安立泽最新说明书
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。
高效的DPP4抑制剂安立泽
格列奈类药物
α-葡萄糖苷酶抑制剂 噻唑烷二酮类药物 DPP-4 抑制剂 GLP-1 受体激动剂
!
!
!
!
!
1、Pan C, et al. Curr Med Res Opin. 2009 Jan;25(1):39-45 2. Nathan DM, et al. Diabetologia. 2009;52:17-30. 3. Stumvoll M, et al. Lancet. 2005;365:1333-46.
Göke B, et al. Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52week randomised controlled trial. Int J Clin Pract 2010;64(12):1619-1631.
Nauck MA, et al. J Clin Endocrinol Metab. 1986;63:492-498.
2型糖尿病中肠促胰素作用减弱
静脉注射葡萄糖 口服葡萄糖
80 胰岛素 (mU/L) 60 40 20 0
正常人
80 60 40
2型糖尿病患者
* * * * * * *
20 0
* *
*
0
30 60 90 120 150180 时间 (min)
0
30 60 90 120150180 时间 (min)
DPP_4抑制剂超药物说明书用法专家共识_0c70cb38_f086_488c_
时间和费用, 往往滞后于严格的临床研究数据。 如果 局限于说明书可能使其临床应用受到严重限制。 故国 内外的 2 型糖尿病防治指南均按药物的作用机制和循 证证据等进行推荐临床应用。
商品名 捷诺维
EMA 批准适应症 单药治疗 西格列汀 + 二甲双胍 西格列汀 + TZD 西格列汀 + SU 西格列汀 + 胰岛素 西格列汀 + 二甲双胍 + SU 西格列汀 + 二甲双胍 + TZD 西格列汀 + 二甲双胍 + 胰岛素 单药治疗 维格列汀 + 二甲双胍 维格列汀 + TZD 维格列汀 + SU 维格列汀 + 胰岛素 维格列汀 + 二甲双胍 + SU 维格列汀 + 胰岛素 + 二甲双胍 单药治疗 沙格列汀 + 二甲双胍 沙格列汀 + TZD 沙格列汀 + SU 沙格列汀 + 胰岛素 沙格列汀 + 二甲双胍 + 胰岛素 单药治疗 利格列汀 + 二甲双胍 无 无 利格列汀 + 胰岛素 利格列汀 + 二甲双胍 + SU 利格列汀 + 二甲双胍 + 胰岛素 单药治疗 阿格列汀 + 二甲双胍 阿格列汀 + TZD 阿格列汀 + SU 阿格列汀 + 胰岛素 无 阿格列汀 + 二甲双胍 + TZD 阿格列汀 + 二甲双胍 + 胰岛素
尼欣娜
Alogliptin 阿格列汀
IV 类药物外, 备注: 1. 按照在中国获批时间顺序 ; 2. 联合治疗的方案中除 DPP其他药物按照药物类别标记 , 详细临床试验证据请参 4 抑制剂 FDA 或 EMA 最新版本的说明书内容 ; 3. 联合治疗的方案中, 考 DPP个别二联治疗可能包括起始联合及单药控制不佳后的 4 抑制剂在各区域最新版本的说明书 ; 4. SU 磺脲类; TZD 噻唑烷二酮类。 FDA 美国食品药品管理 添加治疗, 详细内容请参考 DPP局; EMA: 欧洲药品管理局。
捷诺维
≥7 to <8%
179 167
<7%
117 112
0.0 -0.2
HbA1c 自基线的改变(%)
n=33
21
-0.14 -0.26 -0.59 -0.53
-0.4 -0.6 -0.8 -1.0
-1.2
-1.4 -1.6 -1.8 -2.0
-1.68 -1.76
-1.11
-1.13
西格列汀 + 二甲双胍 格列吡嗪 + 二甲双胍
1. Arechavaleta R et al. Diabetes Obes Metab. 2011;13(2):160–168.
联合二甲双胍Vs磺脲联合二甲双胍(1)
西格列汀低血糖发生率显著低于格列美脲 西格列汀降低体重,格列美脲增加体重
西格列汀+ 二甲双胍(n=443)
LS Mean Change (±SE) in Body Weight From Baseline, kg
联合二甲双胍Vs磺脲联合二甲双胍(2)
捷诺维(西格列汀)降低体重 格列吡嗪增加体重
3 2
格列吡嗪 + 二甲双胍 (n=416) 西格列汀+ 二甲双胍 (n=389)
体重 (kg ± SE)
1 0 -1 -2 -3 0 12 24 38 52
周
第52周 LSM 自基线的改变: 格列吡嗪: +1.1 kg; 西格列汀: –1.5 kg (P<0.001). 第52周 LSM 的组间差异 (95% CI): 体重差值= –2.5 kg [–3.1, –2.0] (P<0.001);
捷诺维(西格列汀)
• 强效降糖
– 单药Vs安慰剂
降糖药不能与哪些药物同时服用
不能与降糖药同时使用的药物主要有如下七类:
糖尿病患者除了定期治疗,生活中也需注意各种诱发因素,尽量减少复发,及时控制不要吃辛辣、刺激性食物;烟酒尽量别沾;坚持劳逸结合,参加适当的文娱活动、体育运动和体力劳动,可促进糖的利用,以利于预防和治疗糖尿病。
中国成年糖尿病多为Ⅱ型糖尿病,一般可先采用口服降糖药治疗,但如果不严格按时间服用,不仅达不到治疗效果,甚至会发生不良反应。现将5种降糖药作一简介,望糖尿病病友在服药时注意。我们来了解一下这五大类降糖药物的最佳服用时间。
药品名生产商/规格/批准文号操作
安立泽
沙格列汀片中美上海施贵宝制药有限公司
5mg*7片/盒
国药准字J20110029安立泽说明书
安立泽价格
购买安立泽
505
参芪降糖胶囊五O五药业有限公司
0.35g*12粒/盒
国药准字Z10980085505说明书
505价格
购买505
佳维乐
维格列汀片瑞士诺华
50mg*14片/盒
1、必须在饭前30分钟服用的药物——主要是指磺脲类降糖药,包括格列苯脲(优降糖)、格列齐特(达美康)、格列吡嗪(美吡达)、格列喹酮(糖适平)。这类降糖药主要是通过刺激胰岛β细胞分泌胰岛素才能发挥作用,故应在餐前30分钟服用。
2、必须在餐前5~20分钟内服用的药物——如非磺脲类胰岛素促泌剂,包括瑞格列奈(诺和龙)、那格列奈(唐力)。此类药物起效快,作用时间短,其作用前提是必须有葡萄糖存在,故仅在进餐时才能刺激胰岛β细胞分泌,餐前半小时或餐后服用可能引起低血糖,故应在餐前5~20分钟口服为好。
家用版大脑生物反馈治疗仪用户手册说明书
家用版大脑生物反馈治疗仪用户手册广州市润杰医疗器械有限公司(已通过质量管理体系认证ISO 9001:2008 和 ISO 13485:2003)技术支持如果您的系统出现问题,并且无法从使用手册中获得帮助,请您直接联系我司,我司技术支持工程师将竭诚为您服务。
联系方式:020-******** 32215212 82115619 82115176传真:************联系地址:广州市经济技术开发区科学城彩频路 11 号广东软件科学园 F 栋 602公司名称:广州市润杰医疗器械有限公司邮编:510500网址:版权声明本手册为广州市润杰医疗器械有限公司的知识产权,我们非常小心的整理此手册。
但我们对于本手册的内容不保证完全正确。
因为我们的产品一直在持续的改良及更新,故我们保留随时修改而不另行通知的权利。
目录第一章产品简介第二章产品说明第三章产品指标及注意事项第四章电极的连接与安装第五章操作界面介绍第一章产品简介一、运行环境1、硬件环境电脑笔记本一台,CPU 双核以上,内存 2G 以上,带独立显卡;显示器分辨率达到1024*768 或以上;放大器一套。
注意:4D训练游戏需要显卡和显示器都必须支持4D 功能,显示器分辨率要达到1920*1080。
2、软件环境操作系统支持 Windows xp 或Win7。
二、功能及性能生物反馈疗法(Biofeedback therapy)又称生物回授疗法,或称植物神经学习法,是在行为疗法的基础上发展起来的一种新的心理治疗技术。
生物反馈仪采用生物反馈的原理,通过采集与分析人体的生理指标如脑电、心率变异性和肌电来确定人体的精神心理状态,并将这些信号以容易理解的视觉、听觉形式展现出来,使个体了解自身的生理变化,通过反复的训练与治疗,帮助个体达到认知、调控自身的生理变化,从而达到缓解和治疗心理紧张、焦虑、抑郁、失眠等精神心理症状的目的。
脑电生物反馈技术通过EEG传感器,采集和放大由脑细胞产生的微弱电信号,不同位置的神经元细胞产生不同节律的波形。
Lixelle β2-微球蛋白分离柱患者指南说明书
A PATIENT GUIDE TO THE LIXELLE® β2-MICROGLOBULINAPHERESIS COLUMNHumanitarian Use DeviceAuthorized by Federal (USA) law for use in the treatment of patients withclinically diagnosed dialysis-related amyloidosis (DRA).The effectiveness of this device for this use has not been demonstrated.CAUTION: Federal (US) law restricts this device to sale by oron the order of a physician.Table of ContentsI. Key medical terms (2)II. How this guide can help you (3)III. Why you are considered a candidate for treatment with the Lixelle® column (4)IV. Indications for Treatment w ith the Lixelle® β2m Apheresis Column (4)V. Contraindications for Treatment with the Lixelle® β2m Apheresis Column (4)VI. Alter natives (5)VII. What is the Lixelle® β2m Apheresis Column? (5)VIII. How is Treatment with the Lixelle® column performed? (6)X. Use of Lixelle® column to treat patients with DRA (7)XII. Safety of treatment with the Lixelle® column (8)XIII. What you can do to minimize adverse reactions (9)I. Key medical termsThe following terms are used in this guide or may be used by your physician in discussing your condition and possible treatments for your condition.Activities of Daily Living (ADL) - term used to refer to daily self-care activities within anindividual's place of residence, in outdoor environments, or both. The ability to perform ADLs isa measurement of the functional status of a person,Adsorption - is the adhesion of atoms, ions, or molecules from a gas, liquid, or dissolved solid toa surfaceAir embolism: - entry of air into your bloodstreamAmyloid fibrils – protein deposits that form in your body due to Dialysis-Related Amyloidosis (DRA)Anemia - not enough iron in your blood or loss of bloodAnticoagulation - blood thinningAnti-hypertensive medications - medications for lowering high blood pressureArrhythmia - irregular heartbeatBolus - a rapid injectionBone cyst - non-cancerous, fluid-containing growths found in bonesCarpal Tunnel Syndrome - a condition that causes tingling, pain, numbness, and other symptoms in the hand and wristEnd Stage Renal Disease (ESRD) – complete loss of kidney functionExtracorporeal - blood is taken outside the body for treatmentHypersensitivity reaction - allergic reactionHypotension - low blood pressureInfection - illness caused by bacteria or viruses.Myocardial infarction - a heart attack: complete or partial blockage of one of the arteries in your heart.Prolonged bleeding (at blood access site(s)) - bleeding at the site where the intravenous device or catheter is placed that continues in excess of 20 minutes after removal of the needle.Plasma - the liquid part of the blood which does not contain the blood cellsSerum albumin - a particular type of protein in your blood. There