RELIVEN 20 MG/ML SOLUTION FOR INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MELOXICAM

Available from:

JUROX PTY LIMITED

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

MELOXICAM UNGROUPED Active 20.0 mg/ml

Units in package:

100 mL; 50 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Product summary:

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 pregnant ewes within 1 1 days of lambing where milk may be use d or processed for human consumption. C attle and Sheep: Repeat treatments (mor e than ONCE), higher doses or injection into the muscle could result in residue s above the MRLs unless the label withho lding period is extended. Pigs: Repeat doses (more than TWICE) or higher doses could result in residues above the MRLs unless the label withholding period is extended. The prescribing veterinarian would need to advise on an extended wit hholding period. Cattle: This product d oes not have an ESI established. Note—ob serving the meat withholding period may not be sufficient to mitigate potential risks to export trade. Trade advice sh ould be sought from Jurox Pty Limited on 1800 023 312 before using this product. Sheep: DO NOT slaughter for export les s than 11 days after final treatment. P igs: DO NOT slaughter for export less th an 4 days after final treatment. The ES I on this label was current at the time of label approval. Before using this pro duct, confirm the current ESI from the manufacturer on 1800 023 312 or the APVM A website (www.apvma.gov.au/residues); Host/pest details: CATTLE: [CATTLE - PAIN DEHORNING, DIARRHOEA, INFECTIONS OF THE RESPIRATORY TRACT, POST SURGICAL PAIN AND INFLAMMATION]; CATTLE LACTATING: [AGALACTIA]; HORSE: [COLIC]; 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, and 28 days for horses before slaughter for human consu mption. Milk: Milk collected from cows within 6 days (12 milkings) following t reatment MUST NOT BE USED or processed for human consumption, or fed to bobby c alves Cattle: Repeat treatments (more than ONCE), higher doses or injection in to the muscle could result in residues above the MRLs unless the label withhold ing period is extended. Pigs: Repeat d oses (more than TWICE) or higher doses c ould result in residues above the MRLs unless the label withholding period is e xtended. The prescribing veterinarian w ould need to advise on an extended withh olding period. Cattle: This product doe s not have an ESI established. Note—obse rving the meat withholding period may n ot be sufficient to mitigate potential r isks to export trade. Trade advice shou ld be sought from Jurox Pty Limited on 1 800 023 312 before using this product. Pigs: DO NOT slaughter for export less t han 4 days after final treatment. The E SI on this label was current at the time of label approval. Before using this pr oduct, confirm the current ESI from the manufacturer on 1800 02 3312 or the APV MA website (www.apvma.gov.au/residues); Host/pest details: CATTLE: [CATTLE - PAIN DEHORNING, DIARRHOEA, INFECTIONS OF THE RESPIRATORY TRACT, POST SURGICAL PAIN AND INFLAMMATION]; CATTLE LACTATING: [AGALACTIA]; HORSE: [COLIC]; PIGS: [ACUTE NON-INFECTIOUS LOCOMOTOR DISORDER, PEUPERAL SEPTICEMIA & TOXEAMIA]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

RELIVEN 20 MG/ML SOLUTION FOR INJECTION
86332/115501
Product Name:
APVMA Approval No:
Label Name:
RELIVEN 20 MG/ML SOLUTION FOR INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
MELOXICAM 20 mg/mL
Claims:
A non-steroidal anti-inflammatory, analgesic and antipyretic for use
in cattle, 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.
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 and
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.
Net Contents:
100 mL RLP APPROVED
50 mL
Directions for Use:
(HEADING ONLY)
Restraints:
Contraindications:
This product is contraindicated for use in animals suffering from
haemorrhagic
gastrointestinal disorders, impaired hepatic, cardiac or renal
function and haemorrhagic
disorders, or where there is evidence

Summary of Product characteristics

RELIVEN 20 MG/ML SOLUTION FOR INJECTION
Page 1 of 9
Issued by: Jurox Pty Limited Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
ISSUED:
22 JANUARY 2019
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
RELIVEN 20 MG/ML SOLUTION FOR
INJECTION
PRODUCT IDENTIFIER:
20 mg/mL meloxicam solution for injection.
PRODUCT CODE:
TBD
RECOMMENDED USE:
A non-steroidal anti-inflammatory, analgesic and antipyretic for use
in cattle, pigs and horses.
RESTRICTIONS ON USE:
For animal treatment only.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
EMAIL:
[e-mail]
NATIONAL POISONS INFORMATION CENTRE:
13 1126 (24 hours)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9am – 5pm, Monday to Friday)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS: This product has been assessed according
to GHS and is classified as follows:
GHS CATEGORY
HAZARD CODE
HAZARD STATEMENT
Flammable Liquid Category 3
H226
Flammable liquid and vapour.
Eye Irritation Category 2A
H319
Causes serious eye irritation.
GHS LABEL ELEMENTS:
Signal Word:
WARNING
Pictograms:
Flame Exclamation Mark
RELIVEN 20 MG/ML SOLUTION FOR INJECTION
Page 2 of 9
Issued by: Jurox Pty Limited Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
Precautionary Statements:
Prevention
P210 Keep away from heat / sparks / open flames / hot surfaces – No
smoking.
P233 Keep container tightly closed.
P242 Use only non-sparking tools.
P243 Take action to prevent static discharges.
P264 Wash hands thoroughly after handling.
P280 Wear protective gloves / eye protection / face protection.
Response
P303+P361+P353 IF ON SKIN (or hair): Take off immediately all
contaminated clothing. Rinse skin with water.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if present and easy to do. Continue
rinsing.
P337+P313 If eye irritation persists: Get me

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
ACTIVE CONSTITUENTS
Meloxicam 20 mg/mL
ACTIONS
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the
oxicam class which acts by inhibition of prostaglandin synthesis,
thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic effects.
INDICATIONS
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 and 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.
CONTRAINDICATIONS
This product is contraindicated for use in animals suffering from
haemorrhagic gastrointestinal disorders, impaired hepatic, cardiac or
renal function and haemorrhagic disorders, or where there is evidence
of individual hypersensitivity to the product.
RELIVEN
®
20 mg/mL Solution for Injection
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
PRECAUTIONS
SHEEP: The safety of this product in lambs