VALGANCICLOVIR Film-coated tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Valganciclovir 450 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 496.3 mg of valganciclovir hydrochloride equivalent to 450 mg of valganciclovir (as free base). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Oval, biconvex, pink colored film-coated tablets approx16.83 7.95 mm.
Therapeutic indications
Valganciclovir is indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir is indicated ...
Posology and method of administration
Posology Caution – Strict adherence to dosage recommendations is essential to avoid overdose (see sections 4.4 and 4.9). Valganciclovir is rapidly and extensively metabolised to ganciclovir after oral ...
Contraindications
Valganciclovir is contra-indicated in patients with hypersensitivity to valganciclovir, ganciclovir or to any of the excipients listed in section 6.1. Valganciclovir is contra-indicated during breast-feeding ...
Special warnings and precautions for use
Cross-hypersensitivity Due to the similarity of the chemical structure of ganciclovir and that of aciclovir and penciclovir, a cross-hypersensitivity reaction between these drugs is possible. Caution should ...
Interaction with other medicinal products and other forms of interaction
Drug interactions with valganciclovir In-vivo drug interaction studies with valganciclovir have not been performed. Since valganciclovir is extensively and rapidly metabolised to ganciclovir; drug interactions ...
Fertility, pregnancy and lactation
Contraception in males and females As a result of the potential for reproductive toxicity and teratogenicity women of child-bearing potential must be advised to use effective contraception during and for ...
Effects on ability to drive and use machines
No studies on the effects on ability to drive and use machines have been performed. Adverse reactions such as seizures, dizziness and confusion have been reported with the use of valganciclovir and/or ...
Undesirable effects
Summary of the safety profile Valganciclovir is a prodrug of ganciclovir, which is rapidly and extensively metabolised to ganciclovir after oral administration. The undesirable effects known to be associated ...
Overdose
Overdose experience with valganciclovir and intravenous ganciclovir It is expected that an overdose of valganciclovir could possibly result in increased renal toxicity (see sections 4.2 and 4.4). Reports ...
Pharmacodynamic properties
Pharmacotherapeutic group: antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors ATC code: J05AB14 Mechanism of action Valganciclovir is an L-valyl ester (prodrug) ...
Pharmacokinetic properties
The pharmacokinetic properties of valganciclovir have been evaluated in HIV- and CMV-seropositive patients, patients with AIDS and CMV retinitis and in solid organ transplant patients. Dose proportionality ...
Preclinical safety data
Valganciclovir is a pro-drug of ganciclovir and therefore effects observed with ganciclovir apply equally to valganciclovir. Toxicity of valganciclovir in pre-clinical safety studies was the same as that ...
List of excipients
Tablet core: Povidone (K30) Crospovidone (Type A) Cellulose, microcrystalline (Vivapur Type 101) Stearic acid 50 Tablet film-coat: Opadry Pink 15B24005 containing: Hypromellose (3cP, 6 cP) Titanium dioxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 24 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
High density polyethylene (HDPE) bottles and child resistant polypropylene (PP) screw cap with induction heat sealing (with aluminum foil). The screw cap has a tamper evident. Pack size: One bottle containing ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Trading as: Zentiva, 12 New Fetter Lane, London EC4A 1JP, UK
Marketing authorization number(s)
PL 17780/0688
Date of first authorization / renewal of the authorization
22/10/2015
Date of revision of the text
20/11/2019
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