are many types of proteins in your blood. A brief decrease in serum albumin does not usually cause serious adverse effects, but if it needs to be treated, your doctor will add an albumin solution to your blood.Serum protein - proteins in your blood. There are many types of proteins in your blood. A brief decrease in serum proteins does not usually cause serious adverse effects, but if it needs to be treated, your doctor can provide these by an intravenous route or change your diet.Thrombocytopenia - a persistent decrease in the platelets in your blood. Platelets help your blood clot. Transient - temporary, brief.II. How this guide can help youThis Patient Guide provides basic information to respond to general questions which you are likely to have about treatment with the Lixelle® column. Please feel free to discuss this information with your doctor who is familiar with your specific medical condition. Treatment with this medical device must be prescribed by a physician and used by medical professionals who have been trained in its specific use.III. Why you are considered a candidate for treatment with the Lixelle® columnYou have been diagnosed with dialysis-related amyloidosis (DRA). DRA is a complication that affects patients with end stage renal disease (ESRD) who have been receiving hemodialysis treatment for a long time (typically 5 years or more). Hemodialysis is not able to remove all of the substances from your blood due to limitations of the dialyzer filter. One molecule that is not removed very well is β2-microglobulin (β2m). The normal kidney filters and removes excess prote ins such as β2m from the blood, keeping blood levels of such proteins normal. When the kidney fails t o function properly, β2m builds up in the blood and may form deposits called amyloid fibrils that deposit in various areas of your body and may cause pain, stiffness and lack of mobility. Patients with DRA may have joint pain, back pain, carpal tunnel syndrome or an increase in the rate of bone cysts and fractures.In summary, you are being considered as a candidate to receive therapy with the Lixelle®column because you have been diagnosed with DRA and other treatment options are limited for this condition.IV. Indications for Treatment w ith the Lixelle® β2m Apheresis Column The Lixelle® β2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).If you meet this condition (criterion) and, after reading this guide and discussing it with your physician, you choose to receive this therapy, you will be closely followed by the medical team, including checking for various symptoms that can occur during Lixelle®column therapy.V. Contraindications for Treatment with the Lixelle® β2m Apheresis ColumnBelow are the medical conditions and circumstances that would not allow your doctor to treat you with the Lixelle® column:(1)Your doctor believes that because you have certain conditions related to bloodclotting (such as severe anemia, severe bleeding, severe stomach ulcers) or becauseyou are receiving medications that reduce the amount of available vitamin K (animportant blood clotting factor) it will not be possible to give you medications thatthin the blood (called anticoagulants) and prevent blood clotting during theprocedure.(2)Your doctor believes that you cannot tolerate therapy with a machine that temporarilyremoves large amounts of blood from your body because you have a medical condition (such as poor heart function), current or recent heart attack (also called acute myocardial infarction), abnormal heart rhythm, recent or current stroke, or severe uncontrollable low blood pressure (hypotension) or(3)You are allergic to parts of the Lixelle® column including cellulose or heparin (a bloodthinner).VI. Alter nativesThe best treatment option for patients with DRA is a kidney transplant, which cures ESRD and gives the patient a normal functioning kidney, which is able to filter and remove β2m from the blood. Sometimes surgery is used to remove amyloid deposits from the joints, but this does not reduce the levels of β2m in your blood and it does not cure DRA. Other treatments, including a specific kind of dialysis called hemodiafiltration, and hemodialysis treatments extended over a long period of time (such as overnight) are options for increased removal of β2-microglobulin, but these treatments are not widely available in the United States.As you consider therapy with the Lixelle®column, you should discuss all other possible treatments for your disease with your physician.VII. What is the Lixelle® β2m Apheresis Column?Lixelle®β2m Apheresis Column is a sterile, plastic column containing round cellulose beads with small holes (pores). The pores and surface chemicals on the Lixelle® column adsorbs (or removes) β2m from your blood. It is used at the same time as your hemodialysis treatment. The column has been especially designed to remove β2m, but to leave behind other substances that your body needs to remain healthy. The column is available in three (3) sizes. Your doctor will choose the column that works best for you, considering your size andmedical condition.Three sizes of the Lixelle® columnLixelle® column connected to the dialyzerVIII. How is Treatment with the Lixelle® column performed?The Lixelle®β2m Apheresis column is attached to the dialysis circuit in front of the dialyzer. The blood passes through the column, β2m is adsorbed selectively, and the filtered blood is then returned to you after it exits the dialyzer.Lixelle® treatment will occur at the same time as your dialysis treatments, generally at least 3times per week. The flow rate through the Lixelle® column must be slower than the blood flow rates that are used for most dialyzers, therefore, your dialysis treatments will have to be extended when you are being treated with Lixelle®. Your doctor will determine how long your treatments need to be in order to ensure that you receive adequate dialysis treatment.X. Use of Lixelle®column to treat patients with DRAThe Lixelle®column has been used to treat patients with DRA in Japan since 1994. Published studies1,2,3,4 describe treatment of approximately 100 patients with the device.Several studies have been done which show that the Lixelle® column can reduce the amounts of β2m in patients’ blood. In these studies, many study subjects experienced a decrease in pain and stiffness and an improved ability to perform their activities of