البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
FENBENDAZOLE
G.W. ORACEL INTERNAT. LTD
SUSPENSION
FENBENDAZOLE 200 MG / 1 ML
PER OS IN DRINKING WATER
Required
BIOVET JSC, BULGARIA
Treatment of chicken infected with Heterakis gallinarum (adult stages) or Ascardia galli (adult stages)
2023-05-23
PACKAGE LEAFLET FOR VETERINARY MEDICINAL PRODUCT This medicine is dispensed with a veterinarian’s prescription only For veterinary use only 1. NAME OF THE MEDICINE, ITS FORM AND STRENGTH: GALLIFEN VETERINARY Suspension for use in drinking water for chickens. 2. ACTIVE INGREDIENT AND OTHER INGREDIENTS 1 ml suspension contains: Fenbendazole 200 mg For the full list of excipients, see section 13 “Other Information”. 3. WHAT IS THE MEDICINE INTENDED FOR Treatment of chicken infected with Heterakis gallinarum (adult stages) or Ascardia galli (adult stages) . 4 . CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 5. ADVERSE REACTIONS None known. You can report side effects to the Ministry of Health by clicking on the link “Report side effects resulting from medicinal treatment” found on the homepage of the Ministry of Health website (www.health.gov.il), which will direct you to the online form for reporting side effects, or by entering the link: https://sideeffects.health.gov.il If you notice any side effects, or you think that the medicine has not worked, please inform your veterinary surgeon. 6 . TARGET SPECIES Chickens 7. DOSAGE, ROUTE AND METHOD OF ADMINISTRATION In drinking water use. Shake well before use. The dose is 1.0 mg fenbendazole per kg body weight per day (equivalent to 0.005 ml of the product). This dose has to be administered on 5 consecutive days. Dose calculation: The required daily amount of product is calculated from the total estimated body weight (kg) of the entire group of chickens to be treated. Please use the following formula: ml product/day = total estimated body weight (kg) of chickens to be treated x 0.005 ml 8. HOW TO USE THE MEDICINAL PRODUCT To ensure administration of the correct dose, body weight should be determined as accurately as possible. Before allowing animals to have access to the medicated water, the water delivery system should be drained, if possible, and flushed with the medicated water to ensure accurac اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Gallifen Veterinary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Fenbendazole 200 mg EXCIPIENTS: Sodium benzoate (E211) 3 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for use in drinking water. White to almost white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of chickens infected with _Heterakis gallinarum _(adult stages)_ _or_ Ascaridia _ _galli _(adult stages), 4.3 CONTRAINDICATIONS Do not use in known cases of 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. • Under dosing, 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. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The safety of the product at overdose has not been evaluated in chickens less than 3 weeks old . Use of the product deviating from the instructions in the SPC may increase the risk of development of resistance. Special precautions to be taken by the person administering the medicinal product to animals - Embryotoxic effects cannot be excluded. Pregnant women must take extra precautions when handling this veterinary medic اقرأ الوثيقة كاملة