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

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Paromomycin

Beschikbaar vanaf:

Huvepharma NV

ATC-code:

QA07AA06

INN (Algemene Internationale Benaming):

Paromomycin

Dosering:

140000 international unit(s)/millilitre

farmaceutische vorm:

Oral solution

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutisch gebied:

paromomycin

Autorisatie-status:

Authorised

Autorisatie datum:

2019-06-07

Productkenmerken

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