OZEMPIC Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Ozempic 0.25 mg solution for injection in pre-filled pen. Ozempic 0.5 mg solution for injection in pre-filled pen. Ozempic 1 mg solution for injection in pre-filled pen.
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 semaglutide* in 1.5 ml solution. Each dose contains 0.25 mg of semaglutide ...
Pharmaceutical form
Solution for injection (injection). Clear and colourless or almost colourless, isotonic solution; pH=7.4.
Therapeutic indications
Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due ...
Posology and method of administration
Posology The starting dose is 0.25 mg semaglutide once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Semaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Semaglutide is not a substitute for insulin. There is no experience in patients with ...
Interaction with other medicinal products and other forms of interaction
Semaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. Semaglutide should be used with caution in patients receiving ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential are recommended to use contraception when treated with semaglutide. Pregnancy Studies in animals have shown reproductive toxicity (see section ...
Effects on ability to drive and use machines
Semaglutide has no or negligible influence on the ability to drive or use machines. When it is used in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid ...
Undesirable effects
Summary of safety profile In 8 phase 3a trials 4,792 patients were exposed to semaglutide. The most frequently reported adverse reactions in clinical trials were gastrointestinal disorders, including nausea ...
Overdose
Overdoses of up to 4 mg in a single dose, and up to 4 mg in a week have been reported in clinical trials. The most commonly reported adverse reaction was nausea. All patients recovered without complications. ...
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 to human GLP-1. ...
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, ...
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 ...
List of excipients
Disodium phosphate dihydrate Propylene glycol Phenol Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. In-use shelf life: 6 weeks. After first use: Store below 30°C or in a refrigerator (2°C to 8°C). Do not freeze Ozempic and do not use Ozempic if it has been frozen. Keep the pen cap on when the ...
Special precautions for storage
Before first use: Store in a refrigerator (2°C to 8°C). Keep away from the cooling element. Do not freeze Ozempic and do not use Ozempic if it has been frozen. For storage conditions after first opening ...
Nature and contents of container
1.5 ml or 3 ml glass cartridge (type I glass) closed at the one end with a rubber plunger (chlorobutyl) and at the other end with an aluminium cap with a laminated rubber sheet (bromobutyl/polyisoprene) ...
Special precautions for disposal and other handling
The patient should be advised to discard the injection needle after each injection and store the pen without an injection needle attached. This may prevent blocked needles, contamination, infection, leakage ...
Marketing authorization holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Marketing authorization number(s)
EU/1/17/1251/002 EU/1/17/1251/003 EU/1/17/1251/004 EU/1/17/1251/005 EU/1/17/1251/006
Date of first authorization / renewal of the authorization
Date of first authorisation: 08 February 2018
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