Tolfegilis Liquid Injection for Cattle and Pigs

국가: 오스트레일리아

언어: 영어

출처: APVMA (Australian Pesticides and Veterinary Medicines Authority)

유효 성분:

TOLFENAMIC ACID

제공처:

AGILIS INTERNATIONAL LIMITED

약제 형태:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

구성:

TOLFENAMIC ACID ANTI-INFLAMMATORY-NON-STEROID Active 40.0 mg/ml

패키지 단위:

100 mL

수업:

VM - Veterinary Medicine

치료 영역:

MUSCULOSKELETAL SYSTEM

제품 요약:

Poison schedule: 4; Withholding period: MEAT (CATTLE): DO NOT USE less than 10 d ays (intramuscular administration) and 4 days (intravenous administration) befor e slaughter for human consumption. MEAT (PIGS): DO NOT USE less than 6 days bef ore slaughter for human consumption. MI LK: Milk collected from cows within 12 h ours (1 milking) following treatment MUS T NOT BE USED or processed for human con sumption, or fed to bobby calves. EXPOR T SLAUGHTER INTERVAL (ESI): An ESI has n ot been established for this product. N ote—observing the meat withholding perio d may not be sufficient to mitigate pote ntial risks to export trade. Trade advic e should be sought from Agilis Internati onal Limited on 0800 244 547 before usin g this product.; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]

승인 상태:

Registered

승인 날짜:

2023-07-01

환자 정보 전단

Tolfegilis
Product Name:
APVMA Approval No:
92497/135727
Label Name:
Tolfegilis
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
40 mg/ mL Tolfenamic acid
Claims:
For use by or under the direction of registered veterinarian.
A non-steroidal anti-inflammatory analgesic-antipyretic for use in
cattle and pigs.
Net Contents:
100 mL
Directions for Use:
Restraints:
DO NOT inject cattle other than into muscle tissues 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.
Contraindications:
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 Tolfegilis liquid injection for cattle and pigs during
pregnancy has not been
established.
Side Effects:
Liquid Injection for Cattle and Pigs
Liquid Injection for Cattle and Pigs RLP APPROVED
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 only 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:
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 of cyclo-oxygenase and
thus to a reduction
of the synthesis of prostaglandins and thromboxanes, which are
important inflammatory
mediators.
Withholding Periods:
MEAT (CATTLE): DO NOT USE less than 10 days (intramuscul