VIPIDIA Film-coated tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Vipidia 6.25 mg film-coated tablets. Vipidia 12.5 mg film-coated tablets. Vipidia 25 mg film-coated tablets.
Qualitative and quantitative composition
<u>Vipidia 6.25 mg film-coated tablets:</u> Each tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin. <u>Vipidia 12.5 mg film-coated tablets:</u> Each tablet contains alogliptin benzoate ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Vipidia 6.25 mg film-coated tablets:</u> Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with TAK and ALG-6.25 printed in grey ...
Therapeutic indications
Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, ...
Posology and method of administration
Posology For the different dose regimens, Vipidia is available in strengths of 25 mg, 12.5 mg and 6.25 mg film-coated tablets. Adults (≥18 years old) The recommended dose of alogliptin is one tablet of ...
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 Vipidia should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Vipidia is not a substitute for insulin in insulin-requiring patients. Use with ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on alogliptin Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2). Interactions ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of alogliptin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a ...
Effects on ability to drive and use machines
Vipidia has no or negligible influence on the ability to drive and use machines. However patients should be alerted to the risk of hypoglycaemia especially when combined with a sulphonylurea, insulin or ...
Undesirable effects
Summary of the safety profile The information provided is based on a total of 9,405 patients with type 2 diabetes mellitus, including 3,750 patients treated with 25 mg alogliptin and 2,476 patients treated ...
Overdose
The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes mellitus (equivalent ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes; dipeptidyl peptidase 4 (DPP-4) inhibitors <b>ATC code:</b> A10BH04 Mechanism of action and pharmacodynamic effects Alogliptin is a potent and highly ...
Pharmacokinetic properties
The pharmacokinetics of alogliptin has been shown to be similar in healthy subjects and in patients with type 2 diabetes mellitus. Absorption The absolute bioavailability of alogliptin is approximately ...
Preclinical safety data
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and toxicology. The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies ...
List of excipients
<u>Tablet core:</u> Mannitol Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate <u>Film-coating:</u> Hypromellose Titanium dioxide (E171) Iron oxide red (E172) ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil. Pack sizes of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets. Not all pack ...
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
Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark medinfoEMEA@takeda.com
Marketing authorization number(s)
EU/1/13/844/001-030
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 September 2013 Date of latest renewal: 24 May 2018
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