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מקור: 衛生ç¦åˆ©éƒ¨é£Ÿå“藥物管ç†ç½² (Ministry of Health and Welfare, Food And Drug Administration)
INSULIN GLULISINE (HOE 901)
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INSULIN GLULISINE (HOE 901) (6820801410) eq to 100 U/mlMG
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SANOFI-AVENTIS DEUTSCHLAND GMBH INDUSTRIEPARK HOECHST D-65926 FRANKFURT AM MAIN GERMANY DE
insulin glulisine
糖尿病。
註銷日期: 2018/08/21; 註銷ç†ç”±: 自請註銷; 有效日期: 2020/05/06; 英文å“å: Apidra 100U/ml Solution for Injection, 10ml Vial
已註銷
2005-05-06
1 1. NAME OF THE MEDICINAL PRODUCT Apidra 100 Units/ml, solution for injection in a vial 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg). Each vial contains 10 ml of solution for injection, equivalent to 1000 Units. Insulin glulisine is produced by recombinant DNA technology in Escherichia coli. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a vial. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of adults, adolescents and children, 6 years or older with diabetes mellitus, where treatment with insulin is required. 4.2 Posology and method of administration The potency of this preparation is stated in units. These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues. See section 5.1 (Pharmacodynamics). Apidra should be given shortly (0-15 min) before or soon after meals. Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents. The dosage of Apidra should be individually adjusted. Administration Apidra should be given by subcutaneous injection or by continuous subcutaneous pump infusion. Apidra should be administered subcutaneously in the abdominal wall, thigh or deltoid or by continuous infusion in the abdominal wall. Injection sites and infusion sites within an-injection area (abdomen, thigh or deltoid) should be rotated from one injection to the next. The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables. Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2). Care should be taken to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be educated t ×§×¨× ×ת המסמך השל×