daily living (such as eating, dressing, bathing, toileting, and personal grooming). Other findings in these studies included a decrease in bone cyst formation and improved grip and pinch strength.After the Lixelle®column was approved for the treatment of DRA in Japan, a post-market study was performed to collect information on the safety of the Lixelle® column. This study included 183 patients who had a total of 13,476 treatments at 58 centers in Japan.. The most common adverse events (safety problems) seen in the study were temporary decrease in blood pressure (hypotension), heart palpitations, pain, fatigue, anemia, nausea/vomiting, and chills/shivering. Most of these adverse reactions are common for patients undergoing dialysis or any extracorporeal therapy, but combined usage with Lixelle®column may increase the frequency at which these side effects occur.1Gejyo F, Kawaguchi Y, Hara S. Arresting Dialysis related amyloidosis: a prospective, multicenter controlled trial of direct hemoperfusion with a β2-microglobulin adsorption column. Artif. Organs. 2004; 28(4): 371-380. 2Abe T., Uchita K., Orita H. Effect of β2-microglobulin adsorption column on dialysis related amyloidosis.Kidney Int. 2003; 64:1522-28.3Yamamoto , Y., Hirawa N, Yamaguchi S., Ogawa N., Takeda H., Shibuya K., Kawahara K., Kojima H., Dobashi Y., Fujita M., Azusima K., Miyazaki N., Kobayashi M., Kobayashi C., Fujiwara A., Yuto J., Saka S., Yatsu, K., Toya Y., Yasuda G., Ohnishi T., Umemura S. Long term efficacy and safety of the small-sized β2-microglobulin adsorption column for dialysis-related amyloidosis. Therap. Apheresis Dialy.; 2011; 15(5): 466-474.4Kuragano T., Inoue T., Yoh K., Shin J., Fujita Y., Yoshiya K., Kim J., Sakai R., Sekita K., Goto T., Fukagawa M., Nakanishi T. Effectiveness of β2-microglobulin adsorption column in treating dialysis-related amyloidosis: A multicenter study. Blood Purif. 2011; 32:317-322.XI. Safety of treatment with the Lixelle® columnNote: A detailed explanation of risks and adverse reactions associated with treatment with the Lixelle® column should be provided by your physician.Adverse Reactions (Side Effects)Most of the adverse reactions are common for patients undergoing dialysis or any extracorporeal therapy, but combined usage with Lixelle® column may increase the frequency at which these side effects occur. Among these adverse reactions, hypotension and anemia are reported to be more frequent when Lixelle®is used. Other adverse reactions that may occur include decreased blood volume, nausea/vomiting, chills/shivering, fatigue/malaise, heart palpitations, decrease in blood platelets, worsening of joint pain, shortness of breath, chest discomfort, high blood pressure, abdominal pain, and throat pain.There are other side effects which you may experience which are also experienced in other extracorporeal therapies, such as hemodialysis. These include abnormal heart rhythms, muscle cramping, itching, headache, dizziness/fainting, damage to blood cells, hematoma (swelling filled with blood) formation at needle insertion sites, infection, anaphylaxis/allergic reactions, and removal of other useful substances from the blood.Some of the adverse events (side effects) are explained in greater detail below:Hypotension or low blood pressure is the most common adverse reaction. If you have a hypotensive reaction during your treatment, it can be corrected by temporarily stopping your treatment, placing your head down and raising your legs, and, in some cases, giving you I.V. fluids. In most cases, the hypotension will go away and your treatment can continue. Your doctor may decide to use a smaller column if you experience low blood pressure during treatment. This may resolve the problem.Anemia may occur because more blood is being removed from your body during Lixelle®treatment, as compared to a standard hemodialysis treatment. As a result, your doctor mayincrease the dose of your medications that are used to prevent the problem. In this case, your doctor will discuss with you the potential side effects of this increase in medications.Stopping the procedure resolves most adverse reactions or complications that may occur during treatment with the Lixelle® column.In addition to β2-microglobulin, other substances are removed by the Lixelle® column. The effect of removing these other substances is unknown. Your doctor will closely monitor your blood chemistry levels (such as salt, potassium, and other electrolytes) and may take action if your blood chemistry levels are changing too much as a result of Lixelle® treatment. These actions may include using a smaller column, prescribing additional medications, or stopping treatment with Lixelle®.No studies have been done to test the safety of the Lixelle® column for pregnant women or their unborn babies. Therefore, probable benefit for this patient population is unknown and there may be unknown adverse reactions for the woman or her unborn baby associated with the use of the device during pregnancy. Also, probable benefit and the effects of treatment are not known for patients with liver or thyroid disease, patients with cancer, and for pediatric (age 21 or less) patients.XII. What you can do to minimize adverse reactions1.Continue to follow your doctor’s advice regarding what you should do before, duringand after your hemodialysis treatments.2.Consult with your doctor which size of Lixelle® column would be most appropriatefor you, considering the risks and benefits of each.3.Do not perform strenuous exercise on the day of your procedure.4.Avoid activities increasing the risk of physical injury for 24 hours after yourtreatment because of the blood thinning medication used.5.Sexually active women of childbearing potential should use oral, implantable, orbarrier methods of birth control (e.g., birth control pills, intrauterine device,condoms) during treatment with the Lixelle® column to prevent pregnancy and any adverse reaction that may harm an unborn child.Manufactured byKANEKA CORPORATION 2-3-18, Nakanoshima Kita-ku, Osaka 530-8288, JapanDistributed byKANEKA PHARMA AMERICA LLC546 Fifth Avenue, 21st FloorNew York, New York 10036Page 11。
DPP-4抑制剂比较PPT-82.406,022资料
DPP-4和DPP-8、9在细胞定位不同
细胞膜
细胞核
• DPP-4酶有游离、细 胞膜结合2种形式,广 泛分布于平滑肌与内 皮细胞,肾、肺、胰、 等器官和中枢。 • 而DPP-8、9均定位于 胞浆,DPP-8、9 的 生理底物或酶活性作 用 尚待体内研究验证
FAP:成纤维细胞激活蛋白,也是DPP-4超家族成员之一 Kirby M, et al. Clin Sci (Lond). 2009 ;118(1):31-41.
