GALVUS MET Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
GALVUS MET 50 mg/850 mg tablet. GALVUS MET 50 mg/1 000 mg tablet.
2. Qualitative and quantitative composition
<u>GALVUS MET 50 mg/850 mg:</u> Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride. <u>GALVUS MET 50 mg/1 000 mg:</u> Each tablet contains 50 mg vildagliptin and 1 000 mg metformin ...
3. Pharmaceutical form
<u>GALVUS MET 50 mg/850 mg:</u> yellow, ovaloid bevelled edge, film-coated tablet imprinted with NVR on one side and SEH on the other side. <u>GALVUS MET 50 mg/1 000 mg:</u> dark yellow, ovaloid bevelled ...
4.1. Therapeutic indications
<u>For patients with Type 2 diabetes mellitus (T2DM):</u> GALVUS MET is indicated as an adjunct to diet and exercise in patients who are already stabilised with the combination of vildagliptin and metformin ...
4.2. Posology and method of administration
In using GALVUS MET do not exceed the maximum daily dose of vildagliptin (100 mg). The recommended starting dose of GALVUS MET should be based on the patients current regimen of vildagliptin and/or metformin ...
4.3. Contraindications
Hypersensitivity GALVUS MET is contraindicated in patients with known hypersensitivity to vildagliptin or metformin hydrochloride or to any of the excipients of GALVUS MET. Renal disease GALVUS MET is ...
4.4. Special warnings and precautions for use
GALVUS MET GALVUS MET is not a substitute for insulin in patients requiring insulin. GALVUS MET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. If metabolic ...
4.5. Interaction with other medicinal products and other forms of interaction
GALVUS MET No clinically relevant pharmacokinetic interaction was observed when vildagliptin (100 mg once daily) was co-administered with metformin hydrochloride (1 000 mg once daily). Medicine interactions ...
4.6. Pregnancy and lactation
Pregnancy Safety in pregnancy has not been established. Lactation Safety in lactation has not been established. GALVUS MET should not be administered to breastfeeding women.
4.7. Effects on ability to drive and use machines
GALVUS MET may cause dizziness. Patients who experience dizziness should avoid driving vehicles or using machines.
4.8. Undesirable effects
GALVUS MET The data presented here refers to the administration of vildagliptin and metformin as a free or fixed combination. Cases of angioedema have been reported on vildagliptin at a similar rate to ...
4.9. Overdose
Signs and symptoms Vildagliptin Reports include muscle pain, paraesthesia, fever and oedema. Increases in lipase levels (2 x ULN), creatine phosphokinase (CPK) levels, aspartate aminotransferase (AST), ...
5.1. Pharmacodynamic properties
<b>Pharmacological Classification:</b> A 21.2. Oral hypoglycaemics GALVUS MET GALVUS MET combines two antihyperglycaemic agents with different mechanisms of action to improve glycaemic control in patients ...
5.2. Pharmacokinetic properties
Absorption GALVUS MET In the bioequivalence studies of GALVUS MET at two dose strengths (50 mg/850 mg and 50 mg/1 000 mg), versus free combination of vildagliptin and metformin hydrochloride tablets at ...
6.1. List of excipients
<u>GALVUS MET 50 mg/850 mg:</u> Hydroxypropyl cellulose, hypromellose, iron oxide yellow, magnesium stearate, polyethylene glycol, talc, titanium dioxide. <u>GALVUS MET 50 mg/1000 mg:</u> Hydroxypropyl ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
18 Months.
6.4. Special precautions for storage
Store at or below 30 °C in the original package. Protect from moisture. Do not remove blister from carton until required for use.
6.5. Nature and contents of container
10, 30, 60, 120, 180 or 360s tablets in PA / AI / PVC (polyamide / aluminium / polyvinylchloride) blisters with an aluminium foil backing. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not Applicable.
7. Marketing authorization holder
Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
8. Marketing authorization number(s)
GALVUS MET 50 mg/850 mg tablet: 43/21.2/1055 GALVUS MET 50 mg/1 000 mg tablet: 43/21.2/1056 <u>Namibia:</u> GALVUS MET 50 mg/850 mg: 12/21.2/0128 NS2 GALVUS MET 50 mg/1 000 mg: 12/21.2/0129 NS2 <u>Botswana: ...
9. Date of first authorization / renewal of the authorization
Date of Registration of medicine: 27 July 2012
10. Date of revision of the text
06 July 2022
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