Curofen 50 mg/g Premix for Medicated Feeding Stuff for Pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fenbendazole

Available from:

Univet Limited

ATC code:

QP52AC13

INN (International Name):

Fenbendazole

Dosage:

50 milligram(s)/gram

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

fenbendazole

Therapeutic indications:

Not Currently Available

Authorization status:

Authorised

Authorization date:

2017-09-08

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Curofen 50 mg/g
Premix for Medicated Feeding Stuff
for Pigs (IE, CZ, EL, ES, HU, PL, PT, RO,
SK)
[Curazole 50 mg/g
Premix for Medicated Feeding Stuff
for Pigs (BE)]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Fenbendazole
50 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for Medicated Feeding stuff
A white powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of benzimidazole susceptible mature and immature (L
4
) forms of the following
nematodes of the gastrointestinal and respiratory tracts of pigs:
_Hyostrongylus rubidus _
(red stomach worm)
_Oesophagostomum _
spp. (nodular worms)
_Ascaris suum _
(eel worm)
_Trichuris suis _
(whip worm)
_Metastrongylus apri _
(Lungworm)
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they
increase the risk of development
of resistance and could ultimately result in ineffective therapy:

Too frequent and repeated use of anthelmintics from the same class,
over an extended period of
time.

Underdosing, which may be due to underestimation of body weight,
misadministration of the
product, or lack of calibration of the dosing device (if any).
2
Suspected clinical cases of resistance to anthelmintics should be
further investigated using appropriate
tests (e.g. Faecal Egg Count Reduction Test). Where the results of the
test(s) strongly suggest
resistance to a particular anthelmintic, an anthelmintic belonging to
another pharmacological class and
having a different mode of action should be used.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Not applicable
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
Embryotoxic effects cannot