| 简介：
部份中文干扰素γ处方资料（仅供参考）
通用名：注射用重组人干扰素γ
英文名：Recombinant Human Interferon γfor Injection
汉语拼音：Zhusheyong Chongzu Ren Ganraosu γ
主要组成成分：重组人干扰素γ
性状
本品为白色或微黄色疏松体，溶解后为澄明液体，不含有肉眼可见的不溶物。
药理毒理
干扰素γ具有较强的免疫调节功能，能增强抗原递呈细胞功能，加快免疫复合物的清除和提高吞噬异物功能，对淋巴细胞具有双向调节功能，提高抗体依赖的细胞毒反应，增强某些免疫活性细胞HLA棦蚶嗫乖泶铩６愿涡亲聪赴?/FONT>HSC）的活化、增生和分泌细胞外基质具有很强的抑制作用，并能抑制胶原合成，促进胶原降解。本品对类风湿性关节炎患者的滑膜纤维母细胞有抑制
长期毒性试验：狗肌内注射人用剂量4倍和20倍本品，大白鼠肌内注射人用剂量4倍、20倍和100倍本品，连续注射90天，全部动物健康存活，血液和骨髓涂片，各种生化指标，主要脏器病理切片检查，均未观察到毒性反应。
药代动力学
本品肌肉或皮下注射后被缓慢吸收达89％以上，皮下注射的消除半衰期为9.35小时，皮下注射后的浓度最高峰出现在3.4小时以后，最高峰浓度达37.4IU/mg。
适应症
本品批准用于治疗类风湿性关节炎。有临床结果表明治疗骨髓增生异常综合症，异位性皮炎和尖锐湿疣有效。美国FDA批准用于治疗转移性肾癌，创伤，异位性皮炎和肉芽肿。日本批准用于治疗肾细胞癌和蕈样真菌病。欧洲批准用于治疗类风湿性关节炎。
用法用量
本品应在临床医师指导下使用。每瓶制品用灭菌注射用水1ml溶解，皮下或肌内注射。开始时每天注射50万国际单位（IU），连续3～4天后，无明显不良反应，将剂量增到每天100万IU，第二个月开始改为隔天注射150～200万IU，总疗程3个月，如能延长疗程为6个月效果更好或遵医嘱。
不良反应
常见的不良反应是发热，常在注射后数小时出现，持续数小时自行消退，多数为低热（38℃以下），但也有少数发热较高，发热时患者有头痛，肌肉痛，关节痛等流感样症状。一般用药3～5天后即不再有发热反应。其他不良反应有疲劳，食欲不振，恶心等。常见的化验异常有白细胞、血小板减少和ALT升高，一般为一过性，能自行恢复。如出现上述患者不能耐受的严重不良反应，应减少剂量或停药，并给予必要的对症治疗。
禁忌
1.已知对干扰素制品、大肠杆菌来源的制品过敏者。
2.有心绞痛、心肌梗塞病史以及其他严重心血管病史者。
3.有其他严重疾病，不能耐受本品可能有的不良反应者。
4.癫痫和其他中枢神经系统功能紊乱者。
注意事项
1.凡有明显过敏体质，特别是对抗生素有过敏史者，本品应慎用，必须使用时应先用本品做皮肤试验（5000IU皮内注射），阴性者方可使用。在使用过程中如发生过敏反应，应立即停药，并给予相应治疗。
2.使用前应仔细检查瓶子，如瓶或瓶塞有裂缝、破损不可使用。在加入灭菌注射用水后稍加震摇，制品应溶解良好，如有不能溶解的块状或絮状物，不可使用。
3.制品溶解后应一次用完，不得分次使用。
孕妇及哺乳期妇女用药
本品在孕妇及哺乳期妇女中使用经验不多，在孕妇及哺乳期妇女使用中应十分谨慎，应在医师严密观察下应用。
儿童用药
本品在儿童中使用经验不多，在儿童中特别幼龄儿童中使用应十分谨慎，并在儿科医师严密观察下应用。
老年患者用药
本品可在老年患者中应用，但患有禁忌症项所列疾病者除外。对年老体衰者应慎重考虑是否能耐受本品可能发生的不良反应，应在医师严密观察下应用。必要时可先用小剂量，然后逐渐加大剂量可减少不良反应。
药物相互作用
未系统研究过重组人干扰素γ与其他药物的相互作用。本制品在临床应用中，应注意不要与抑制骨髓造血功能的药物同时使用。
药物过量
根据临床试验的研究结果，受试者可耐受400万IU/天以下的不同剂量。药物过量未做系统研究。
贮藏
2～8℃避光保存。
IMUNOMAX-gamma for Injection 300（イムノマックス‐γ注300）
Brand name : IMUNOMAX-gamma for Injection 300
Active ingredient: Interferon gamma-1a (Genetical recombination)
Dosage form: injection
Print on wrapping:
Effects of this medicine
This medicine inhibits cancer cell growth by acting on cancer cells directly. It improves immunity by activating lymphocytes, and it also damages cancer cells via immune reactions.
It is usually used for the treatment of kidney cancer.
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 or vaccines.
•If you are 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>>
•Kidney cancer (daily use): In general, for adults, this medicine is administered by intravenous drip infusion once a day, on consecutive days.
Kidney cancer (intermittent use): In general, for adults, this medicine is administered by intravenous drip infusion once a day, for 5 days, and then it is discontinued for 9 days. After this dosing schedule is repeated 2 times, this medicine is administered by intravenous drip infusion once a day, 3 times on alternate days, and then it is discontinued for 9 days. This dosing schedule is repeated more than 2 times.
•The schedule for use is determined according to your symptoms. Consult with your doctor about your concrete schedule for use.
Precautions while taking this medicine
•If you are breastfeeding, avoid breastfeeding while using this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include influenza-like symptoms (fever, chill, shiver, malaise), loss of appetite, nausea, vomiting, fever, facial hot flush, itch and hives. 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.
•fever, dry cough, breathing difficulty [interstitial pneumonia]
•feeling depressed and unmotivated, anxiety, sleeplessness, malaise [serious depression]
•swelling, shortness of breath, cough [heart failure]
•sore throat, fever, nose and/or gum bleeding, malaise, dizziness [leukocytopenia, thrombocytopenia, pancytopenia]
•thirstiness, excessive fluid intake, increased urine output [diabetes mellitus]
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
•[To family members] The patient may have serious depression. Therefore, consult with your doctor immediately if the symptoms such as sleeplessness and anxiety occur.
Shionogi & Co., Ltd.Injection
Published: 2/2014
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.
http://www.info.pmda.go.jp/go/pack/6399408F4020_1_20/
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