FLUKIVER BOVIS 50 mg/ml Solution for Injection for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Closantel

Available from:

Elanco GmbH

ATC code:

QP52AG09

INN (International Name):

Closantel

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic area:

closantel

Authorization status:

Authorised

Authorization date:

2012-10-12

Summary of Product characteristics

Health Products Regulatory Authority
03 May 2019
CRN0091QM
Page 1 of 5
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
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.
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_
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.
Health Products Regulatory Authority
03 May 2019
CRN0091QM
Page 2 of 5
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.
The use of this product should be based on local (regional, farm)
epidemiologic