Krajina: Austrália
Jazyk: angličtina
Zdroj: APVMA (Australian Pesticides and Veterinary Medicines Authority)
TULATHROMYCIN
TROY LABORATORIES PTY LTD
PARENTERAL LIQUID/SOLUTION/SUSPENSION
TULATHROMYCIN ANTIBIOTIC Active 100.0 mg/ml
100 mL; 50 mL
VM - Veterinary Medicine
ANTIBIOTIC & RELATED
Poison schedule: 4; Withholding period: MEAT: Cattle - DO NOT USE less than 35 d ays before slaughter for human consumpti on. Pigs - DO NOT USE less than 14 da ys before slaughter for human consumptio n. Any variation by the prescribing v eterinarian to the approved use pattern, may require an extended withholding per iod. EXPORT SLAUGHTER INTERVAL (ESI): Cattle: DO NOT USE less than 35 days b efore slaughter for export. Pigs: DO NOT USE less than 26 days before slaught er for export. Before using this prod uct, confirm the current ESI from Troy L aboratories on (+61) 2 8808 3600 or the APVMA website (apvma.gov.au/residues).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE FIRST MATING) – BOVINE (DAIRY): [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; PIG - ADULT: [HAEMOPHILUS SPP., MYCOPLASMA HYOPNEUMONIAE, PASTEURELLA MULTOCIDA, RESPIRATORY DISEASE]; Poison schedule: 4; Withholding period: MEAT: Cattle: DO NOT USE less than 35 da ys before slaughter for human consumptio n. Pigs: DO NOT USE less than 14 days b efore slaughter for human consumption. MILK: DO NOT USE in dairy cows (except r eplacement dairy heifers) that are produ cing milk or may in the future produce m ilk for human consumption or processing. DO NOT USE in bobby calves. DO NOT US E in dairy heifers following the first m ating. Any variation by the prescribing veterinarian to the approved dose, freq uency, duration, route, disease or targe t species may result in the need to exte nd the approved withholding period. EXP ORT SLAUGHTER INTERVAL (ESI): Cattle: D O NOT USE less than 35 days before slaug hter for export. Pigs: DO NOT USE less than 26 days before slaughter for export . The ESIs on this label were correct a t the time of label approval. Before usi ng this product, confirm the current ESI from the manufacturer on (02) 8808 3600 or the APVMA website (www.apvma.gov.au/ residues/).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE FIRST MATING) – BOVINE (DAIRY): [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; PIG - ADULT: [HAEMOPHILUS SPP., MYCOPLASMA HYOPNEUMONIAE, PASTEURELLA MULTOCIDA, RESPIRATORY DISEASE]; Poison schedule: 4; Withholding period: MEAT: Cattle: DO NOT USE less than 35 da ys before slaughter for human consumptio n. Pigs: DO NOT USE less than 14 days b efore slaughter for human consumption. MILK: DO NOT USE in dairy cows (except r eplacement dairy heifers) that are produ cing milk or may in the future produce milk for human consumption or processing . DO NOT USE in bobby calves. DO NOT U SE in dairy heifers following the first mating. Any variation by the prescribin g veterinarian to the approved dose, fre quency, duration, route, disease or tar get species may result in the need to ex tend the approved withholding period. EXPORT SLAUGHTER INTERVAL (ESI): Cattle : DO NOT USE less than 35 days before sl aughter for export. Pigs: DO NOT USE le ss than 26 days before slaughter for exp ort. The ESIs on this label were correc t at the time of label approval. Before using this product, confirm the current ESI from the manufacturer on (02) 8808 3600 or the APVMA website (www.apvma.go v.au/residues/).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE FIRST MATING) – BOVINE (DAIRY): [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; PIG - ADULT: [HAEMOPHILUS SPP., MYCOPLASMA HYOPNEUMONIAE, PASTEURELLA MULTOCIDA, RESPIRATORY DISEASE]
Registered
2022-07-01
