SDS Number 110618 Approved/Revised 01-Feb-2005 Version 15 Material AVANDAMET SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
Material AVANDAMET Synonyms
AVANDIA/METFORMIN COMBINATION TABLET * ROSIGLITAZONE 1 MG +METFORMIN 500 MG TABLET * ROSIGLITAZONE 2 MG + METFORMIN 500MG TABLET * ROSIGLITAZONE 4 MG + METFORMIN 500 MG TABLET *ROSIGLITAZONE 2MG + METFORMIN 1000MG TABLET * ROSIGLITAZONE4MG + METFORMIN 1000MG TABLET * 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 * NDC NO. 0007-3163-18 * NDC NO. 0007-3163-20 * NDC NO. 0007-3164-18 * NDC NO. 0007-3164-20 * NDC NO. 0007-3166-21 * NDC NO. 0007-3167-21 * NDC NO. 0007-3168-21 * ROSIGLITAZONE/METFORMIN,FORMULATED PRODUCT
Company Name
GlaxoSmithKline, Corporate Environment, Health & Safety
US number, available 24 hoursMulti-language response
GlaxoSmithKline, Corporate Environment, Health & Safety
+1-703-527-3887US number, available 24 hoursMulti-language response
2. COMPOSITION / INFORMATION ON INGREDIENTS
Ingredients Percentage Fire and Explosion SDS Number 110618 Approved/Revised 01-Feb-2005 Version 15 Material AVANDAMET
Handling this product in its final form presents minimal risk fromoccupational exposure. Health effects information is based on hazards of components. Environment
No information is available about the potential of this product to produceadverse environmental effects. Ingestion
Never attempt to induce vomiting. Do not attempt to give any solid or liquidby mouth if the exposed subject is unconscious or semi-conscious. Washout the mouth with water. If the exposed subject is fully conscious, giveplenty of water to drink. Obtain medical attention. Inhalation
Physical form suggests that risk of inhalation exposure is negligible. Skin Contact
Using appropriate personal protective equipment, remove contaminatedclothing and flush exposed area with large amounts of water. Obtainmedical attention if skin reaction occurs, which may be immediate ordelayed. Eye Contact
Wash immediately with clean and gently flowing water. Continue for at least15 minutes. Obtain medical attention. NOTES TO HEALTH PROFESSIONALS Medical Treatment
Medical treatment in cases of overexposure should be treated as anoverdose of a drug for the treatment of Type 2 diabetes. Treat according tolocally accepted protocols. For additional guidance, refer to the currentprescribing information or to the local poison control information centre. Medical Conditions Caused or Aggravated by Exposure Antidotes
No specific antidotes are recommended. Fire and Explosion
Not expected for the product, although the packaging is combustible. Extinguishing Media
Water or foam extinguishers are recommended. Carbon dioxide or dry powder extinguishers may be ineffective. Special Firefighting
For single units (packages): No special requirements needed. Procedures
For larger amounts (multiple packages/pallets) of product: Since toxic,corrosive or flammable vapours might be evolved from fires involving thisproduct and associated packaging, self contained breathing apparatus andfull 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
Products
expected when the product is exposed to fire. Personal Precautions
Wear protective clothing and equipment consistent with the degree ofhazard. Environmental Precautions
For large spills, take precautions to prevent entry into waterways, sewers, orsurface drainage systems. Clean-up Methods
Collect and place it in a suitable, properly labelled container for recovery ordisposal. Decontamination
No specific decontamination or detoxification procedures have been
Procedures SDS Number 110618 Approved/Revised 01-Feb-2005 Version 15 Material AVANDAMET HANDLING General Requirements
No storage requirements necessary for occupational hazards. Followproduct information storage instructions to maintain efficacy. INGREDIENT GSK Occupational Hazard Category GSK Occupational Exposure Limit INGREDIENT GSK Occupational Hazard Category GSK Occupational Exposure Limit ENGINEERING CONTROLS Containment
Open handling may result in overexposure. Ventilation
Local exhaust ventilation (LEV) should be used in conjunction with othercontrol measures as a means of removing material incidentally released. Administrative
Entry to the working area should be controlled. Other Equipment or
None required for normal handling. Wash hands and arms thoroughly after
Procedures Appearance Physical Form Stability
This product is expected to be stable. Conditions to Avoid
None for normal handling of this product. Oral Toxicity
Not expected to be toxic following ingestion. Skin Effects
Minor irritation might occur following direct contact. Eye Effects
Minor irritation might occur following direct contact with eyes. Target Organ Effects
No specific target organ effects have been identified. Sensitisation
Sensitisation (allergic skin reaction) is not expected. Genetic Toxicity
Not expected to be genotoxic under occupational exposure conditions. Carcinogenicity
No components are listed as carcinogens by GSK, IARC, NTP or USOSHA. Reproductive Effects
Contains components which have been classified as: Possible risk ofimpaired fertility in human females. Possible risk of toxicity in developinghuman offspring. SDS Number 110618 Approved/Revised 01-Feb-2005 Version 15 Material AVANDAMET Pharmacological Effects
This product contains active ingredient(s) with the following activity: aperoxisome proliferator activated receptor (PPAR) agonist. * Other Adverse Effects
None known for occupational exposure. * Summary
This material contains two or more active pharmaceutical ingredients thathave been tested, one of which may be harmful if released directly to theenvironment. Specific information on that active pharmaceutical ingredient,Rosiglitazone maleate, is provided below. Consult the MSDS of the activeingredient for specific information about potential environmental effects. Appropriate precautions should be taken to limit release of this material tothe environment. Local regulations and procedures should be consultedprior to environmental release. ECOTOXICITY * Activated Sludge
This material contains an active pharmaceutical ingredient that is not toxic
Respiration
> 1000 mg/L, 3 Hours, Activated sludge, Nominal
This material contains an active pharmaceutical ingredient that is very toxicto algae.
