Ovu-Mate Injection for Horses

Država: Australija

Jezik: engleski

Izvor: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktivni sastojci:

ALTRENOGEST

Dostupno od:

RANDLAB AUSTRALIA PTY LTD

Farmaceutski oblik:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sastav:

ALTRENOGEST STEROID-PROGESTIN Active 50.0 mg/ml

Jedinice u paketu:

30 mL

Razred:

VM - Veterinary Medicine

Područje terapije:

ENDOCRINE SYSTEM

Proizvod sažetak:

Poison schedule: 4; Withholding period: WHP: DO NOT use in horses intended for h uman consumption.; Host/pest details: HORSE MARE (FEMALE): [OESTRUS SUPPRESSION]

Status autorizacije:

Registered

Datum autorizacije:

2023-07-01

Uputa o lijeku

PRODUCT NAME:
APNMA APPROVAL NO:
OVU-MATE INJECTION FOR HORSES
83216/107741
LABEL NAME:
Ovu-Mate Injection for Horses
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
CONSTITUENT
STATEMENTS:
Altrenogest 50 mg/mL
CLAIMS:
For the suppression of oestrus in normally cycling mares
NET CONTENTS:
30 mL
DIRECTIONS FOR USE:
Use entire contents within 28 days of first broaching the vial. Store
upright.
RESTRAINTS:
DO NOT USE in horses intended for human consumption.
CONTRAINDICATIONS:
This product is contraindicated for use in stallions or geldings. This
product is
contraindicated for use in mares with a previous or current history of
uterine inflammation
(i.e. acute, subacute or chronic endometritis), as progestogens may
exacerbate existing
low-grade uterine inflammation into a fulminating uterine infection.
PRECAUTIONS:
There is evidence that when progestagens are administered to rats
during the embryonic
stage of pregnancy at doses higher than the recommended equine dose,
foetal
abnormalities (specifically masculinization of female genitalia) can
result.
If used in performance animals, the regulations of the relevant
authorities regarding
medication should be observed
SIDE EFFECTS: RLP APPROVED
DOSAGE AND
ADMINISTRATION:
3mL per 500kg bodyweight by intramuscular injection once every 5-7
days as required to
suppress signs of oestrus.
The dose rate should be extrapolated according to bodyweight if
treating lighter or heavier
horses (for example, ponies or heavy horses).
GENERAL DIRECTIONS:
Altrenogest acts similarly to the natural hormone, progesterone, by
suppressing the normal
sexual cycle and preventing signs of heat and ovulation. Mares return
to heat and release
natural hormones again once treatment stops. Treatment with
altrenogest makes it possible
to regulate the breeding of mares.
Pharmacokinetic data from mares treated with Ovu-Mate, have shown
blood levels of
altrenogest are maintained for 6 days following administration of the
injection.

Svojstava lijeka

PRODUCT NAME: OVU-MATE INJECTION
PAGE: 1 OF 5
This revision issued: March, 2017
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:
For regulation and control of the breeding cycle of mares.
TRADE NAME:
OVU-MATE INJECTION
PRODUCT USE:
Blend of ingredients; active ingredient is a hormone
CREATION DATE:
MARCH, 2015
THIS VERSION ISSUED:
MARCH, 2017
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:
Not classified as 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:
None allocated.
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: WARNING
Acute Toxicity Oral Category 4
Acute Toxicity Dermal Category 4
Acute Toxicity Inhalation Category 4
HAZARD STATEMENT:
H302: Harmful if swallowed.
H312: Harmful in contact with skin.
H332: Harmful if inhaled.
PREVENTION
P102: Keep out of reach of children.
P261: Avoid breathing fumes, mists, vapours or spray.
P262: Do not get in eyes, on skin, or on clothing.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well ventilated area.
P281: Use personal protective equipment as required.
RESPONSE
P363: Wash contaminated clothing before reuse.
P301+P312: IF SWALLOWED: Call a POISON CENTRE or doctor if you feel
unwell.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.