Flukiver 50 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Closantel sodium

Available from:

Elanco GmbH

ATC code:

QP52AG09

INN (International Name):

Closantel sodium

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

closantel

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2012-10-12

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver 50 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
50 mg Closantel (as Closantel sodium)
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Propylene Glycol
Povidone
Citric Acid Monohydrate
Sodium Hydroxide
Citric Acid Water for Injections
Clear yellow solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For treatment of adult and immature liver flukes and haematophagous
nematodes in cattle.
TREMATODES
_Fasciola hepatica _
_Fasciola gigantica _
NEMATODES
_Haemonchus placei _
_Bunostomum phlebotomum _
_Oesophagostomum radiatum _
ARTHROPODS
_Hypoderma bovis _
_Hypoderma lineatum _
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Do not exceed the stated dose.
Care should be taken to ensure that all injection procedures are
correctly carried out and body weights
accurately assessed.
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.
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.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
None
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
Wash hands after administration. Take care to avoid accidental
self-administration.
Special preca