BioRelin Injection

国家: 澳大利亚

语言: 英文

来源: APVMA (Australian Pesticides and Veterinary Medicines Authority)

有效成分:

DESLORELIN AS DESLORELIN ACETATE

可用日期:

RANDLAB AUSTRALIA PTY LTD

药物剂型:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

组成:

DESLORELIN AS DESLORELIN ACETATE UNGROUPED Active 1.25 mg/ml

每包单位数:

10 mL

类:

VM - Veterinary Medicine

治疗领域:

ENDOCRINE SYSTEM

產品總結:

Poison schedule: 4; Withholding period: MEAT WITHHOLDING PERIOD: Zero (0) days; Host/pest details: HORSE - BREEDING: [INDUCTION OF OVULATION]

授权状态:

Registered

授权日期:

2023-07-01

资料单张

Product Name:
APVMA Approval No:
BioRelin Injection
89636/125483
Label Name:
BioRelin Injection
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each mL contains 1.25 mg DESLORELIN (as deslorelin acetate)
Claims:
Biorelin Injection is an injectable Gonadotrophin Releasing Hormone
(GnRH) analogue for
the induction of ovulation in the mare.
This product is indicated for inducing ovulation within 48 hours in
oestrous mares with an
ovarian follicle greater than 30 mm in diameter.
Net Contents:
10 mL multi-dose vials
Directions for Use:
Restraints:
Contraindications:
Precautions:
Side Effects:
Adverse Reactions
In a clinical trial conducted in Australia injection site reactions
were observed in 15.6% of
treated mares. The reactions were mild to moderate swellings at the
injection site which
may be painful on palpation. These reactions typically resolve within
36 hours.
Dosage and
Administration:
For administration by intramuscular injection only.
Discard vial within 28 days of initial broaching.
Shake well prior to use. RLP APPROVED
Standard Dose
Inject 1.0 mL by intramuscular (IM) injection (1.25 mg deslorelin per
dose).
This product should only be administered to oestrous mares that have
been demonstrated
by rectal palpation and/or ultrasonography to have an ovarian follicle
greater than 30 mm in
diameter.
General Directions:
Biorelin Injection is a synthetic GnRH analogue (deslorelin) in a
non-aqueous injection and
is indicated for the induction of ovulation in oestrus mares with an
ovarian follicle greater
than 30 mm in diameter within 48 hours.
CLINICAL PHARMACOLOGY
The long duration of oestrus in mares, and the varying time from the
onset of oestrus to
ovulation, typically results in the need for multiple breedings or
inseminations in order
to achieve conception. This product assists ovulation within 48 hours
after treatment in
oestrous mares with a developing follicle greater than 30 mm in
diameter. Deslorelin
induces ovulation by increa

产品特点

Product Name: BioRelin Injection
Page: 1 of 5
This version issued: October, 2020
SAFETY DATA SHEET
Issued by: Randlab Australia Pty Ltd
Phone: [phone]
Section 1 - Identification of The Material and Supplier
Randlab Australia Pty Ltd
Phone: [phone]
7/85 Alfred Road
Fax: [phone]
Chipping Norton NSW 1270 AUSTRALIA
Trade Name:
BioRelin Injection
Chemical nature:
Injection containing deslorelin.
Product Use:
Veterinary product. An injectable Gonadotrophin Releasing Hormone
(GnRH) analogue
for the induction of ovulation in the mare.
This version issued:
October, 2020 and is valid for 5 years from this date.
Poisons Information Centre: Phone 13 1126 from anywhere in Australia
Section 2 - Hazards Identification
Prevention:
P102:
Keep out of reach of children.
P103:
Read label before use.
P201:
Obtain special instructions before use.
P202
Do not handle until all safety precautions have been read and
understood.
P264:
Wash skin thoroughly after handling.
P270:
Do not eat, drink or smoke when using this product.
P280:
Wear protective gloves.
P281:
Use personal protective equipment as required.
Response:
P101:
If medical advice is needed, have product container or label at hand.
P312
Call a POISON CENTER or doctor/physician if you feel unwell.
P322
See first aid instruction on the label.
P363
Wash contaminated clothing before reuse.
P301 + P312:
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel
unwell.
P330:
Rinse mouth.
P302 + P352:
IF ON SKIN: Wash with plenty of soap and water.
P308 + P313:
IF exposed or concerned: Get medical advice/ attention.
Storage:
P405:
Store locked up.
Disposal:
P501:
Dispose of contents and containers as specified on the registered
label.
GHS Class
GHS Category
Hazard Code
Hazard Statement
Acute toxicity: oral
Category 4
H302
Harmful if swallowed.
Acute toxicity: skin
Category
H312
Harmful in contact with skin.
Reproductive toxicity
Category 2
H361
Suspected of damaging fertility or the unborn child.
Signal word:
Warning
GHS Pictogram:
Product Name: Bio