Parofor crypto 140 000 IU/ml oral solution for sheep and goats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paromomycin sulfate

Available from:

Huvepharma NV

ATC code:

QA07AA06

INN (International Name):

Paromomycin sulfate

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:

2019-07-05

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Parofor crypto 140 000 IU/ml oral solution for sheep and goats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
140 000 IU of paromomycin activity (as 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
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
Sheep (pre-ruminant) and goats (pre-ruminant).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Reduction of the severity and the duration of diarrhoea associated
with
_Cryptosporidium parvum_
in
individual animals confirmed to have cryptosporidial oocysts in their
faeces.
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
Lambs and goat kids should only receive the treatment upon
confirmation of cryptosporidial oocysts in
their faeces and as soon as possible after the onset of diarrhoea
(see section 3.5)
.
In field studies investigating the effect of the veterinary medicinal
product on diarrhoea associated
with cryptosporidiosis, the median duration of clinically relevant
diarrhoea was 3 days for treated
lambs compared to 6 days for untreated lambs and 4 days in treated kid
goats compared to 7 days for
the untreated goats, during the 7-day treatment period.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Since the veterinary medicinal product is potentially ototoxic and
nephrotoxic, it is recommended to
assess kidney function, especially when considering administration of
the veterinary medicinal product
to