VICTOZA Solution for injection (2023)
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Περιεχόμενα
Name of the medicinal product
Victoza 6 mg/ml solution for injection in pre-filled pen.
Qualitative and quantitative composition
1 ml of solution contains 6 mg of liraglutide*. One pre-filled pen contains 18 mg liraglutide in 3 ml. * human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in <em>Saccharomyces ...
Pharmaceutical form
Solution for injection. Clear and colourless or almost colourless, isotonic solution; pH=8.15.
Therapeutic indications
Victoza is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy ...
Posology and method of administration
Posology To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose should be increased to 1.2 mg. Some patients are expected to benefit ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Liraglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Liraglutide is not a substitute for insulin. Diabetic ketoacidosis has been reported ...
Interaction with other medicinal products and other forms of interaction
<em>In vitro</em>, liraglutide has shown very low potential to be involved in pharmacokinetic interactions with other active substances related to cytochrome P450 and plasma protein binding. The small ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of liraglutide in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Liraglutide ...
Effects on ability to drive and use machines
Victoza has no or negligible influence on the ability to drive and use machines. Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when ...
Undesirable effects
Summary of the safety profile In five large long-term clinical phase 3a trials over 2,500 adult patients have received treatment with Victoza alone or in combination with metformin, a sulfonylurea (with ...
Overdose
From clinical trials and marketed use, overdoses have been reported of up to 40 times (72 mg) the recommended maintenance dose. Events reported included severe nausea, vomiting, diarrhoea and severe hypoglycaemia. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, glucagon-like peptide-1 (GLP-1) analogues <b>ATC code:</b> A10BJ02 Mechanism of action Liraglutide is a GLP-1 analogue with 97% sequence homology ...
Pharmacokinetic properties
Absorption The absorption of liraglutide following subcutaneous administration is slow, reaching maximum concentration 8–12 hours post dosing. Estimated maximum liraglutide concentration was 9.4 nmol/l ...
Preclinical safety data
Non-clinical 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 were seen in 2-year ...
List of excipients
Disodium phosphate dihydrate Propylene glycol Phenol Water for injections
Incompatibilities
Substances added to Victoza may cause degradation of liraglutide. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
30 months. <u>After first use:</u> 1 month.
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Store away from the freezer compartment. After first use: Store below 30°C or store in a refrigerator (2°C–8°C). Do not freeze. Keep the cap on the pen ...
Nature and contents of container
Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polyolefin and polyacetal. Each pen ...
Special precautions for disposal and other handling
Victoza should not be used if it does not appear clear and colourless or almost colourless. Victoza should not be used if it has been frozen. Victoza can be administered with needles up to a length of ...
Marketing authorization holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Marketing authorization number(s)
EU/1/09/529/001-005
Date of first authorization / renewal of the authorization
Date of first authorisation: 30 June 2009 Date of last renewal: 11 April 2014
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