Clinagel-Vet, Gentamicin 0.30% w/w Eye Gel

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Gentamicin

Available from:

Ecuphar NV

ATC code:

QS01AA11

INN (International Name):

Gentamicin

Pharmaceutical form:

Gel

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

2001-11-23

Summary of Product characteristics

Revised 26 November 2008
AN: 01133/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clinagel-Vet, gentamicin 0.30% w/w eye gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE SUBSTANCE(S)_
_% W/W_
Gentamicin
0.30
(as Gentamicin sulphate)
_EXCIPIENT(S)_
Benzalkonium chloride
0.01
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye gel.
Clear, colourless, viscous gel.
4.
CLINICAL PARTICULARS
4.1.
_TARGET SPECIES_
Dogs and cats.
4.2.
_INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES_
Indicated for the treatment of infections of the external structures
of the eyes
and the eyelids caused by bacteria which are sensitive to gentamicin.
These
infections include bacterial conjunctivitis, keratitis and bacterial
kerato-
conjunctivitis, ulcers and abscesses of the cornea, blepharitis and
blepharo-
conjunctivitis, acute meibomitis and dacryocystitis.
Treatment of infectious complications caused by foreign material in
the cornea
or conjunctiva and infections associated with traumata caused by a
physical or
chemical agent.
4.3.
_CONTRA-INDICATIONS_
Hypersensitivity to one of the components of the product.
4.4.
_SPECIAL WARNINGS FOR EACH TARGET SPECIES_
For use under veterinary supervision only. In cases of long-term
treatment, re-
examination should be performed at intervals (see also 4.5).
Revised 26 November 2008
AN: 01133/2008
4.5.
I. _SPECIAL PRECAUTIONS FOR USE_ _IN ANIMALS_
As is the case for other antibiotics, long term topical treatment can
cause
overgrowth of non-sensitive organisms such as fungi.
Avoid contact between the tube and the eye.
For external use only.
Do not use concurrently with other antimicrobial ophthalmic products.
Due to likely variability (time, geographical) in the occurrence of
resistance of
bacteria for Gentamicin sulphate, bacteriological sampling and
susceptibility
testing are recommended.
II. _SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE _
_MEDICINAL PRODUCT TO THE ANIMALS_
People with known allergy (hypersensitiv