Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

JALRA Tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

Jalra 50 mg tablets.

Qualitative and quantitative composition

Each tablet contains 50 mg of vildagliptin. Excipient with known effect: 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 in the treatment of type 2 diabetes mellitus in adults: As monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate ...

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 3,784 patients exposed to vildagliptin at a daily dose of 50 mg (once daily) or 100 mg (50 mg twice daily or 100 mg once daily) in ...

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

Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors ATC code: A10BH02 Vildagliptin, a member of the islet enhancer class, is a potent and selective DPP-4 inhibitor. ...

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 and other handling

No special 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

Date of first authorisation: 19 November 2008 Date of latest renewal: 28 November 2013

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.