Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
fenbendazole
Intervet International BV
QP52AC13
fenbendazole
Pigs; Chicken
Anthelmintics, , Benzimidazoles and related substances, fenbendazole
For the treatment and control of gastro-intestinal nematodes in pigs infected with:Ascaris suum (adult, intestinal and migrating larval stages);Oesophagostomum spp. (adult stages);Trichuris suis (adult stages).For the treatment of gastro-intestinal nematodes in chickens infected with:Ascaridia galli (L5 and adult stages);Heterakis gallinarum (L5 and adult stages);Capillaria spp. (L5 and adult stages).
Revision: 6
Authorised
2011-12-09
B. PACKAGE LEAFLET 14 PACKAGE LEAFLET: PANACUR AQUASOL 200 MG/ML SUSPENSION FOR USE IN DRINKING WATER FOR PIGS AND CHICKENS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Manufacturer responsible for batch release: Intervet Productions S.A. Rue de Lyons 27460 Igoville France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Panacur AquaSol 200 mg/ml suspension for use in drinking water for pigs and chickens Fenbendazole 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS The veterinary medicinal product is a white to off-white suspension for use in drinking water containing 200 mg/ml of fenbendazole and 20 mg/ml of benzyl alcohol (E1519). 4. INDICATION(S) Pigs: Treatment and control of gastro-intestinal nematodes in pigs infected with: _-_ _ _ _Ascaris suum _ (adult, intestinal and migrating larval stages) _-_ _ _ _Oesophagostomum _ spp. (adult stages) _-_ _ _ _Trichuris suis _ (adult stages) Chickens: Treatment of gastro-intestinal nematodes in chickens infected with: _-_ _ _ _Ascaridia galli _ (L5 and adult stages) _-_ _ _ _Heterakis gallinarum _ (L5 and adult stages) _-_ _ _ _Capillaria_ spp. (L5 and adult stages) 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS None known. 15 If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Pigs and chickens. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION In drinking water use. To ensure administration of the correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked. Pigs: The dose is 2.5 mg fenbendazole per kg body weight per day (equivalent to 0.0125 ml Panacur AquaSol). For the treatment and control of _Ascaris suum_ and _Oesophagostomum _ Lestu allt skjalið
_ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Panacur AquaSol 200 mg/ml suspension for use in drinking water for pigs and chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Fenbendazole 200 mg EXCIPIENT: Benzyl alcohol (E1519) 20 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off-white suspension for use in drinking water. The suspension particles are in the sub micron size range. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: Treatment and control of gastro-intestinal nematodes in pigs infected with: - _Ascaris suum _ (adult, intestinal and migrating larval stages) _- Oesophagostomum _ spp. (adult stages) - _Trichuris suis _ (adult stages) Chickens: Treatment of gastro-intestinal nematodes in chickens infected with: _- Ascaridia galli _ (L5 and adult stages) _- Heterakis gallinarum _ (L5 and adult stages) _- Capillaria _ spp. (L5 and adult stages) _ _ 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Parasitic resistance to any particular class of anthelmintic may develop following frequent repeated use of an anthelmintic of that class. 2 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals In the absence of available data, treatment of chicken less than 3 weeks of age should be based on a benefit/risk assessment by the responsible veterinarian. Special precautions to be taken by the person administering the veterinary medicinal product to animals This veterinary medicinal product may be toxic to humans after ingestion. Embryotoxic effects cannot be excluded. Pregnant women must take extra precautions when handling this veterinary medicinal product. Avoid contact with skin, eye and mucous membranes. People with known hypersensitivity to fenbendazole should avoid contact with the veterinary medicinal product. Personal protective equipment consisting of gloves should be worn when ha Lestu allt skjalið