羟基化物
21
CYP3A4 CYP2C8 氧化物、羟基化 硫酸盐和葡糖苷 酸轭合物 无活性 肾 中等
2 未发现
水解葡糖苷酸轭 合物 无活性 肝 迅速
10 未发现
去甲基化、乙酰 化 无活性 肾 中等
10 CYP3A4
去甲基化
50% 肝肾 迅速
无活性 胆道 在肾脏中清除慢
1. Scheen AJ. Diabetes, Obesity and Metabolism. 2010; 12: 648 –658. 2. Golightly LK, et al. Clin Pharmacokinet . 2012; 51 (8): 501-514
DPP-4抑制剂的代谢、生物转化和清除
沙格列汀 2.5 3.1(活性代谢 产物) 西格列汀 维格列汀 阿格列汀 利格列汀
半衰期(h)1
12.4
2-3
12.4-21.4
128-184
肝脏代谢(%) 2
主要CYP异构 体2 主要代谢产物2 与原型相比代谢 产物活性2 主要排泄途径2 相对清除速度2
51 CYP3A4/5
0.7-3
最大药物浓度2
药物曲线下面 积2 生物利用度 (%)2 蛋白结合率 (%)2 分布容积(L)2
安立泽(沙格列汀片)使用说明
安立泽(沙格列汀片)【用法用量】口服,推荐剂量5mg每日1次,服药时间不受进餐影响。
【注意事项】一般情况:沙格列汀不能用于1型糖尿病或糖尿病酮症酸中毒的患者。
尚未进行沙格列汀与胰岛素联用的研究。
肾功能不全:沙格列汀用于中重度肾功能不全患者的临床试验数据有限,不推荐用于这类人群(参见用法用量和药代动力学)。
肝功能受损:沙格列汀用于中度肝功能受损患者需谨慎,不推荐用于重度肝功能不全的患者(参见用法用量和药代动力学)。
过敏反应:沙格列汀不可用于对二肽基肽酶-4(DPP4)抑制剂存在严重过敏反应的患者。
皮肤疾病:有报告在猴子的非临床毒理学试验中发现,猴的四肢出现溃疡和坏死性皮肤损伤(参见药理毒理学)。
尽管在临床上并未发现皮损的发生率升高,但糖尿病并发皮损的患者使用沙格列汀的临床经验有限。
上市后报告显示在使用DPP4抑制剂类的患者中出现了皮疹,因此皮疹也被列为沙格列汀的不良反应之一(参见不良反应)。
在糖尿病患者的日常管理中,建议观察皮肤是否存在水泡,皮疹和溃疡。
心力衰竭:在纽约心功能分级(NYHA)为I-II的患者中的临床经验有限,对NYHA 为III-IV的患者使用沙格列汀的情况没有临床经验。
免疫功能低下患者:沙格列汀临床试验并未对接受器官移植或者明确诊断为免疫缺陷综合征的免疫功能低下的患者进行研究。
因此,尚未获得沙格列汀在此类患者中的有效性和安全性。
乳糖:本品含有乳糖一水合物。
罕见的半乳糖不耐受遗传疾病,Lapp乳糖酶缺乏症或葡萄糖-半乳糖吸收不良患者不得服用本品。
与已知会引起低血糖的药物合用:胰岛素促泌剂(如磺脲类)会引起低血糖。
因此,与沙格列汀合用时,需减少胰岛素促泌剂的剂量,以降低发生低血糖的风险。
大血管风险终点事件研究:目前尚无结论性的临床研究证明沙格列汀或其他任何糖尿病治疗药物可降低大血管并发症的风险。
【不良反应】临床试验:由于各个临床试验的条件差异很大,一个药物在临床试验中的发生率不能直接与另一个药物临床试验中的发生率相比较,该发生率也不能反映药物在实际应用中的发生率。
安立泽最新说明书
H2H2O核准日期:2011年05月05日修改日期:2011年7月18日2011年8月30日2012年5月10日沙格列汀片说明书请仔细阅读说明书并在医生指导下使用【药品名称】通用名称:沙格列汀片商品名称:安立泽/ONGLYZA英文名称:Saxagl iptin Tablets汉语拼音: Shagel ietin g Pian【成份】本品活性成份为沙格列汀。
化学名称:(1S,3S,5S)-2-[(2S)-2-氨基-2-(3-羟基-l-金刚烷基)-l-羰基乙基]-2-氮杂双环[3.1.0]己烷-3-腈,一水合物化学结构式:分子式: C18H25N3O2·H2O分子量: 333.43 (一水合物);315.41 (无水游离碱基)【性状】2.5mg :本品为微黄色至浅黄色薄膜衣片,除去包衣以后显白色。
5mg :本品为粉红色薄膜衣片,除去包衣以后显白色。
【适应症】用于2型糖尿病。
单药治疗可作为单药治疗,在饮食和运动基础上改善血糖控制。
联合治疗当单独使用盐酸二甲双胍血糖控制不佳时,可与盐酸二甲双胍联合使用,在饮食和运动基础上改善血糖控制。
重要的使用限制由于对于1型糖尿病和糖尿病酮症酸中毒的有效性尚未确定,故本品不用于1型糖尿病或糖尿病酮症酸中毒的患者。
尚未对本品与胰岛素的联合使用进行研究。
尚未在有胰腺炎病史的患者中进行本品的研究。
尚未确定有胰腺炎病史的患者使用本品是否会增加胰腺炎发生的风险(参见注意事项)。
【规格】(1)2.5mg (2)5mg【用法用量】口服,推荐剂量5m g,每日1次,服药时间不受进餐影响。
肾功能不全患者轻度肾功能不全的患者无需调整剂量。
中或重度肾功能不全的患者应将剂量调整为2.5mg,每日1次。
重度肾功能不全的患者用药经验非常有限,因此本品用于此类患者时应谨慎。
RNAzol RNA Isolation Reagent 产品说明书
1.IDENTIFICATION OF THE SUBSTRANCE/PREPARATION AND THECOMPANY/UNDERTAKINGPOSITION/INFORMATION ON INGREDIENTS3.HAZARDS IDENTIFICATIONMaterial Safety Data SheetRevision Date:February 23,2018Product code QP020Product name RNAzol®RT RNA Isolation ReagentContact manufacturer GeneCopoeia,Inc.9620Medical Center Drive,Suite 101Rockville,MD 20850USAPhone:301-762-0888Toll free:1-866-360-9531Fax:301-762-3888Chemical Name CAS-No Weight %Phenol108-95-230-60Guanidine isothiocyanate 593-84-015-40Ammonium thiocyanate1762-95-47-13Contact with acids or bleach liberates toxic gases.DO NOT ADD acids or bleach to any liquid wastes containing this product.We recommend handling all chemicals with caution.GHS –Classification Signal Word DANGERHealth HazardsAcute oral toxicity Category 4Acute dermal toxicityCategory 4Acute Inhalation Toxicity -Vapors Category 4Skin corrosion/irritationCategory 1B Serious eye damage/eye irritationCategory 1Specific target organ systemic toxicity (single exposure)Category 3Specific target organ systemic toxicity (repeated exposure)Category 3Health Hazards(continued)Mutagenicity Mutagenic category2Physical hazardsNot hazardousHazard StatementsH314-Causes severe skin burns and eye damageH341-Suspected of causing genetic defectsH373-May cause damage to organs through prolonged or repeated exposureH412-Harmful to aquatic life with long lasting effectsH302-Harmful if swallowedH312-Harmful in contact with skinH332-Harmful if inhaledH335-May cause respiratory irritationPrecautionary StatementsP301+P312-IF SWALLOWED:Call a POISON CENTER or doctor/physician if you feel unwellP304+P340-IF INHALED:Remove victim to fresh air and keep at rest in a position comfortable for breathingP301+P330+P331-IF SWALLOWED:rinse mouth.Do NOT induce vomitingP303+P361+P353-IF ON SKIN(or hair):Remove/Take off immediately all contaminated clothing.Rinse skin withwater/showerP305+P351+P338-IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses,if present and easy to do.Continue rinsingP310-Immediately call a POISON CENTER or doctor/physicianP308+P313-IF exposed or concerned:Get medical advice/attentionP273-Avoid release to the environmentP280-Wear protective gloves/protective clothing/eye protection/face protectionPrinciple Routes of ExposurePotential Health EffectsEyes Causes burns.Risk of serious damage to eyes.Corrosive to the eyesand may cause severe damage including blindness.Skin Causes burns.Possible risk of irreversible effects.Harmful in contactwith skin.Irritating to skin and mucous membranes.Inhalation Harmful by inhalation.Ingestion Harmful if swallowed.Ingestion causes burns of the upper digestive andrespiratory tracts.Ingestion may cause gastrointestinal irritation,nausea,vomiting and diarrhea.Specific effectsCarcinogenic effects Phenol has been classified by the International Agency for Research onCancer(IARC)as not classifiable as to carcinogenicity to humans(Group3).Mutagenic effects Not ApplicableReproductive