Genta 50 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gentamicin sulfate

Available from:

Kela n.v.

ATC code:

QJ01GB03

INN (International Name):

Gentamicin sulfate

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

gentamicin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2003-10-01

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2017
CRN000V9W
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Genta 50 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES
Gentamicin sulphate equivalent to Gentamicin
50
mg
EXCIPIENTS
Methyl Parahydroxybenzoate (E218)
0.45
mg
Propyl Parahydroxybenzoate (E216)
0.05
mg
Sodium Metabisulphite (E223)
1.4
mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Clear, almost colourless solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of septicaemia and infections of the
gastro-intestinal and
urogenital tracts and skin caused by organisms sensitive to
gentamicin.
4.3 CONTRAINDICATIONS
Do not use in animals with impaired renal function.
Do not use in animals with known hypersensitivity to the active
ingredient.
Do not use in pregnant animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
17 November 2017
CRN000V9W
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not administer in association with general anaesthetics or muscle
relaxant drugs,
in order to avoid neuromuscular block (respiratory paralysis).
Do not exceed the stated dose.
Use GENTA 50 Injectable with care in young animals.
Use of the product should be based on susceptibility testing of the
bacteria isolated
from the animal. If this is not possible, therapy should be based on
local (regional,
farm level) epidemiological information about susceptibility of the
target bacteria.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT TO
ANIMALS
Wash hands before and after treatment.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
- Transient swelling may occur at the injection site.
- Renal function disturbance, ototoxicity (deafness and balance
disturbances) may
occur after prolonged administration. In particular, young animals
appear to be
se