0.88 mg/L, 96 Hours, Selenastrum capricornutum,green algae
0.14 mg/L, 96 Hours, Selenastrum capricornutum,green algae
* Daphnid
This material contains an active pharmaceutical ingredient that is toxic todaphids.
6.8 mg/L, 48 Hours, Daphnia magna, Static test
No toxicity to fish was observed for the active pharmaceutical ingredient,but the upper range of the test was limited by the low water solubility of thecompound.
Juvenile Pimephales promelas, fathead minnow
> 14.5 mg/L, 96 Hours, Static renewal test
MOBILITY * Solubility
This material contains an active pharmaceutical ingredient that forenvironmental fate predictions has limited solubility in water. * Volatility
This material contains an active pharmaceutical ingredient that will notreadily enter into air from water. * Adsorption
This material contains an active pharmaceutical ingredient that is not likelyto adsorb to sludge or biomass if released directly to the environment. * Partitioning
This material contains an active pharmaceutical ingredient withoctanol/water partition coefficient data that suggests that for environmentalfate predictions the active pharmaceutical ingredient will not have thetendency to distribute into fats. PERSISTENCE/DEGRADATION SDS Number 110618 Approved/Revised 01-Feb-2005 Version 15 Material AVANDAMET * Biodegradation
This material contains an active pharmaceutical ingredient that is notreadily biodegradable but is inherently biodegradable (as defined by 1993OECD Testing Guidelines) and is not expected to persist in theenvironment.
50 %, 1 Day, Batch activated sludge (BAS),Activated sludge
* BIOACCUMULATION
This material contains an active pharmaceutical ingredient that will not havea tendency to bioaccumulate in the food chain. Disposal
Collect for recycling or recovery if possible. The disposal method for
Recommendations
rejected products/returned goods must ensure that they cannot be re-sold orre-used. Regulatory Requirements
Observe all local and national regulations when disposing of this material.
The SDS should accompany all shipments for reference in the event of spillage or accidental release. Onlyauthorised persons trained and competent in accordance with appropriate national and internationalregulatory requirements may prepare dangerous goods for transport. UN Classification and Labelling Transport Information
Transportation and shipping of this product is not restricted. It has no known,significant hazards requiring special packaging or labelling for air, maritime, USor European ground transport purposes.
The information included below is an overview of the major regulatory requirements. It should not beconsidered to be an exhaustive summary. Local regulations should be consulted for additional requirements. * EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinalproduct, cosmetic product or medical device. US OSHA Standard (29 CFR Part 1910.1200) Classification
This dosage form is exempt from the requirements of the OSHA HazardCommunication Standard. Other US Regulations TSCA Status References Date Approved/Revised 01-Feb-2005 SDS Version Number 15 SDS Sections Updated Sections Subsections
Activated Sludge RespirationAdsorptionAlgalAlgal DegradationBioaccumulationBiodegradation
SDS Number 110618 Approved/Revised 01-Feb-2005 Version 15 Material AVANDAMET SDS Sections Updated Sections Subsections
DaphnidDistributionEarthwormEcotoxicityFishHydrolysisMicrobial Growth InhibitionMicrotoxMobilityOther Adverse EffectsOther Species - AquaticOther Species - TerrestrialPartitioningPersistence/DegradationPhotolysisSolubilitySummaryVolatility
European Union Classification and LabellingRequirements
The information and recommendations in this safety data sheet are, to the best of our knowledge, accurateas of the date of issue. Nothing herein shall be deemed to create any warranty, express or implied. It is theresponsibility of the user to determine the applicability of this information and the suitability of the materialor product for any particular purpose. For further information please refer to the appropriate productinformation.
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SDS Number 110618