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

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Fenbendazole

Fáanlegur frá:

Univet Ltd

ATC númer:

QP52AC13

INN (Alþjóðlegt nafn):

Fenbendazole

Lyfjaform:

Premix for medicated feeding stuff

Gerð lyfseðils:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Meðferðarhópur:

Pigs

Lækningarsvæði:

Anthelmintic

Leyfisstaða:

Authorized

Leyfisdagur:

2017-06-28

Vara einkenni

Revised July 2022
AN: 02175/2021 & 02176/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Curofen 50 mg/g Premix for Medicated Feeding Stuff for Pigs
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.
Revised July 2022
AN: 02175/2021 & 02176/2021
Page 2 of 6
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).
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