SDS Number 110618 Approved/Revised 15-Oct-2002 Version 10
Material AVANDAMET
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material AVANDAMET
AVANDIA/METFORMIN COMBINATION TABLET * ROSIGLITAZONE 1 MG +
Synonyms
METFORMIN 500 MG TABLET * ROSIGLITAZONE 2 MG + METFORMIN 500
MG TABLET * ROSIGLITAZONE 4 MG + METFORMIN 500 MG TABLET *
ROSIGLITAZONE/METFORMIN, FORMULATED PRODUCT * NDC NO.
0007-3166-18 * NDC NO. 0007-3166-20 * NDC NO. 3166-61 * NDC NO.
0007-3167-18 * NDC NO. 0007-3167-20 * NDC NO. 0007-3167-25 * NDC NO.
3167-61 * NDC NO. 0007-3168-18 * NDC NO. 0007-3168-20 * NDC NO.
0007-3168-25 * NDC NO. 3168-61
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
General Information: +44-1920-884242
UK number, answer phone
Transport Emergency, UK: +44-1865-407333
UK number, available 24 hours
Medical Emergency +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
General Information: +610-239-5229
US number, answer phone
Transport Emergency: +703-527-3887
except UK US number, available 24 hours
Multi-language response
2. COMPOSITION / INFORMATION ON INGREDIENTS
Percentage
Ingredients CAS RN
ROSIGLITAZONE MESYLATE 0.48 to 0.92
155141-29-0
METFORMIN HYDROCHLORIDE 87.7 to 90.9
1115-70-4
NON-HAZARDOUS INGREDIENTS 8.42 to 11.47
Unassigned
3. HAZARDS IDENTIFICATION
This product is expected to be non-combustible.
Fire and Explosion
Page 1 / 5
SDS Number 110618 Approved/Revised 15-Oct-2002 Version 10
Material AVANDAMET
Skin Contact Irritation following direct contact is not expected. Potential to produce
allergic skin reaction is not known. Symptoms such as itching, redness,
swelling or pain might be delayed.
Eye Contact Irritation with redness, swelling, or blurred vision can occur following direct
contact with broken tablets.
Inhalation Not expected to occur during normal handling of this product.
Ingestion Toxicity following ingestion is not expected. Avoid occupational ingestion.
No effects on blood sugar are expected in normal individuals.
Environment No information is available about the potential of this product to produce
adverse environmental effects.
4. FIRST-AID MEASURES
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 Conditions None for occupational exposure.
Caused or Aggravated
by Exposure
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 This material is expected to be combustible. Water, dry powder or foam
extinguishers are recommended. Carbon dioxide extinguishers may be
ineffective.
Special Firefighting For larger amounts (multiple packages/pallets) of product: Since toxic,
corrosive or flammable vapours might be evolved from fires involving this
Procedures
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. For single units
(packages): No special requirements needed.
Hazardous Combustion Toxic, corrosive or flammable thermal decomposition products are
expected when the material is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
Spills
Page 2 / 5
SDS Number 110618 Approved/Revised 15-Oct-2002 Version 10
Material AVANDAMET
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.
Decontamination Water can be used for clean-up and decontamination operations. No
specific decontamination or detoxification procedures have been identified
Procedures
for this material. Consider use of water, detergent solutions, or other
soluble solvents (as specified in Section 9 of this SDS), for clean-up and
decontamination operations.
7. HANDLING AND STORAGE
Handling Avoid breaking or crushing tablets.
Storage No storage requirements necessary for occupational hazards. Follow
storage instructions described in the product insert to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
ROSIGLITAZONE MESYLATE
INGREDIENT
3
GSK Occupational
Hazard Category
REPRODUCTIVE HAZARD
GSK Occupational 30 mcg/m3 (8 HR TWA)
Exposure Limit
METFORMIN HYDROCHLORIDE
INGREDIENT
1
GSK Occupational
Hazard Category
GSK Occupational 3000 mcg/m3 (8 HR TWA)
Exposure Limit
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields or cover goggles if eye
contact is possible.
Gloves None required for the normal handling of this material.
Respirators Respiratory protective equipment (RPE) is not required for normal handling
of this material.
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Tablet.
Physical Form
10. STABILITY AND REACTIVITY
Stability This material is expected to be stable.
Conditions to Avoid None for normal handling of this material.
11. TOXICOLOGICAL INFORMATION
Page 3 / 5
SDS Number 110618 Approved/Revised 15-Oct-2002 Version 10
Material AVANDAMET
Oral Toxicity Adverse effects might occur following ingestion. The oral LD50 is expected
to be less than 2000 mg/kg in rats, based on calculations relating to the
effects of individual components and concentrations present.
Inhalation Toxicity Not applicable for finished products.
Skin Effects Irritation is not expected based on effects of individual components.
Eye Effects Irritation might occur following direct contact with eyes. Assessment based
upon effects of individual components.
Sensitisation No studies have been conducted.
Carcinogenicity Assessment based upon effects of individual components. Not expected to
produce cancer in humans under occupational exposure conditions.
Positive results occurred in some studies that are not considered to be
relevant to occupational exposure conditions. No components in this
mixture are listed as carcinogens by IARC, NTP or US OSHA.
12. ECOLOGICAL INFORMATION
Summary No information is available about the potential of this material to produce
adverse environmental effects. Local regulations and procedures should be
consulted prior to environmental release.
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 material.
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 material 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
Classification(s)
US OSHA Standard (29 CFR Part 1910.1200)
Classification This material is not classified as hazardous according to the OSHA Hazard
Communication Standard.
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 15-Oct-2002 SDS Version Number 10
SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
Page 4 / 5
SDS Number 110618 Approved/Revised 15-Oct-2002 Version 10
Material AVANDAMET
SDS Sections Updated
Sections Subsections
OTHER INFORMATION Disclaimer Safety Data Sheet
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. Please see accompanying complete prescribing information.
Page 5 / 5
|