Virgan 0.15% eye gel

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Ganciclovir

Prieinama:

Thea Pharmaceuticals Ltd

ATC kodas:

S01AD09

INN (Tarptautinis Pavadinimas):

Ganciclovir

Dozė:

1.5mg/1gram

Vaisto forma:

Eye gel

Vartojimo būdas:

Ocular

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 11030300; GTIN: 3662042000393

Prekės savybės

OBJECT 1
VIRGAN
Summary of Product Characteristics Updated 13-Jan-2016 | Thea
Pharmaceuticals Ltd
1. Name of the medicinal product
VIRGAN 0.15% w/w eye gel.
2. 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.
3. Pharmaceutical form
Eye gel. Colourless opalescent gel.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of acute herpetic keratitis (dendritic and geographic
ulcers).
4.2 Posology and method of administration
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. The treatment does not
usually exceed 21 days.
_Use in the elderly:_
The dosage in the elderly is the same as in adults (see above). There
is no need to adjust the dosage in the
elderly as in clinical trials patients up to the age of 85 years have
been treated and no specific health
concerns were observed.
_Use in children:_
Use of the medicinal product in children under 18 years is not
recommended since no specific studies
have been conducted.
METHOD OF ADMINISTRATION
Ocular instillation.
4.3 Contraindications
Hypersensitivity to ganciclovir or acyclovir or to any of the
excipients listed in section 6.1.
4.4 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 studies were performed in immunodepressed
subjects.
Benzalkonium chloride may cause eye irritation. Avoid contact with
soft contact lenses. Remove contact
lenses prior to application and wait at least 15 min before
reinsertion. Known to discolour soft contact
lenses.
4.5 Interaction with other medicinal products and other forms of
interaction
If more than one topical ophthalmic drug is being used, the dru