Metacoxx 20 mg/mL Solution for Injection for Cattle, Pigs, Horses and Sheep

Country: Australia

Bahasa: Inggeris

Sumber: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Bahan aktif:

MELOXICAM

Boleh didapati daripada:

LE VET BEHEER B. V.

Borang farmaseutikal:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Komposisi:

MELOXICAM UNGROUPED Active 20.0 mg/ml

Unit dalam pakej:

100 mL; 50 mL

Kelas:

VM - Veterinary Medicine

Kawasan terapeutik:

MUSCULOSKELETAL SYSTEM

Ringkasan produk:

Poison schedule: 4; Withholding period: MEAT: Cattle - DO NOT USE less than 8 da ys before slaughter for human consumptio n. Pigs - DO NOT USE less than 4 days b efore slaughter for human consumption. Sheep - DO NOT USE less than 11 days bef ore slaughter for human consumption. Ho rses - DO NOT USE less than 28 days befo re slaughter for human consumption. MIL K: Cattle - Milk collected from cows wit hin 6 days (12 milkings) following treat ment MUST NOT BE USED or processed for h uman consumption or fed to bobby calves. Sheep - DO NOT USE in lactating or pre gnant ewes or within 11 days of lambing where milk may DO NOT USE in lactating ewes or within 11 days of lambing where milk may be used or processed for human consumption. CATTLE and SHEEP: Repeat treatments (more than ONCE), higher dose s or injection into the muscle could res ult in residues above the MRLs unless th e label withholding period is extended. PIGS: Repeat doses (more than TWICE) or higher doses could result in residues a bove the MRLs unless the label withholdi ng period is extended. Any variation by the prescribing veterinarian to the app roved use pattern, may require an extend ed withholding period. CATTLE: An ESI h as not been established for this product . Note - observing the meat withholding period may not be sufficient to mitigate potential risks to export trade. Trad e advice should be sought from Dechra Ve terinary Products (Australia) Pty Ltd on 1300 015 825 before using the product. SHEEP: DO NOT USE less than 11 days bef ore slaughter for export. PIGS: DO NOT USE less than 4 days before slaughter fo r export. Before using this product, co nfirm the current ESI from Dechra Veteri nary Products (Australia) Pty Ltd on 130 0 015 825 or the APVMA website (www.apvm a.gov.au/residues).; Host/pest details: CALF: [CATTLE - PAIN DEHORNING, DIARRHOEA, INFECTIONS OF THE RESPIRATORY TRACT]; CATTLE LACTATING: [MASTITIS]; HORSE: [COLIC, MUSCOSKELETAL DISCOMFORT]; LAMB OVER 2 WEEKS OF AGE: [PAIN AND INFLAMMATION]; PIGS: [ACUTE NON-INFECTIOUS LOCOMOTOR DISORDER, PEUPERAL SEPTICEMIA & TOXEAMIA]; SHEEP: [PAIN AND INFLAMMATION]; Poison schedule: 4; Withholding period: MEAT: DO NOT USE less than 8 days for ca ttle, 4 days for pigs, 11 days for sheep and 28 days for horses before slaughter for human consumption. MILK: Milk coll ected from cows within 6 days (12 milkin gs) following treatment MUST NOT BE USED or processed for human consumption, or fed to bobby calves. DO NOT USE in lact ating ewes or within 11 days of lambing where milk may be used or processed for human consumption. CATTLE and SHEEP: Re peat treatments (more than ONCE), higher doses or injection into the muscle coul d result in residues above the MRLs unle ss the label withholding period is exten ded. PIGS: Repeat doses (more than TWIC E) or higher doses could result in resid ues above the MRLs unless the label with holding period is extended. The prescri bing veterinarian would need to advise o n an extended withholding period. CATTL E: An ESI has not been established for t his product. Note - observing the meat w ithholding period may not be sufficient to mitigate potential risks to export tr ade. Trade advice should be sought fro m Dechra Veterinary Products (Australia) Pty Ltd on 1300 015 825 before using th e product. SHEEP: DO NOT USE less than 11 days before slaughter for export. PI GS: DO NOT USE less than 4 days before s laughter for export. Before using this product, confirm the current ESI from De chra Veterinary Products (Australia) Pty Ltd on 1300 015 825 or the APVMA websit e (www.apvma.gov.au/residues).; Host/pest details: CALF: [CATTLE - PAIN DEHORNING, DIARRHOEA, INFECTIONS OF THE RESPIRATORY TRACT]; CATTLE LACTATING: [MASTITIS]; HORSE: [COLIC, MUSCOSKELETAL DISCOMFORT]; LAMB OVER 2 WEEKS OF AGE: [PAIN AND INFLAMMATION]; PIGS: [ACUTE NON-INFECTIOUS LOCOMOTOR DISORDER, PEUPERAL SEPTICEMIA & TOXEAMIA]; SHEEP: [PAIN AND INFLAMMATION]; Poison schedule: 4; Withholding period: MEAT: DO NOT USE less than 8 days for c attle, 4 days for pigs, 11 days for shee p and 28 days for horses before slaught er for human consumption. MILK: Milk c ollected from cows within 6 days (12 mil kings) following treatment MUST NOT BE USED or processed for human consumption, or fed to bobby calves. DO NOT USE in lactating ewes or within 11 days of lamb ing where milk may be used or processed for human consumption. CATTLE and SHEE P: Repeat treatments (more than ONCE), h igher doses or injection into the muscl e could result in residues above the MRL s unless the label withholding period is extended. PIGS: Repeat doses (more th an TWICE) or higher doses could result i n residues above the MRLs unless the la bel withholding period is extended. The prescribing veterinarian would need to advise on an extended withholding period . CATTLE: An ESI has not been establish ed for this product. Note - observing th e meat withholding period may not be su fficient to mitigate potential risks to export trade. Trade advice should be so ught from Dechra Veterinary Products (Au stralia) Pty Ltd on 1300 015 825 before using the product. SHEEP: DO NOT USE l ess than 11 days before slaughter for ex port. PIGS: DO NOT USE less than 4 days before slaughter for export. Before us ing this product, confirm the current ES I from Dechra Veterinary Products (Aust ralia) Pty Ltd on 1300 015 825 or the AP VMA website (www.apvma.gov.au/residues).; Host/pest details: CALF: [DIARRHOEA, INFECTIONS OF THE RESPIRATORY TRACT]; CATTLE LACTATING: [MASTITIS]; HORSE: [COLIC, MUSCOSKELETAL DISCOMFORT]; LAMB OVER 2 WEEKS OF AGE: [PAIN AND INFLAMMATION]; PIGS: [ACUTE NON-INFECTIOUS LOCOMOTOR DISORDER, PEUPERAL SEPTICEMIA & TOXEAMIA]; SHEEP: [PAIN AND INFLAMMATION]

