JALRA Tablet (2023)
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Περιεχόμενα
Name of the medicinal product
Jalra 50 mg tablets.
Qualitative and quantitative composition
Each tablet contains 50 mg of vildagliptin. <u>Excipient with known effect:</u> Each tablet contains 47.82 mg lactose (anhydrous). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to light yellowish, round (8 mm diameter), flat-faced, bevelled-edge tablet. One side is debossed with NVR, and the other side with FB.
Therapeutic indications
Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications ...
Posology and method of administration
Posology Adults When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a sulphonylurea, or in combination with insulin (with or ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
General Jalra is not a substitute for insulin in insulin-requiring patients. Jalra should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Renal impairment There ...
Interaction with other medicinal products and other forms of interaction
Vildagliptin has a low potential for interactions with co-administered medicinal products. Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of vildagliptin in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Patients who experience dizziness as an adverse reaction should avoid driving vehicles or using machines.
Undesirable effects
Summary of the safety profile Safety data were obtained from a total of 5 451 patients exposed to vildagliptin at a daily dose of 100 mg (50 mg twice daily) in randomised double-blind placebo-controlled ...
Overdose
Information regarding overdose with vildagliptin is limited. Symptoms Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Jalra for ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors <b>ATC code:</b> A10BH02 Vildagliptin, a member of the islet enhancer class, is a potent and selective ...
Pharmacokinetic properties
Absorption Following oral administration in the fasting state, vildagliptin is rapidly absorbed, with peak plasma concentrations observed at 1.7 hours. Food slightly delays the time to peak plasma concentration ...
Preclinical safety data
Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/kg (7-fold human exposure based on C<sub>max</sub>). Accumulation of foamy alveolar macrophages in the lung ...
List of excipients
Lactose, anhydrous Cellulose, microcrystalline Sodium starch glycolate (type A) Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in the original package in order to protect from moisture.
Nature and contents of container
Aluminium/Aluminium (PA/Al/PVC//Al) blister. Available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks containing 336 (3 packs of 112) tablets. Not all pack sizes ...
Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/08/485/001-011
Date of first authorization / renewal of the authorization
ate of first authorisation: 19 November 2008 Date of latest renewal: 28 November 2013
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