HomeMy WebLinkAboutMerck Varivax & ZostavaxSDS221 CSL Limited Version 1
Varivax® and Zostavax®
MATERIAL SAFETY DATA SHEET
Page 1 of 4 - Date of Issue: 21 October 2010
IMPORTANT NOTICE This Material Safety Data Sheet (MSDS) is prepared by CSL Limited in accordance with the Australian
National Occupational Health & Safety Commission National Code of Practice for the Preparation of Material Safety Data Sheets
[NOHSC:2011(2003)]. The information contained herein must not be altered or deleted. Additional information may be appended to
the MSDS, but it must be marked clearly to indicate that it is not part of the original.
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Product Name Varivax®, Zostavax®
Other Names Attenuated Varicella Virus
Manufacturer's Product Code Varivax®: 80740501, 80740507, 80740507. Zostavax®: 80760101, 80760107
Use Vaccination against Varicella infection (chicken pox).
Suppliers Name CSL Limited (ABN 99 051 588 348)
Address 45 Poplar Road, Parkville, Victoria 3052, Australia
Telephone +61 03 9389 1911
Emergency Telephone 03 9389 1984 (24hr)
2. HAZARDS IDENTIFICATION
Not classified as hazardous according to the criteria of SWA
Not classified as a dangerous good by the criteria of the ADG Code
3. COMPOSITION/INFORMATION ON INGREDIENTS
Chemical name: CAS Number:
Proportion:
Active ingredient:
Oka/Merck varicella virus (weakened strain
of varicella virus)
--- 1350PFU (plaque forming unit)
when constituted with diluents
and stored at room temperature
for 150 mins per 0.5mL dose.
Inactive ingredients:
Sucrose, hydrolysed gelatine, sodium chloride, monosodium glutamate, sodium phosphate dibasic,
potassium phosphate monobasic, potassium chloride, urea, neomycin, bovine (beef) serum.
Diluent:
Water
MATERIAL SAFETY DATA SHEET
Varivax® and Zostavax® Page 2 of 4
Date of Issue: 21 October 2010
SDS221 CSL Limited Version 1
4. FIRST AID MEASURES
Eye
Flush eye thoroughly with water for at least 15 minutes. If irritation occurs, seek
immediate medical attention.
Ingestion
DO NOT induce vomiting. Wash out mouth with water and give plenty of water to
drink.
Skin
Remove contaminated clothing. Wash skin thoroughly with water. If irritation
occurs, seek medical attention.
Inhaled
If inhaled, remove to fresh air. If breathing is difficult, give oxygen. If not breathing,
give artificial respiration. Get medical attention if symptoms occur.
First Aid Facilities
Ensure water is available at point of use.
Advice to Doctor
Treat symptomatically.
5. FIRE FIGHTING MEASURES
Fire/Explosion Hazard
None known.
Fire Extinguishing Media
In case of fire, use water spray (fog), foam, dry chemical or CO2.
Hazchem Code
None allocated.
6. ACCIDENTAL RELEASE MEASURES
Minor Spills
Contain spilled material. Use absorbent (or soil, in absence of other suitable
material), scoop up material and place in a sealed, liquid-proof container for
disposal. Disinfect the affected area with 70% ethanol or a freshly made 10% bleach
solution.
Major Spills
Contain material ensuring runoff does not reach a waterway. Place spilled material in
an appropriate container for disposal. Minimise contact of spilled material with soils
to prevent runoff to surface waterways. Disinfect the affected area with 70% ethanol
or a freshly made 10% bleach solution.
7. HANDLING AND STORAGE
- Avoid contact with skin and eyes.
- Keep it where children cannot reach it.
- Store at 2-8oC – not in the door compartment.
-
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Standards
No exposure limits set by NOHSC or ACGIH
Engineering Controls Adequate ventilation should be provided if there is risk of aerosol formation. None
required when handling sealed vials.
MATERIAL SAFETY DATA SHEET
Varivax® and Zostavax® Page 3 of 4
Date of Issue: 21 October 2010
SDS221 CSL Limited Version 1
Personal Protection None is required when handling sealed vials. Safety glasses and protective gloves
should be worn when handling product. The choice of protection should be based on
the job activity and potential for exposure to the eyes and face.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance White powder
Odour Not determined
pH Not determined
Boiling Point/Melting Point Not determined
Vapour Pressure Not determined
Vapour Density Not determined
Specific Gravity Not determined
Flashpoint Not determined
Flammability Limits Not determined
Solubility in Water Not determined
10. STABILITY AND REACTIVITY
Reactivity
Not available
Stability
Not available
Decomposition Products
None known
11. TOXICOLOGICAL INFORMATION
Eye Formulation may be irritating
Ingestion Not available
Skin
May cause mild irritation.
MATERIAL SAFETY DATA SHEET
Varivax® and Zostavax® Page 4 of 4
Date of Issue: 21 October 2010
SDS221 CSL Limited Version 1
Inhalation Not an expected route of exposure.
Chronic Health Effects No chronic health effects expected under conditions of use.
Special circumstances
Immune status: Changes in the immune system due to cancer or cancer therapy
(radiation or chemotherapy), steroid use, tuberculosis, organ transplant or
diseases of the immune system (including HIV/AIDS) must be reported
immediately to their occupational health group or personal physician, as
appropriate. The US Advisory Committee on Immunizations Practices (ACIP) has
recommended severely immune compromised individuals not be exposed to live
virus vaccines, as there is a risk of severe complications.
Pregnancy: Women who are considering pregnancy should consult with their
occupational health group or physician prior to conception. Since the wild0type
virus can damage the developing fetus (congenital varicella syndrome), a registry
has been established by Merck and the Centers for Disease Control and
Prevention (CDC) to follow pregnant women inadvertently inoculated with the
varicella vaccine or who became pregnant within 3 months of being vaccinated.
Fetuses of women with known immunity are not considered to be at risk for
congenital varicella syndrome.
12. ECOLOGICAL INFORMATION
- No data available.
- For good environmental practice avoid discharge to waterways.
13. DISPOSAL CONSIDERATIONS
In accordance with state land and waste management authority.
14. TRANSPORT INFORMATION
UN Number None allocated
DG Class None allocated
Subsidiary Group None allocated
Packing Group None allocated
Hazchem Code None allocated
15. REGULATORY INFORMATION
Poisons Schedule Number Schedule 4 (S4) – Prescription only medicine
16. OTHER INFORMATION
MATERIAL SAFETY DATA SHEET
Varivax® and Zostavax® Page 5 of 4
Date of Issue: 21 October 2010
SDS221 CSL Limited Version 1
Last Revised Original MSDS
Abbreviations
SWA Safe Work Australia
NOHSC National Occupational Health and Safety Commission
ADG Code Australian Dangerous Goods Code
UN Number United Nations Number
DG Class Dangerous Goods Class
CAS Number Chemical Abstract Service Number
Contact Point
Company Contact:
Australian Poisons Information Centre, 24 hour service:
Australian Police, Fire Brigade or Ambulance:
+61 3 9389 1984 (24hr)
13 11 26
000
Whilst the information contained in this document is based on data which, to the best of our knowledge, was accurate and reliable
at the time of preparation, no responsibility can be accepted by us for errors and omissions. Users are advised to make their own
determination as to the suitability of this information in relation to their particular purposes and specific circumstances. Since the
information contained in this document may be applied under conditions beyond our control, we can accept no responsibility for
any loss or damage by any person acting or refraining from action as a result of this information.