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KOMBOGLYZE Film-coated tablet (2023)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Komboglyze 2.5 mg/850 mg film-coated tablets. Komboglyze 2.5 mg/1,000 mg film-coated tablets.

2. Qualitative and quantitative composition

<u>Komboglyze 2.5 mg/850 mg film-coated tablets:</u> Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 850 mg of metformin hydrochloride. <u>Komboglyze 2.5 mg/1,000 mg film-coated tablets: ...

3. Pharmaceutical form

Film-coated tablet (tablet). <u>Komboglyze 2.5 mg/850 mg film-coated tablets:</u> Light brown to brown, biconvex, round, film-coated tablets, with 2.5/850 printed on one side and 4246 printed on the other ...

4.1. Therapeutic indications

Komboglyze is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients inadequately controlled on their maximally tolerated dose of ...

4.2. Posology and method of administration

Posology Adults with normal renal function (GFR ≥90 mL/min) For patients inadequately controlled on maximal tolerated dose of metformin monotherapy Patients not adequately controlled on metformin alone ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and ...

4.4. Special warnings and precautions for use

General Komboglyze should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Acute pancreatitis Use of DPP4 inhibitors has been associated with a risk ...

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

Co-administration of multiple doses of saxagliptin (2.5 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either saxagliptin or metformin in patients ...

4.6. Fertility, pregnancy and lactation

Pregnancy The use of Komboglyze or saxagliptin has not been studied in pregnant women. Studies in animals have shown reproductive toxicity at high doses of saxagliptin alone or in combination with metformin ...

4.7. Effects on ability to drive and use machines

Saxagliptin or metformin has a negligible influence on the ability to drive and use machines. When driving or using machines, it should be taken into account that dizziness has been reported in studies ...

4.8. Undesirable effects

There have been no therapeutic clinical trials conducted with Komboglyze tablets, however, bioequivalence of Komboglyze with co-administered saxagliptin and metformin has been demonstrated (see section ...

4.9. Overdose

No data are available with regard to overdose of Komboglyze. Saxagliptin Saxagliptin has been shown to be well-tolerated with no clinically meaningful effect on QTc interval or heart rate at oral doses ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, Combinations of oral blood glucose lowering drugs <b>ATC code:</b> A10BD10 Mechanism of action and pharmacodynamic effects Komboglyze combines ...

5.2. Pharmacokinetic properties

The results of bioequivalence studies in healthy subjects demonstrated that Komboglyze combination tablets are bioequivalent to co-administration of corresponding doses of saxagliptin and metformin hydrochloride ...

5.3. Preclinical safety data

Co-administration of saxagliptin and metformin A 3-month dog study and embryo-foetal development studies in rats and rabbits have been conducted with the combination of saxagliptin and metformin. Co-administration ...

6.1. List of excipients

<u>Tablet core:</u> Povidone K30 Magnesium stearate <u>Film coating:</u> <em>Komboglyze 2.5 mg/850 mg film-coated tablets:</em> Polyvinyl alcohol Macrogol 3350 Titanium dioxide (E171) Talc (E553b) Iron ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Alu/Alu blister. Pack sizes of 14, 28, 56 and 60 film-coated tablets in non-perforated blisters. Multipacks containing 112 (2 packs of 56) and 196 (7 packs of 28) film-coated tablets in non-perforated ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

8. Marketing authorization number(s)

<u>Komboglyze 2.5 mg/850 mg film-coated tablets:</u> EU/1/11/731/001 28 film-coated tablets EU/1/11/731/002 56 film-coated tablets EU/1/11/731/003 60 film-coated tablets EU/1/11/731/004 112 (2 packs of ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 24 November 2011 Date of latest renewal: 15 July 2016

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