toxicity Not ApplicableSensitization Not ApplicableTarget Organ Effects SkinLungsLiverSpleen4.FIRST AID MEASURES5.FIRE-FIGHTING MEASURES6.ACCIDENTAL RELEASE MEASURES7.HANDLING AND STORAGEKidneyHMISHealth 3*Chronic HazardFlammability 1ReactivitySkin contact Wash off immediately with soap and plenty of water while removing all contaminated clothes and shoes.Call a physician immediately.Eye contactIF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses,if present and easy to do.Continue rinsing.Rinseimmediately with plenty of water,also under the eyelids,for at least 15minutes.Call a physician immediately.Ingestion Call a physician or poison control center immediately.Rinse mouth.Do not induce vomiting without medical advice.Never give anything by mouth to an unconscious person.InhalationRemove to fresh air.Call a physician or poison control center immediately.Notes to physicianTreat symptomatically.Suitable extinguishing media Dry chemical.Carbon dioxide (CO2).Water spray.Foam.Special protective equipment for firefightersWear self-contained breathing apparatus and protective suit.Australia HazChem Code2XPersonal precautionsELIMINATE all ignition sources (no smoking,flares,sparks or flames in immediate area).Use personal protection equipment.Avoid contact with skin,eyes or clothing.Ensure adequate ventilation.Keep people away from and upwind of spill/leak.Evacuate personnel to safe areas.Methods for cleaning upPrevent product from entering drains.Soak up with inert absorbentmaterial.Neutralize spill with slaked lime,sodium bicarbonate or crushed limestone.Collect powdered material and deposit in sealed containers and dispose of phenol as hazardous waste.Isolate area and deny entry.Environmental precautionsPrevent further leakage or spillage if safe to do so.Prevent product from entering drains.Do not allow material to contaminate ground water system.See Section 12for more information8.EXPOSURE CONTROLS /PERSONAL PROTECTIONHandling Always wear recommended Personal Protective Equipment.Avoid contact with skin,eyes or clothing.Remove all sources of ignition.StorageKeep containers tightly closed in a cool,well-ventilated place.Keep away from heat,sparks,flame and other sources of ignition (i.e.,pilot lights,electric motors and static electricity).Protect from sunlight.Exposure limitsChemical name OSHA PELOSHA PEL (Ceiling)ACGIH OEL (TWA)ACGIH OEL (STEL)Phenol5ppm 19mg/m 3None 5ppm None Guanidine isothiocyanate None None None None Ammonium thiocyanate5mg/m 3NoneNoneNoneEngineering measures Use in a chemical fume hoodPersonal protective equipmentPersonal Protective Equipment requirements are dependent on the user institution's risk assessment and are specific to the risk assessment for each laboratory where this material may be used.Respiratory protection In case of insufficient ventilation wear suitable respiratory equipment RespiratorUp to 50ppmRecommendations,National Institute of Occupational Safety and Health,U.S.(APF =10)Any air-purifying half-mask respirator with organic vaporcartridge(s)in combination with an N95,R95,or P95filter.The following filters may also be used:N99,R99,P99,N100,R100,P100.(APF =10)Any supplied-air respirator Up to 125ppm:(APF =25)Any supplied-air respirator operated in a continuous-flow mode.(APF =25)Any powered air-purifying respirator with an organic vapor cartridge in combination with a high-efficiency particulate filter.Up to 250ppm:(APF =50)Any air-purifying full-facepiece respirator equipped with organic vapor cartridge(s)in combination with an N100,R100,or P100filter.(APF =50)Any air-purifying,full-facepiece respirator (gas mask)with a chin-style,front-or back-mounted organic vapor canister having an N100,R100,or P100filter.(APF =50)Any powered,air-purifying respirator with a tight-fitting facepiece and organic vapor cartridge(s)in combination with a high-efficiency particulate filter.(APF =50)Any self-contained breathing apparatus with a full facepiece.(APF =50)Any supplied-air respirator with a full facepiece.Emergency or planned entry into unknown concentrations or IDLH conditions:(APF =10,000)Any self-contained breathing apparatus that has a full facepiece and is operated in a pressure-demand or other positive-pressure mode.9.PHYSICAL AND CHEMICAL PROPERTIES10.STABILITY AND REACTIVITY11.TOXICOLOGICAL INFORMATION(APF =10,000)Any supplied-air respirator that has a full facepiece and is operated in a pressure-demand or other positive-pressure mode in combination with an auxiliary self-contained positive-pressure breathing apparatus.Escape:(APF =50)Any air-purifying,full-facepiece respirator (gas mask)with a chin-style,front-or back-mounted organic vapor canister having an N100,R100,or P100filter./Any appropriate escape-type,self-contained breathing apparatus.Hand protectionImpervious gloves.S24-Avoid contact with skin.S36-Wear suitable protective clothing.Eye protectionTight sealing safety goggles.Skin and body protection Impervious clothing.Hygiene measuresContaminated work clothing should not be allowed out of the workplace.Avoid contact with skin,eyes or clothing.Handle in accordance with good industrial hygiene and safety