吸入溶液说明书

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吸入用硫酸沙丁胺醇溶液(万托林)的说明书

吸入用硫酸沙丁胺醇溶液(万托林)的说明书对于呼吸道疾病来说，传染性是非常强的。

雾霾天气导致呼吸道疾病的发病率逐渐上升，治疗呼吸道疾病刻不容缓。

药物治疗呼吸道疾病是绝大多数人都选择的一种治疗方式，目前服用吸入用硫酸沙丁胺醇溶液(万托林)治疗呼吸道疾病是很多人的选择，该药物对于呼吸道疾病拥有很好的效果。

【药品名称】通用名称：吸入用硫酸沙丁胺醇溶液商品名称：吸入用硫酸沙丁胺醇溶液(万托林)英文名称：Salbutamol Sulfate Solution for Inhalation拼音全码：XiRuYongLiuSuanShaDingAnChunRongYe(WanTuoLin)【主要成份】本药的主要成分是沙丁胺醇，其化学名为1-(4-羟基-3-羟甲基苯基)-2-(叔丁氨基)乙醇。

【性状】气雾剂的内容物为白色或微黄色混悬液。

【适应症/功能主治】本品主要用于缓解哮喘或慢性阻塞性肺部疾患(可逆性气道阻塞疾病)患者的支气管痉挛，及急性预防运动诱发的哮喘，或其他过敏原诱发的支气管痉挛。

【规格型号】5mg*20ml【用法用量】本品只可在医生的指导下，采用呼吸器或适当的驱动式喷雾器给药，切不可注射或口服。

【不良反应】骼肌肉可能有轻微震颤现象，通常手部较为明显。

服用β-肾上腺素受体激动剂的病人一般有此症状。

偶见有头痛的病例报告。

有些病人可能会有外周血管舒张及轻微的代偿性心率加速的情况发生。

肌肉痉挛症状亦曾有报告，但十分罕有。

过敏反应包括血管神经性水肿、荨麻疹、支气管痉挛、低血压、虚脱等病例亦曾有报告，但十分罕有。

正如使用其他吸入治疗法一样，给药后可能会立刻引起反常性支气管痉挛及增加有响声地呼吸，应立即给予另一类含有此药物成分的制药，或一个不同的有快速缓解效用支气管扩张剂，若有此症状，应即时停止吸用本药，评估病人的状况。

【禁忌】本品禁用于对其任何成份曾有过敏史的病人。

各类硫酸沙丁胺醇吸入剂不应该使用来处理早产，不应用于先兆流产。

硫酸沙丁胺醇雾化吸入溶液说明书

【药品名称】通用名称：硫酸沙丁胺醇雾化吸入溶液商品名称：达芬科闯英文名称：Salbutamol Sulfate Nebules Inhalation Solution拼音全码：DaFenKeChuang【主要成份】硫酸沙丁胺醇。

【成份】化学名：1-(4-羟基-3-羟甲基苯基)-2-(叔丁氨基)乙醇的半硫酸盐分子式：C13H21NO3?1/2H2SO4分子量：288.35【性状】本品为无色或几乎无色澄清液体。

【适应症/功能主治】严重的支气管哮喘（哮喘持续状态）及对常规疗法治疗无效的慢性支气管痉挛。

【规格型号】0.1g:20ml【用法用量】本品只可在医生指导下，采用呼吸器或适当的驱动式喷雾器给药，切不可注射或口服。

1.间歇性用法：间歇性治疗每日重复4次，应从低剂量开始。

成人：0.5或1.0毫升（2.5或5.0mg）, 以注射用生理盐水稀释至2.0或2.5毫升,喷雾可维持约10分钟；部分成人可能需要10mg的较高剂量，可不经稀释,将2.0毫升（10mg）本品直接置入喷雾装置中，雾化吸入，直至支气管得到扩张为止，通常约需要3 5分钟。

儿童：一岁半到十二岁以下儿童的常用剂量为0.5毫升（2.5毫克沙丁胺醇）以注射用生理盐水稀释到2.0或2.5毫升，部分儿童可能需要增至5毫克,由于有可能发生短暂的低氧血症，可考虑辅以氧气治疗。

