yours sincerely,[Your Name]。
罕见病的英文说法
Disease 疾病anemia, anaemia 贫血angina pectoris 心绞痛appendicitis 阑尾炎arthritis 关节炎bronchitis 支气管炎cancer 癌catarrh 卡他, 粘膜炎chicken pox, varicella 水痘cholera 霍乱cold 感冒, 伤风, 着凉(head) cold 患感冒diabetes 糖尿病diphtheria 白喉eczema 湿疹epilepsy 癫痫erysipelas 丹毒gangrene 坏疽German measles, rubella 风疹gout 痛风headache 头痛hemiplegy, hemiplegia 偏瘫, 半身不遂icterus, jaundice 黄疸indigestion 消化不良influenza, flu 流感insanity 精神病leukemia 白血病malaria 疟疾malnutrition 营养不良Malta fever 马耳他热, 波状热measles 麻疹migraine, splitting headache 偏头痛miocardial infarction 心肌梗塞mumps 流行性腮腺炎neuralgia 神经痛neurasthenia 神经衰弱paralysis 麻痹peritonitis 腹膜炎pharyngitis 咽炎phtisis 痨病, 肺结核pneumonia 肺炎poliomyelitis 脊髓灰质炎rabies 狂犬病rheumatism 风湿病rickets, rachitis 佝偻病scabies, itch 疥疮scarlet fever 猩红热sciatica 坐骨神经痛sclerosis 硬化septicemia, septicaemia 败血病sinusitis 窦炎smallpox 天花swamp fever 沼地热syncope 晕厥syphilis 梅毒tetanus 破伤风thrombosis 血栓形成torticollis, stiff neck 斜颈tuberculosis 结核病tumour,tumor 瘤typhus 斑疹伤寒urticaria, hives 荨麻疹whooping cough 百日咳yellow fever 黄热病zona, shingles 带状疮疹。
ICD——10疾病编码查询
ICD——10疾病编码查询ICD——10疾病编码查询入门之一ICD——10是疾病和有关健康问题的国际统计分类第十次修订本的符号,在我们使用的电子病历系统中,可以查询ICD——10疾病编码,有的疾病编码只要输入疾病名称,就能查到相应的疾病的ICD——10编码,但是,有时输入疾病全名并不好查,只有输入关键词,在关键词项目中才能查找到你所需要的疾病的ICD——10疾病编码。
所以,我们今天共同来摸索如何使用疾病名称和关键词两种方法来查询ICD——10疾病编码(我今天只是抛砖引玉,还请各位下去多摸索,是否还有其他更方便的方法查找)。
一、输入关键词查找是重点,如“骨折”、“出血”、“脓肿”、“囊肿”、“损伤”、“妊娠”、“炎”及“糖尿病”、“高血压”等等。
如:某部位的骨折,只要输入关键词“骨折”,就能在骨折项中查找到你所需要的与骨折疾病有关的疾病的ICD——10疾病编码。
但是,目前,我还没有掌握骨折部位的“左、右”如何查找,个人认为,可能不分“左、右”,因为,在系统中查不到“左、右骨折”,如股骨颈的骨折,查到的是S72.002,没有左股骨颈的骨折,或右股骨颈的骨折。
下面举例说明:如:尺、桡骨骨干骨折 S52.4051 ncluding based life support (BLS), and senior heart life support (ACLS), and based trauma life support (BTLS) and senior trauma life support (ATLS) of based knowledge; common emergency technology of application; common emergency of causes identification, and clinical performance and the processing specification; common emergency auxiliary check of select refers to levy, and results judge and the clinical meaning; Indications, effects ofcommon emergency drugs, side effects, as well as specific applications (medicine, for expansion of vasoactive drugs, cardiac diuretic, antispasmodic and anti-asthmatic drugs, analgesic drugs, Hemostatic, antiarrhythmic drugs, such as Cortina). Understand: the new development of the theory of life support; cardiac respiratory and cardiopulmonary resuscitation after cardiac syndrome etiology, pathophysiology, clinical manifestations, diagnosis, and treatment. 2. basic requirements (1) species and cases of study requirements: disease disease fever acute abdominal pain chest pain and difficulty breathing faint coma shock in acute poisoning with cardiac respiratory arrest bleeding (hemoptysis, hematemesis, hematuria, etc) requires at least 45 cases of arrhythmia.(2) basic skills requirements name name heart lung孟氏骨折 S62.0051股骨头骨折 S72.001股骨颈骨折 S72.002股骨干骨折 S72.301股骨干开放性骨折 S72.3150如:某部位的血肿,只要输入关键词“血肿”,就能在血肿项中查找到你所需要的与血肿疾病有关的疾病的ICD——10疾病编码。
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1Unplugging Your Life 你的生活不插电2Unplugging Your Life 你的生活不插电Living without the Media 在没有网络媒体的世界中生活Read the text below and do the activity that follows. 阅读下面的短文,然后完成练习:Are you a media addict who would go mad after two hours without TV, friend requests, exciting online games and your mobile – or would you easily survive?Recently, university students around the world were asked to volunteer in a global experiment called Unplugged. It was designed to see how young people would react if they were asked to observe a total media ban by unplugging all forms of media devices for 24 hours.Unplugged is being run by Dr Roman Gerodimos, a lecturer in Communication and Journalism at Bournemouth University. The