Land: Australien
Språk: engelska
Källa: APVMA (Australian Pesticides and Veterinary Medicines Authority)
TOLFENAMIC ACID; BENZYL ALCOHOL
VETOQUINOL AUSTRALIA PTY LTD
tolfenamic acid(40mg/mL)
PARENTERAL LIQUID/SOLUTION/SUSPENSION
TOLFENAMIC ACID ANTI-INFLAMMATORY-NON-STEROID Active 40.0 mg/ml; BENZYL ALCOHOL BENZENE Other 1.04 %w/v
100mL; 250mL; 50mL
VM - Veterinary Medicine
CATTLE | PIGS | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | GILT | HEI
MUSCULOSKELETAL SYSTEM
AGALACTIA | ANTI-INFLAMMATORY AGENT | MASTITIS | METRITIS | PNEUMONIA | ANTIPYRETIC | BACTERIAL PNEUMONIA | BONE SORENESS | BRUISING | BURSITIS | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MASTITIS-METRITIS-AGALACTIA | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SPRAINS | STRAINS | SUBCLINICAL MASTITIS | TENDON SPRAINS | TRAUMATIC SWELLING
Poison schedule: 4; Withholding period: MEAT: Cattle by intramuscular administra tion: DO NOT USE less than 10 days befor e slaughter for human consumption. Catt le by intravenous administration: DO NOT USE less than 4 days before slaughter f or human consumption. Pigs by intramusc ular administration: DO NOT USE less tha n 6 days before slaughter for human cons umption. MILK: Cattle by intramuscular or intravenous administration: Milk coll ected from cows within 12 hours (1 milki ng) following treatment MUST NOT BE USED for human consumption or processing. Th is milk should not be fed to bobby calv es. DO NOT USE less than 21 days (pi gs) or 28 days (cattle) before slaughter for export. The ESI on this label was c orrect at the time of label approval. B efore using this product confirm the cur rent ESI from the registrant on 02 9517 1166 or the APVMA website (apvma.gov.au/ residues/ESI.shtml); Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; Poison schedule: 4; Withholding period: WHP: MEAT: Cattle by intramuscular adm inistration: DO NOT USE less than 10 da ys before slaughter for human consumpti on. Cattle by intravenous administratio n: DO NOT USE less than 4 days before slaughter for human consumption. Pigs b y intramuscular administration: DO NOT USE less than 6 days before slaughter f or human consumption. MILK: Cattle by i ntramuscular or intravenous administrat ion: Milk collected from cows within 12 hours (1 milking) following treatment MUST NOT BE USED for human consumption or processing. This milk should not be fed to bobby calves. ESI: DO NOT USE l ess than 21 days (pigs) or 28 days (cat tle) before slaughter for export. The E SI on this label was correct at the tim e of label approval. Before using this product confirm the current ESI from t he registrant on 02 9517 1166 or the AP VMA website (apvma. gov.au/residues/ESI .shtml); Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; A non-steroidal anti-inflammatory analgesic - antipyretic for use in cattle and pigs.See RESTRAINTS & PRECAUTIONS on label.
Registered
2023-07-01
Product Name: APVMA Approval No: TOLFEDINE CS INJECTION 52850/129251 Label Name: TOLFEDINE CS INJECTION Signal Headings: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Constituent Statements: 40 mg/mL TOLFENAMIC ACID 1.04 %w/v BENZYL ALCOHOL as a preservative Claims: A non-steroidal anti-inflammatory anlagesic-antipyretic for use in cattle and pigs. For use by or under the direction of a registered veterinarian. As an aid in the treatment of pneumonia and acute mastitis in cattle and metritis-mastitis- agalactia in pigs. Net Contents: 50mL 100mL 250mL Directions for Use: Restraints: DO NOT inject cattle other than into muscle tissue high on the side of the neck. Injection of product into muscles other than as described is likely to result in residues in meat and above the MRL or ESI. Re-treatment intervals: A single treatment regime consists of either 1 x intravenous injection (cattle) or 2 x intramuscular injections at 48 h (cattle) or 1 x intramuscular injection (pigs). DO NOT repeat treatment less than 21 days after treatment of pigs, or 28 days after last treatment of cattle. Contraindications: Precautions: Safe use of TOLFEDINE CS Injection during pregnancy has not been established. RLP APPROVED Side Effects: Dosage and Administration: Discard unused portion within 28 days after first broaching the vial. Cattle: Pneumonia: 2 mg/kg (1 mL/20 kg bw) by intramuscular injection high in the neck. Treatment may be repeated once after 48 hours. Mastitis: 4 mg/kg (1 mL/10 kg bw) as a single intravenous injection. Pigs: Metritis-mastitis-agalactia: 2 mg/kg (1 mL/20 kg bw) as a single intramuscular injection into the rump. General Directions: PHARMACOLOGY Pharmacodynamic properties Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) is a non-steroidal anti- inflammatory drug (NSAID) belonging to the fenamate group. Tolfenamic acid exerts anti-inflammatory, analgesic and antipyretic activities. The anti-inflammatory activity of tolfenamic acid is mainly due to an inhibition Läs hela dokumentet
