0.25 mg syringe
Composition: Active ingredients: ORSEMA 0.25 mg: each pre-filled syringe contains semaglutide 0.25 mg in 0.188 ml of solution. ORSEMA 0.50 mg: each pre-filled syringe contains semaglutide 0.50 mg in 0.375 ml of solution. Excipients: sodium hydrogen phosphate dihydrate, propylene glycol, phenol, water for injections.
Form: Solution for subcutaneous injection. Each pack contains 1 pre-filled syringe.
Indications: In adults with type 2 diabetes, as an adjunct to diet and exercise to improve glycaemic control: as monotherapy or in combination with other oral glucose-lowering medicines or insulin when previous treatment has not achieved adequate control. To reduce the risk of major cardiovascular events in patients with type 2 diabetes and high cardiovascular risk, in addition to standard cardiovascular treatment.
Contraindications: • Hypersensitivity to semaglutide or any excipient. • Personal or family history of medullary thyroid cancer. • Multiple endocrine neoplasia type 2 (MEN 2). • Type 1 diabetes. • Diabetic ketoacidosis. Use is contraindicated in the following groups and conditions because efficacy and safety data are absent or experience is limited: pregnancy; breastfeeding; age under 18; severe hepatic impairment; end-stage renal failure (creatinine clearance <15 ml/min); NYHA class IV chronic heart failure. Use with caution in moderate renal impairment.
Dosage: Inject subcutaneously into the abdomen, thigh or upper arm once weekly, at any time of day, with or without food. Do not administer intravenously or intramuscularly. Start with 0.25 mg once weekly for 4 weeks, then increase to 0.5 mg once weekly. If needed, after at least 4 weeks at 0.5 mg, increase to 1 mg once weekly. The 0.25 mg dose is not therapeutic; doses above 1 mg per week are not recommended. Administer a missed dose within 5 days. If more than 5 days have passed, skip it and administer the next dose on the usual day. When changing the injection day, allow more than 72 hours between doses.
Side effects: The most frequently reported reactions were nausea, diarrhoea, vomiting, decreased appetite, abdominal pain and constipation. Injection-site redness and itching, and lipodystrophy may occur. Hypoglycaemia may occur with insulin or sulfonylureas. See the instruction document for the full list.
Interactions: Delayed gastric emptying may affect absorption of oral medicines, particularly those requiring rapid absorption. Insulin or sulfonylurea doses may need to be reduced to lower the risk of hypoglycaemia. Do not mix with other medicines, including infusion solutions.
Warnings: Discontinue if pancreatitis is suspected; do not restart if acute pancreatitis is confirmed. Patients with diabetic retinopathy require monitoring. Use with caution in moderate renal impairment.
Age restrictions: Contraindicated under 18 years of age.
Pregnancy: Contraindicated during pregnancy and breastfeeding.
Manufacturer: INCEPTA PHARMACEUTICALS LTD
Storage conditions: Refrigerate at 2–8°C, away from the freezer compartment and out of reach of children. Protect from light and excessive heat. Do not freeze.
Shelf life: 3 years. Do not use after the expiry date.
Dispensing conditions: Prescription only.