Fertagyl - Issue 2
MATERIAL SAFETY DATA SHEET
FERTAGYL庐
January 7th, 2002
Issue Date:
January 7th, 2004
Review Date:
Company Address: Intervet Australia Pty Limited
Box 2800
Bendigo Delivery Centre
VIC 3554
Phone: 03 5442 5011
Fax: 03 5442 3162
Emergency Tel. No.: Matt Playford
Veterinary Services Manager
Intervet Australia Pty Limited
03 5442 5011
Poisons Information Centre: 13 11 26
1. IDENTIFICATION
1.10 Product Name: Fertagyl Synthetic Gonadotrophin Releasing Hormone
1.11 Correct Shipping Name: Not Available
1.12 Other Names: Gonadorelin Synthetic GnRH
1.13 UNNO: None Allocated
1.14 Hazchem Code: None Allocated (not listed as a hazardous substance)
1.15 Dangerous Goods Class: None
Sub-risk: None Allocated (not listed as a hazardous substance)
1.16 Poison Schedule: S4
1.17 Manufacturers Product
Code: 21133
1.18 Use: Prescription Only drug for animal treatment only 鈥? To
induce ovulation, treat cystic ovaries and improve fertility
post partum in cattle.
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Fertagyl - Issue 2
1.2 Ingredients
1.20 Chemical Entity CAS No. Proportion per mL
*Gonadorelin (100%) 33515-09-2 0.12 mg
Benzyl alcohol 100-51-6 +
Sodium chloride 7647-14-5 +
Water for injection 7732-18-5 To 1.00 mL
* Active Constituent
+ Confidential Manufacturing Information
1.21 Chemical Characterisation: Gonadorelin (Synthetic GnRH) 0.1 mg/mL in sterile
injection
1.3 Physical Description / Properties
1.30 Form: Sterile liquid contained in 5mL dose in packs of 10
1.31 Colour: Colourless, clear aqueous solution
1.32 Odour: None
1.33 Change in Physical State: Not relevant
1.34 SG: Approximately 1
1.35 Vapour Pressure: Not available
1.36 Viscosity: Not relevant
1.37 Solubility in Water: Miscible
1.38 pH Value: 4.5 - 7
1.39 Flash Point: Non flammable
1.40 Ignition Temperature: Not relevant
1.41 Explosive Limits: Not relevant
1.42 Particle Size: Not relevant
1.5 Other Properties
1.51 Further Information: See Martindale Extra Pharmacopoeia 29th ed., page 1442
2. HEALTH HAZARD INFORMATION
2.1 Health Effects:
2.10 Information on Toxicity: Gonadorelin is a substance of very low toxicity. Some
adverse reactions have occurred in humans following its
therapeutic use therein.
a) Adverse Effects in Humans
Gonadorelin and its analogues may cause gastro-
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Fertagyl - Issue 2
intestinal adverse effects, usually nausea and
abdominal pain or discomfort. There may be
headache or lightheadedness and an increase in
menstrual bleeding. Reactions or pain may occur
at the site of injection with rash, swelling or pruritus.
Bronchospasm has been reported.
b) Low Toxicity in Animals
GnRH is a naturally occurring, non-toxic hormone:
Mice : 50 mg/kg I/V no adverse effects.
Cows : 50 mg (100 X clinical dose) I/V no
adverse effects.
Benzyl alcohol hypersensitivity reactions have been
reported in humans.
2.2 First Aid
2.20 First Aid: a. Eye contact - Flush eyes with copious
amounts of water for at least 15 minutes. Seek
medical advice.
b. Skin contact - Flush skin for 15 minutes with
copious amounts of cold water . Remove and wash
contaminated clothing before reuse.
c. Self Administration - Wash and disinfect self
injection injuries. Seek medical advice if irritancy or
an allergic response occurs. Take this Material
Safety Data Sheet to your doctor.
