FLUBENDAZOLE ELANCO 50 MG/G ORAL POWDER FOR PIGS
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
26-05-2015
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Viambatanisho vya kazi:
FLUBENDAZOLE
Inapatikana kutoka:
Elanco Animal Health, Eli Lilly and Company Limited
ATC kanuni:
QP52AC12
INN (Jina la Kimataifa):
FLUBENDAZOLE
Kipimo:
50 mg/g
Dawa fomu:
Oral Powder
Dawa ya aina:
POM
Kundi la matibabu:
Porcine
Eneo la matibabu:
Flubendazole
Matibabu dalili:
Endoparasiticide
Idhini hali ya:
Authorised
Idhini ya tarehe:
2013-02-22
Tabia za bidhaa
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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