practice.Environmental exposure ControlsPrevent product from entering drains.General information FormLiquid.Appearance Red,maroon.OdorMedicinal,sweet,tar-like.Boiling point/range °C No data available °F No data available Melting point/range °C No data available °F No data available Flash point°C No data available °F No data available Autoignition temperature °C No data available °F No data availableOxidizing properties No information available Water solubilitySolubleStabilityStable under normal conditions.Materials to avoidStrong oxidizing agents.Strong acids.Isocyanates.Heat.Nitriles,Nitrides.Alkaline earth metals.Strong oxidizers,alkali metals and alkaline earth metals may cause fires or explosions.Hazardous decomposition Toxic gas.Sulphur oxides.Hydrogen cyanide (hydrocyanic acid).Carbon oxides,ProductsNitrogen Oxides.PolymerizationHazardous polymerization does not occur.Acute toxicityChemical name LD50(oral,rat/mouse)LD50(dermal,rat/rabbit)LC50(inhalation,rat/mouse)Phenol=317mg/kg (Rat)No data available =316mg/m3(Rat)Guanidine isothiocyanate571mg/kg2000mg/kg5.319mg/L (4H)12.ECOLOGICAL INFORMATION13.DISPOSAL CONSIDERATIONS14.TRANSPORT INFORMATIONAmmonium thiocyanate =500mg/kg (Rat)No data available No data availablePrinciple Routes of Exposure Potential Health Effects Eyes Causes burns.Risk of serious damage to eyes Corrosive to the eyes and may cause severe damage including blindness.Skin Causes burns.Possible risk of irreversible effects Harmful in contact with skin.Irritating to skin and mucous membranes.Inhalation Harmful by inhalationIngestionHarmful if swallowed Ingestion causes burns of the upper digestive and respiratory tracts Ingestion may cause gastrointestinal irritation,nausea,vomiting and diarrheaCarcinogenic effects Phenol has been classified by the International Agency for Research on Cancer (IARC)as not classifiable as to carcinogenicity to humans (Group 3).Mutagenic effects No information available.Reproductive toxicity No information available.SensitizationNo information available.Target organ effectsSkin.Lungs.Liver.Spleen.Kidney.EcotoxicityHarmful to aquatic organisms,may cause long-term adverse effects in the aquatic environment.Chronic aquatic toxicity Category 3MobilitySee log PowBiodegradation Inherently biodegradable Bioaccumulation No information availableChemical name Freshwater algae data Water flea data Freshwater fish species dataMicrotox dataLog Pow PhenolDesmodesmusDaphnia magna =316mg/m3(Rat)logPow1.subspicatus EC50187EC5047-279mg/L (72h) 4.24-10.7mg/L Pseudokirchneriella (48subcapitata EC50h)Daphnia 46.42mg/L (96h)magnaEC5010.2-15.5mg/L (48h)Dispose of contents/containers in accordance with local regulations.IATA15.REGULATARY INFORMATIONProper shipping name Corrosive liquid,n.o.s.(guanidine thiocyanate-phenol solution).Hazard Class 8Subsidiary class None Packing group II UN-No 1760ERG Code 153ComponentTSCA Phenol,108-95-2(30-60)Listed Guanidine isothiocyanate,593-84-0(15-40)Listed Ammonium thiocyanate 1762-95-4(7-13)ListedUS Federal Regulations SARA 313This product contains the following toxic chemical(s)subject to the notification requirements of section 313of Title III of the Superfund Amendments and Reauthorization Act of 1986.This law requires certain manufacturers to report on annual emissions of specified chemicals and chemical categories.Please note that if you repackage,or otherwise redistribute,this product to industrial customers,a notice similar to this one should be sent to those customers:Chemical name CAS-No.Weight %SARA 313-Threshold values Phenol108-95-230-60 1.0Ammonium thiocyanate1762-95-47-131.0Clean Air Act,Section 112Hazardous Air Pollutants (HAPs)(see 40CFR 61)This product contains the following HAPs:Component CAS-No.Weight %HAPS data Phenol108-95-230-60PresentAmmonium thiocyanate1762-95-47-13Present (XCN where X=H or any other group where a formal dissociation may occur.For example KCN or Ca[CN]2)US state regulations Chemical name Massachusetts -RTK New Jersey-RTK Pennsylvania-RTK Illinois-RTK Rhode Island-RTK PhenolListed Listed Listed Listed Listed Guanidine isothiocyanate -----Ammonium thiocyanateListed-ListedListedListedCalifornia Proposition 65This product does not contain any Proposition 65chemicals.WHMIS Hazard Class D1A -Very toxic materials E -Corrosive material16.OTHER INFORMATIONThis product has been classified in accordance with the hazard criteria of the Controlled Products Regulations (CPR)and the MSDS contains all the information required by the CPR.Reason for revision Not Applicable.SDS sections updated.For research use only."The above information was acquired by diligent search and/or investigation and the recommendations are based on prudent application of professional judgment.The information shall not be taken as being all inclusive and is to be used only as a guide.All materials and mixtures may present unknown hazards and should be used withcaution.Since the Company cannot control the actual methods,volumes,or conditions of use,the Company shall not be held liable for any damages or losses resulting from the handling or from contact with the product as described herein.THE INFORMATION IN THIS SDS DOES NOT CONSTITUTE A WARRENTY,EXPRESSED OR IMPLIED,INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PUPOSE"End of Safety Data Sheet。
