SDS Number 4258 Approved/Revised 14-Aug-2003 Version 06
Material TEMOPEN VIALS



SAFETY DATA SHEET




1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material TEMOPEN VIALS
TEMOPEN 1 GRAM VIAL * TEMOCILLIN SODIUM, FORMULATE Synonyms
PRODUCT * D1003603
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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

GlaxoSmithKline, Corporate Environment, Health & Safety
2200 Renaissance Blvd, Suite 105
King of Prussia, PA 19406 US
US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response

2. COMPOSITION / INFORMATION ON INGREDIENTS
Percentage
Ingredients CAS RN
TEMOCILLIN SODIUM 100
61545-06-0

3. HAZARDS IDENTIFICATION
This product is expected to be non-combustible.
Fire and Explosion
Health Exposure might occur via skin; eyes; ingestion; inhalation.
May produce allergic skin reactions.
Respiratory allergen.
Possible effects of overexposure in the workplace include: symptoms of
hypersensitivity (such as skin rash, hives, itching, and difficulty breathing);
nausea; vomiting; diarrhoea.
Health effects information is based on hazards of components.
Environment No information is available about the potential of this product to produce
adverse environmental effects.

4. FIRST-AID MEASURES


SDS Number 4258 Approved/Revised 14-Aug-2003 Version 06
Material TEMOPEN VIALS


Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid
by mouth if the 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.
Inhalation Using appropriate personal protective equipment, move exposed subject to
fresh air. If breathing is difficult or ceases, ensure and maintain ventilation.
Give oxygen as appropriate. The exposed subject should be kept warm and
at rest. Obtain medical attention in cases of known or possible over
exposure, or with symptoms including chest pain, difficulty breathing, loss of
consciousness or other adverse effects, which may be delayed.
Skin Contact Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
delayed.
Eye Contact Wash immediately with clean and gently flowing water. Continue for at least
15 minutes. Obtain medical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment Treat according to locally accepted protocols. For additional guidance, refer
to the current prescribing information or to the local poison control
information centre. Medical treatment in cases of overexposure should be
treated as an overdose of penicillin antibiotic. In allergic individuals,
exposure to this material may require treatment for initial or delayed allergic
symptoms and signs. This may include immediate and/or delayed treatment
of anaphylactic reactions.
Medical Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product. Ocular
Caused or Aggravated
symptoms may be indicative of allergic reaction. Pulmonary symptoms may
by Exposure
indicate allergic reaction or asthma. This material may cause or aggravate
allergy to penicillin antibiotics.
Antidotes No specific antidotes are recommended.

5. FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Extinguishing Media Water, dry powder or foam extinguishers are recommended. Carbon
dioxide extinguishers may be ineffective.
Special Firefighting For single units (packages): No special requirements needed. For larger
amounts (multiple packages/pallets) of product: Since toxic, corrosive or
Procedures
flammable vapours might be evolved 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.
Hazardous Combustion Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products

6. ACCIDENTAL RELEASE MEASURES
Personal Precautions Wear protective clothing and equipment consistent with the degree of
hazard.
Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or
surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.


SDS Number 4258 Approved/Revised 14-Aug-2003 Version 06
Material TEMOPEN VIALS


Decontamination No specific decontamination or detoxification procedures have been
identified for this product. Water can be used for clean-up and
Procedures
decontamination operations.

7. HANDLING AND STORAGE
HANDLING
General Requirements No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
handling of this product.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
TEMOCILLIN SODIUM
INGREDIENT
1
GSK Occupational
Hazard Category
RESPIRATORY SENSITISER, SKIN
GSK Occupational 1000 MCG/M3 (8 HR TWA)
SENSITISE Exposure Limit
Other Equipment or Wear appropriate clothing to avoid skin contact. Wash hands and arms
thoroughly after handling.
Procedures

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Off-white/light yellow.
Colour
Lyophilised pellet.
Physical Form
Vial.
Packaging
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid None for normal handling of this product.

11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
Inhalation Toxicity Adverse effects might occur following inhalation.
Skin Effects No studies have been conducted.
Eye Effects No studies have been conducted.
Target Organ Effects No specific target organ effects have been identified.
Sensitisation Allergic skin reactions might occur following dermal exposure. Assessment
based upon information from human exposure. Respiratory sensitisation
(allergic) reactions might occur following exposure.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Assessment based upon effects of structurally similar substances.
Carcinogenicity Not expected to produce cancer in humans under occupational exposure
conditions. No components are listed as carcinogens by GSK, IARC, NTP
or US OSHA.
Reproductive Effects No adverse effects have been reported following extensive use or exposure
in humans.
Pharmacological Effects This material is a penicillin; an antibiotic.

SDS Number 4258 Approved/Revised 14-Aug-2003 Version 06
Material TEMOPEN VIALS



12. ECOLOGICAL INFORMATION
Summary No information is available about the potential of this product to produce
adverse environmental effects. Local regulations and procedures should be
consulted prior to environmental release.
PERSISTENCE/DEGRADATION
Biodegradation Penicillins are generally susceptible to degradation by a number of
micro-organisms found in wastewater treatment plants and the general
environment. Resulting degradation products are readily mineralised by
environmental micro-organisms.

13. DISPOSAL CONSIDERATIONS
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
Regulatory Requirements Observe all local and national regulations when disposing of this product.

14. TRANSPORT INFORMATION
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.
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
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.
EU Classification and Labelling
None.

US OSHA Standard (29 CFR Part 1910.1200)
Classification This dosage form is exempt from the requirements of the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt

16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 14-Aug-2003 SDS Version Number 6
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.






TEMOCILLIN