VOLIBRIS Film-coated tablet (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Volibris 5 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 5 mg of ambrisentan. Excipient(s) with known effect: Each tablet contains approximately 95 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately ...
Pharmaceutical form
Film-coated tablet (tablet). Pale-pink, square, convex, film-coated tablet with GS debossed on one side and K2C on the other side.
Therapeutic indications
Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy ...
Posology and method of administration
Treatment must be initiated by a physician experienced in the treatment of PAH. Posology Ambrisentan monotherapy Volibris is to be taken orally to begin at a dose of 5 mg once daily and may be increased ...
Contraindications
Hypersensitivity to the active substance, to soya, or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6). Women of child-bearing potential who are not using reliable contraception ...
Special warnings and precautions for use
Ambrisentan has not been studied in a sufficient number of patients to establish the benefit/risk balance in WHO functional class I PAH. The efficacy of ambrisentan as monotherapy has not been established ...
Interaction with other medicinal products and other forms of interaction
Ambrisentan does not inhibit or induce phase I or II drug metabolising enzymes at clinically relevant concentrations in in vitro and in vivo non-clinical studies, suggesting a low potential for ambrisentan ...
Fertility, pregnancy and lactation
Women of childbearing potential Ambrisentan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception ...
Effects on ability to drive and use machines
Ambrisentan has minor or moderate influence on the ability to drive and use machines. The clinical status of the patient and the adverse reaction profile of ambrisentan (such as hypotension, dizziness, ...
Undesirable effects
Summary of the safety profile The safety of ambrisentan has been evaluated as monotherapy and/or in combination in clinical trials of more than 1200 patients with PAH (see section 5.1). Adverse reactions ...
Overdose
There is no experience in PAH patients of ambrisentan at daily doses greater than 10 mg. In healthy volunteers, single doses of 50 and 100 mg (5 to 10 times the maximum recommended dose) were associated ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-hypertensives, other anti-hypertensives ATC code: C02KX02 Mechanism of action Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) ...
Pharmacokinetic properties
Absorption Ambrisentan is absorbed rapidly in humans. After oral administration, maximum plasma concentrations (C<sub>max</sub>) of ambrisentan typically occur around 1.5 hours post-dose under both fasted ...
Preclinical safety data
Due to the class primary pharmacologic effect, a large single dose of ambrisentan (i.e. an overdose) could lower arterial pressure and have the potential for causing hypotension and symptoms related to ...
List of excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Film coat: Polyvinyl alcohol (partially hydrolysed) Talc (E553b) Titanium dioxide (E171) Macrogol 3350 ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PVDC/aluminium foil blisters. Pack sizes with unit dose blisters of 10x1 or 30x1 film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
EU/1/08/451/001 EU/1/08/451/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 April 2008 Date of latest renewal: 24 April 2013
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