experiment is now over but he doesn't yet know the full findings .However, during the experiment, Dr Gerodimos said there were already signs of how much the exercise affected volunteers. He said: "They're reporting withdrawal symptoms , overeating , feeling nervous, isolated and disconnected ."During their 24-hour ordeal , three of the experiment's guinea pigs had to endure one intrusion from the media: a BBC reporter plus cameraman who followed them around for the day. They were asked to write down 100 lines about their day offline , but of course, they all waited until the next day when they had access to their laptops.Elliot Day wrote: "Today, my whole morning routine was thrown up into the air . Despite being aware of the social importance of the media, I was surprised by how empty my life felt without the radio or newspapers."From Caroline Scott, we read: "I didn't expect it, but being deprived of the media for 24 hours resulted in my day-to-day activities becoming so much harder to carry out than usual… I didn't break out in a cold sweat like our lecturer expected us all to, but it's not something I would like to do again!"And Charlotte Gay wrote: "I have to say the most difficult item for me to be without has been my mobile; not only is it a social gadget , it's my main access point of communication."Earlier in the year, a UK government study found that in the UK we spend about half our waking hours using the media, often plugged into several things at once. And a recent study by Nielson found that on average, US teenagers send and receive over 3,000 texts per month – that's about six texts per waking hour.So, with technology continuing to develop at an alarming rate, how much time will you set aside for sleep in the future?3Glossary 词汇表addict – 有…瘾的人 friend request – 好友请求to observe – 尝试去做某事 unplugging – 停止(原意指拔掉插头) the full findings – 完整的调查结果withdrawal symptom - 脱瘾症状(戒除某习惯时所引起的痛苦和不适) overeating – 过度饱食isolated – 与世隔绝的to be disconnected – (与现实)分离的 ordeal – 煎熬 guinea pig – 参加试验的人 to endure – 忍受 intrusion – 入侵offline – 脱机的to be thrown up into the air – 被打乱 to be deprived of – 不能使用 to break out into a cold sweat – 吓得浑身冒冷汗gadget – 小工具 waking hours – 醒着的时间to set aside – 留出来1. Reading Quiz 阅读测验Are these sentences true or false? Circle the correct answer.以下句子哪句是真?哪句是假?请圈出正确答案。
1. Unplugged only used students in the UK.True / False2. Dr Gerodimos's findings following the Unplugged experiment are conclusive.True / False3. Media devices help people to organise their day-to-day lives.True / False4. The 24-hour media ban affected Caroline Scott's temperature.True / False5. People in the UK spend about half the time while they are awake using themedia.True / False42. Expressions Using the Word 'Hour' 和单词 ‘Hour’ 连用的短语a) In the article the expression 'our waking hours' was used, meaning the time when we are awake rather than sleeping. Below are some moreexpressions that use the word 'hour' or 'hours'. Match each expression with its definition.在今天的短文里,我们学习了短语 ‘our waking hours’ 我们醒着的时间。
下面的短语都用到了单词 ‘hour’ 或 ‘hours’. 请把这些短语和其正确解释连线。
1. someone's finest hour a. the time when a company isallowed to sell alcoholic drinks.2. in someone's hour of need b. the time when employees stopwork to eat lunch.3. paid by the hour c. the time of day when most peopleare travelling to and from work.4. licensing hours d. the time when we most requirehelp from other people.5. rush hour e. the time when we are at our verybest and feel really proud.6. lunch hour f. a system where workers are onlypaid for the hours they work.b) Now complete the sentences below using the correct expression. You may need to change the expression slightly to fit the grammar of the sentence.请用以上练习中的短语来完成下列句子。