VIRGAN Eye gel (2019)
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Περιεχόμενα
Name of the medicinal product
VIRGAN 0.15% w/w eye gel.
Qualitative and quantitative composition
1 g gel contains 1.5 mg ganciclovir (0.15% w/w). Excipient with known effect: benzalkonium chloride (75 µg/g). For a full list of excipients, see section 6.1.
Pharmaceutical form
Eye gel. Colourless opalescent gel.
Therapeutic indications
Treatment of acute herpetic keratitis (dendritic and geographic ulcers).
Posology and method of administration
Posology Instil one drop of gel in the inferior conjunctival sac of the eye to be treated, 5 times a day until complete corneal re-epithelialisation. Then 3 instillations a day for 7 days after healing. ...
Contraindications
Hypersensitivity to ganciclovir or acyclovir or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
This medicinal product is not indicated in the treatment of cytomegalovirus (CMV) retina infections. Efficacy in other viral types of keratoconjunctivitis has not been demonstrated. No specific clinical ...
Interaction with other medicinal products and other forms of interaction
If more than one topical ophthalmic drug is being used, the drugs should be administered at least fifteen minutes apart. VIRGAN should be instilled last. Although the quantities of ganciclovir passing ...
Pregnancy and lactation
There is insufficient experience regarding administration during pregnancy or lactation for evaluating the safety of VIRGAN during these periods. Teratogenicity and effect on fertility have been observed ...
Effects on ability to drive and use machines
Patients should refrain from driving a vehicle or operating machines on the occurrence of any visual disturbance or other visual symptomatology.
Undesirable effects
The following adverse reactions were reported during four clinical trials with VIRGAN 0.15% w/w eye gel (three phase IIB trials and one Phase III trial). Adverse events are categorised by frequency as ...
Overdose
There is practically no risk of adverse events due to accidental oral ingestion since a tube of 5g contains 7.5mg ganciclovir compared to the daily adult i.v. dose of 500-1000mg. In the unlikely event ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiinfectives, antivirals; ATC code: S01AD09 VIRGAN is a formulation of 0.15% ganciclovir in a transparent aqueous gel with a hydrophilic polymer base. Ganciclovir, 9-(1,3-dihydroxy-2-propoxymethyl)guanine ...
Pharmacokinetic properties
Studies of ocular pharmacokinetics in rabbits have shown a rapid and relevant penetration of ganciclovir into the cornea and the anterior segment of the eye, allowing concentrations higher than the effective ...
Preclinical safety data
Carcinogenic and mutagenic potential Carcinogenic effects in animals were only seen following long term systemic exposure (20 mg/kg orally) with 50-fold the systemic exposure of patients treated with VIRGAN. ...
List of excipients
Benzalkonium chloride Carbomer 974P Sorbitol Sodium hydroxide Purified water
Incompatibilities
Not applicable.
Shelf life
<u>In the unopened container:</u> 3 years. <u>In the opened container:</u> 4 weeks.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
5g tube (polyethylene-aluminium) with dropper nozzle (polyethylene) and screw cap (polyethylene).
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
LABORATOIRES THEA, 12 RUE LOUIS-BLERIOT, Z.I. DU BREZET, 63017 CLERMONT, FERRAND CEDEX 2, FRANCE
Marketing authorization number(s)
PL 20162/0006
Date of first authorization / renewal of the authorization
21/07/2000 / 20/07/2005
Date of revision of the text
10/01/2019
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