Parofor crypto 140 000 IU/ml oral solution for pre-ruminant cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paromomycin

Available from:

Huvepharma NV

ATC code:

QA07AA06

INN (International Name):

Paromomycin

Dosage:

140000 international unit(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

paromomycin

Authorization status:

Authorised

Authorization date:

2019-06-07

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Parofor crypto 140 000 IU/ml oral solution for pre-ruminant cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
140 000 IU of paromomycin activity
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
Methyl parahydroxybenzoate (E218)
1.0 mg
Propyl parahydroxybenzoate
0.1 mg
Sodium metabisulfite (E223)
4.0 mg
A clear yellow to amber solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (pre-ruminant).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Reduction in the occurrence of diarrhoea due to diagnosed
_Cryptosporidium parvum_
.
_ _
Calves should only receive the veterinary medicinal product upon
confirmation of cryptosporidial
oocysts in their faeces and before the onset of diarrhoea.
Paromomycin reduces faecal oocyst shedding.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, 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.
3.4
SPECIAL WARNINGS
In field studies investigating the effect of the veterinary medicinal
product on diarrhoea associated
with cryptosporidiosis, 23% to 32% of calves in treated groups
presented with diarrhoea, in
comparison to 53% to 73% of calves in untreated groups, during the
7-day treatment period.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
The use of the veterinary medicinal product should be combined with
good management practices e.g.
good hygiene, proper ventilation and no overstocking. Repeated use of
the veterinary medicinal
product on farms should be avoided by improving management practices
and through cleaning and
disinfection.
Aminoglycosides are considered as critically important in human
medicine. Use of the veterinary
medicinal product deviating from the instructio