2．连续性治疗：将本品以注射用生理盐水稀释成每毫升含50μg~100μg沙丁胺醇的溶液, 雾化吸入的通常给药速率为1mg/小时，最高可增至2mg/小时。

【不良反应】雾化吸入本品可产生下列不良反应：肌肉震颤（通常表现为手颤），头晕，头痛，不安，失眠，心动过速，低钾血症，口、咽剌激感。

罕见下列不良反应：肌肉痉挛，过敏反应（血管性水肿、皮疹、支气管痉挛、低血压）。

【禁忌】对本品成份及其它肾上腺素受体激动药过敏者禁用。

【注意事项】1.下列情况应慎用：伴有心血管疾患（冠状动脉供血不足、心律不齐、高血压）、甲状腺机能亢进、糖尿病及惊厥患者。

富马酸福莫特罗吸入溶液说明书

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PERFOROMIST safely and effectively. See full prescribing information for PERFOROMIST.These highlights do not include all the information needed to use PERFOROMIST Inhalation Solution safely and effectively. See full prescribing information for PERFOROMIST Inhalation Solution. PERFOROMIST® (formoterol fumarate) Inhalation SolutionInitial U.S. Approval: 2001WARNING: ASTHMA-RELATED DEATHSee full prescribing information for complete boxed warning• Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. (5.1)• A placebo-controlled study with another long-acting beta2-adrenergic agonist (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. (5.1)• The finding of an increased risk of asthma-related death with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST. The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication. (4, 5.1)INDICATIONS AND USAGEPERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for:• Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1)Important limitations of use:• PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2)• PERFOROMIST Inhalation Solution is not indicated to treat asthma. (1.2)DOSAGE AND ADMINISTRATIONFor oral inhalation only.• One 20 mcg/2 mL vial every 12 hours (2)• For use with a standard jet nebulizer (with a facemask or mouthpiece) connected to an air compressor (2)DOSAGE FORMS AND STRENGTHSInhalation Solution (unit dose vial for nebulization); 20 mcg/2 mL solution (3)CONTRAINDICATIONS• All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication. (4)WARNINGS AND PRECAUTIONS• Do not initiate PERFOROMIST Inhalation Solution in acutely deteriorating patients. (5.2)• Do not use for relief of acute symptoms. Concomitant short-acting beta2 agonists can be used as needed for acute relief. (5.2)• Do not exceed the recommended dose. Excessive use of PERFOROMIST Inhalation Solution, or use in conjunction with other medications containing long-acting beta2-agonists, can result in clinically significant cardiovascular effects, and may be fatal. (5.3, 5.5)• Life-threatening paradoxical bronchospasm can occur. Discontinue PERFOROMIST Inhalation Solution immediately. (5.4)• Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or with sensitivity to sympathomimetic drugs. (5.6, 5.7)ADVERSE REACTIONSMost common adverse reactions (>2% and more common than placebo)are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia (6.2)To report SUSPECTED ADVERSE REACTIONS, contact Dey Pharma, L.P. at 1-800-429-7751 or FDA at 1-800-FDA-1088 or / medwatch.To report SUSPECTED ADVERSE REACTIONS, contact Dey Pharma, LP at or FDA at 1-800-FDA-1088 or /medwatchDRUG INTERACTIONS• Other adrenergic drugs may potentiate effect. Use with caution. (5.3, 7.1) • Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. (5.7, 7.2, 7.3)• MAO inhibitors, tricyclic antidepressants and drugs that prolong QTc interval may potentiate effect on the cardiovascular system. Use with extreme caution. (7.4)• Beta-blockers may decrease effectiveness. Use with caution and only when medically necessary. (7.5)See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication GuideRevised: 05/2010FULL PRESCRIBING INFORMATION: CONTENTS *WARNING: ASTHMA-RELATED DEATH1 INDICATIONS AND USAGE1.1 Maintenance Treatment of COPD1.2 Important Limitations of Use2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Asthma-Related Deaths5.2 Deterioration of Disease and Acute Episodes5.3 Excessive Use and Use with Other Long-Acting Beta2-Agonists5.4 Paradoxical Bronchospasm5.5 Cardiovascular Effects5.6 Coexisting Conditions5.7 Hypokalemia and Hyperglycemia5.8 Immediate Hypersensitivity Reactions6 ADVERSE REACTIONS6.1 Beta2-Agonist Adverse Reaction Profile6.2 Clinical Trials Experience6.3 Postmarketing Experience7 DRUG INTERACTIONS7.1 Adrenergic Drugs7.2 Xanthine Derivatives, Steroids, or Diuretics7.3 Non-potassium Sparing Diuretics7.4 MAO Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs7.5 Beta-blockers8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Labor and Delivery8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Pharmacology14 CLINICAL STUDIES14.1 Adult COPD Trial16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION* Sections or subsections omitted from the full prescribing information are not listedFULL PRESCRIBING INFORMATIONWARNING: ASTHMA-RELATED DEATHLong-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST Inhalation Solution. The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication [see CONTRAINDICATION (4), WARNINGS AND PRECAUTIONS (5.1)].1 INDICATIONS AND USAGE1.1 Maintenance Treatment of COPDPERFOROMIST (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.1.2 Important Limitations of UsePERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2)].PERFOROMIST Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma have not been established.2 DOSAGE AND ADMINISTRATIONThe recommended dose of PERFOROMIST (formoterol fumarate) Inhalation Solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended. PERFOROMIST Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected toan air compressor. The safety and efficacy of PERFOROMIST Inhalation Solution have been established in clinical trials when administered using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) and the PRONEB® Ultra compressor. The safety and efficacy of PERFOROMIST Inhalation Solution delivered from non-compressor based nebulizer systems have not been established.PERFOROMIST Inhalation Solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE. Contents of any partially used container should be discarded.If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered.The drug compatibility (physical and chemical), efficacy, and safety of PERFOROMIST Inhalation Solution when mixed with other drugs in a nebulizer have not been established.3 DOSAGE FORMS AND STRENGTHSPERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each vial contains formoterol fumarate dihydrate, USP equivalent to 20 mcg/2 mL of formoterol fumarate.4 CONTRAINDICATIONSAll LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication. [see WARNINGS and PRECAUTIONS (5.1)].5 WARNINGS AND PRECAUTIONS5.1 Asthma-Related Deaths[See BOXED WARNING]Data from a large placebo-controlled study in asthma patients showed that long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Data are not available to determine whether the rate of death in patients with COPD is increased by long- acting beta2-adrenergic agonists.A 28-week, placebo-controlled US study comparing the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs.3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34). The increased risk of asthma-related death is considereda class effect of the long-acting beta2-adrenergic agonists, including PERFOROMIST Inhalation Solution. No study adequateto determine whether the rate of asthma related death is increased in patients treated with PERFOROMIST Inhalation Solutionhas been conducted. The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication. [see CONTRAINDICATIONS (4)].Clinical studies with formoterol fumarate administered as a dry powder inhaler suggested a higher incidence of serious asthma exacerbations in patients who received formoterol than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups.5.2 Deterioration of Disease and Acute EpisodesPERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. PERFOROMIST Inhalation Solution has not been studied in patients with acutely deteriorating COPD. The use of PERFOROMIST Inhalation Solution in this setting is inappropriate.PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. PERFOROMIST Inhalation Solution has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.When beginning PERFOROMIST Inhalation Solution, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. When prescribing PERFOROMIST Inhalation Solution, the healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient how it should be used. Increasing inhaled beta2-agonist useis a signal of deteriorating disease for which prompt medical attention is indicated. COPD may deteriorate acutely over a periodof hours or chronically over several days or longer. If PERFOROMIST Inhalation Solution no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short-acting beta2-agonist becomes less effective or the patient needs more inhalation of short-acting beta2-agonist than usual, these may be markers of deterioration of disease. In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dosage of PERFOROMIST Inhalation Solution beyond the recommended 20 mcg twice daily dose is not appropriate in this situation.5.3 Excessive Use and Use with Other Long-Acting Beta2-AgonistsAs with other inhaled beta2-adrenergic drugs, PERFOROMIST Inhalation Solution should not be used more often, at higherdoses than recommended, or in conjunction with other medications containing long-acting beta2-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.5.4 Paradoxical BronchospasmAs with other inhaled beta2-agonists, PERFOROMIST Inhalation Solution can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, PERFOROMIST Inhalation Solution should be discontinued immediately and alternative therapy instituted.5.5 Cardiovascular EffectsPERFOROMIST Inhalation Solution, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms. If such effects occur, PERFOROMIST Inhalation Solution may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.5.6 Coexisting ConditionsPERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines. Doses of the related beta2 agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.5.7 Hypokalemia and HyperglycemiaBeta-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see CLINICAL PHARMACOLOGY (12.2)]. The decrease in serum potassium is usually transient, not requiring supplementation. Beta-agonist medications may produce transient hyperglycemia in some patients. Clinically significant changes in serum potassium and blood glucose were infrequent during clinical studies with long-term