SDS Number 110377 Approved/Revised 12-Aug-2008 Version 11
TWINRIX JUNIOR
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
space
Material TWINRIX JUNIOR
space
TWINRIX PAEDIATRIC INJECTION * TWINRIX PAEDIATRIC PRE-FILLED SYRINGE *
Synonym(s)
TWINRIX PEDIATRIC PFS * TWINRIX PAEDIATRIC INJECTION 360 EL U AND 10
MCG/0.5 ML * TWINRIX KINDER FERTIGSPRITZE MIT 0.5 ML SUSPENSION * HEPATITIS
A VIRUS (INACTIVATED) AND HEPATITIS B SURFACE ANTIGEN COMBINED VACCINE
space
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
space
UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
space
GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
space
US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
2. HAZARDS IDENTIFICATION
space
This product is classified as non-flammable.
Fire and Explosion
space
Handling this product in its final form presents minimal risk from occupational exposure.
Health
May produce allergic skin reactions. Possible effects of overexposure in the workplace
include: symptoms of hypersensitivity (such as skin rash, hives, itching, and difficulty
breathing). Health effects information is based on hazards of components.
space
No information is available about the potential of this product to produce adverse
Environment
environmental effects.
.
* 3. COMPOSITION / INFORMATION ON INGREDIENTS
space
Ingredients CAS # Percent EC-No.
HEPATITIS A VIRUS INACTIVATED Unassigned Not
Applicable
HEPATITIS B VIRUS SURFACE ANTIGEN Unassigned Not
Applicable
NON-HAZARDOUS INGREDIENTS Unassigned > 99
Page 1 / 4
SDS Number 110377 Approved/Revised 12-Aug-2008 Version 11
TWINRIX JUNIOR
Material
4. FIRST-AID MEASURES
space
Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the
Ingestion
exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the
exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention.
space
Physical form suggests that risk of inhalation exposure is negligible.
Inhalation
space
Using appropriate personal protective equipment, remove contaminated clothing and flush
Skin Contact
exposed area with large amounts of water. Obtain medical attention if skin reaction occurs,
which may be immediate or delayed.
space
Wash immediately with clean and gently flowing water. Continue for at least 15 minutes.
Eye Contact
Obtain medical attention.
space
NOTES TO HEALTH PROFESSIONALS
None.
Medical Treatment
space
The components contained in this vaccine are generally not considered to cause disease in
Medical Conditions
humans.
Caused or Aggravated by
Exposure
space
No specific antidotes are recommended.
Antidotes
.
5. FIRE-FIGHTING MEASURES
space
Not expected for the product, although the packaging is combustible.
Fire and Explosion Hazards
space
Water is recommended for fires involving packaging.
Extinguishing Media
space
For single units (packages): No special requirements needed. For larger amounts (multiple
Special Firefighting
packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved
Procedures
from fires involving this product and associated packaging, self contained breathing
apparatus and full protective equipment are recommended for firefighters. If possible, contain
and collect firefighting water for later disposal.
space
Toxic, corrosive or flammable thermal decomposition products are expected when the
Hazardous Combustion
product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
space
Wear protective clothing and equipment consistent with the degree of hazard.
Personal Precautions
space
For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage
Environmental Precautions
systems.
space
Collect and place it in a suitable, properly labelled container for recovery or disposal.
Clean-up Methods
space
Water can be used for clean-up and decontamination operations. Sodium hypochlorite
Decontamination Procedures
(bleach) or other strong oxidizers can be used in clean-up decontamination operations.
Contaminated surfaces should be washed with water, then bleach or other oxidizing solution,
followed by another water wash.
7. HANDLING AND STORAGE
space
HANDLING
No special control measures required for the normal handling of this product. Normal room
General Requirements
ventilation is expected to be adequate for routine handling of this product.
space
No storage requirements are considered necessary for the control of fire and explosion
STORAGE
hazards.
DO NOT FREEZE. Dispose of properly if frozen.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
space
None required for normal handling. Wash hands and arms thoroughly after handling.
Other Equipment or
Procedures
Page 2 / 4
SDS Number 110377 Approved/Revised 12-Aug-2008 Version 11
TWINRIX JUNIOR
Material
9. PHYSICAL AND CHEMICAL PROPERTIES
space
Appearance
Liquid suspension.
Physical Form
10. STABILITY AND REACTIVITY
space
DO NOT FREEZE - dispose of properly if frozen.
Stability
space
None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
space
Routes of Exposure
Not expected to be toxic following ingestion.
Oral Toxicity
space
No studies have been conducted.
Inhalation Toxicity
space
Irritation is not expected following direct contact.
Skin Effects
space
Irritation is not expected following direct contact with eyes.
Eye Effects
space
Allergic skin reactions might occur following dermal exposure. Assessment based upon
Sensitisation
effects of structurally similar substances. Respiratory sensitisation (allergic) reactions might
occur following exposure.
space
Not expected to be genotoxic under occupational exposure conditions.
Genetic Toxicity
space
Not expected to produce cancer in humans under occupational exposure conditions. No
Carcinogenicity
components are listed as carcinogens by GSK, IARC, NTP or US OSHA.
space
Not expected to produce adverse effects on fertility or development under occupational
Reproductive Effects
exposure conditions.
space
None known for occupational exposure.
Other Adverse Effects
12. ECOLOGICAL INFORMATION
space
No information is available about the potential of this product to produce adverse
Summary
environmental effects. Local regulations and procedures should be consulted prior to
environmental release.
13. DISPOSAL CONSIDERATIONS
space
The disposal method for rejected products/returned goods must ensure that they cannot be
Disposal Recommendations
re-sold or re-used.
space
Observe all local and national regulations when disposing of this product.
Regulatory Requirements
14. TRANSPORT INFORMATION
space
The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons
trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous
goods for transport.
space
UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US or
European ground transport purposes.
15. REGULATORY INFORMATION
space
The information included below is an overview of the major regulatory requirements. It should not be considered to be an
exhaustive summary. Local regulations should be consulted for additional requirements.
space
EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product,
cosmetic product or medical device.
Page 3 / 4
SDS Number 110377 Approved/Revised 12-Aug-2008 Version 11
TWINRIX JUNIOR
Material
space
US OSHA Standard (29 CFR Part 1910.1200)
This product is exempt from the requirements of the OSHA Hazard Communication
Classification
Standard.
space
Other US Regulations
Exempt
TSCA Status
16. OTHER INFORMATION
space
GSK Hazard Determination
References
space
11
SDS Version Number
space
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
space
The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of
issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine
the applicability of this information and the suitability of the material or product for any particular purpose.
Page 4 / 4
|