2.21 Advice to Doctor: Treat symptomatically any allergic reaction.
PRECAUTIONS FOR USE
3.1 Exposure Standards / Engineering Control
3.10 Regulations: This product is not subject to the Australian Code for the
Transport of Dangerous Goods by Road and Rail.
This product is a Poison Schedule 4 prescription drug and
may only be possessed and used by those people with
appropriate authorisation.
3.11 Technical Protective No special measures are required. Exercise normal care
Measures: to prevent accidental ingestion. Store away from food,
drink or animal feeding stuffs. Store below 25oc. Do not
freeze.
3.2 Personal Protective Measures
3.21 Personal Protective
Equipment: None required
3.22 Industrial Hygiene: Avoid contact with the skin and eyes
3.3 Flammability
3.31 Protection Against Fire: The product is alcohol based and flammable. Do not
expose to excessive heat.
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Fertagyl - Issue 2
4. MEASURES IN CASE OF ACCIDENTS AND FIRES
4.1 Storage and Transport
4.11 Classification under the
Transportation of Dangerous
Goods Code:
Shipping Name: Not Available
Packing Group: None
UNNO: None Allocated
DG Class: None
Sub-risk: None
Hazchem: None
4.12 DG storage/transport in accordance with State and Territory regulations. This product is
not subject to the requirements of the Australian Code for the Transport of Dangerous
Goods by Road and Rail. Product should be stored and handled in accordance with
regulations governing Schedule 4 (prescription) drugs.
4.13 International Transport
Codes: Not relevant
4.2 Spills and Disposals
4.21 Dispose of unused or expired material in an authorised landfill.
4.22 After Spillage/Leakage: Spillage quantities will be minor due to the small volumes
of
product normally transported and stored. Prevent the spill
spreading to contaminate other areas. Do not allow the
product to contact skin or eyes. Wear rubber gloves for
clean-up operations. Do not smoke or eat during clean-up
operations. If contact occurs immediately wash off with
soap and water.
4.23 Disposal of Spillage: Absorb into paper towel, hydrated lime, soil or sand,
depending on quantity involved. Dispose of contaminated
absorbent material in an appropriate manner. Rinse area
of spill with detergent and water.
On completion of clean-up wash all exposed skin areas
and any contaminated protective clothing. Inform the local
water authority if large amounts enter the drainage system.
4.3 Fire / Exposure Hazards
4.35 Thermal Decomposition: In fire incidents toxic fumes of nitrogen oxides, sulphur
oxides, carbon monoxide may be formed.
4.36 Hazardous Decomposition Do not use expired, pre-used or past date material in
Products: animals.
4.37 Hazardous Reactions: None
4.38 Extinguishing Media: Not relevant
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Fertagyl - Issue 2
5. OTHER INFORMATION
5.10 Information on Ecological There is no data on ecological effects. It is not anticipated
Effects: that this product will enter the environment as a
consequence of normal use.
6. CONTACT POINT ( For Non-Emergency Calls )
6.10 Product Safety Coordinator: Matt Playford
Veterinary Services Manager
Intervet Australia Pty Limited
03 5442 5011
DISCLAIMER
The Material Safety Data Sheet has been developed according to WORKSAFE Australia / NOHSC guidelines.
The data, information and recommendations herein (鈥渋nformation鈥?) are represented in good faith and believed to be
correct as of the date hereof.
The purpose of this Material Safety Data Sheet is to describe product in terms of their safety requirements.
Intervet Australia Pty Limited makes no representation of merchantability, fitness for a particular purpose or
application, or of any other nature with respect to the information or the product to which the information refers (鈥渢he
product鈥?).
The information is supplied upon the condition that the persons receiving same will make their own determination as
to its suitability for their purposes prior to use of the product.
The physical data shown herein are typical values based on material tested. These values should not be construed
as a guaranteed analysis of any specific lot or as guaranteed specification for the product or specific lots thereof.
Due care should be taken to make sure that the use or disposal of this product is in compliance with relevant Federal,
State and Local Government regulations.
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