FLUKIVER BOVIS 50 MG/ML SOLUTION FOR INJECTION FOR CATTLE

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

CLOSANTEL SODIUM DIHYDRATE

Tersedia dari:

Elanco Animal Health, Eli Lilly and Company Limited

Kode ATC:

QP52AG09

INN (Nama Internasional):

CLOSANTEL SODIUM DIHYDRATE

Dosis:

50 Mg/Ml

Bentuk farmasi:

Solution for Injection

Jenis Resep:

LM-Licensed Merchant

Kelompok Terapi:

Bovine

Area terapi:

Closantel

Indikasi Terapi:

Endoparasiticide

Status otorisasi:

Authorised

Tanggal Otorisasi:

2012-10-12

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
FLUKIVER BOVIS 50 mg/ml Solution for Injection for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow to amber solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of liver fluke, gastro-intestinal nematodes and arthropods.
TREMATODES
_Fasciola hepatica_
_Fasciola gigantica_
NEMATODES
_Haemonchus placei_
_Bunostomum phlebotomum_
_Oesophagostomum radiatum_
ARTHROPODS
_Hypoderma bovis_
_Hypoderma lineatum_
Each ml contains:
ACTIVE SUBSTANCE:
Closantel
50
mg
(equivalent to closantel sodium dihydrate
54.375 mg)
EXCIPIENTS:
Propylene glycol
414.4 mg
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 31/07/2015_
_CRN 7020124_
_page number: 1_
4.3 CONTRAINDICATIONS
See section 4.11.
Do not administer to animals with known hypersensitivity to the active ingredient.
Not for i.v. or i.m. use.
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 su