Product Name: APVMA Approval No: Ilium Tulathromycin Injection 88512/121563 Label Name: Ilium Tulathromycin Injection Signal Headings: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Constituent Statements: 100 mg/mL TULATHROMYCIN Claims: For the treatment of respiratory infections in cattle and pigs. For subcutaneous injection in cattle, including dairy heifers up to the point of first mating, and intramuscular injection in pigs. Cattle Ilium Tulathromycin Injection is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. Pigs Ilium Tulathromycin Injection is indicated for the treatment of swine respiratory disease (SRD) associated with Pasteurella multocida, Mycoplasma hyopneumoniae, and Haemophilus parasuis sensitive to tulathromycin. Net Contents: 50 mL 100 mL Directions for Use: Restraints: USE ONLY in respiratory infections of cattle and swine. DO NOT USE in dairy cows (except replacement dairy heifers) that are producing milk or may in the future produce milk for human consumption or processing. DO NOT USE in bobby calves. DO NOT TREAT dairy heifers following the first mating. RE-TREATMENT INTERVALS: Cattle: DO NOT RE-TREAT cattle for 12 weeks after last treatment. Dairy heifers: DO NOT RE-TREAT dairy heifers RLP APPROVED Pigs: DO NOT RE-TREAT pigs for 8 weeks after last treatment. Contraindications: Precautions: Avoid using the product simultaneously with other macrolides or lincosamides. Laboratory studies in rats and rabbit have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. However, the effects of Ilium Tulathromycin Injection on bovine and porcine reproductive performance, pregnancy and lactation have not been determined Side Effects: Subcutaneous administration of Ilium Tulathromycin Injection to cattle frequently causes transient pain reactions, and local swellings at the injection site that can p Prečítajte si celý dokument
TROY LABORATORIES PTY LTD Chemwatch Hazard Alert Code: 3 ILIUM TULA INJECTION Chemwatch: 5436-74 Version No: 2.1.1.1 Safety Data Sheet according to WHS and ADG requirements Issue Date: 18/11/2020 Print Date: 23/11/2020 S.GHS.AUS.EN SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY / UNDERTAKING PRODUCT IDENTIFIER PRODUCT NAME Ilium Tula Injection SYNONYMS Ilium Tulathromycin Injection; APVMA number 88512 OTHER MEANS OF IDENTIFICATION Not Available RELEVANT IDENTIFIED USES OF THE SUBSTANCE OR MIXTURE AND USES ADVISED AGAINST RELEVANT IDENTIFIED USES To be used as directed on product label. Use according to manufacturer's directions. DETAILS OF THE SUPPLIER OF THE SAFETY DATA SHEET REGISTERED COMPANY NAME TROY LABORATORIES PTY LTD ADDRESS 37 Glendenning Road Glendenning NSW 2761 Australia TELEPHONE 02 8808 3600 FAX 02 9677 9300 WEBSITE EMAIL admin@troylab.com.au EMERGENCY TELEPHONE NUMBER ASSOCIATION / ORGANISATION TROY LABORATORIES PTY LTD EMERGENCY TELEPHONE NUMBERS 02 8808 3600 (Office hours (8am – 4pm, Monday to Friday)) OTHER EMERGENCY TELEPHONE NUMBERS Not Available SECTION 2 HAZARDS IDENTIFICATION CLASSIFICATION OF THE SUBSTANCE OR MIXTURE POISONS SCHEDULE S4 CLASSIFICATION [1] Skin Corrosion/Irritation Category 2, Serious Eye Damage Category 1, Skin Sensitizer Category 1 _LEGEND:_ _1. Classified by Chemwatch; 2. Classification drawn from HCIS; 3. Classification drawn from Regulation (EU) No 1272/2008 - Annex VI_ LABEL ELEMENTS HAZARD PICTOGRAM(S) SIGNAL WORD DANGER HAZARD STATEMENT(S) H315 Causes skin irritation. H318 Causes serious eye damage. H317 May cause an allergic skin reaction. PRECAUTIONARY STATEMENT(S) PREVENTION P280 Wear protective gloves/protective clothing/eye protection/face protection. P261 Avoid breathing mist/vapours/spray. P272 Contaminated work clothing should not be allowed out of the workplace. PRECAUTIONARY STATEMENT(S) RESPONSE P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue Prečítajte si celý dokument