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149-44-0 1309-48-4 9003-39-8 7732-15-5

File Name: 149-44-0_1309-48-4_9003-39-8_7732-15.asp

                                                                         ENGEMYCIN 100 - Issue 2




MATERIAL SAFETY DATA SHEET
ENGEMYCIN?100


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: Engemycin 100

1.11 Correct Shipping Name: Not Available

1.12 Other Names: Oxytetracycline Hydrochloride

1.13 UNNO: None Allocated

1.14 Hazchem Code: None Allocated

1.15 Dangerous Goods Class: None
Sub-risk: None Allocated

1.16 Poison Schedule: S4

1.17 Manufacturers Product
Code:

1.18 Use: Prescription Only drug for animal treatment only - Broad
spectrum antibiotic injection for use in horses, cattle,
sheep, pigs, dogs and cats




Page 1 of 5
ENGEMYCIN 100 - Issue 2




1.2 Ingredients

1.20 Chemical Entity CAS No. Proportion per mL

*Oxytetracycline hydrochloride 2058-46.0 108.00 mg
Sodium formaldehyde sulfoxylate 149-44-0 +
Magnesium oxide 1309-48-4 +
Povidone K12 9003-39-8 +
Ethanolamine 141-43.5 +
Water for Injection 7732-15-5 0.702mL

* Active Constituent
+ Confidential Manufacturing Information

1.21 Chemical Characterisation: Oxytetracycline Hydrochloride Sterile Injection

1.3 Physical Description / Properties

1.30 Form: Sterile liquid contained in 100 mL & 250 mL multidose vials

1.31 Colour: Colourless, clear yellow aqueous solution

1.32 Odour: None

1.33 Change in Physical State: Not relevant

1.099 at 25oc
1.34 SG:

1.35 Vapour Pressure: The vapour pressure of ethanolamine is low. UPO, 0.2mm
20oc

1.36 Viscosity: Not relevant

1.37 Solubility in Water: Miscible

1.38 pH Value: 8.5 - 9.5

1.39 Flash Point: Non flammable

1.40 Ignition Temperature: Not relevant

1.41 Explosive Limits: Not relevant

1.5 Other Properties

1.51 Further Information: See Martindale Extra Pharmacopoeia 29th ed., pages
313-322


2. HEALTH HAZARD INFORMATION

2.1 Health Effects: The oxytetracycline component may be taken as non toxic.
The ethanolamine component has some toxicity




Page 2 of 5
ENGEMYCIN 100 - Issue 2




2.10 Information on Toxicity: Ethanolamine LD50 oral - rat 2050 mg/kg
Ethanolamine eye irritancy- 763 microgram severe
irritation
Engemycin - skin irritation 1000 mg/kg rabbit
Sensitization - can occur to tetracyclines but is usually
limited to urticarial type rashes

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 Injection - Wash and disinfect self injection
injuries. Seek medical advice if irritancy or an
allergic response occurs.

2.21 Advice to Doctor: Accidental self injection of any tetracycline injection may
cause some local irritation in humans (or even thrombo-
phlebitis if given intravenously). Haemopoeitic diseases
occur in humans rarely. The injection of out of date
material in humans causes Fanconi type symptoms due to
degradation products.

The Fanconi symptoms, due to accidental self injection of
out of date material, are reversible and include polyuria,
polydipsia, nausea, proteinuria, glycosuria acidosis and
hypocalcaemia.

Treat symptomatically any allergic reaction to tetracycline
or any local irritancy caused by ethanolamine.


3. 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 Poisons 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 self-injection. 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




Page 3 of 5
ENGEMYCIN 100 - Issue 2




3.3 Flammability

3.31 Protection Against Fire: The product is water based and not flammable


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.




Page 4 of 5
ENGEMYCIN 100 - Issue 2




4.36 Hazardous Decomposition Do not use expired, pre-used or past date material
Products: in animals.

4.37 Hazardous Reactions: None

4.38 Extinguishing Media: Not relevant

4.39 Further Information: Because the vapour pressure of ethanolamine is low,
spillages must be cleared promptly before significant
amounts of ethanolamine are volatilized.


5. OTHER INFORMATION

5.10 Information on There is no data on ecological effects. It is not anticipated
Ecological Effects: there will be any effect on the environment as a
consequence of normal use. Accidental spillage of large
shipments could be a problem as the entry into sewerage
treatment plants of large volumes of antibiotics may inhibit
processing. Thus, disposal of large volumes into drainage
sewerage system of local councils should be avoided if
possible.


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 ("information") 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 ("the
product").

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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