FLUKIVER BOVIS 50 mg/ml Solution for Injection for cattle

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Closantel

から入手可能:

Elanco GmbH

ATCコード:

QP52AG09

INN（国際名）:

Closantel

投薬量:

50 milligram(s)/millilitre

医薬品形態:

Solution for injection

処方タイプ:

LM: Licensed Merchant as defined in relevant national legislation

治療領域:

closantel

認証ステータス:

Authorised

承認日:

2012-10-12

製品の特徴

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