XULTOPHY insulin degludec 100 units/mL liraglutide 3.6 mg/mL solution for injection/pre-filled pen 3 mL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Insulin degludec, Quantity: 100 U/mL; Liraglutide, Quantity: 3.6 U/mL

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: phenol; zinc; glycerol; water for injections; sodium hydroxide; hydrochloric acid

Administration route:

Subcutaneous

Units in package:

5, 3, 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Xultophy is indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with metformin, with or without other oral glucose-lowering medicinal products (see Section 5.1 Pharmacodynamic Properties-Clinical trials and Section 4.4 Special Warnings and Precautions for Use? for available data on the different combinations).

Product summary:

Visual Identification: Clear, colourless solution provided in a 3 mL pre-filled multidose disposable pen.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-12-22