administration of PERFOROMIST Inhalation Solution at the recommended dose.5.8 Immediate Hypersensitivity ReactionsImmediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angiodema, rash, and bronchospasm.6 ADVERSE REACTIONSLong acting beta2-adrenergic agonists such as formoterol increase the risk of asthma-related death [See BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)].6.1 Beta2-Agonist Adverse Reaction ProfileAdverse reactions to PERFOROMIST Inhalation Solution are expected to be similar in nature to other beta2-adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, muscle cramps, palpitations, nausea, dizziness, fatigue, malaise, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis.6.2 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Adults with COPDThe data described below reflect exposure to PERFOROMIST Inhalation Solution 20 mcg twice daily by oral inhalation in 586 patients, including 232 exposed for 6 months and 155 exposed for at least 1 year. PERFOROMIST Inhalation Solution was studied in a 12-week, placebo-and active-controlled trial (123 subjects treated with PERFOROMIST Inhalation Solution) and a 52-week, active-controlled trial (463 subjects treated with PERFOROMIST Inhalation Solution). Patients were mostly Caucasians (88%) between40-90 years old (mean, 64 years old) and had COPD, with a mean FEV1 of 1.33 L. Patients with significant concurrent cardiac and other medical diseases were excluded from the trials.Table 1 shows adverse reactions from the 12-week, double-blind, placebo-controlled trial where the frequency was greater than or equal to 2% in the PERFOROMIST Inhalation Solution group and where the rate in the PERFOROMIST Inhalation Solution group exceeded the rate in the placebo group. In this trial, the frequency of patients experiencing cardiovascular adverse events was 4.1% for PERFOROMIST Inhalation Solution and 4.4% for placebo. There were no frequently occurring specific cardiovascular adverse events for PERFOROMIST Inhalation Solution (frequency greater than or equal to 1% and greater than placebo). The rate of COPD exacerbations was 4.1% for PERFOROMIST Inhalation Solution and 7.9% for placebo.TABLE 1Number of patients with adverse reactions in the 12-week multiple-dose controlled clinical trial Adverse Reaction PERFOROMIST PlaceboInhalationSolution20 mcgn (%) n (%) Total Patients 123 (100) 114 (100)Diarrhea 6 (4.9) 4 (3.5)Nausea 6 (4.9) 3 (2.6) Nasopharyngitis 4 (3.3) 2 (1.8)Dry Mouth 4 (3.3) 2 (1.8)Vomiting 3 (2.4) 2 (1.8)Dizziness 3 (2.4) 1 (0.9)Insomnia 3 (2.4) 0 0 Patients treated with PERFOROMIST Inhalation Solution 20 mcg twice daily in the 52-week open-label trial did not experience an increase in specific clinically significant adverse events above the number expected based on the medical condition and age of the patients.6.3 Postmarketing ExperienceThe following adverse reactions have been reported during post-approval use of PERFOROMIST. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Anaphylactic reactions, urticaria, angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema), rash, and bronchospasm.7 DRUG INTERACTIONS7.1 Adrenergic DrugsIf additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol may be potentiated [see WARNINGS AND PRECAUTIONS (5.3, 5.5, 5.6, 5.7)].7.2 Xanthine Derivatives, Steroids, or DiureticsConcomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists [see WARNINGS AND PRECAUTIONS (5.7)].7.3 Non-potassium Sparing DiureticsThe ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics.7.4 MAO Inhibitors, Tricyclic Antidepressants, QTc Prolonging DrugsFormoterol, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.7.5 Beta-blockersBeta-adrenergic receptor antagonists (beta-blockers) and formoterol may inhibit the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.8 USE IN SPECIFIC POPULATIONS8.1 PregnancyTeratogenic Effects: Pregnancy Category CFormoterol fumarate administered throughout organogenesis did not cause malformations in rats or rabbits following oral administration. However, formoterol fumarate was found to be teratogenic in rats and rabbits in other testing laboratories. When given to rats throughout organogenesis, oral doses of 0.2 mg/kg (approximately 40 times the maximum recommended daily inhalation dose in humans on a mg/m2 basis) and above delayed ossification of the fetus, and doses of 6 mg/kg (approximately 1200 times the maximum recommended daily inhalation dose in humans on a mg/m2 basis) and above decreased fetal weight. Formoterol fumarate has been shown to cause stillbirth and neonatal mortality at oral doses of 6 mg/kg and above in rats receiving the drug during thelate stage of pregnancy. These effects, however, were not produced at a dose of 0.2 mg/kg. Because there are no adequate and well-controlled studies in pregnant women, PERFOROMIST Inhalation Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Women should be advised to contact their physician if they become pregnant while taking PERFOROMIST Inhalation Solution.8.2 Labor and DeliveryThere are no adequate and well-controlled human studies that have investigated the effects of PERFOROMIST Inhalation Solution during labor and delivery.Because beta-agonists may potentially interfere with uterine contractility, PERFOROMIST Inhalation Solution should be used during labor only if the potential benefit justifies the potential risk.8.3 Nursing MothersIn reproductive studies in rats, formoterol was excreted in the milk. It is not known whether formoterol is excreted in human milk, but because many drugs are excreted in human milk, caution should be exercised if PERFOROMIST Inhalation Solution is administered to nursing women. There are no well-controlled human studies of the use of PERFOROMIST Inhalation Solution in nursing mothers. Women should be advised to contact their physician if they are nursing while taking PERFOROMIST Inhalation Solution.8.4 Pediatric UsePERFOROMIST Inhalation Solution is not indicated for use in children. The safety and effectiveness of PERFOROMIST Inhalation Solution in pediatric patients have not been established. The pharmacokinetics of formoterol fumarate has not been studied in pediatric patients.8.5 Geriatric UseOf the 586 subjects who received PERFOROMIST Inhalation Solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. Of the 123 subjects who received PERFOROMIST Inhalation Solution in the 12-week safety and efficacy trial,48 (39%) were 65 years of age or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.The pharmacokinetics of PERFOROMIST Inhalation Solution has not been studied in elderly subjects.10 OVERDOSAGEThe expected signs and symptoms with overdosage of PERFOROMIST Inhalation Solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under ADVERSE REACTIONS. Signs and symptoms may include angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, and metabolic acidosis. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of PERFOROMIST Inhalation Solution.Treatment of overdosage consists of discontinuation of PERFOROMIST Inhalation Solution together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearingin mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of PERFOROMIST Inhalation Solution. Cardiac monitoring is recommended in cases of overdosage.The minimum lethal inhalation dose of formoterol fumarate in rats is 156 mg/kg (approximately 32,000 times the maximum recommended daily inhalation dose in humans on a mg/m2 basis). The median lethal oral doses in Chinese hamsters, rats, and mice provide even higher multiples of the maximum recommended daily inhalation dose in humans.For additional information about overdose treatment, call a poison control center (1-800-222-1222).11 DESCRIPTIONPERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate.The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is:Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2•C4H4O4•2H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether.PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizerflow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.12 CLINICAL PHARMACOLOGY12.1 Mechanism of ActionFormoterol fumarate is a long-acting, beta2-adrenergic receptor agonist (beta2-agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. In vitro studies have shown that formoterol has more than 200-fold greater agonist activity at beta2-receptors than at beta1-receptors. Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1 receptors are the predominant receptors in the heart, there are also beta2-receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects.The pharmacologic effects of beta2-adrenoceptor agonist drugs, including formoterol, are at least in part attributable to stimulationof intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.In vitro tests show that formoterol is an inhibitor of the release of mast cell mediators, such as histamine and leukotrienes, fromthe human lung. Formoterol also inhibits histamine-induced plasma albumin extravasation in anesthetized guinea pigs and inhibits allergen-induced eosinophil influx in dogs with airway hyper-responsiveness. The relevance of these in vitro and animal findings to humans with COPD is unknown.12.2 PharmacodynamicsSystemic Safety and Pharmacokinetic / Pharmacodynamic RelationshipsThe major adverse effects of inhaled beta2-agonists occur as a result of excessive activation of the systemic beta-adrenergic receptors. The most common adverse effects in adults include skeletal muscle tremor and cramps, insomnia, tachycardia, decreases in plasma potassium, and increases in plasma glucose.Changes in serum potassium and serum glucose were evaluated in 12 COPD patients following inhalation of single doses of PERFOROMIST Inhalation Solution containing 10, 20 and 244 mcg of formoterol fumarate (calculated on an anhydrous basis) in a crossover study. At 1 hour after treatment with formoterol fumarate inhalation solution, mean (± standard deviation) serum glucose rose 26 ± 30, 29 ± 28, and 38 ± 44 mg/dL, respectively, and was not significantly different from baseline or trough level at 24 hours post-dose. At 1 hour after dosing with formoterol fumarate inhalation solution 244 mcg, serum potassium fell by 0.68 ± 0.4 mEq/L, and was not different from baseline or trough level at 24 hours post-dose.。

