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Xultophy 100units/ml insulin degludec+3.6mg/mL liraglutide solution for injection in a pre-filled pen
2014-12-22 11:44:10 来源: 作者: 【 】 浏览:594次 评论:0
1. Name of the medicinal product

Xultophy▼ 100 units/mL + 3.6 mg/mL solution for injection.

2. Qualitative and quantitative composition

1 mL solution contains 100 units insulin degludec* and 3.6 mg liraglutide*.

*Produced in Saccharomyces cerevisiae by recombinant DNA technology.

One pre-filled pen contains 3 mL equivalent to 300 units insulin degludec and 10.8 mg liraglutide.

One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection.

Clear, colourless, isotonic solution.

4. Clinical particulars
 
4.1 Therapeutic indications

Xultophy is indicated for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations).

4.2 Posology and method of administration

Posology

Xultophy is given once daily by subcutaneous administration. Xultophy can be administered at any time of the day, preferably at the same time of the day.

Xultophy is to be dosed in accordance with the individual patient's needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose.

Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concom

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