PRODUCT NAME: TOLFEDINE CS INJECTION PAGE: 1 OF 5 THIS VERSION ISSUED: JANUARY, 2016 SAFETY DATA SHEET Issued by: Vetoquinol Australia Pty Ltd Phone: 1800 032 355 (BUSINESS HOURS) POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800 764 766 IN NEW ZEALAND) SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER VETOQUINOL AUSTRALIA PTY LTD PHONE: 1800 032 355 (BUSINESS HOURS) UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK, FAX: 1800 648 460 BRISBANE AIRPORT, QLD 4008 CHEMICAL NATURE: Tolfedine is a highly effective and safe Non Steroidal Anti-Inflammatory, COX-2 preferential inhibitor. TRADE NAME: TOLFEDINE CS INJECTION APVMA CODE: 52850 PRODUCT USE: Nonsteroidal anti-inflammatory, analgesic, antipyretic for cattle and pigs. CREATION DATE: OCTOBER, 2015 THIS VERSION ISSUED: JANUARY, 2016 and is valid for 5 years from this date. POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA SECTION 2 - HAZARDS IDENTIFICATION STATEMENT OF HAZARDOUS NATURE This product is classified as: Xi, Irritating. N, Dangerous to the environment. Hazardous according to the criteria of SWA. Not a Dangerous Good according to Australian Dangerous Goods (ADG) Code, IATA or IMDG/IMSBC criteria. SUSMP CLASSIFICATION: S4 ADG CLASSIFICATION: None allocated. Not a Dangerous Good according to Australian Dangerous Goods (ADG) Code, IATA or IMDG/IMSBC criteria. UN NUMBER: None allocated GHS SIGNAL WORD: NONE. NOT HAZARDOUS. PREVENTION P102: Keep out of reach of children. P262: Do not get in eyes, on skin, or on clothing. P281: Use personal protective equipment as required. RESPONSE P353: Rinse skin or shower with water. P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. P370+P378: Not combustible. Use extinguishing media suited to burning materials. STORAGE P410: Protect from sunlight. P402+P404: Store in a dry place. Store in a closed container. P403+P235: Store in a well-ventilated place. Keep cool, below 30°C. DISPOSAL P501: Dispose of small quantities and empty containers by wrapping with Läs hela dokumentet
PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY _T_ _OLFEDINE_ _®_ _CS_ _INJECTION_ TOLFENAMIC ACID 40MG/ML CONTAINS 1.04% W/V BENZYL ALCOHOL AS A PRESERVATIVE. A NON-STEROIDAL ANTI-INFLAMMATORY ANALGESIC-ANTIPYRETIC FOR USE IN CATTLE AND PIGS. 100ML READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT INDICATIONS FOR USE BY OR UNDER THE DIRECTION OF A REGISTERED VETERINARIAN AS AN AID IN THE TREATMENT OF PNEUMONIA AND ACUTE MASTITIS IN CATTLE AND METRITIS-MASTITIS-AGALACTIA IN PIGS. DIRECTIONS FOR USE RESTRAINTS: DO NOT INJECT CATTLE OTHER THAN INTO MUSCLE TISSUE HIGH ON THE SIDE OF THE NECK (SEE LEAFLET FOR DIAGRAM). INJECTION OF PRODUCT INTO MUSCLES OTHER IN RESIDUES IN MEAT ABOVE THE MRL OR ESI. PRECAUTIONS: Repeat treatments or higher doses could result in residues above the MRL unless the label withholding period is extended. The prescribing Veterinarian would need to advise on an extended withholding period. Safe use of TOLFEDINE CS Injection during pregnancy has not been established. DOSAGE AND ADMINISTRATION: USE THE CONTENTS WITHIN 3 MONTHS OF FIRST BROACHING OF THE VIAL. DISCARD THE UNUSED PORTION. RE-TREATMENT INTERVAL: A single treatment regime consists of either 1 x IV injection (cattle) or 2 x IM injections at 48h (cattle) or 1 x IM injection (pigs). DO NOT repeat treatment less than 21 days after treatment of pigs, or 28 days after last treatment of cattle. CATTLE – PNEUMONIA: 2mg/kg (1mL per 20kg bw) by intramuscular injection high in the neck (see leaflet for diagram). Treatment may be repeated once only after 48 hours. Mastitis: 4mg/kg (1mL per 10kg bw) as a single intravenous injection. PIGS – METRITIS-MASTITIS-AGALACTIA: 2mg/kg (1mL per 20kg bw) as a single intramuscular injection. WITHHOLDING PERIODS MEAT CATTLE BY INTRAMUSCULAR ADMINISTRATION: DO NOT USE LESS THAN 10 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION. CATTLE BY INTRAVENOUS ADMINISTRATION: DO NOT USE LESS THAN 4 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION. PIGS BY INTRAMUSCULAR ADMINISTRATION: Läs hela dokumentet