Gabbrovet 140 mg/ml solution for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paromomycin

Available from:

Ceva Santé Animale

ATC code:

QA07AA06

INN (International Name):

Paromomycin

Dosage:

140 milligram(s)/millilitre

Pharmaceutical form:

Solution for use in drinking water/milk

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

paromomycin

Therapeutic indications:

Antibiotics

Authorization status:

Authorised

Authorization date:

2018-04-13

Summary of Product characteristics

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gabbrovet 140 mg/ml solution for use in drinking water, milk or milk
replacer for pre-ruminant cattle
and pigs [FR AT BE BG HR CY CZ DK EE DE EL HU IE LV LT LU NL PL PT RO
SK SI ES IS
UK]
AMMINOFARMA BS 140 mg/ml solution for use in drinking water, milk or
milk replacer for pre-
ruminant cattle and pigs [IT]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Paromomycin (as sulfate)
140 mg
(equivalent to 140 000 IU of paromomycin activity)
(equivalent to approximately 200 mg of paromomycin sulfate)
EXCIPIENTS:
Benzyl alcohol
(E1519)
7.5 mg
Sodium metabisulfite
(E223)
3.0 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for use in drinking water, milk or milk replacer
Pale yellow to yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (pre-ruminant cattle), pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of gastro-intestinal infections caused by
_Escherichia coli _
susceptible to paromomycin.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to paromomycin,
other aminoglycosides or any of
the excipients.
Do not use in cases with impaired function of the kidneys or liver.
Do not use in ruminating animals.
Do not use in turkeys due to the risk of selection for antimicrobial
resistance in intestinal bacteria.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
3
The uptake of medication by animals can be altered as a consequence of
illness. In case of insufficient
uptake of water/milk animals should be treated parenterally using a
suitable injectable product
following the advice of the veterinarian.
The use of the product should be combined with good management
practices e.g. good hygiene, proper
ventilation, no overstocking.
Since the product is potentially ototoxic and nephrotoxic, it is
recommended to assess kidney function.
Special care should be taken when considering administrat