GentaDug 85 mg/ml Solution for Injection for Horses, Cattle, Pigs, Dogs and Cats

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Gentamicin Sulphate

Inapatikana kutoka:

Bela-Pharm GmbH & Co. KG

ATC kanuni:

QJ01GB03

INN (Jina la Kimataifa):

Gentamicin Sulphate

Dawa fomu:

Solution for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cats, Cattle, Dogs, Horses, Pigs

Eneo la matibabu:

Antimicrobial

Idhini hali ya:

Authorized

Idhini ya tarehe:

2023-07-28

Tabia za bidhaa

Issued : July 2023
AN: 00003/2022
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GentaDug 85 mg/ml solution for injection for horses, cattle, pigs,
dogs and cats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1.0 ml solution for injection contains:
ACTIVE SUBSTANCE:
Gentamicin sulphate
85 mg
(equivalent to Gentamicin 50 mg)
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Methyl parahydroxybenzoate
0.9 mg
Propyl parahydroxybenzoate
0.1 mg
Sodium metabisulfite
Water for injection
A clear, colourless to slight yellow solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses (non-food producing horses), cattle, pigs, dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of the following infections:
Horses: for the treatment of infections of the lower respiratory tract
in horses caused
by aerobic Gram-negative bacteria.
Cattle: infections of the genital tract.
Calves: infections of the respiratory tract, infections of the
gastro-intestinal tract,
septicaemia, infections of the joints, infections of the auditory
meatus.
Pigs: infections of the respiratory tract, metritis, mastitis and
agalactia (MMA)
complex.
Piglets, weaners: infections of the respiratory tract, enzootic
pneumonia, infections
caused by _E. coli_.
Dogs, cats: infections of the respiratory tract, infections of the
gastro-intestinal tract,
infections of the kidneys, the urinary and the genital tract,
septicaemia, infections of
the auditory meatus.
Issued : July 2023
AN: 00003/2022
Page 2 of 9
3.3
CONTRAINDICATIONS
Do not use in animals with impaired renal function.
Do not use in dehydrated animals due to the risk of acute renal
failure.
Do not use in animals with disturbances of the vestibular or auditory
systems.
Do not use in cases of known hypersensitivity to the active substance
or to any of the
excipients.
Do not inject intravenously if used concomitantly w