Ovu-Late Injection

País: Australia

Idioma: inglés

Fuente: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredientes activos:

CLOPROSTENOL AS THE SODIUM SALT

Disponible desde:

VETOQUINOL AUSTRALIA PTY LTD

formulario farmacéutico:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composición:

CLOPROSTENOL AS THE SODIUM SALT PROSTAGLANDIN Active 250.0 ug/ml

Unidades en paquete:

100mL; 20mL

clase:

VM - Veterinary Medicine

Área terapéutica:

ENDOCRINE SYSTEM

Resumen del producto:

Poison schedule: 4; Withholding period: MEAT: (COWS): DO NOT USE less than 1 day before slaughter for human consumption. (HORSES): NOT TO BE USED in horses int ended for human consumption. MILK: NIL; Host/pest details: COW: [CYSTIC OVARIES, INDUCE ABORTION, INDUCTION OF PARTURITION, PYOMETRA, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]; HORSE MARE (FEMALE): [CONTROL OF OESTRUS, EARLY FOETAL DEATH, EXTENDED DIOESTRUS, INDUCE ABORTION, LACTATION ANOESTRUS, PSEUDO-PREGNANCY, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]

Estado de Autorización:

Registered

Fecha de autorización:

2023-07-01

Información para el usuario

_Vial label _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
OVU-LATE INJECTION
ACTIVE CONSTITUENT: CLOPROSTENOL (as the sodium salt) 250 µg/mL
For luteolysis of functional corpora lutea in cows and mares.
(20 mL, 100 mL)
_Vial ancillary panel _
READ ENCLOSED LEAFLET BEFORE USE
DIRECTIONS FOR USE:
This product is contraindicated in mares suffering from acute or
subacute disorders
of the gastrointestinal or respiratory system. This product should not
be used in
pregnant animals when abortion or induced parturition is not the
objective. This
product should not be administered intravenously. Following withdrawal
of the first
dose, use the remainder of the vial within 28 days or discard the
unused portion.
COWS: Single or repeat doses of 2 mL by intramuscular injection.
MARES: Less than 400 kg bodyweight: 0.5-1 mL by intramuscular
injection. Greater
than 400 kg bodyweight: 1-2 mL by intramuscular injection.
WITHHOLDING PERIODS:
MEAT: (COWS): DO NOT USE LESS THAN 1 DAY BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
(HORSES): NOT TO BE USED IN HORSES INTENDED FOR HUMAN CONSUMPTION.
MILK: NIL
TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): ESI not established.
FIRST AID: If poisoning occurs, contact a doctor or Poisons
Information Centre.
Phone Australia 13 11 26.
Dispose of empty container by wrapping with paper and putting in
garbage. Store
below 25°C (air conditioning). Protect from light.
RANDLAB AUSTRALIA PTY LTD
7/85 Alfred Road,
Chipping Norton NSW 2170 Australia
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Batch No.
Expiry
Ovu-Late Injection draft label
page 1 of 8
20 mL, 100 mL vial, carton and leaflet
Version 1 19/07/2018
APVMA Approval no. 80077/100160 RLP APPROVED
_Carton label front and back _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
OVU-LATE INJECTION
ACTIVE CONSTITUENT: CLOPROSTENOL (as the sodium salt) 250 µg/mL
For luteolysis of functional corpora lutea in cows and mares.
(20 mL, 100 mL)
_logo _
_Carton

Ficha técnica

PRODUCT NAME: OVU-LATE SYNTHETIC PROSTAGLANDIN FOR
CATTLE AND HORSES
PAGE: 1 OF 5
This revision issued: July, 2018
SAFETY DATA SHEET
Issued by: Randlab Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
RANDLAB AUSTRALIA PTY LTD
PHONE: [phone]
7/85 ALFRED RD
FAX: [phone]
CHIPPING NORTON, NSW 2170, AUSTRALIA
CHEMICAL NATURE:
Cloprostenol is a synthetic prostaglandin.
TRADE NAME:
OVU-LATE SYNTHETIC PROSTAGLANDIN FOR CATTLE AND HORSES
PRODUCT USE:
A luteolytic agent for clinical use and the control of the bovine and
equine oestrus
cycles.
CREATION DATE:
DECEMBER, 2010
THIS VERSION ISSUED:
JULY, 2018
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:
Hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA and IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: DANGER.
HAZARD STATEMENT:
H360: May damage fertility or the unborn child.
PREVENTION
P102: Keep out of reach of children.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and
understood.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P337: If eye irritation persists: seek medical attention.
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P308+P313: If exposed or concerned: Get medical advice.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P411: Store at temperatures not exceeding 30°C.
DISPOSAL
P501: Dispose of small quantit