Status kebenaran:

Registered

Tarikh kebenaran:

2023-07-01

Risalah maklumat

Product Name:
APVMA Approval No:
Metacoxx 20 mg/mL Solution for Injection for Cattle, Pigs, Horses and
Sheep
88026/140350
Label Name:
METACOXX 20 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS, HORSES AND
SHEEP
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
20 mg/mL MELOXICAM
Claims:
A non-steroidal anti-inflammatory, analgesic, antipyretic for use in
cattle, sheep, pigs and
horses.
Indications
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the
oxicam class
which acts by inhibition of prostaglandin synthesis, thereby exerting
anti-inflammatory,
antiendotoxic, anti-exudative, analgesic and antipyretic properties.
Cattle:
For the reduction of pain associated with surgery.
For use in acute respiratory infection and diarrhoea in combination
with appropriate
antibiotic therapy to reduce clinical symptoms in calves and young
cattle.
For use in acute mastitis, in combination with antibiotic therapy, as
appropriate, to reduce
clinical symptoms in lactating cows.
For use to assist in the control of pain following the dehorning of
cattle particularly that
following heat cautery dehorning of young cattle. It is recommended
that the injection
be administered approximately 10 minutes before dehorning and be
accompanied by a
cornual nerve block anaesthesia.
Sheep:
For single dose use in sheep and lambs 14 days of age or older for the
alleviation of pain
and inflammation.
Pigs:
For use in acute non-infectious locomotor disorders to reduce the
symptoms of lameness
and inflammation.
For use in puerperal septicaemia and toxaemia
(mastitis-metritis-agalactia syndrome) with
appropriate antibiotic therapy to reduce clinical signs of
inflammation, oppose the effects of
endotoxins and hasten recovery.
Horses:
For single dose rapid initiation of therapy of musculoskeletal
disorders and relief of pain
associated with colic. RLP APPROVED
Net Contents:
100 mL
50 mL
Directions for Use:
Restraints:
Contraindications:
This product is contraindicated fo

Ciri produk

SAFETY DATA SHEET (REGULATION (EC) NO. 1907/2006 – REACH)
PAGE 1 OF 7
DATE: 27/01/2018
NAME: MELOXIDOLOR 20 MG/ML SOLUTION FOR INJECTION
REVISION: 1
SAFETY DATA SHEET
(REACH regulation no. 1907/2006 and 453/2010)
SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE
COMPANY/UNDERTAKING
1.1
PRODUCT IDENTIFIER
Product name: Meloxidolor 20 mg/ml solution for injection
1.2 RELEVANT IDENTIFIED USES OF THE SUBSTANCE OR MIXTURE AND USES
ADVISED AGAINST
Use: Non-Steroidal Anti-Inflammatory Drug (NSAID)
1.3 DETAILS OF THE SUPPLIER OF THE SAFETY DATA SHEET
Registered company name: Le Vet Beheer B.V.
Address: Wilgenweg 7, 3421 TV Oudewater, The Netherlands
Telephone: [phone].
Fax: [phone]
[e-mail]
www.levetpharma.com
1.4
EMERGENCY TELEPHONE NUMBER:
[phone]
SECTION 2: HAZARDS IDENTIFICATION
APPEARANCE:
CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
GHS – CLASSIFICATION
Reproductive Toxicity: Category 1
EU CLASSIFICATION:
EU Indication of danger: Not classified
LABEL ELEMENTS
SIGNAL WORD:
Harmful
HAZARD STATEMENTS:
H301 – Toxic if swallowed
H360 – May damage fertility or the unborn child
PRECAUTIONARY STATEMENTS:
P201 – Obtain special instructions before use
P202 – Do not handle until all safety precautions have been read and
understood
P280 – Wear protective gloves/protective clothing/eye
protection/face protection
P264 – Wash hands thoroughly after handling
P270 – Do not eat, drink or smoke when using this product
P263 – Avoid contact during pregnancy/while nursing
P308 + P313 – IF exposed or concerned: Get medical attention/advice
P501 – Dispose of contents/container in accordance with all local
and national
regulations
SAFETY DATA SHEET (REGULATION (EC) NO. 1907/2006 – REACH)
PAGE 2 OF 7
DATE: 27/01/2018
NAME: MELOXIDOLOR 20 MG/ML SOLUTION FOR INJECTION
REVISION: 1
SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS
3.1 SUBSTANCES
No substances fulfill the criteria set forth in annex II section A of
the REACH regulation (EC) no. 1907/2006
3.2 MIXTURES
C