Parofor Crypto 140 000 IU/ml Oral Solution for Sheep and Goats

Land: Storbritannien

Språk: engelska

Källa: VMD (Veterinary Medicines Directorate)

Aktiva substanser:

Paromomycin

Tillgänglig från:

Huvepharma N.V.

ATC-kod:

QA07AA06

INN (International namn):

Paromomycin

Läkemedelsform:

Oral solution

Receptbelagda typ:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk grupp:

Goats, Sheep

Terapiområde:

Antimicrobial

Bemyndigande status:

Authorized

Tillstånd datum:

2019-06-20

Produktens egenskaper

Issued: June 2019
AN: 00152/2018
Page 1 of 5
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:
Methyl parahydroxybenzoate (E218)
1.0 mg
Propyl parahydroxybenzoate
0.1 mg
Sodium metabisulfite (E223)
4.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
A clear yellow to amber solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep (pre-ruminant lambs) and goats (pre-ruminant kids).
4.2
INDICATIONS FOR USE, SPECIFYING THE 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.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to paromomycin,
other
aminoglycosides or any of the excipients.
Do not use in cases with impaired function of the kidneys or liver.
Do not use in ruminating animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 4.5i).
In field studies investigating the effect of the 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.
Issued: June 2019
AN: 00152/2018
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Since the product is potentially ototoxic and nephrotoxic, it is
recommended to
assess kidney function, especially when considering administration of
the product to
newborn a