VALACICLOVIR Film-coated tablet (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Valaciclovir 500 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains valaciclovir hydrochloride (hydrated) equivalent to 500 mg valaciclovir. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Blue, film-coated, capsule shaped tablets with a partial score bar on both sides containing F on one side and 9 and 3 on the other side. The tablet can be divided into equal doses. ...
Therapeutic indications
Varicella zoster virus (VZV) infections – herpes zoster Valaciclovir is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see sections 4.4). Valaciclovir ...
Posology and method of administration
Method of administration Oral use. The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food. Varicella zoster virus (VZV) ...
Contraindications
Hypersensitivity to valaciclovir or aciclovir or any of the excipients (listed in section 6.1).
Special warnings and precautions for use
Hydration status Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration, particularly the elderly. Use in patients with renal impairment and in elderly patients ...
Interaction with other medicinal products and other forms of interaction
The combination of valaciclovir with nephrotoxic medicinal products should be made with caution, especially in subjects with impaired renal function, and warrants regular monitoring of renal function. ...
Fertility, pregnancy and lactation
Pregnancy A limited amount of data on the use of valaciclovir and a moderate amount of data on the use of aciclovir in pregnancy is available from pregnancy registries (which have documented the pregnancy ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. The clinical status of the patient and the adverse reaction profile of Valaciclovir should be borne in mind when ...
Undesirable effects
The most common adverse reactions (ARs) reported in at least one indication by patients treated with valaciclovir in clinical trials were headache and nausea. More serious ARs such as thrombotic thrombocytopenic ...
Overdose
Symptoms and Signs Acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, decreased consciousness and coma, have been reported in patients receiving overdoses of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Nucleosides and nucleotides excluding reverse transcriptase inhibitors ATC code: J05AB11 Antivirals for systemic use. Mechanism of action Valaciclovir, an antiviral, is the L-valine ...
Pharmacokinetic properties
Absorption Valaciclovir is a prodrug of aciclovir. The bioavailability of aciclovir from valaciclovir is about 3.3 to 5.5-fold greater than that historically observed for oral aciclovir. After oral administration ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Valaciclovir did not affect ...
List of excipients
Core: Cellulose, microcrystalline Crospovidone (Type A) Povidone K90 Magnesium stearate Film-coating: Hypromellose Indigo carmine aluminium lake (E132) Titanium dioxide (E171) Macrogol 400 Polysorbate ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage condition.
Nature and contents of container
Clear PVC/PVdC Aluminium foil blister or HDPE bottle with PP closure. Pack sizes: Blister: 7, 10, 21, 30, 42, 50, 90 & 112 tablets. HDPE bottle: 30 & 500 tablets. Not all pack sizes may be marketed.
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
Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom
Marketing authorization number(s)
PL 16363/0271
Date of first authorization / renewal of the authorization
04/11/2011
Date of revision of the text
18.07.2016
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