VARGATEF Soft capsule (2020)
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
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
Vargatef 100 mg soft capsules. Vargatef 150 mg soft capsules.
Qualitative and quantitative composition
Vargatef 100 mg soft capsules: Each soft capsule contains 100 mg nintedanib (as esilate). Excipients with known effect: Each capsule contains 1.2 mg of soya lecithin. Vargatef 150 mg soft capsules: Each ...
Pharmaceutical form
Soft capsule (capsule). Vargatef 100 mg soft capsules: Peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and 100. Vargatef ...
Therapeutic indications
Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour ...
Posology and method of administration
Treatment with Vargatefshould be initiated and supervised by a physician experienced in the use of anticancer therapies. Posology The recommended dose of nintedanib is 200 mg twice daily administered approximately ...
Contraindications
Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Gastrointestinal disorders Diarrhoea was the most frequently reported gastro-intestinal adverse reaction and appeared in close temporal relationship with the administration of docetaxel (see section 4.8). ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. P-glycoprotein (P-gp) Nintedanib is a substrate of P-gp (see section 5.2). Co-administration with the potent P-gp inhibitor ketoconazole increased ...
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception Nintedanib may cause foetal harm in humans (see section 5.3). Women of childbearing potential being treated with Vargatef should be advised to avoid becoming ...
Effects on ability to drive and use machines
Vargatef has minor influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines during treatment with Vargatef.
Undesirable effects
Summary of the safety profile The safety data provided in the sections below are based on the global, double-blind randomised pivotal phase 3 trial 1199.13 (LUME-Lung 1) comparing treatment with nintedanib ...
Overdose
There is no specific antidote or treatment for nintedanib overdose. The highest single dose of nintedanib administered in phase I studies was 450 mg once daily. In addition, 2 patients had an overdose ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE31 Mechanism of action Nintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor ...
Pharmacokinetic properties
Absorption Nintedanib reached maximum plasma concentrations approximately 2-4 hours after oral administration as soft gelatin capsule under fed conditions (range 0.5-8 hours). The absolute bioavailability ...
Preclinical safety data
General toxicology Single dose toxicity studies in rats and mice indicated a low acute toxic potential of nintedanib. In repeat dose toxicology studies in rats, adverse effects (e.g. thickening of epiphyseal ...
List of excipients
Capsule content: Triglycerides, medium-chain Hard fat Soya lecithin (E322) Capsule shell: Gelatin Glycerol (85 %) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Printing ink: Shellac ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Aluminium/aluminium blisters containing 10 capsules each. Vargatef 100 mg soft capsules: Pack-sizes: 60 or 120 capsules, or multipack of 120 (2 60) capsules (2 cartons of 60 capsules each, wrapped in ...
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
Marketing authorization number(s)
Vargatef 100 mg soft capsules: EU/1/14/954/001 EU/1/14/954/002 EU/1/14/954/003 Vargatef 150 mg soft capsules: EU/1/14/954/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 November 2014 Date of latest renewal: 26 August 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