硫酸沙丁胺醇雾化吸入溶液说明书

硫酸沙丁胺醇雾化吸入溶液说明书
硫酸沙丁胺醇雾化吸入溶液是一种常见的药物溶液，用于治疗呼
吸道疾病，如支气管炎、哮喘和支气管炎等症状。

该药溶液包含硫酸
沙丁胺醇，能够有效缓解呼吸道病症，减少胸闷气喘和鼻水等症状。

用法用量是：婴儿、儿童以及小婴3—8岁应根据体重将2—4毫
升溶液按对应剂量雾化吸入，大于8岁的儿童及成人根据体重可将3—
5毫升溶液按对应剂量雾化吸入，间隔4—6小时重复一次，最多两次，一日最多三次治疗。

不良反应可能有：嗓子干燥、喉咙痛、口腔溃疡、食欲不振、嗓
音消失、皮肤瘙痒和过敏症状等；以上症状严重者，应立即停止使用，并向医生咨询。

禁忌症：本产品不宜于对硫酸沙丁胺醇过敏者使用，以及严重肝、肾功能不全者，血液病及反应活性人士不得使用。

注意事项：使用前应仔细阅读药物说明书，并严格按照使用指示
和医嘱进行；对症状不明者须向诊所或其他医疗机构就诊。

本药不宜
代用其他药物及混合使用，使用过程中如有不良反应则需及时作出变更。

吸入用硫酸沙丁胺醇溶液（万托林）（吸入用硫酸沙丁胺醇溶液）

吸入用硫酸沙丁胺醇溶液（万托林）（吸入用硫酸沙丁胺醇溶液）【药品名称】通用名称：吸入用硫酸沙丁胺醇溶液商品名称：吸入用硫酸沙丁胺醇溶液(万托林)英文名称：Salbutamol Sulfate Solution for Inhalation【主要成份】本药的主要成分是沙丁胺醇，其化学名为1-(4-羟基-3-羟甲基苯基)-2-(叔丁氨基)乙醇。

【性状】本品为无色至淡黄色溶液。

pH值为3.5.每毫升(ml)含5毫克(mg)沙丁胺醇(以硫酸沙丁胺醇形式)。

【适应症/功能主治】本品主要用于对传统治疗无效的慢性支气管痉挛的常规处理及治疗严重的急性哮喘发作。

【规格型号】5mg*20ml(万托林)【用法用量】本品应通过喷雾器并在医生的指导下使用，不可注射或口服。

患者可采用间歇疗法或连续疗法进行治疗。

沙丁胺醇对大多数患者的作用时间可持续4至6小时。

用药时需以毫升（ ml）计算药量。

1.间歇疗法成人：用注射用生理盐水将0.5ml本品（含2.5mg 沙丁胺醇）稀释至2ml。

也可将1ml本品稀释至2.5ml。

稀释后的溶液由患者通过适当的驱动式喷雾器吸入，直至不再有气雾产生为止。

如喷雾器和驱动器装置匹配得当，则可维持10分钟喷雾。

本品可不经稀释而供间歇性使用。

为此，可将2.0ml本品（含10.0mg沙丁胺醇）置于喷雾器中，让患者吸入雾化的溶液，直至支气管得到扩张为止，该过程通常需3-5分钟。

某些成年患者可能需用较高剂量的沙丁胺醇，剂量可高达10mg，在这种情况下，应持续吸入未经稀释的溶液所产生的气雾，直至气雾停止产生。

儿童：12岁以下儿童的最小起始剂量为将0.5ml雾化溶液（含2.5mg沙丁胺醇），用注射用生理盐水稀释至2至2.5ml。

用药方式同成人。

然而某些儿童可能需要高达5.0mg 的沙丁胺醇。

间歇疗法可每日重复四次。

2.连续疗法将本品用注射用生理盐水稀释至每ml含50-100μg沙丁胺醇，（1-2ml药液稀释成100ml）。

特布他林雾化吸入溶液说明书

特布他林雾化吸入溶液说明书
特布他林雾化吸入溶液说明书
【药品名称】特布他林雾化吸入溶液
【成份】本品每瓶含有特布他林2.5mg。

【性状】本品为无色透明液体。

【适应症】用于治疗哮喘、慢性阻塞性肺疾病等呼吸系统疾病的急性发作和缓解期。

【规格】每盒装有10支，每支容量为2ml。

【用法用量】成人每次1支（2ml），儿童按体重计算，一般为
0.05mg/kg，每日不超过3次。

使用前请先将药液倒入雾化器中，按使用说明书操作。

【注意事项】
1. 严格按医嘱使用，不得随意增减剂量或停止用药。

2. 使用时请避免误吸或咽下药液。

3. 使用过程中如出现呼吸困难、心悸、胸闷等不适反应，请立即停止使用并就医。

4. 孕妇、哺乳期妇女及儿童慎用。

5. 对本品过敏者禁用，过敏体质者应在医师指导下使用。

6. 本品不宜与其他药物同时使用，如需联合用药，请在医师指导下使用。

【贮藏】密封，置于阴凉干燥处。

【包装】每盒装有10支，外包装为纸盒。

【有效期】24个月
【生产厂家】XX制药有限公司
【批准文号】国药准字HXXX（XX）
以上是特布他林雾化吸入溶液的详细说明书，请在医师指导下正确使用。

盐酸左沙丁胺醇雾化吸入溶液的说明书

盐酸左沙丁胺醇雾化吸入溶液的说明书全文共四篇示例，供读者参考第一篇示例：盐酸左沙丁胺醇雾化吸入溶液说明书一、药品名称二、成分每1毫升含有盐酸左沙丁胺醇相当于左沙丁胺醇1毫克。

