BOMEROL 1MG/ML OESTRADIOL BENZOATE INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OESTRADIOL BENZOATE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

oestradiol benzoate(1mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

OESTRADIOL BENZOATE STEROID-ESTROGEN Active 1.0 mg/ml

Units in package:

100mL; 20mL

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

CATTLE - ADULT | HEIFER | BOVINE

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

FERTILITY PROBLEMS | STIMULATE OVULATION | ANOESTRUS | OESTRUS CYCLE | OVARIAN CYSTS | PROMOTE OVULATION | SUPEROVULATION

Product summary:

Poison schedule: 4; Withholding period: WHP: As per label. MEAT: Zero (0) days MILK: Zero (0) days; Host/pest details: CATTLE - ADULT: [FERTILITY PROBLEMS, STIMULATE OVULATION]; HEIFER: [FERTILITY PROBLEMS, STIMULATE OVULATION]; Poison schedule: 4; Withholding period: WHP: Nil; Host/pest details: CATTLE - ADULT: [FERTILITY PROBLEMS, STIMULATE OVULATION]; HEIFER: [FERTILITY PROBLEMS, STIMULATE OVULATION]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE - ADULT: [FERTILITY PROBLEMS, STIMULATE OVULATION]; HEIFER: [FERTILITY PROBLEMS, STIMULATE OVULATION]; For use in conjunction with an intravaginal insert containing progesterone (1.379 g/insert), in oestrous synchronisation programmes in cycling cattle, and the treatment of anoestrus in cattle.Administration of high doses to pregnant cattle has been shown to cause abortion

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

BOMEROL 1MG/ML OESTRADIOL BENZOATE INJECTION
57865/138415
Product Name:
APVMA Approval No:
Label Name:
BOMEROL 1MG/ML OESTRADIOL BENZOATE INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
1 mg/mL OESTRADIOL BENZOATE
Claims:
INDICATIONS
To improve the precision of the onset of oestrus and maximise
fertility in oestrous
synchronisation programmes using an intravaginal insert containing
progesterone (1.379 g/
insert) in cycling cattle.
To induce oestrus and ovulation after progesterone priming with an
intravaginal insert
containing progesterone (1.379 g/insert) in the treatment of anoestrus
in cattle.
Net Contents:
20 mL
100 mL
Directions for Use:
Restraints:
Contraindications:
Administration of high doses of oestradiol benzoate to pregnant cattle
has been shown to
cause abortion.
Precautions:
Side Effects:
Dosage and
Administration:
Use within 7 days of opening. Discard the unused portion. RLP APPROVED
Inject by intramuscular injection in the anterior half of the neck.
For use in oestrous synchronisation programmes in cycling cattle
inject 1 mL in heifers
or 2 mL in adult cows at the time of administration of the
intravaginal insert containing
progesterone (1.379 g/insert) (for further information refer to
intravaginal insert containing
progesterone’s product label).
For use in the treatment of anoestrous cattle inject 1 mL between 24
and 48 hours after
the removal of the intravaginal insert containing progesterone (1.379
g/insert) (for further
information refer to intravaginal insert containing progesterone’s
product label).
General Directions:
MODE OF ACTION
The intramuscular injection of oestradiol benzoate at the initiation
of progesterone
treatment in cycling cattle (e.g. at the same time as the
administration of an intravaginal
insert containing progesterone (1.379 g/insert)) results in follicular
turnover and the
emergence of a new follicular wave about four days after treatment.
The synchronous
emergence of this new foll

Summary of Product characteristics

PAGE 1 OF 5
SAFETY DATA SHEET
A18240/04/AUS
BOMEROL 1MG/ML OESTRADIOL BENZOATE INJECTION
SECTION 1 – IDENTIFICATION, CONTACTS
Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073
EMERGENCY TELEPHONE NUMBER
1800 033 111
24 hour Emergency Service Australia Wide, Toll Free
CONTACT POINT (FOR NON-EMERGENCY CALLS)
Animal Health Division
[phone]
Full Product Name
BOMEROL 1MG/ML OESTRADIOL BENZOATE INJECTION
Other Names
N/A
Product Use
FOR ANIMAL TREATMENT ONLY
For use in conjunction with an intravaginal insert containing
progesterone (1.379 g/insert), in oestrous synchronisation
programmes in cycling cattle, and the treatment of anoestrus in
cattle.
Creation Date
18
th
March 2011
Revision Date
5 November 2014
SECTION 2 – HAZARDS IDENTIFICATION
Hazard Classification
CLASSIFIED AS A HAZARDOUS SUBSTANCE
CLASSIFIED AS NON DANGEROUS GOODS
according to criteria of NOHSC Australia and ADG Code.
Poison Schedule S4
Risk Phrases
R42/43 May cause sensitisation by inhalation and skin contact.
Safety Phrases
S23 Do not breathe fumes/vapour/spray.
S24 Avoid contact with skin.
SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Oestradiol benzoate
50-50-0
1mg/mL
This is a commercial product whose exact ratio of components may vary
slightly. Other non
hazardous ingredients are also present.
A18240/04/AUS
BOMEROL 1mg/mL OESTRADIOL BENZOATE INJECTION
PAGE 2 OF 5
SECTION 4 – FIRST AID MEASURES
Label Regulated First
Aid Statement
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 131126.
Scheduled Poisons
Poison schedule S4.
Poisons Information Centres in each State capital city can provide
additional assistance for scheduled poisons. Phone 131126.
Inhalation
Remove individual from exposure and into fresh air. Seek medical
attention if breathing difficulty occurs
Skin contact
Remove contaminated clothing and clean before reuse. Flush skin
with copious amounts of water for at least 15 minutes. Seek medical
attention if irritation develops.
Eye contact
Hold eyelids open and flush with a