VIVANZA Film-coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Vivanza 5 mg film-coated tablets. Vivanza 10 mg film-coated tablets. Vivanza 20 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet of 5 mg film-coated tablets contains 5 mg of vardenafil (as hydrochloride). Each tablet of 10 mg film-coated tablets contains 10 mg of vardenafil (as hydrochloride). Each tablet of 20 mg film-coated ...
Pharmaceutical form
Film-coated tablet. <u>Vivanza 5 mg film-coated tablets:</u> Orange round tablets marked with v on one side and 5 on the other side. <u>Vivanza 10 mg film-coated tablets:</u> Orange round tablets marked ...
Therapeutic indications
Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vivanza to be ...
Posology and method of administration
Posology Use in adult men The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg or decreased ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is ...
Special warnings and precautions for use
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Prior to initiating ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on vardenafil <em>In vitro</em> studies Vardenafil is metabolised predominantly by hepatic enzymes via cytochrome P450 (CYP) isoform 3A4, with some contribution from ...
Fertility, pregnancy and lactation
Vivanza is not indicated for use by women. There are no studies of vardenafil in pregnant women. There are no fertility data available.
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. As dizziness and abnormal vision have been reported in clinical trials with vardenafil, patients should be aware ...
Undesirable effects
Summary of the safety profile The adverse reactions reported with Vivanza film-coated tablets or 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature. ...
Overdose
In single dose volunteer studies, doses up to and including 80 mg vardenafil (film-coated tablets) per day were tolerated without exhibiting serious adverse reactions. When vardenafil was administered ...
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction ATC code: G04BE09 Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction. In ...
Pharmacokinetic properties
Bioequivalence studies have shown that vardenafil 10 mg orodispersible tablet is not bioequivalent to vardenafil 10 mg film-coated tablets. Therefore the orodispersible formulation should not be used as ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
List of excipients
<u>Tablet core:</u> Crospovidone Magnesium stearate Microcrystalline cellulose Silica, colloidal anhydrous <u>Film coat:</u> Macrogol 400 Hypromellose Titanium dioxide (E171) Ferric oxide yellow (E172) ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PP/Aluminium foil blisters in cartons of 2, 4, 8, 12 and 20 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Bayer AG, 51368, Leverkusen, Germany
Marketing authorization number(s)
EU/1/03/249/001-004, 013 EU/1/03/249/005-008, 014 EU/1/03/249/009-012, 015
Date of first authorization / renewal of the authorization
Date of first authorisation: 4 March 2003 Date of latest renewal: 4 March 2008
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