三、性状本品为透明无色溶液。

四、适应症盐酸左沙丁胺醇雾化吸入溶液主要用于治疗慢性阻塞性肺病（COPD）、支气管哮喘等呼吸系统疾病。

五、用法用量成人及12岁以上儿童：每次吸入1毫升（含左沙丁胺醇1毫克），每日3次。

六、注意事项1. 本品仅供雾化吸入使用，不得口服或注射。

2. 使用本品前请充分摇匀，以确保药物均匀混合。

3. 使用雾化器进行吸入时，请依照雾化器说明书操作。

4. 对本品过敏者禁用，过敏体质者慎用。

5. 忌与其他药物混用，避免药物相互作用。

6. 如出现不适症状，如心悸、震颤等，请立即停药并就医。

7. 在使用本品期间应避免饮酒，以免影响疗效。

七、不良反应使用过程中可能引起干咳、头痛、恶心等不良反应，如有不适请及时就医。

八、药物相互作用本品可能与其他药物发生相互作用，使用前请告知医生或药师正在使用的其他药物。

九、储存请将本品存放在阴凉干燥处，避免阳光直射。

十、生产企业XXX药业有限公司十一、有效期本品的有效期为36个月。

以上就是关于盐酸左沙丁胺醇雾化吸入溶液的说明书，如有不清楚的地方请咨询医生或药师。

祝您早日康复！第二篇示例：盐酸左沙丁胺醇雾化吸入溶液使用说明书二、主要成分：盐酸左沙丁胺醇、溶液剂三、适应症：用于治疗支气管哮喘和慢性阻塞性肺疾病（COPD）等呼吸系统疾病。

四、用法用量：1. 成人及12岁及以上的青少年：一次使用一瓶（2.5ml），每日三次。

2. 儿童：一次使用一瓶（2.5ml），每日三次。

五、使用方法：1. 打开药瓶盖，将药液倒入雾化器中。

2. 将雾化器紧贴口腔，深呼吸，慢慢吸入雾化药物。

3. 使用完毕后，及时清洗雾化器并晾干。

六、注意事项：1. 本品仅供雾化吸入使用，不得口服。

2. 使用前请检查药瓶封口是否完好，避免使用过期药物。

万托林(吸入用硫酸沙丁胺醇溶液)

万托林(吸入用硫酸沙丁胺醇溶液)【药品名称】商品名称：万托林通用名称：吸入用硫酸沙丁胺醇溶液英文名称：Salbutamol Sulfate Solution for Inhalation【成份】本药的主要成分是沙丁胺醇，其化学名为1-(4-羟基-3-羟甲基苯基)-2-(叔丁氨基)乙醇。

气雾剂的内容物为白色或微黄色混悬液。

雾化吸入液每毫升含有5 mg硫酸沙丁胺醇，其化学名为1-(4-羟基-3-羟甲基苯基)-2-(叔丁氨基)乙醇。

【适应症】本品主要用于缓解哮喘或慢性阻塞性肺部疾患（可逆性气道阻塞疾病）患者的支气管痉挛及急性预防运动诱发的哮喘或其他过敏原诱发的支气管痉挛【用法用量】本品只能经口腔吸入使用，对吸气与吸药同步进行有困难的患者可借助储雾器。

【不良反应】不良事件依照发生的系统，器官和发生率分别列出。

发生率定义为：非常常见(≥1/10)，常见(≥1/100且【禁忌】对本品中任何成分有过敏史者禁用【注意事项】哮喘的控制应常规按照阶梯治疗原则进行，并通过临床和肺功能试验监测患者的治疗反应。

支气管扩张剂不应该作为患有严重哮喘及不稳定性哮喘患者的唯一的或主要的治疗药物。

在哮喘控制中出现突然的和进行性的恶化提示有生命危险的可能时，应考虑使用或增加激素用量，被认为有危险的患者应监测其每日峰流速。

医生应该考虑给这些患者使用最大推荐剂量的吸入皮质激素和/或给予口服皮质激素进行治疗。

若需要更大剂量的短效支气管扩张药，特别是短效吸入型β2-激动剂以缓解症状，表明哮喘的控制恶化。

应告诫患者，如发现使用短效支气管扩张剂疗效下降或需使用比平时更大剂量，应去咨询医生。

在这种情况下，应重新评估患者的病情，并考虑加强抗炎治疗(如：加大吸入皮质激素的剂量或口服一个疗程皮质激素），必须采取常规的方式治疗严重恶化的哮喘。

若认为患者病情危险，则应改为监测每日晨起峰流速。

动物实验显示，一些拟交感神经药物在高剂量下会引起心脏反应。

吸入用伊洛前列素溶液(万他维)的说明书

吸入用伊洛前列素溶液(万他维)的说明书中老年人当中经常会听到某某患有心脑血管类疾病，这些老人的生命时刻都在被威胁着，通过输液的方式疏通血管是不科学的，相对来说药物治疗血栓等疾病效果不错。

我们在电视上经常会看到各种关于治疗心脑血管疾病的药物，面对众多的药物中，患者该怎么选择呢?现在就给您介绍下吸入用伊洛前列素溶液(万他维)这种治疗心脑血管疾病的药物，效果非常显著。

【药品名称】通用名称：吸入用伊洛前列素溶液商品名称：吸入用伊洛前列素溶液(万他维)英文名称：Iloprost Solution for Inhalation拼音全码：XiRuYongYiLuoQianLieSuRongYe(WanTaWei)【主要成份】伊洛前列素。

其化学名为：5-(E)-(1S,5S,6R,7R)-7-羟基-6-[(E)-(3S,4RS)-3-羟基-4-甲基-1-辛烯-6-炔基]-双环[3.3.0]辛-3-亚基-戊酸【成份】分子式：C22H32O4分子量：360.49【性状】本品为无色或微黄色的澄清液体，3毫升I型无色玻璃安瓿内含2毫升吸入用伊洛前列素溶液。

【适应症/功能主治】治疗中度原发性肺动脉高压。

【规格型号】(20μg:2ml)*5支【用法用量】成人每次吸入应从2.5微克开始(吸入装置中口含器所提供的剂量)。

可根据不同患者的需要和耐受性逐渐增加伊洛前列素剂量至5.0微克。

根据不同患者的需要和耐受性，每天应吸入伊洛前列素6-9次。

根据口含器与雾化器所需的药物剂量，每次吸入时间大约应为5-10分钟。

肾功能或肝功能不全患者肝功能异常以及肾功能衰竭需要血液透析的患者，伊洛前列素的清除率是降低的，应考虑减少用药剂量（参见[注意事项]以及[药代动力学]）。

疗程：长期治疗。

雾化器的使用：如果某种雾化器能达到下列标准，则认为它适用于本药溶液的雾化：液滴的中位空气动力学直径（MMAD）或中位直径（MMD）为3-4m；口含器输出剂量为：每次吸入伊洛前列素2.5或5ug；一个剂量为2.5或5ug伊洛前列素的雾化时间：大约为4-10分钟（为了避免全身性副作用，4分钟内输出的伊洛前列素不得超过5ug）。

