SOLIGENTAL
Land: Frankrike
Språk: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Preparatomtale
(SPC)
09-04-2013
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Aktiv ingrediens:
gentamicin sulfate 3000 IU/ml
Tilgjengelig fra:
Virbac S.A.
ATC-kode:
QS01AA11
Legemiddelform:
Eye drops
Terapeutisk gruppe:
gentamicin
Terapeutisk område:
Cats, Dogs
Autorisasjon dato:
2009-11-30
Preparatomtale
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
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