地氯雷他定片说明书
地氯雷他定片说明书地氯雷他定片(地恒塞)适用于缓解慢性特发性荨麻疹等症状,那么说明书中还有哪些功效作用和注意事项呢?下面是店铺整理的地氯雷他定片说明书,欢迎阅读。
地氯雷他定片说明书【通用名称】地氯雷他定片【商品名称】地氯雷他定片(地恒塞)【英文名称】DesloratadineTablets【拼音全码】DiLvLeiTaDingPian(DiHengSai)【主要成份】地氯雷他定片(地恒塞)主要成份为地氯雷他定。
化学名:8-氯-6,11-二氢-11-(4-亚哌啶基)-5H-苯并-[5,6]-庚烷[1,2-b]吡啶分子式:C19H19ClN2分子量:310.82【性状】地氯雷他定片(地恒塞)为薄膜衣片,除去包衣后显白色或类白色。
【适应症/功能主治】用于缓解慢性特发性荨麻疹及常年性过敏性鼻炎的全身及局部症状。
【规格型号】5mg*6s【用法用量】口服,成人和12岁以上青少年,每次5mg(一片),一日一次。
【不良反应】地氯雷他定片(地恒塞)主要不良反应为恶心、头晕、头痛、困倦、口干、乏力、偶见嗜睡,健忘及晨起面部肢端水肿。
【禁忌】对地氯雷他定片(地恒塞)过敏者或特异体质的患者禁用。
【注意事项】1、12岁以下儿童服用地氯雷他定片(地恒塞)的有效性和安全性尚未建立,不推荐使用地氯雷他定片(地恒塞)。
2、肝、肾、心脏功能严重损害者、排尿不畅者、青光眼患者慎用。
3、妊娠期、哺乳期妇女服用地氯雷他定片(地恒塞)的安全性尚未建立不推荐使用。
与抗胆碱药、中枢抑制药合用时可增加地氯雷他定片(地恒塞)的不良反应。
4、由于抗组胺药能清除或减轻皮肤对所有变应原的阳性反应,因而在进行任何皮肤过敏性试验前48小时,应停止使用地氯雷他定片(地恒塞)。
【儿童用药】地氯雷他定对12岁以下的儿童患者的疗效和安全性尚未确定。
【老年患者用药】老年患者用药量与成人相同。
【孕妇及哺乳期妇女用药】孕妇及哺乳期妇女慎用地氯雷他定。
【药物相互作用】如与其他药物同时使用可能会发生药物相互作用,详情请咨询医师或药师。
5种 DPP-4抑制剂比较资料介绍
Burkey BF, et al. Diabetes, Obesity and Metabolism. 2008; 10: 1057–1061
第十七页,编辑于星期五:八点 十九分。
DPP-4选择性 结论
• 体外研究显示,DPP-4抑制剂对DPP-8、9的亲和性远低于 DPP-4,不同DPP-4抑制剂之间可比性较差
Deacon CF. Diabetes, Obesity and Metabolism. 2011; 13: 7–18 Kirby M, et al. Clin Sci (Lond). 2009 ;118(1):31-41.
第十一页,编辑于星期五:八点 十九分。
DPP-4和DPP-8、9在细胞定位不同
药物间相互作用
• 临床研究篇 • 全球获批情况及中国适应症比较
第五页,编辑于星期五:八点 十九分。
DPP-4抑制剂的吸收和分布
沙格列汀
西格列汀
维格列汀
阿格列汀
达峰时间(h)1 最大药物浓度2 药物曲线下面积
2
生物利用度(%)2
2 24ng/mL 78ng·h/mL
75
1-4
1.75
1-2
817±250ng/mL
沙格列汀
阿格列汀
第二页,编辑于星期五:八点 十九分。
DPP-4抑制剂的相似点和不同点
不同点
相似点
• 化学结构
• 疗效(HbA1c下降)
• 选择性(体外实验)
• 耐受性
• 代谢(改变/未改变;代谢产物有/无活 • 安全性
性)
• 清除(肾/肝)
• 药效(治疗剂量)
• 给药频率(每天一次/两次)
• 特殊人群应用(如肝/肾功能不全)
安立泽(沙格列汀片)
安立泽(沙格列汀片)
【药品名称】
商品名称:安立泽
通用名称:沙格列汀片
英文名称:Saxagliptin tablets
【适应症】
用于2型糖尿病。
单药治疗:可作为单药治疗,在饮食和运动基础上改善血糖控制。
联合治疗:当单独使用盐酸二甲胍血糖控制不佳时,可与盐酸二甲胍联合使用,在饮食和运动基础上改善血糖控制。
重要的使用限制:由于对于1型糖尿病酮症酸中毒的有效性尚未确定,故本品不用于1型糖尿病或糖尿病酮症酸中毒的患者。
尚未对本品与胰岛素的联合使用进行研究
【批准文号】
国药准字J20110028
【生产企业】
企业名称:Bristol-Myers Squibb Company
生产地址:4601 Highway 62,Mount Vernon,IN47620,U.S.A.。
Easyhaler(布地奈德吸入粉雾剂)使用说明
Easyhaler(布地奈德吸入粉雾剂)【用法用量】口腔吸入,本品的剂量应依不同的病人加以调整。
建议患者长期规则用药。
当开始以本品治疗时,对哮喘和口服糖皮质激素减量或停药的患者。
本品的分别为:成人(包括12岁以上的儿童):一日200-1600ug。
对于轻度哮喘的患者,一次200-400ug,一日一~二次;对于中度和重度哮喘的患者,日剂量可增加至1600ug。
每天早晚使用或每晚同一时间使用,若哮喘症状恶化,泽每日剂量应增加。
6至12岁的儿童:一次200-400ug,一日一~二次。
当哮喘控制后,应缓缓降低剂量至可有效控制哮喘的维持剂量,维持剂量的范围:成人(包括老人和12岁以上的儿童):一日200-1600ug6至12岁的儿童:一日200~800ug。
惯用口服糖皮质激素的患者:患者应处于较为稳定的状态才开始于常规口服治疗外加一次400~800ug(成人和12岁以上的儿童)或一次200~400ug(6至12岁额儿童),一日二次吸入治疗,大约10天后,应逐步降低口服糖皮质激素的剂量至最低有效剂量(例如以相当于每月2.5mg强的松龙的减量方式)。
需特别强调的是,口服糖皮质激素撤除的速度要慢,通常患者可完全以本品代口服糖皮质激素治疗。
为降低口腔念珠菌感染和声音嘶哑的危险,应指导患者每次吸药后用水漱口或刷牙。
口腔念珠菌感染可使用局部抗菌药治疗,无需中断使用本品。
【注意事项】1.运动员慎用。
2.不应试图靠本品快速缓解哮喘急性发作。
此时仍需吸入垣效支气管扩张剂。
如发现恩者健用短效支气管扩张剂无效或他们所需的吸入剂量较平时增加,则应就诊.此时应考虑增强抗炎抬疗.如吸入较高剂童的本品或口服一疗程糖皮质漱素。
3.本品是一种预防治疗药物.因而.尽管在病症不发作时也应该常规使用以获得最佳的治疗效果,不可突然停药。
4.对于由糖皮质做索口服治疗过渡到吸入治疗的患者需特别观察.对于肾上腺功能损伤的患者改为吸入治疗时,在紧急倩况下.如创伤、手术、感染或哮喘恶化时,需要额外的全身糖皮质激素治疗.这也适用于那些长期接受高剂量吸入性糖皮质激索治疗的患者:这些患者的肾上腺功能可能己经损伤。
氨氮 安卓屏 泽天版操作说明书
4 安装 ............................................................................................................14 4.1 拆箱检查..........................................................................................14
I
4.2 确定安装地点..................................................................................15 4.3 管路连接..........................................................................................15 4.4 电路连接..........................................................................................15 4.5 通讯连接..........................................................................................16 4.6 接线端子示意图..............................................................................16 4.7 分析仪对外接口..............................................................................17 4.8 取水预处理装置..............................................................................17 5 运行 ............................................................................................................19 5.1 运行准备..........................................................................................19 5.2 试剂准备..........................................................................................19 5.3 开机调试..........................................................................................22 5.4 日常维护..........................................................................................22 6 软件操作 ....................................................................................................24 6.1 软件功能..........................................................................................24 6.2 菜单结构..........................................................................................24 6.3 操作说明..........................................................................................25
沙格列汀片说明书
沙格列汀片说明书沙格列汀片(安立泽)用于2型糖尿病。
下面是店铺整理的沙格列汀片说明书,欢迎阅读。
沙格列汀片商品介绍通用名:沙格列汀片生产厂家: Bristol-Myers Squibb Company(美国)(中美上海施贵宝制药有限公司分装)批准文号:国药准字J20110029药品规格:5mg*7片药品价格:¥78.5元沙格列汀片说明书【通用名称】沙格列汀片【商品名称】沙格列汀片(安立泽)【英文名称】SaxagliptinTablets【拼音全码】AnLiZeShaGeLieTingPian【主要成份】沙格列汀。
其化学名为:(1S,3S,5S)-2-[(2S)-2-氨基-2-(3-羟基-l-金刚烷基)-l-羰基乙基]-2-氮杂双环[3.1.0]己烷-3-腈,一水合物。
