QTERN Film-coated tablet (2023)
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Περιεχόμενα
Name of the medicinal product
Qtern 5 mg/10 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin. <u>Excipient with known effect:</u> Each tablet ...
Pharmaceutical form
Film-coated tablet (tablet). Light brown to brown, biconvex, 0.8 cm round, film-coated tablet, with 5/10 printed on one side, and 1122 printed on the other side, in blue ink.
Therapeutic indications
Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea ...
Posology and method of administration
Posology The recommended dose is one 5 mg saxagliptin/10 mg dapagliflozin tablet once daily (see sections 4.5 and 4.8). Missed dose If a dose is missed and it is ≥12 hours until the next dose, the dose ...
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 ...
Special warnings and precautions for use
Acute pancreatitis Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. Patients should be informed of the characteristic symptoms of acute pancreatitis; persistent, ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Diuretics Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4). Use with medicinal ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of saxagliptin and dapagliflozin in pregnant women. Studies in animals with saxagliptin have shown reproductive toxicity at high doses (see section 5.3). Studies ...
Effects on ability to drive and use machines
Qtern has no or 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 combined ...
Undesirable effects
Summary of the safety profile of saxagliptin plus dapagliflozin The combination of saxagliptin 5 mg and dapagliflozin 10 mg in 1169 adults with type 2 diabetes mellitus (T2DM) and inadequate glycaemic ...
Overdose
There is no information available on overdose with the saxagliptin/dapagliflozin fixed dose combination. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, combinations of oral blood glucose lowering drugs <b>ATC code:</b> A10BD21 Mechanism of action This medicinal product combines saxagliptin and ...
Pharmacokinetic properties
Saxagliptin/dapagliflozin combination Overall, the pharmacokinetics of saxagliptin and dapagliflozin were not affected in clinically relevant manner when administered as a fixed dose combination compared ...
Preclinical safety data
Non-clinical studies of either saxagliptin or dapagliflozin revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity or carcinogenicity. Saxagliptin produced ...
List of excipients
<u>Tablet core:</u> Microcrystalline cellulose (E460i) Croscarmellose sodium (E468) Lactose Magnesium stearate (E470b) Dental type silica (E551) <u>Film-coating:</u> Poly(vinyl alcohol) (E1203) Macrogol ...
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
PA/Alu/PVC-Alu blister. Pack sizes of 14, 28, and 98 film-coated tablets in calendar blisters. Pack size of 30 film-coated tablets in blisters. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
PA/Alu/PVC-Alu blister. Pack sizes of 14, 28, and 98 film-coated tablets in calendar blisters. Pack size of 30 film-coated tablets in blisters. Not all pack sizes may be marketed.
Marketing authorization holder
AstraZeneca AB, SE-151 85, Södertälje, Sweden
Marketing authorization number(s)
EU/1/16/1108/001 14 film-coated tablets EU/1/16/1108/002 28 film-coated tablets EU/1/16/1108/003 98 film-coated tablets EU/1/16/1108/004 30 film-coated tablets
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 July 2016 Date of latest renewal: 19 May 2021
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