ONGLYZA Film-coated tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Onglyza 2.5 mg film-coated tablets. Onglyza 5 mg film-coated tablets.
Qualitative and quantitative composition
<u>Onglyza 2.5 mg film-coated tablets:</u> Each tablet contains 2.5 mg saxagliptin (as hydrochloride). <u>Onglyza 5 mg film-coated tablets:</u> Each tablet contains 5 mg saxagliptin (as hydrochloride). ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Onglyza 2.5 mg film-coated tablets:</u> Onglyza 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets, with 2.5 printed on one side and 4214 ...
Therapeutic indications
Onglyza is indicated in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: as monotherapy when metformin is inappropriate due to intolerance or ...
Posology and method of administration
Posology The recommended dose of Onglyza is 5 mg once daily. When Onglyza is used in combination with insulin or a sulphonylurea, a lower dose of the insulin or sulphonylurea may be required to reduce ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, ...
Special warnings and precautions for use
General Onglyza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Onglyza is not a substitute for insulin in insulin-requiring patients. Acute ...
Interaction with other medicinal products and other forms of interaction
Clinical data described below suggest that the risk for clinically meaningful interactions with co-administered medicinal products is low. The metabolism of saxagliptin is primarily mediated by cytochrome ...
Fertility, pregnancy and lactation
Pregnancy The use of saxagliptin has not been studied in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Onglyza ...
Effects on ability to drive and use machines
Onglyza may have 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 with saxagliptin. ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions in placebo-controlled trials reported in ≥5% of patients treated with Onglyza 5 mg and more commonly than in patients treated ...
Overdose
Onglyza had no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose). In the event of an overdose, appropriate supportive ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes. Dipeptidyl peptidase 4 (DPP4) inhibitors <b>ATC code:</b> A10BH03 Mechanism of action and pharmacodynamic effects Saxagliptin is a highly potent ...
Pharmacokinetic properties
The pharmacokinetics of saxagliptin and its major metabolite were similar in healthy subjects and in patients with type 2 diabetes. Absorption Saxagliptin was rapidly absorbed after oral administration ...
Preclinical safety data
In cynomolgus monkeys saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) at doses ≥3 mg/kg/day. The no effect level (NOEL) ...
List of excipients
<u>Tablet core:</u> Lactose monohydrate Cellulose, microcrystalline (E460i) Croscarmellose sodium (E468) Magnesium stearate <u>Film-coating:</u> <em>Onglyza 2.5 mg film-coated tablets:</em> Polyvinyl alcohol ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Alu/Alu blister. Onglyza 2.5 mg film-coated tablets: Pack sizes of 14, 28, and 98 film-coated tablets in non-perforated calendar blisters. Pack sizes of 30x1 and 90x1 film-coated tablets in perforated ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
AstraZeneca AB, SE-151 85, Södertälje, Sweden
Marketing authorization number(s)
<u>Onglyza 2.5 mg film-coated tablets:</u> EU/1/09/545/011 14 film-coated tablets (calendar blister) EU/1/09/545/012 28 film-coated tablets (calendar blister) EU/1/09/545/013 98 film-coated tablets (calendar ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 October 2009 Date of latest renewal: 18 July 2014
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