分子式:C18H25N3O2·H2O分子量:333.43【性状】安立泽沙格列汀片为粉红色薄膜衣片,除去包衣以后显白色。
【适应症/功能主治】用于2型糖尿病。
【规格型号】5mg*7s【用法用量】口服,推荐剂量5mg,每日1次,服药时间不受进餐影响。
【不良反应】1、低血糖。
2、过敏反应。
【禁忌】对安立泽沙格列汀片有严重超敏反应史(例如速发过敏反应、血管性水肿或剥脱性皮肤损害)的患者。
【注意事项】以下症状慎用:1、沙格列汀不能用于1型糖尿病或糖尿病酮症酸中毒的患者。
尚未进行沙格列汀与胰岛素联用的研究。
2、肾功能不全。
3、肝功能受损。
4、超敏反应。
5、皮肤疾病。
6、心力衰竭。
7、免疫功能低下患者。
8、乳糖。
9、与已知会引起低血糖的药物合用。
【儿童用药】尚未在儿童患者中开展沙格列汀的安全性盒有效性研究,不推荐儿童患者应用。
【老年患者用药】沙格列汀及其活性代谢物部分通过肾脏消除,因为老年患者肾功能降低的可能性更高,所以老年患者用药时应根据肾功能慎重选择用药剂量。
【孕妇及哺乳期妇女用药】尚未在孕妇中开展充分且良好对照的研究,不推荐孕妇使用。
- 1、下载文档前请自行甄别文档内容的完整性,平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益,请联系客服反馈,我们会尽快为您处理(人工客服工作时间:9:00-18:30)。
H2H2O核准日期:2011年05月05日修改日期:2011年7月18日2011年8月30日2012年5月10日沙格列汀片说明书请仔细阅读说明书并在医生指导下使用【药品名称】通用名称:沙格列汀片商品名称:安立泽/ONGLYZA英文名称:Saxagliptin Tablets汉语拼音: Shagelieting Pian【成份】本品活性成份为沙格列汀。
化学名称:(1S,3S,5S)-2-[(2S)-2-氨基-2-(3-羟基-l-金刚烷基)-l-羰基乙基]-2-氮杂双环[3.1.0]己烷-3-腈,一水合物化学结构式:分子式: C18H25N3O2·H2O分子量: 333.43 (一水合物);315.41 (无水游离碱基)【性状】2.5mg :本品为微黄色至浅黄色薄膜衣片,除去包衣以后显白色。
5mg :本品为粉红色薄膜衣片,除去包衣以后显白色。
【适应症】用于2型糖尿病。
单药治疗可作为单药治疗,在饮食和运动基础上改善血糖控制。
联合治疗当单独使用盐酸二甲双胍血糖控制不佳时,可与盐酸二甲双胍联合使用,在饮食和运动基础上改善血糖控制。
重要的使用限制由于对于1型糖尿病和糖尿病酮症酸中毒的有效性尚未确定,故本品不用于1型糖尿病或糖尿病酮症酸中毒的患者。
尚未对本品与胰岛素的联合使用进行研究。
尚未在有胰腺炎病史的患者中进行本品的研究。
尚未确定有胰腺炎病史的患者使用本品是否会增加胰腺炎发生的风险(参见注意事项)。
【规格】(1)2.5mg (2)5mg【用法用量】口服,推荐剂量5mg,每日1次,服药时间不受进餐影响。
肾功能不全患者轻度肾功能不全的患者无需调整剂量。
中或重度肾功能不全的患者应将剂量调整为2.5mg,每日1次。
重度肾功能不全的患者用药经验非常有限,因此本品用于此类患者时应谨慎。
本品不推荐用于需要进行血液透析的终末期肾病患者(参见注意事项和药代动力学)。
根据肾功能情况,本品的剂量可能应限于2.5mg,因此在本品治疗前建议评估肾功能,并且在常规治疗的同时,应定期评估肾功能(参见注意事项和药代动力学)。
肝功能受损患者轻或中度肝功能受损的患者无需进行剂量调整(参见药代动力学)。
本品用于中度肝功能受损的患者需谨慎,不推荐用于严重肝功能受损的患者(参见注意事项)。
强效细胞色素P450 3A4/5(CYP3A4/5)抑制剂与强效CYP3A4/5抑制剂(如酮康唑、阿扎那韦、克拉霉素、茚地那韦、伊曲康唑、奈法唑酮、奈非那韦、利托那韦、沙奎那韦和泰利霉素)合用时,应将本品的剂量限制为2.5mg/天。
【不良反应】临床试验由于各个临床试验的条件差异很大,一个药物在临床试验中的不良反应发生率不能直接与另一个药物临床试验中的不良反应发生率相比较,该发生率也不能反映药物在实际应用中的不良反应发生率。
单药治疗和联合治疗在2项为期24周的安慰剂对照的单药治疗试验中,分别给予患者沙格列汀2.5mg/天、5mg/天和安慰剂。
此外,还进行了3项为期24周、安慰剂对照、联合治疗的试验,分别联合应用二甲双胍、噻唑烷二酮类(TZD)药物(吡格列酮或罗格列酮)和格列本脲,将患者随机分配至沙格列汀2.5mg/天、5mg/天或安慰剂联合治疗组。
在其中1项单药治疗试验和1项二甲双胍联合治疗的试验中,还包括沙格列汀10mg剂量组。
对2项单药治疗试验、与二甲双胍联合应用试验、与噻唑烷二酮类药物联合应用试验、与格列本脲联合应用试验24周的数据(包括因高血糖需要接受补救治疗的患者)进行汇总分析,结果显示在2.5mg和5mg剂量组治疗的不良事件总发生率与安慰剂相似(分别为72.0%、72.2%与70.6%)。
由于不良事件而中止治疗的患者比例分别为:2.5mg组为2.2%、5mg组为3.3%、安慰剂组为1.8%。
导致提前中止治疗最常见不良事件(2.5mg治疗组至少报告2例,或5mg治疗组至少报告2例)包括淋巴细胞减少(2.5mg组、5mg组和安慰剂组分别为0.1%、0.5%与0%)、皮疹(2.5mg组、5mg组和安慰剂组分别为0.2%、0.3%与0.3%)、血肌酐升高(2.5mg组、5mg组和安慰剂组分别为0.3%、0%与0%)、血磷酸肌酸激酶升高(2.5mg组、5mg组和安慰剂组分别为0.1%、0.2%与0%)。
汇总分析报告中,沙格列汀5mg治疗后最常见(发生率≥5%,且高于安慰剂)的不良反应(不考虑研究者评估的因果关系)列于表1。
表1: 安慰剂对照试验*中报告的服用沙格列汀5mg治疗后最常见(发生率≥5%,且高于安慰剂)的不良反应(不考虑研究者评估的因果关系)5项安慰剂对照试验,其中包括2项沙格列汀单药治疗试验以及1项沙格列汀联合二甲双胍试验、1项沙格列汀联合噻唑烷二酮类药物试验、1项沙格列汀联合格列本脲试验。
表中显示了24周的试验数据,其中包括因高血糖需要接受补救治疗的患者的数据。
在接受沙格列汀2.5mg治疗的患者中,头痛(6.5%)是唯一的发生率≥5%且高于安慰剂组的不良反应。
在汇总分析中,沙格列汀2.5mg或5mg治疗组患者报告的发生率≥2%,且与安慰剂组相比发生率≥1%的不良事件包括:鼻窦炎(2.5mg组、5mg组和安慰剂组分别为2.9%、2.6%与1.6%)、腹痛(2.5mg组、5mg组和安慰剂组分别为2.4%、1.7%与0.5%)、胃肠炎(2.5mg组、5mg组和安慰剂组分别为1.9%、2.3%与0.9%)和呕吐(2.5mg组、5mg组和安慰剂组分别为2.2%、2.3%与1.3%)。
在沙格列汀联合噻唑烷二酮类药物的试验中,5mg治疗组的外周性水肿发生率高于安慰剂治疗组(分别为8.1%和4.3%),2.5mg治疗组的外周性水肿发生率为3.1%。
没有因外周性水肿的不良反应而中止研究药物治疗的病例。
沙格列汀单药治疗试验中,2.5mg、5mg和安慰剂治疗组的外周性水肿发生率分别为3.6%、2%和3%;二甲双胍联合沙格列汀治疗的试验中发生率分别为2.1%、2.1%和2.2%;格列本脲联合沙格列汀治疗的试验中发生率分别为2.4%、1.2%和2.2%。
沙格列汀(2.5mg、5mg和10mg剂量组的汇总分析)和安慰剂治疗组的骨折发生率分别为1.0和0.6/100个患者年。
随着治疗时间的延长,接受沙格列汀治疗的患者骨折发生率没有增加。
尚未明确用药和骨折间的因果关系,临床前研究结果也未显示沙格列汀对骨骼有不良作用。
临床试验中观察到1例血小板减少症,经诊断为特发性血小板减少性紫癜。
该事件与沙格列汀用药的关系尚未明确。
对于应用药物初始治疗的2型糖尿患者,采用二甲双胍联合沙格列汀治疗的不良反应对应用药物初始治疗的患者使用沙格列汀联合二甲双胍治疗的、24周的、阳性对照试验中,发生率≥5%的不良反应(不考虑研究者评估的因果关系)见于表2。
表2: 药物初治疗的患者采用沙格列汀和二甲双胍联合治疗后,在(沙格列汀5mg+二甲双胍)治疗组中发生率≥5%,且高于二甲双胍单药治疗组的不良反应(不考虑研究者评估的因果关系)*二甲双胍的初始剂量为500mg/天,逐渐增加到最高剂量2000mg/天。
低血糖低血糖不良反应是以所有低血糖的报告为基础的,未要求进行血糖检测以进一步确认。
在沙格列汀联合格列本脲的试验中,沙格列汀2.5mg和5mg组低血糖的总发生率比对照组高(分别为13.3%、14.6%和10.1%),确认的低血糖(即有低血糖症状且伴毛细血管血糖值≤50mg/dL)的发生率,分别为2.4%、0.8%和0.7%。
沙格列汀单药治疗试验中,沙格列汀2.5mg、5mg和对照组低血糖报告的发生率分别为4.0%、5.6%和4.1%;在沙格列汀联合二甲双胍的试验中,沙格列汀2.5mg组、5mg组、对照组低血糖发生率分别为7.8%、5.8%和5%;在沙格列汀联合噻唑烷二酮类药物的试验中,沙格列汀2.5mg、5mg和对照组低血糖发生率分别为4.1%、2.7%和3.8%。
应用药物初始治疗的患者采用沙格列汀5mg联合二甲双胍治疗后报告低血糖的发生率为3.4%,二甲双胍单药治疗组患者发生率为4.0%。
过敏反应对5项为期24周的试验进行汇总分析,在沙格列汀2.5mg、5mg和对照组中,过敏相关事件(如荨麻疹和面部水肿)报告的发生率分别为1.5%、1.5%和0.4%。
发生这些事件的沙格列汀治疗的患者中没有需要住院治疗或被研究者认为威胁到患者生命的。
此汇总分析中,有1例沙格列汀治疗的患者由于全身性荨麻疹和面部水肿而中止治疗。
生命体征沙格列汀治疗的患者中未观察到有临床意义的生命体征变化。
实验室检查淋巴细胞绝对计数在接受沙格列汀治疗的患者中,观察到与剂量相关的淋巴细胞绝对计数降低。
对5项安慰剂对照、24周的临床研究的观察数据进行汇总分析的结果显示,平均淋巴细胞绝对计数基线约为2200个细胞/mL,与安慰剂相比,沙格列汀5mg和10mg治疗后平均淋巴细胞绝对计数分别下降了约100和120个细胞/mL。
同样的结果也可以在沙格列汀5mg与二甲双胍起始联合治疗试验中观察到,与二甲双胍单药治疗相比,联合治疗使淋巴细胞绝对计数降低。
沙格列汀2.5mg治疗与安慰剂相比,淋巴细胞绝对计数没有变化。
沙格列汀2.5mg、5mg、10mg和安慰剂治疗后,报告淋巴细胞计数≤750个细胞/mL的患者比例分别为0.5%、1.5%、1.4%和0.4%。
虽然有些患者再次给药后重现淋巴细胞计数下降,且最后导致沙格列汀治疗中止,但大部分患者再次服用沙格列汀后没有再次出现淋巴细胞计数下降。
淋巴细胞计数减少被认为是非临床相关的不良反应。
与安慰剂相比,沙格列汀治疗后淋巴细胞计数减少的临床意义尚不清楚。
当出现罕见或持续的感染的临床现象时,必须测定淋巴细胞计数。
沙格列汀对携带异常淋巴细胞(如人免疫缺陷病毒)患者的淋巴细胞数的影响尚未明确。
血小板6项双盲对照的临床安全性和有效性试验结果表明,沙格列汀对血小板数目的影响没有临床意义或不一致。
上市后经验:在本品的上市后使用过程中有一些不良反应的报告。
由于这些不良反应是自发报告,来自样本量不确定的人群,因此无法可靠估计这些不良反应的发生率,也无法确定它们与药物暴露之间是否存在因果关系。
•超敏反应(包括速发过敏反应、血管性水肿、剥脱性皮肤损害)(参见禁忌和注意事项)。
•急性胰腺炎(参见重要的使用限制和注意事项)。
【禁忌】对本品有严重超敏反应史(例如速发过敏反应、血管性水肿或剥脱性皮肤损害)的患者(参见注意事项和不良反应)。
【注意事项】一般情况沙格列汀不能用于1型糖尿病或糖尿病酮症酸中毒的患者。
尚未进行沙格列汀与胰岛素联用的研究。
肾功能不全中或重度肾功能不全的患者推荐进行单剂量调整。
本品用于重度肾功能不全的患者应谨慎,并且不推荐用于需要进行血液透析的终末期肾病患者。
在开始本品治疗前建议评估肾功能,并且在维持常规治疗的同时,应定期进行肾功能评估(参见用法用量和药代动力学)。