(完整版)硫酸沙丁胺醇雾化吸入溶液说明书

【成份】化学名：1-(4-羟基-3-羟甲基苯基)-2-(叔丁氨基)乙醇的半硫酸盐分子式：C13H21NO3?1/2H2SO4分子量：288.35【性状】本品为无色或几乎无色澄清液体。

【适应症/功能主治】严重的支气管哮喘（哮喘持续状态）及对常规疗法治疗无效的慢性支气管痉挛。

【规格型号】0.1g:20ml【用法用量】本品只可在医生指导下，采用呼吸器或适当的驱动式喷雾器给药，切不可注射或口服。

1.间歇性用法：间歇性治疗每日重复4次，应从低剂量开始。

2．连续性治疗：将本品以注射用生理盐水稀释成每毫升含50μg~100μg沙丁胺醇的溶液, 雾化吸入的通常给药速率为1mg/小时，最高可增至2mg/小时。

【不良反应】雾化吸入本品可产生下列不良反应：肌肉震颤（通常表现为手颤），头晕，头痛，不安，失眠，心动过速，低钾血症，口、咽剌激感。

罕见下列不良反应：肌肉痉挛，过敏反应（血管性水肿、皮疹、支气管痉挛、低血压）。

【禁忌】对本品成份及其它肾上腺素受体激动药过敏者禁用。

【注意事项】1.下列情况应慎用：伴有心血管疾患（冠状动脉供血不足、心律不齐、高血压）、甲状腺机能亢进、糖尿病及惊厥患者。

吸入用硫酸沙丁胺醇溶液说明书

吸入用硫酸沙丁胺醇溶液以下内容仅供参考，请以药品包装盒中的说明书为准。

妊娠：Ｃ哺乳：Ｌ１吸入用硫酸沙丁胺醇溶液说明书【说明书修订日期】核准日期：2011年10月21日【药品名称】吸入用硫酸沙丁胺醇溶液【英文名称】SalbutamolSulfate Inhalation Solution【汉语拼音】XiruyongLiusuanshading'anchun Rongye【成份】本品主要成份为：沙丁胺醇。

【性状】本品为无色至淡黄色的澄清溶液。

【适应症】本品适用于对传统治疗方法无效的慢性支气管痉挛的治疗及严重的急性哮喘发作的治疗。

【规格】2.5ml：5mg(以沙丁胺醇计)【用法用量】本品应通过雾化器并在医生的指导下使用，不可注射或吞服。

沙丁胺醇对大多数患者的作用时间可持续4至6小时。

本品的治疗作用与不良反应之间具有很大的安全范围，然而，因为持续给药可能会引起用药剂量得不到控制，因此应优先选择以间歇给药法给予适量本品。

成人：可将2.5mg～5mg本品置于雾化器中，让患者吸入雾化的溶液，直至支气管得到扩张为止，该过程通常需3～5分钟。

某些成年患者可能需用较高剂量的沙丁胺醇。

剂量可高达10mg。

儿童：12岁以下儿童的最小起始剂量为2.5mg沙丁胺醇。

用药方式同成人。

某些儿童可能需要高达5.0mg的沙丁胺醇。

每日可重复四次。

使用方法本品只供吸入法使用，并配一适宜的雾化器。

可通过一个面罩。

T形装置或通过一气管导管吸入已经雾化的溶液。

可采用间歇性正压通气法，但只在极少情况有此需要。

当因肺换气不足而有缺氧危险时。

应在吸入的空气中加入氧气。

因许多雾化器产生的气流是连续的，雾化的药物很可能被释放至周围环境中。

故应在通气良好的房间中使用本品，特别是在医院内当数位患者同时使用雾化器时。

【不良反应】不良事件依照发生的系统，器官类别和发生率如下。

发生率定义为：非常常见(≥1/10)，常见(≥1/100且＜1/10)，不常见(≥1/1000且＜1/100)，罕见(≥1/10000且＜1/1000)，非常罕见(＜1/10000)包括个案报道。

沙丁胺醇雾化吸入溶液说明书

沙丁胺醇雾化吸入溶液说明书沙丁胺醇雾化吸入溶液是一种使用易便捷、作用快速、副作用较小的呼吸道解痉药物。

以下是有关该药的完整说明。

一、药物名称商品名称：沙丁胺醇雾化吸入溶液通用名称：沙丁胺醇雾化吸入剂二、药物成份每毫升溶液含沙丁胺醇0.5毫克。

三、药理作用沙丁胺醇为选择性β2受体激动剂，能够舒张支气管平滑肌，增加气道通透性，缓解支气管痉挛，改善呼吸功能。

四、适应症适用于治疗反复发作性哮喘、慢性支气管炎、急性支气管炎、支气管扩张等呼吸系统疾病。

同时还可以用于预防运动性哮喘。

五、使用方法1、准备工作：按照说明书组装好雾化器，将溶液倒入雾化器腔体中，连接好口罩或嘴唇口型。

2、使用方法：(1) 请按照医生建议使用药物。

(2) 按下雾化器开关，直接吸入呼入口，或戴上口罩进行吸入。

(3) 建议在安静状态下进行药物吸入，并且禁止将药物吸入过程中减速。

请注意：1、药物吸入过程中不得交谈或饮食。

2、吸入药物后请漱口以减少药物残留在口腔和喉部的可能性。

3、使用前请注意瓶身是否破损或液体变色等问题。

若出现异常，请不要使用该瓶溶液。

六、不良反应使用沙丁胺醇雾化吸入溶液可能会出现以下不良反应：1、心悸、手震、头晕等情况。

2、因过敏反应或不良反应导致的呼吸困难、咳嗽、荨麻疹等情况。

3、先兆流产等情况（临床罕见）。

七、禁忌证以下情况禁止使用沙丁胺醇雾化吸入溶液：1、对本品过敏者禁用。

2、妊娠34周以内的孕妇禁止使用本品。

3、有心律不齐、心动过缓、高血压等心血管疾病者慎用。

八、药物相互作用1、与其他选择性β受体阻滞剂合用时，可能会严重影响呼吸系统功能。

2、与利福平、噻嗪等利尿药合用时，可能会引起低钾血症。

3、与儿茶酚胺代谢抑制剂合用时，可能增加心理药物的毒性。

九、药物贮藏1、药品应置于阴凉、干燥处。

2、请勿放置在儿童接触得到的地方。

十、药物包装规格每瓶药品净重20ml，每盒6瓶装。

十一、生产企业生产企业：xx制药有限公司以上就是沙丁胺醇雾化吸入溶液的详细说明，希望您在使用药物时能够注意药品的正确使用方法，遵守医生的建议，在保证安全的前提下将疾病得到更好的缓解。

