Ozempic (Novo Nordisk) 0,25 mg

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Ozempic 0.25 mg solution for injection in pre-filled pen.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ozempic 0.25 mg solution for injection

One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 2 mg of semaglutide* in 1.5 ml of solution. Each dose contains 0.25 mg of semaglutide in 0.19 ml of solution.

Ozempic 0.5 mg solution for injection

1.5 ml: One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 2 mg of semaglutide* in 1.5 ml of solution. Each dose contains 0.5 mg of semaglutide in 0.37 ml of solution.

3 ml: One ml of solution contains 0.68 mg of semaglutide*. One pre-filled pen contains 2 mg of semaglutide* in 3 ml of solution. Each dose contains 0.5 mg semaglutide in 0.74 mL of solution.

Ozempic 1 mg solution for injection

One mL of solution contains 1.34 mg semaglutide*. One pre-filled pen contains 4 mg semaglutide* in 3 mL of solution. Each dose contains 1 mg semaglutide in 0.74 mL of solution.

Ozempic 2 mg solution for injection

One mL of solution contains 2.68 mg semaglutide*. One pre-filled pen contains 8 mg semaglutide* in 3 mL of solution. Each dose contains 2 mg semaglutide in 0.74 mL of solution.

*Human analogue of glucagon-like peptide-1 (GLP-1) produced by recombinant DNA technology in Saccharomyces cerevisiae cells.

3. PHARMACEUTICAL FORM

Solution for injection (injectable).

Clear, colourless or almost colourless, isotonic solution; pH=7.4.

4. CLINICAL PARTICULARS
4.1. Therapeutic indications

Ozempic is indicated for the treatment of adults with type 2 diabetes mellitus, who have not been adequately controlled, as an adjunct to diet and exercise

• as monotherapy, when metformin is not considered appropriate due to intolerance or contraindications

• added to other medicinal products for the treatment of diabetes.

For the results of clinical trials regarding combinations, effects on glycaemic control and cardiovascular events, as well as the populations studied, see sections 4.4, 4.5 and 5.1.

4.2. Dosage and method of administration

Dosage

The starting dose is 0.25 mg semaglutide once a week. After 4 weeks, the dose should be increased to 0.5 mg once weekly. After at least 4 weeks on a dose of 0.5 mg once weekly, the dose may be increased to 1 mg once weekly to further improve glycaemic control. After a minimum of 4 weeks on a dose of 1 mg once weekly, the dose may be increased to 2 mg once weekly to further improve glycaemic control.

Semaglutide 0.25 mg is not a maintenance dose. Weekly doses higher than 2 mg are not recommended.

If Ozempic is added to existing treatment with metformin and/or a thiazolidinedione or a sodium-glucose cotransporter type 2 (SGLT2) inhibitor, the current doses of metformin and/or thiazolidinedione or SGLT2 inhibitor may be maintained unchanged.

If Ozempic is added to existing sulfonylurea or insulin therapy, a reduction in the dose of the sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (see sections 4.4 and 4.8).

Self-monitoring of blood glucose is not necessary to adjust the dose of Ozempic. Self-monitoring of blood glucose is necessary to adjust the dose of sulfonylurea and insulin, especially when starting treatment with Ozempic and reducing the insulin dose. A gradual reduction of the insulin dose is recommended.

Missed dose

If a dose is missed, it should be taken as soon as possible and within 5 days of the missed dose. If more than 5 days have elapsed, the missed dose should be skipped and the next dose should be taken as usual on the scheduled day. In either case, patients may then resume their usual once-weekly dosing schedule.

Changing the day of administration

The weekly dosing day may be changed if necessary, provided that the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, once-weekly dosing should be continued.

Special populations

Elderly

No dose adjustment is necessary based on age. Therapeutic experience in patients ≥75 years is limited (see section 5.2).

Renal impairment

No dose adjustment is necessary in patients with mild, moderate or severe renal impairment. Experience with the use of semaglutide in patients with severe renal impairment is limited. The use of semaglutide in patients with end-stage renal disease is not recommended (see section 5.2).

Hepatic impairment

No dose adjustment is necessary in patients with hepatic impairment. Experience with the use of semaglutide in patients with severe hepatic impairment is limited. Caution should be exercised when treating such patients with semaglutide (see section 5.2).

Paediatric population

The safety and efficacy of semaglutide in children and adolescents below 18 years of age have not yet been established. No data are available.

Method of administration

Subcutaneous route.

Ozempic should be injected subcutaneously into the abdomen, thigh or upper arm. The injection site can be changed without dose adjustment. Ozempic should not be administered intravenously or intramuscularly.

Ozempic should be administered once weekly at any time of day, with or without food.