Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
gentamicin sulfate 3000 IU/ml
Virbac S.A.
QS01AA11
Eye drops
gentamicin
Cats, Dogs
2009-11-30
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SOLIGENTAL 3000 IU/ml eye drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains : ACTIVE SUBSTANCE: Gentamicin ............................................................................. 3000 IU (as sulfate form) EXCIPIENTS: Sodium metabisulfite (E223)..................................................... 1.50 mg Parahydroxybenzoic acid ......................................................... 0.90 mg Trometamol ............................................................................ 6.00 mg Excipient .............................................................................qs 1 ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops. Sterile aqueous solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs and cats: Curative treatment of bacterial conjunctivitis and keratoconjunctivitis due to sensitive gentamicin bacteria, as supported by an antibiotic sensitivity assay. 4.3 CONTRAINDICATIONS Do not use in animal with known for hypersensibility to gentamicin, other aminoglycosides or sodium metabisulfite. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS To prevent any contamination of the solution, stop close the container after use. 2 SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS People with known hypersensitivity to aminoglycosides or sodium sulphite should avoid contact with the product. Wash hands after use. 4..6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNE Read the complete document