Χώρα: Σιγκαπούρη
Γλώσσα: Αγγλικά
Πηγή: HSA (Health Sciences Authority)
Insulin glargine
SANOFI-AVENTIS SINGAPORE PTE. LTD.
A10AE04
100Units/ml(10.9134mg/3ml)
INJECTION, SOLUTION
Insulin glargine 100Units/ml(10.9134mg/3ml)
SUBCUTANEOUS
Prescription Only
Sanofi-Aventis Deutschland GmbH
ACTIVE
2011-09-01
1 PODEVTA ® 100 UNITS/ML solution for Injection in cartridge _Insulin glargine_ [sanofi-aventis logo] 1) Solution for injection in cartridge to be used with OptiClik ® 2) Solution for injection in cartridge to be used with OptiPen ® THIS PACKAGE INSERT IS CONTINUALLY UPDATED: PLEASE READ CAREFULLY BEFORE USING A NEW PACK. IN CASE OF ANY QUESTION, PLEASE CONTACT YOUR PHYSICIAN OR PHARMACIST. COMPOSITION Each ml of the solution for injection contains 3.64mg of the active substance insulin glargine, corresponding to 100 IU human insulin. Each cartridge contains 3ml, equivalent to 300 IU. Insulin glargine is an insulin analogue produced by recombinant DNA technology using _Escherichia coli _(K 12 strains). For excipients, see section “List of excipients” PHARMACEUTICAL FORM Solution for injection. Podevta is a clear colourless solution. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS For the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required. POSOLOGY AND METHOD OF ADMINISTRATION Podevta contains insulin glargine an insulin analogue with a prolonged duration of action. It should be administered once daily at any time but at the same time each day. The dosage and timing of dose of Podevta should be individually adjusted. In patients with type 2 diabetes mellitus, Podevta can also be given together with orally active anti-diabetic medicinal products. CHILDREN In children, efficacy and safety of Podevta have only been demonstrated when given in the evening. Due to limited experience, the efficacy and safety of Podevta have not been demonstrated in children below the age of 6 years. TRANSITION FROM OTHER INSULINS TO PODEVTA When changing from a treatment regimen with an intermediate or long-actin Διαβάστε το πλήρες έγγραφο
1 PODEVTA ® 100 UNITS/ML solution for Injection in cartridge _Insulin glargine_ [sanofi-aventis logo] 1) Solution for injection in cartridge to be used with OptiClik ® 2) Solution for injection in cartridge to be used with OptiPen ® THIS PACKAGE INSERT IS CONTINUALLY UPDATED: PLEASE READ CAREFULLY BEFORE USING A NEW PACK. IN CASE OF ANY QUESTION, PLEASE CONTACT YOUR PHYSICIAN OR PHARMACIST. COMPOSITION Each ml of the solution for injection contains 3.64mg of the active substance insulin glargine, corresponding to 100 IU human insulin. Each cartridge contains 3ml, equivalent to 300 IU. Insulin glargine is an insulin analogue produced by recombinant DNA technology using _Escherichia coli _(K 12 strains). For excipients, see section “List of excipients” PHARMACEUTICAL FORM Solution for injection. Podevta is a clear colourless solution. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS For the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required. POSOLOGY AND METHOD OF ADMINISTRATION Podevta contains insulin glargine an insulin analogue with a prolonged duration of action. It should be administered once daily at any time but at the same time each day. The dosage and timing of dose of Podevta should be individually adjusted. In patients with type 2 diabetes mellitus, Podevta can also be given together with orally active anti-diabetic medicinal products. CHILDREN In children, efficacy and safety of Podevta have only been demonstrated when given in the evening. Due to limited experience, the efficacy and safety of Podevta have not been demonstrated in children below the age of 6 years. TRANSITION FROM OTHER INSULINS TO PODEVTA When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Podevta, a change of the dose of the basal insulin may be required and the concomitant anti- diabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast- acting insulin analogues o Διαβάστε το πλήρες έγγραφο