País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
Lixisenatide
SANOFI-AVENTIS SINGAPORE PTE. LTD.
A10BX10
50mcg/mL
INJECTION, SOLUTION
Lixisenatide 50mcg/mL
SUBCUTANEOUS
Prescription Only
Sanofi-Aventis Deutschland GmbH
ACTIVE
2014-10-30
1 1. NAME OF THE MEDICINAL PRODUCT Lyxumia 10 micrograms solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml). Excipient(s) with known effects: Each dose contains 54 micrograms of metacresol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with metformin, sulphon ylurea, or a basal insulin, metformin and sulphonylurea, and basal insulin and metformin when these, together with diet and exercise, do not provide adequate glycaemic control. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Starting dose: dosing is initiated at 10 mcg Lyxumia once daily for 14 days. Maintenance dose: a fixed maintenance dose of 20 mcg Lyxumia once daily is started on Day 15. Lyxumia 20 micrograms solution for injection is available for the maintenance dose. Lyxumia is administered once daily, within the hour prior to any meal of the day. It is preferable that the prandial injection of Lyxumia is performed before the same meal every day, when the most convenient meal has been chosen. If a dose of Lyxumia is missed, it should be injected within the hour prior to the next meal. When Lyxumia is added to existing metformin therapy, the current metformin dose can be continued unchanged. When Lyxumia is added to existing therapy of a sulphonylurea or a basal insulin, a reduction in the Leia o documento completo
1 1. NAME OF THE MEDICINAL PRODUCT Lyxumia 10 micrograms solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml). Excipient(s) with known effects: Each dose contains 540 micrograms of metacresol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with metformin, sulphonylurea, or a basal insulin, metformin and sulphonylurea, and basal insulin and metformin when these, together with diet and exercise, do not provide adequate glycaemic control. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Starting dose: dosing is initiated at 10 mcg Lyxumia once daily for 14 days. Maintenance dose: a fixed maintenance dose of 20 mcg Lyxumia once daily is started on Day 15. Lyxumia 20 micrograms solution for injection is available for the maintenance dose. Lyxumia is administered once daily, within the hour prior to any meal of the day. It is preferable that the prandial injection of Lyxumia is performed before the same meal every day, when the most convenient meal has been chosen. If a dose of Lyxumia is missed, it should be injected within the hour prior to the next meal. When Lyxumia is added to existing metformin therapy, the current metformin dose can be continued unchanged. When Lyxumia is added to existing therapy of a sulphonylurea or a basal insulin, a reduction in the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycaemia. Lyxumia should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia (see section 4.4). The use of Lyxumia does not require specific blood glucose monitoring. However, when used in combination with a sulphonylurea or a basal insulin, blood glucose monitorin Leia o documento completo