País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Triclabendazole; Ivermectin
Chanelle Pharmaceuticals Manufacturing Limited
QP54AA51
Triclabendazole; Ivermectin
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
ivermectin, combinations
2023-01-20
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tribamec Duo 50 mg/ml + 1 mg/ml Oral Suspension for Sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES : Triclabendazole 50 mg Ivermectin 1 mg EXCIPIENTS : Methyl parahydroxybenzoate (E218) 1.2 mg Propyl parahydroxybenzoate 0.5 mg Benzyl alcohol 27.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension A smooth white to off white uniform suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES For sheep over 3 months of age. 4.2 INDICATION FOR USE Treatment of mixed trematode (fluke) and nematode or arthropod infections due to gastrointestinal roundworms, lungworms, liver fluke and nasal bots. GASTROINTESTINAL NEMATODES (ADULT AND IMMATURE): _Haemonchus contortus, Teladorsagia (Ostertagia) circumcincta, Trichostrongylus _ spp _, Cooperia _ spp _, _ _Nematodirus _ spp including _N. battus_ , _Strongyloides papillosus, Oesophagostomum _ spp, and adult _Chabertia ovina. _ Inhibited larval stages and benzimidazole resistant strains of _Haemonchus contortus_ and _Teladorsagia _ _(Ostertagia) circumcincta_ are also controlled. LIVER FLUKE (MATURE, IMMATURE AND EARLY IMMATURE STAGES DOWN TO LESS THAN 1 WEEK OF AGE): _Fasciola hepatica _ _ _ LUNGWORMS (ADULT AND IMMATURE): _Dictyocaulus filaria _ _ _ NASAL BOTS (ALL STAGES): _Oestrus ovis _ 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active ingredients or 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 bodyweight, misadministration of the product or lack of calibration of the dosing device (if any). Suspected clinical cases of resistance to anthelmintics shou Leia o documento completo