Gabbrovet 140 mg/ml Solution for Use in Drinking Water, Milk or Milk Replacer for Pre-ruminant Cattle and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Paromomycin Sulfate

Available from:

Ceva Animal Health Ltd

ATC code:

QA07AA06

INN (International Name):

Paromomycin Sulfate

Pharmaceutical form:

Solution for use in drinking water/milk

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2018-04-10

Summary of Product characteristics

Revised: November 2022
AN: 01048/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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
Pre-ruminant cattle:
Colibacillosis
Treatment of gastro-intestinal infections caused by _ Escherichia
coli_ susceptible to
paromomycin.
Cryptosporidiosis
Treatment of infections caused by diagnosed Cryptosporidium
parvum, by reduction
of diarrhoea and reduction of faecal oocyst shedding. Administration
has to start
within 24 hours after the onset of diarrhoea.
Pigs:
Colibacillosis
Treatment of gastro-intestinal infections caused by Escherichia coli
susceptible to
paromomycin
Revised: November 2022
AN: 01048/2022
Page 2 of 7
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
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