Label approval numbers The APVMA has given new approval numbers (Column 6 of Table 1) to uniquely identify the labels varied resulting from this review. Table 1: Product registrations affirmed following variation of relevant particulars Product number Product name Holder Label approvals cancelled Label approvals varied and no longer in force New (varied) label approvals Label variation: Removed all indications for stimulating growth and improving feed efficiency, added the restraint statement presented in Section 2.1 45175 LIENERT TYLAN 50 PREMIX ALLTECH LIENERT AUSTRALIA PTY LTD 45175/62500 45175/RV0318D 53703 TYLOMIX 100 TYLOSIN TARTRATE PREMIX ABBEY LABORATORIES PTY LTD 53703/0502 53703/RV0318E 53752 TYLECO 250 GRANULAR INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD 53752/1102 53752/0707 53752/0702 53752/0701 53752/0108 53752/0104 53752/55127 53572/RV0318F 54573 TYLECO 50 GRANULAR INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD 54573/55132 54573/1201 54573/1102 54573/0807 54573/0702 54573/0108 54573/0104 54573/61777 54573/RV0318G 59908 TYLODOX 250 DOX-AL AUSTRALIA PTY LTD 59908/55525 59908/0609 59908/0206 59908/55915 59908/RV0318H 60283 CCD TYLOSIN 100 (TYLOSIN PHOSPHATE) PREMIX CCD ANIMAL HEALTH PTY LTD 60283/0906 60283/1207 60283/RV0318I 60891 TYLODOX 50 G MICROGRANULATE FEED ADDITIVE DOX-AL AUSTRALIA PTY LTD 60891/62024 60891/0207 60891/55916 60891/RV0318J 61913 PHARMASIN 250 GRANULAR PREMIX HUVEPHARMA EOOD 61913/0809 61913/RV0318L
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.
Table A-15: Changes to the varied label for Product 64657 Tylodox 250 G Microgranulate Feed Additive Species Indication Dose rate Changes Cattle Poultry Pigs Liver abscess Necrotic enteritis Ileitis Enteric disease Stimulating growth Improving feed efficiency 11 ppm 100 mg/kg feed 7 days 40–100 g/tonne feed 40–100 g/tonne feed 10–100 g/tonne feed 10–100 g/tonne feed Indications for Use: Delete ‘TYLODOX 250 G Microgranulate feed additive is used for increased growth stimulation and improved 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. Table A-16: Changes to the varied label for Product 67990 Tylogran 250 BMP Species Indication Dose rate Changes Cattle Poultry Pigs Liver abscess Necrotic enteritis Ileitis Enteric disease Stimulating growth Improving feed efficiency 11 ppm 100 mg/kg feed 7 days 40–100 g/tonne feed 40–100 g/tonne feed 10–100 g/tonne feed 10–100 g/tonne feed Indications for Use: Delete ‘TYLOGRAN 250 BMP is used for increased growth stimulation and improved feed efficiency in pigs.’ Dosage and administration: 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.
Changes to label instructions: 260 g/kg Tylosin Oral Pre-mix product Table A-17: Changes to the varied label for Product 61525 Elanco AF0248 Tylan Granular Tylosin Phosphate 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. Changes to label instructions: 903 g/kg Tylosin Oral Pre-mix product Table A-18: Changes to the varied label for Product 65360 Tylodox 1000 Species Indication Dose rate Changes Cattle Pigs Liver abscess Ileitis Stimulating growth Improving feed efficiency 11 ppm 40 g/tonne feed 10–100 g/tonne feed 10–100 g/tonne feed Indications for Use: Delete ‘For increase growth stimulation and improved feed efficiency in pigs.’ Dosage and administration: Delete all uses and recommended dose rates for stimulating growth and improving feed efficiency in pigs: Up to 20 kg body weight, 20 kg – 50 kg body weight and Over 50 kg to slaughter. Restraints: Add the restraint statement presented in Section 2.1.