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

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Paromomycin

Available from:

Ceva Animal Health Ltd

ATC code:

QA07AA06

INN (International Name):

Paromomycin

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:

2022-08-24

Summary of Product characteristics

Issued: August 2022
AN: 00579/2021
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gabbrovet Multi 140 mg/ml solution for use in drinking water/ milk for
pre-ruminant
cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Paromomycin (as sulfate):
140.0 mg
(equivalent to 140 000 IU of paromomycin activity)
(equivalent to approximately 200 mg of paromomycin sulfate)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
Benzyl alcohol (E1519)
7.5 mg
Sodium metabisulfite (E223)
3.0 mg
Disodium edetate
Not applicable
Purified water
Not applicable
After dilution in water, clear colourless or light-yellow solution.
After dilution in milk, white to pale yellow liquid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (pre-ruminant cattle and newborn calves) and pigs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
CATTLE (PRE RUMINANT CATTLE):
_Colibacillosis_
Treatment of gastro-intestinal infections caused by _Escherichia coli_
susceptible to
paromomycin.
Issued: August 2022
AN: 00579/2021
Page 2 of 9
CATTLE (NEWBORN CALVES):
_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.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to paromomycin, to other
aminoglycosides or
to 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.
3.4
SPECIAL WARNINGS
Cross-resistance has been shown between paromomycin and neomycin in
Enterobac