Država: Singapur
Jezik: angleščina
Source: HSA (Health Sciences Authority)
Insulin glulisine
SANOFI-AVENTIS SINGAPORE PTE. LTD.
A10AB06
3.49 mg
INJECTION, SOLUTION
Insulin glulisine 3.49 mg
SUBCUTANEOUS
Prescription Only
Sanofi-Aventis Deutschland GmbH
ACTIVE
2005-05-31
APIDRA® 100 UNITS/ML _Insulin glulisine_ Solution for injection in vial [Sanofi-Aventis Logo] 1. NAME OF THE MEDICINAL PRODUCT Apidra 100Units/ml, solution for injection in 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 vial. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adults, adolescents and children of 6 years or above 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 b Preberite celoten dokument
APIDRA® 100 UNITS/ML _Insulin glulisine_ Solution for injection in vial [Sanofi-Aventis Logo] 1. NAME OF THE MEDICINAL PRODUCT Apidra 100Units/ml, solution for injection in 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 vial. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adults, adolescents and children of 6 years or above 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 ente Preberite celoten dokument