可必特(吸入用复方异丙托溴铵溶液)使用说明

可必特(吸入用复方异丙托溴铵溶液)【用法用量】本品可通过合适的雾化器或间歇正压通气机给药。

以下推荐剂量适用于成人(包括老年人)和12岁以上的青少年：1.急性发作期:大部分情况下1个小瓶即治疗剂量能缓解症状。

对于严重的病例1个小瓶治疗剂量不能缓解症状时，可使用2个小瓶药物进行治疗，但病人须尽快看医生或去就近的医院就诊。

2.维持治疗期:每天3～4次，每次使用1个小瓶即可。

3.使用说明：(1)本品只能通过合适的雾化装置吸入，不能口服或其它途径给药。

(2)按生产厂商要求或在医生指导下准备雾化器以加入雾化吸入剂，从药品条板上撕下一个小瓶，用力扭顶部，打开小瓶。

将小瓶中的药液挤入雾化器药皿中。

安装好雾化器，按说明书用药。

(3)雾化器使用完毕后，应按生产厂商说明书要求，弃去雾化器药皿中剩余药液并将雾化器清洗干净，以备下次使用。

4.由于本品不含防腐剂，因此，为避免药物被细菌污染，在药瓶打开后应立即使用，每次吸入治疗时应使用一新的小药瓶是非常重要的。

已开瓶的或有破损的药瓶应丢弃，不宜使用。

5.特别应提醒使用者注意的是：不要把本品与其它药品混在同一雾化器中使用。

【注意事项】极少病例报道，使用本品后可能会迅速发生过敏反应，如荨麻疹、血管水肿、皮疹、支气管痉挛和口咽部水肿。

眼部并发症。

当雾化的异丙托溴铵单独或与肾上腺素β2受体激动剂合用雾化剂进入眼睛时，有个别报告出现眼部并发症(如瞳孔散大、眼内压增高、闭角性青光眼、眼痛)。

眼睛疼痛或不适，视物模糊、结膜充血和角膜水肿所导致的红眼而视物有光晕或有色成像可能是急性闭角性青光眼的征象。

如果出现某些上述症状，应首先使用缩瞳药并立即求助医生。

患者应在指导下正确使用本品。

应注意避免使眼睛接触到药液或气雾。

建议患者通过口件吸入雾化溶液，如果得不到该装置，可以使用合适的雾化面罩。

特别提醒有青光眼倾向的患者应注意保护眼睛。

有以下疾患，特别是用药剂量超过推荐剂量时，应在权衡危险/利益后，慎重使用本品：尚未有效控制的糖尿病，近期心肌梗塞，严重的器质性心血管疾病，甲亢、嗜铬细胞瘤、闭角性青光眼高危者、前列腺肥大或膀胱癌颈部阻塞。

吸入用乙酰半胱氨酸溶液的说明书

吸入用乙酰半胱氨酸溶液的说明书1. 介绍吸入用乙酰半胱氨酸溶液是一种用于治疗呼吸道疾病的药物，它的主要成分是乙酰半胱氨酸。

乙酰半胱氨酸是一种氨基酸，它在人体内起着重要的生理作用，可以帮助清除呼吸道内的痰液，改善呼吸道通畅。

吸入用乙酰半胱氨酸溶液通常用于治疗慢性阻塞性肺疾病（COPD）和支气管哮喘等疾病。

2. 使用方法（1）按照医生的指导使用。

在使用吸入用乙酰半胱氨酸溶液之前，应该先交流医生，了解具体的使用方法和剂量。

（2）准备吸入装置。

将药液倒入吸入装置中，确保吸入装置清洁并且正常工作。

（3）吸入药液。

在使用吸入装置时，应该深呼吸，吸入药液到达肺部，然后缓慢呼气。

（4）注意事项。

在使用吸入用乙酰半胱氨酸溶液时，应该注意避免药液进入眼睛、口腔或皮肤，以免引起不良反应。

3. 适应症吸入用乙酰半胱氨酸溶液适用于慢性阻塞性肺疾病（COPD）和支气管哮喘等呼吸道疾病的治疗。

它可以帮助患者改善呼吸道通畅，减少呼吸困难和咳嗽等症状，提高生活质量。

4. 注意事项（1）过敏反应。

在使用吸入用乙酰半胱氨酸溶液时，如果出现过敏反应，如皮疹、呼吸困难等症状，应该立即停止使用并就医。

（2）药物相互作用。

在使用吸入用乙酰半胱氨酸溶液时，应该避免与其他药物混合使用，以免发生药物相互作用。

（3）副作用。

吸入用乙酰半胱氨酸溶液在使用过程中可能会出现头痛、咽痛、恶心等副作用，如果症状严重，应该交流医生。

5. 总结吸入用乙酰半胱氨酸溶液是一种重要的用于呼吸道疾病治疗的药物，它可以帮助患者改善呼吸道通畅，减轻症状，提高生活质量。

在使用时应该注意医生的指导，遵循使用方法，注意药物的剂量和注意事项，在使用过程中如有不适应该及时就医。

个人观点：吸入用乙酰半胱氨酸溶液作为一种治疗呼吸道疾病的药物，对于患有慢性阻塞性肺疾病（COPD）和支气管哮喘等疾病的患者来说，具有重要的意义。

它可以帮助患者减轻呼吸困难和咳嗽等症状，改善生活质量。

然而，在使用时应当注意药物的使用方法和注意事项，避免发生不良反应和药物相互作用。

吸入用复方异丙托溴铵溶液-详细说明书与重点

吸入用复方异丙托溴铵溶液英文名：Compound Ipratropium Bromide Solution for Inhalation汉语拼音：Xi Ru Yong Fu Fang Yi Bing Tuo Xiu An Rong Ye【成份】本品为复方制剂，其组份为：每小瓶（2．5ml）吸入用溶液含异丙托溴铵0．500mg（相当于异丙托溴铵一水合物0．522mg）和硫酸沙丁胺醇3．013mg（相当于沙丁胺醇碱2．500mg）。

