Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Oxfendazole
Zoetis UK Limited
QP52AC02
Oxfendazole
Pulsatile-release intraruminal device
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Cattle
Anthelmintic
Authorized
1998-08-21
Revised: August 2020 AN: 00656/2020 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERSITICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Autoworm First Grazer 8750 mg Pulsatile-Release Intraruminal Device 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE CONSTITUENT mg/tablet Oxfendazole 1250.0 EXCIPIENTS Indigo Carmine Lake (E132) 20.0 Each intraruminal device contains: 7 tablets each containing oxfendazole 1250 mg 1 PVC cap segment 7 PVC tablet segments 8 silicone rubber sealing washers 1 magnesium alloy core 1 steel end-weight For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Pulsatile-release intraruminal device A cylindrical device 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle weighing between 100 kg and 400 kg 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For administration to cattle weighing between 100 kg and 400 kg at the time the bolus is given. Designed for dosing prior to turnout of cattle in their first grazing season. In grazing cattle, the device will deliver seven doses of oxfendazole for the treatment of both adult and immature gastro-intestinal roundworms and lungworms and tapeworms at regular intervals of approximately three weeks during a period of approximately 21 weeks, the first dose being released around three weeks after administration. The device thus delivers a programmed therapeutic anthelmintic dosing regime over a period of approximately twenty-one weeks. Revised: August 2020 AN: 00656/2020 Page 2 of 7 Oxfendazole is an established treatment for: Gastro-intestinal roundworms: _Telodorsagia (Ostertagia), Haemonchus, _ _Trichostrongylus, Nematodirus, Cooperia_, _Capillaria, Oesophagostomum, _ _Chabertia, Trichuris;_ Lungworms: _Dictyocaulus viviparus_; Tapeworms: _Moniezia_, heads and segments. At the recommended dose rate in cattle, oxfendazole is effective against inhibited/arrested larvae of _Cooperia_ and usually effective against inhibited/arrested larvae of _Ostertagia_. It is also ovicidal against nematode eggs. 4.3 CONTRA-INDICATIONS Do not administer to Read the complete document