Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, UK: VIRGAN Eye gel (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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 follows: ...

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

In the unopened container: 3 years. In the opened container: 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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: