Pays: Israël
Langue: anglais
Source: Ministry of Health
INSULIN GLULISINE
SANOFI ISRAEL LTD
A10AB06
SOLUTION FOR INJECTION
INSULIN GLULISINE 100 U/ML
S.C
Required
SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY
INSULIN GLULISINE
INSULIN GLULISINE
Treatment of adults, adolescents and children, 6 years or older with diabetes mellitus, where treatment with insulin is required.
2020-05-31
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_APIDRA-SPC-18.0 _ _ _ 1 1. NAME OF THE MEDICINAL PRODUCT APIDRA 100 Units/ml, solution for injection in a vial. APIDRA 100 Units/ml, solution for injection in a prefilled pen SoloStar. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg). _APIDRA 100 Units/ml, solution for injection in a vial _ Each vial contains 10 ml of solution for injection, equivalent to 1000 Units. _APIDRA 100 Units/ml, solution for injection in a pre filled pen SoloStar _ Each pen contains 3 ml of solution for injection, equivalent to 300 Units. Insulin glulisine is produced by recombinant DNA technology in _Escherichia coli_. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _Apidra 100 Units/ml, solution for injection in a vial _ Solution for injection in a vial. _Apidra 100 Units/ml, solution for injection in a pre filled pen SoloStar_ Solution for injection in a pre filled pen SoloStar. 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 Posology 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). 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 dose of Apidra should be individually adjusted. Special populations _Renal impairment _ The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment. However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2). _ _ _Hepatic impairment _ The pharmacokinetic properties of insulin glulisine have not been investigated in patients with decreased liver function. In Lire le document complet