Gentaject 10% Solution for Injection for Horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gentamicin sulfate

Available from:

Franklin Pharmaceuticals Ltd.

ATC code:

QJ01GB03

INN (International Name):

Gentamicin sulfate

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Horses, Non food-producing horses

Therapeutic area:

gentamicin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Gentaject 10% Solution for Injection for Horses.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, sterile, almost colourless,aqueous solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses (non food producing horses).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections of the lower respiratory tract in
horses caused by aerobic Gram-negative bacteria
susceptible to gentamicin.
4.3 CONTRAINDICATIONS
Do not use in known cases of renal dysfunction.
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
Do not exceed the proposed dosing regimen.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Not applicable
Each ml contains:
ACTIVE SUBSTANCE
Gentamicin (as gentamicin sulphate)
100 mg
EXCIPIENTS
Sodium Metabisulphite
1.0 mg
Sodium Methyl parahydroxybenzoate (E219) 0.9 mg
Sodium Propyl parahydroxybenzoate (E217)
0.1 mg
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Horses:
Gentamicin is well known to induce nephrotoxicity even at therapeutic
doses. There are also isolated reports of
ototoxicity with gentamicin. No marg