FLUKIVER 50 MG/ML SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOSANTEL (AS CLOSANTEL SODIUM DIHYDRATE PH. EUR.)

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QP52AG09

INN (International Name):

CLOSANTEL (AS CLOSANTEL SODIUM DIHYDRATE PH. EUR.)

Dosage:

50 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

LM: Licensed Merchant 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

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver 50 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Closantel (as Closantel sodium)
50 mg/ml
EXCIPIENTS
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
TREMATODES
_Fasciola hepatica_
_Fasciola gigantica_
NEMATODES
_Haemonchus placei_
_Bunostomum phlebotomum_
_Oesophagostomum radiatum_
ARTHROPODS
_Hypoderma bovis_
_Hypoderma lineatum_
4.3 CONTRAINDICATIONS
None.
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 shoul