देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Fenbendazole
Univet Limited
QP52AC13
Fenbendazole
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
fenbendazole
2022-12-23
2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Curazole 100 mg/ml oral suspension for horses. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Fenbendazole 100 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t _ _ Methyl Parahydroxybenzoate (E218) 2 mg Propyl Parahydroxybenzoate (E216) 0.2 mg Sodium Metabisulphite 1 mg Polysorbate 80 Sodium Citrate Citric Acid Simethicone Emulsion Xanthan Gum Purified Water A white to off white suspension. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Horses. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the treatment of immature and mature stages of nematodes of the gastro-intestinal and respiratory tract, including encysted mucosal small strongyle larvae (cyathostomes). The veterinary medicinal product has an ovicidal effect on roundworm eggs. For the treatment of horses infected with adult large strongyles and adult and larval small strongyles. For the treatment of ascarids and _Oxyuris equi_ . 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS 3 Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infection based on its epidemiological features, for each individual animal / herd. Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole herd should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted s पूरा दस्तावेज़ पढ़ें