GENTAJECT 10% SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
09-07-2015
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Active ingredient:
GENTAMICIN
Available from:
Franklin Pharmaceuticals Ltd.
ATC code:
QJ01GB03
INN (International Name):
GENTAMICIN
Dosage:
100 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Equine Non Food
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
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 07/07/2015_
_CRN 7021440_
_page number: 1_
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 margin of safety has been established under the approved dosing regimen. As such,
gentamicin has a narrow margin of safety. The product should therefore only be used based on the benefit-risk
assessment by the responsible veterinary surgeon for each individual horse, taking into account alternative available
treatmen
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