FLUBENDAZOLE ELANCO 50 MG/G ORAL POWDER FOR PIGS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

FLUBENDAZOLE

제공처:

Elanco Animal Health, Eli Lilly and Company Limited

ATC 코드:

QP52AC12

INN (국제 이름):

FLUBENDAZOLE

복용량:

50 mg/g

약제 형태:

Oral Powder

처방전 유형:

POM

치료 그룹:

Porcine

치료 영역:

Flubendazole

치료 징후:

Endoparasiticide

승인 상태:

Authorised

승인 날짜:

2013-02-22

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flubendazole Elanco 50 mg/g oral powder for pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Flubendazole
50mg/g
EXCIPIENT(S):
Titanium dioxide (E171) 20mg/g
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Powder.
White to slightly yellow powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of helminthiasis due to mature and immature stages of the following nematodes of the gastro-intestinal tract:
_Ascaris suum_, (large roundworm), _Hyostrongylus rubidus_, (red stomach worm), _Oesophagostomum dentatum _(nodular
worm), _Trichuris suis _(whipworm), Strongyloides _ransomi _(threadworm) (adult).
Flubendazole is ovicidal.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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