Pays: Royaume-Uni
Langue: anglais
Source: VMD (Veterinary Medicines Directorate)
Gentamicin Sulphate
Virbac
QS01AA11
Gentamicin Sulphate
Eye drops, solution
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs, Rabbits
Antimicrobial
Authorized
1993-01-29
Revised: August 2023 AN: 00016/2023 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tiacil 0.50% w/v Eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE(S) Gentamicin sulphate, (activity 600 IU/mg)………………………… % W/V 0.50 EXCIPIENTS Parahydroxybenzoic acid……………………………………………. 0.09 Disodium Edetate…………………………………………………….. 0.50 For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Eye drops, solution. Sterile, opalescent, aqueous solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats, dogs and rabbits 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of blepharitis, conjunctivitis, keratoconjunctivitis (including post- operative keratitis) and anterior uveitis, in dogs, cats and rabbits 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to gentamicin or other aminoglycosides. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Official, national and regional antimicrobial policies should be taken into Revised: August 2023 AN: 00016/2023 Page 2 of 4 account when the product is used. Where possible, in vitro sensitivity tests should be undertaken prior to treatment. Occular re-examination should be made at frequent intervals during prolonged therapy. Tiacil Ophthalmic solution may be used in case of corneal erosion or superficial ulcer. ii. Special precautions for the person administering the veterinary medicinal product to animals People with known allergy (hypersensitivity) to aminoglycosides should avoid contact with this product. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Rare cases of local intolerance (conjunctival inflammatory reactions) can be observed at the onset of treatment. In rare cases acute irritation and pain may occur. These reactions are transitory, and they disappear spontaneousl Lire le document complet