Changes to labels instructions: 250 g/kg Tylosin Oral Pre-mix products Table A-11: Changes to the varied label for Product 36806 Elanco AF0250 Tylan 250 Tylosin Phosphate Premix Species Indication Dose rate Changes Cattle Liver abscess 11 ppm Restraints: Add the restraint statement presented in Section 2.1. Poultry Necrotic enteritis 100 mg/kg feed 7 days Pigs Ileitis 40–100 g/tonne feed Enteric disease 40–100 g/tonne feed Table A-12: Changes to the varied label for Product 53752 Tyleco 250 Granular Species Indication Dose rate Changes Cattle Liver abscess 11 ppm Indications for Use: Delete increased growth stimulation and ‘For improving feed efficiency in pigs’ Pigs Ileitis 40–100 g/tonne feed Directions for Use: Enteric disease 40–100 g/tonne Delete all uses and recommended dose rates Stimulating growth feed for stimulating growth and improving feed efficiency in pigs: Improving feed 10–100 g/tonne efficiency feed Up to 20 kg body weight, 20 kg to 50 kg body weight and Over 50 kg to slaughter. 10–100 g/tonne feed Restraints: Add the restraint statement presented in Section 2.1.
Changes to labels instructions: 250 g/kg Tylosin Oral Pre-mix products Table A-11: Changes to the varied label for Product 36806 Elanco AF0250 Tylan 250 Tylosin Phosphate Premix Species Indication Dose rate Changes Cattle Poultry Pigs Liver abscess Necrotic enteritis Ileitis Enteric disease 11 ppm 100 mg/kg feed 7 days 40–100 g/tonne feed 40–100 g/tonne feed Restraints: Add the restraint statement presented in Section 2.1. Table A-12: Changes to the varied label for Product 53752 Tyleco 250 Granular Species Indication Dose rate Changes Cattle Pigs Liver abscess Ileitis Enteric disease Stimulating growth Improving feed efficiency 11 ppm 40–100 g/tonne feed 40–100 g/tonne feed 10–100 g/tonne feed 10–100 g/tonne feed Indications for Use: Delete ‘For increased growth stimulation and improving feed efficiency in pigs’ Directions for Use: Delete all uses and recommended dose rates for stimulating growth and improving feed efficiency in pigs: Up to 20 kg body weight, 20 kg to 50 kg body weight and Over 50 kg to slaughter. Restraints: Add the restraint statement presented in Section 2.1.
29196-macrolides_-_rd_report_final_a1090768.docx