【性状】无色或几乎无色的澄清液体。

【适应症】适用于需要多种支气管扩张剂联合应用的患者，用于治疗气道阻塞性疾病有关的可逆性支气管痉挛。

【规格】2.5ml/支【用法用量】本品可通过合适的雾化器或间歇正压通气机给药。

以下推荐剂量适用于成人(包括老年人)和12岁以上的青少年：急性发作期：大部分情况下1个小瓶即治疗剂量能缓解症状。

对于严重的病例1个小瓶治疗剂量不能缓解症状时，可使用2个小瓶药物进行治疗，但病人须尽快看医生或去就近的医院就诊。

维持治疗期：每天3～4次，每次使用1个小瓶即可。

特殊人群:由于缺少儿童用药资料，因此本品不适用于小儿患者。

尚未对肝和肾功能不全患者进行可必特用药研究，因此此类患者需慎用本品。

治疗哮喘时，应考虑同时使用抗炎药。

如果加大本品吸入量也未能很好地改善急性或快速恶化的呼吸困难，建议患者立即咨询医生或去附近医院就诊。

如果需要使用超过本品推荐的剂量来控制症状，应对该患者的治疗方案进行评估。

本品的治疗应当在医疗监督（如医院环境）下开始和给药。

仅在特殊情况下（如出现严重症状或者有使用经历的患者需要更高剂量），当低剂量的速效β-受体激动剂不足以缓解症状，且在与有临床经验的医生咨询后才建议在家中进行治疗。

本品的治疗通常应当从最低推荐剂量（1小瓶治疗剂量）开始。

在非常严重的病例中，可能需要2小瓶的剂量才能缓解症状。

当症状得到足够的缓解时，应当停止给药。

使用说明：本品只能通过合适的雾化装置吸入，不得口服或其他途径给药。

吸入溶液说明书

吸入溶液说明书
吸入溶液是一种用于治疗呼吸道疾病的药品，通常以液体形式存在，通过吸入方式进入呼吸道。

在使用吸入溶液之前，请仔细阅读说明书并遵循以下使用说明：
1. 适用人群：吸入溶液适用于呼吸道疾病患者，如哮喘、慢性阻塞性肺病等。

使用前请咨询医生或药师，确保药品适用于您的病情。

2. 使用方法：请按照医生的建议或说明书上的指示使用吸入溶液。

一般来说，您需要将吸入溶液倒入吸入器中，然后通过吸气将溶液吸入呼吸道。

在使用前请确保吸入器干净且未受到污染。

3. 剂量和频率：请按照医生的建议或说明书上的指示使用适量的吸入溶液。

通常，吸入溶液的使用频率为每天数次，具体取决于病情和药品的种类。

4. 注意事项：在使用吸入溶液时，请注意以下几点：
吸入溶液可能会引起一些副作用，如喉咙不适、咳嗽、呼吸困难等。

如果
出现这些症状，请立即停止使用并咨询医生。

吸入溶液可能会与其他药物相互作用，因此在使用前请咨询医生或药师。

请勿将吸入溶液用于其他用途或超过建议的剂量。

请将吸入溶液放在儿童无法接触的地方，并妥善保管。

5. 储存：请按照说明书上的指示储存吸入溶液。

一般来说，吸入溶液应该存放在干燥、阴凉的地方，避免阳光直射和高温。

总之，在使用吸入溶液时，请遵循说明书上的使用说明，并咨询医生或药师的意见。

如果您有任何疑问或不适，请及时咨询医生或药师。

吸入用氯化钠溶液说明书

吸入用氯化钠溶液说明书
吸入用氯化钠溶液是一种常见的药物，通常用于治疗呼吸道疾
病和炎症。

以下是关于吸入用氯化钠溶液的一些常见问题和回答：
1. 什么是吸入用氯化钠溶液？
吸入用氯化钠溶液是一种含有氯化钠（即食盐）的药物溶液，
通常用于通过吸入的方式直接作用于呼吸道。

2. 吸入用氯化钠溶液的主要作用是什么？
吸入用氯化钠溶液主要用于稀释和清洁呼吸道分泌物，帮助改
善呼吸道炎症和症状。

3. 什么病症适合使用吸入用氯化钠溶液？
吸入用氯化钠溶液通常用于治疗慢性阻塞性肺疾病（COPD）、
支气管炎、哮喘等呼吸道疾病，以及帮助稀释和清除呼吸道分泌物。

4. 如何正确使用吸入用氯化钠溶液？
通常情况下，吸入用氯化钠溶液是通过雾化器或喷雾器进行吸
入的。

使用前需要仔细阅读药品说明书或咨询医生，按照指示正确
使用。

5. 吸入用氯化钠溶液有哪些注意事项？
使用吸入用氯化钠溶液时，需要注意药物的保存、过期时间、
使用方法等，同时也需要注意可能的过敏反应和不良反应，如咳嗽、呼吸困难等，及时就医。

总之，吸入用氯化钠溶液是一种常用的治疗呼吸道疾病的药物，正确使用并注意相关注意事项对于治疗和管理呼吸道疾病非常重要。

在使用前请务必咨询医生或药剂师，严格按照医嘱使用。

万他维(吸入用伊洛前列素溶液)

万他维(吸入用伊洛前列素溶液)【药品名称】商品名称：万他维通用名称：吸入用伊洛前列素溶液英文名称：Iloprost Solution for Inhalation【成份】本品主要成分为伊洛前列素。

【适应症】治疗中度原发性肺动脉高压。

【用法用量】1.成人:每次吸入应从2.5微克开始(吸入装置中口含器所提供的剂量)。

可根据不同患者的需要和耐受性逐渐增加伊洛前列素剂量至5.0微克。

根据不同患者的需要和耐受性，每天应吸入伊洛前列素6-9次。

2.根据口含器与雾化器所需的药物剂量，每次吸入时间大约应为5-10分钟。

肾功能或肝功能不全患者,肝功能异常以及肾功能衰竭需要血液透析的患者，伊洛前列素的清除率是降低的，应考虑减少用药剂量。

【不良反应】除了由于吸入用药的局部不良反应如咳嗽加重外，吸入伊洛前列素的不良反应主要与前列环素药理学特性有关。

临床试验中最常见的不良反应包括血管扩张，头疼以及咳嗽加重。

非常常见的不良反应(100位患者中可能有10或者更多的人出现下述情况)：因血管扩张而出现潮热或者面部发红；咳嗽增加；血压降低（低血压）。

常见不良反应（100位患者中可能有1-10人出现下述情况）：头痛；颊肌痉挛（口腔开合困难）；晕厥：晕厥是该疾病的一种常见症状，临床试验中伊洛前列素治疗组与对照组晕厥的发生率无明显差异，但是也可能在使用本药时发生，请参见注意事项部分。

其他可能的反应：如果患者服用抗凝剂(抗凝血剂)，也许会发生微量的出血。

由于大部分肺动脉高压患者服用抗凝药物，常见出血事件（大部分为血肿）。

伊洛前列素组出血事件的发生频率与安慰剂对照组相比无明显差异。

【禁忌】以下患者禁用：对伊洛前列素或任何赋形剂过敏。

出血危险性增加的疾病（如活动性消化性溃疡，外伤，颅内出血或者其他出血），由于本药对血小板的作用可能会使出血的危险性增加。

患有心脏病的患者，如：严重心律失常、严重冠状动脉性心脏病、不稳定性心绞痛、发病6个月内的心肌梗塞、未予控制和治疗的或未在严密检测下的非代偿性心力衰竭、先天性或获得性心脏瓣膜疾病伴非肺动脉高压所致的有临床意义的心肌功能异常。