英文药名:Histaglobin S.C. inj(Histamine dihydrochloride)
中文药名:二盐酸组胺S.C.注射剂
生产厂家:日本脏器制药
ヒスタグロビン皮下注用
治疗类别名称 嗜酸性细胞浸润抑制 过敏性疾病的治疗剂(注射剂,干燥和小瓶) 批准日期:2009年9月 商標名 Histaglobin S.C. inj. 组成 成分含量(1瓶) 人免疫球蛋白为12mg 组胺二盐酸盐0.15μg 添加剂 硫代硫酸钠水合物32mg的 附件:溶解液 注射用水1.5ml 人免疫球蛋白组分是人血液来源的组分。 (原料血采血国家:日本,采血方法:献血) 另外,这种药物已被使用在制造过程中(肝素)的猪的肠粘膜来源的组分 操作注意事项 保存记录 由于这种药物是对应于特定生物制品,如果用这个药,药名(品牌名),序列号和生产代码(批号),使用日期,谁使用的名称的患者,记录地址等等,可以存储在至少20年。 药效药理 1. 嗜酸性细胞浸润抑制作用 这种药物每周两次在致敏小鼠,施用3周皮下,并在50〜150毫克/公斤/天的范围由T细胞依赖性嗜酸性粒细胞浸润过敏原诱导的剂量依赖性。在这种药物为150mg/ kg /天的剂量的时间看出抑制效果大致相同施用环孢菌素为100mg/ kg /天的时间。此外,观察到的混合组分组胺和单独给药γ-球蛋白(150毫克/千克/天当量)任何抑制效果。 2. 组胺释放的抑制作用 本剤在体外大鼠肥大细胞脱颗粒和组胺的释放,也能抑制从人白细胞的组胺释放。 3. 组胺防御力格兰特 通过这种药物的重复给药,赢得缺乏过敏性疾病的患者的组胺的防御力,已经提出以增强组胺的阻力。 适应病症 过敏性鼻炎,血管运动性鼻炎,过敏性皮肤疾病(特应性皮炎,荨麻疹,慢性湿疹) 支气管哮喘 用法用量 以原处方说明为准 包装规格 12mg/0.15μg 6瓶: 6安瓿(附 1.5毫升溶液) 30瓶:30安瓿(附 1.5毫升溶液) 60瓶:60安瓿(附 1.5毫升溶液)
制造厂商 日本脏器制药有限公司 完整处方资料来源:http://www.info.pmda.go.jp/go/pack/6399500D2037_1_06/ Histaglobin S.C. inj.(Histamine dihydrochloride) Histaglobin S.C. inj.(ヒスタグロビン皮下注用) Brand name : Histaglobin S.C. inj. Active ingredient: Histamine dihydrochloride Human immunoglobulin Dosage form: injection Print on wrapping: Effects of this medicine This medicine suppresses eosinophilic infiltration which causes aggravation/chronicity of allergic symptoms. It also suppresses release of histamines which cause allergy and increases resistance to histamine. It is usually used for allergic rhinitis, vasomotor rhinitis, allergic skin diseases (atopic dermatitis, hives, chronic eczema) and bronchial asthma. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you are in state of asthma attack, just before/during menstrual period or significantly debilitated. •If you are pregnant, possibly pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, inject subcutaneously once or twice a week for adults, once a week for children. •In general, inject 3 or 6 times for allergic rhinitis, vasomotor rhinitis, allergic skin diseases and 6 times for bronchial asthma. The subsequent treatment span depends on your response. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include hives, rash, asthma attack, temporally aggravation of nasal symptoms, itch, cough, respiratory distress and paroxysmal sneezing. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •reduction in blood pressure, skin/mucosa (lips/nails) turning bluish-purple to dark purple, respiratory distress [shock] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •This medicine is made from blood withdrawn in Japan. Since it is blood product, the virus cleaning process is performed. Virus infection by the injection has not been observed to date. However, risk of infection through the blood products can not be ruled out. Nippon Zoki Pharmaceutical Co., Ltd.Injection Published: 8/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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