WEGOVY Solution for injection (2024)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Wegovy 0.25 mg solution for injection in pre-filled pen. Wegovy 0.5 mg solution for injection in pre-filled pen. Wegovy 1 mg solution for injection in pre-filled pen. Wegovy 1.7 mg solution for injection ...

2. Qualitative and quantitative composition

Pre-filled pen, single-dose Wegovy 0.25 mg solution for injection: Each single-dose pre-filled pen contains 0.25 mg semaglutide* in 0.5 mL solution. One mL of solution contains 0.5 mg of semaglutide*. ...

3. Pharmaceutical form

Solution for injection (injection). Clear and colourless isotonic solution; pH=7.4.

4.1. Therapeutic indications

Adults Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass ...

4.2. Posology and method of administration

Posology Adults The maintenance dose of semaglutide 2.4 mg once-weekly is reached by starting with a dose of 0.25 mg. To reduce the likelihood of gastrointestinal symptoms, the dose should be escalated ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Dehydration Use of GLP-1 receptor ...

4.5. Interaction with other medicinal products and other forms of interaction

Semaglutide delays gastric emptying and could potentially influence the absorption of concomitantly administered oral medicinal products. No clinically relevant effect on the rate of gastric emptying was ...

4.6. Pregnancy and lactation

Women of childbearing potential Women of childbearing potential are recommended to use contraception when treated with semaglutide (see section 4.5). Pregnancy Studies in animals have shown reproductive ...

4.7. Effects on ability to drive and use machines

Semaglutide has no or negligible influence on the ability to drive or use machines. However, dizziness can be experienced mainly during the dose escalation period. Driving or use of machines should be ...

4.8. Undesirable effects

Summary of safety profile In four phase 3a trials, 2,650 adult patients were exposed to Wegovy. The duration of the trials were 68 weeks. The most frequently reported adverse reactions were gastrointestinal ...

4.9. Overdose

Overdose with semaglutide may be associated with gastrointestinal disorders which could lead to dehydration. In the event of overdose the patient should be observed for clinical signs and appropriate supportive ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, glucagon-like peptide-1 (GLP-1) analogues ATC code: A10BJ06 Mechanism of action Semaglutide is a GLP-1 analogue with 94% sequence homology ...

5.2. Pharmacokinetic properties

Compared to native GLP-1, semaglutide has a prolonged half-life of around 1 week making it suitable for once weekly subcutaneous administration. The principal mechanism of protraction is albumin binding, ...

5.3. Preclinical safety data

Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity or genotoxicity. Non-lethal thyroid C-cell tumours observed in rodents are ...

6.1. List of excipients

Pre-filled pen, single-dose: Disodium phosphate, dihydrate Sodium chloride Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections Pre-filled pen, FlexTouch: ...

6.2. Incompatibilities

In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

Pre-filled pen, single-dose: 1 year. Wegovy may be stored unrefrigerated for up to 28 days at a temperature not above 30°C. Discard the pen if it has been out of the refrigerator for more than 28 ...

6.4. Special precautions for storage

Store in a refrigerator (2°C-8°C). Keep away from the cooling element. Do not freeze. Pre-filled pen, single-dose: Store the pen in the original carton in order to protect from light. Pre-filled ...

6.5. Nature and contents of container

Pre-filled pen, single-dose: 1 mL glass syringe (type I glass) with attached stainless steel needle, rigid needle shield (type II/polyisoprene) and a rubber plunger (type I/chlorobutyl). Pre-filled ...

6.6. Special precautions for disposal and other handling

Wegovy should not be used if it does not appear clear and colourless. The pen should not be used if it has been frozen. Any unused medicinal product or waste material should be disposed of in accordance ...

7. Marketing authorization holder

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

8. Marketing authorization number(s)

EU/1/21/1608/001 EU/1/21/1608/002 EU/1/21/1608/003 EU/1/21/1608/004 EU/1/21/1608/005 EU/1/21/1608/006 EU/1/21/1608/007 EU/1/21/1608/008 EU/1/21/1608/009 EU/1/21/1608/010 EU/1/21/1608/011 EU/1/21/1608/012 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 06 January 2022

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