GentaDug 85 mg/ml solution for injection for horses, cattle, pigs, dogs and cats

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Gentamicin sulfate

Διαθέσιμο από:

Bela-Pharm GmbH & Co. KG

Φαρμακολογική κατηγορία (ATC):

QJ01GB03

INN (Διεθνής Όνομα):

Gentamicin sulfate

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

gentamicin

Ημερομηνία της άδειας:

2023-08-04

Αρχείο Π.Χ.Π.

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 PRODUC
t
_ _
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.
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 with muscle
relaxants.
Do not use concomitantly with bacteriostatic antibiotics.
Do not administer concurrently with diur