Gabbrovet Multi 140 mg/ml solution for use in drinking water/milk

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

Pharmaceutical form:

Solution for use in drinking water/milk

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

paromomycin

Authorization date:

2022-09-02

Summary of Product characteristics

2
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
[FR AT BE BG HR CY CZ EE DE EL HU IE IT LV LT LU NL PL PT RO SK SI ES
IS UKNI]
Paromocrypto 140 mg/ml solution for use in drinking water/ milk for
pre-ruminant cattle and pigs
[DK]
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 PRODUC
t
_ _
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.
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
3.3
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-re