SDS Number 2943 Approved/Revised 14-Feb-2007 Version 17
REQUIP TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material REQUIP TABLETS
REQUIP 0.25mg TABLETS * REQUIP 0.5mg TABLETS * REQUIP 1mg
Synonyms
TABLETS * REQUIP 2mg TABLETS * REQUIP 3mg TABLETS * REQUIP 4mg
TABLETS * REQUIP 5mg TABLETS * NDC NO. 0007-4890-14 * NDC NO.
0007-4890-20 * NDC NO. 0007-4890-61 * NDC NO. 0007-4890-62 * NDC NO.
0007-4890-63 * NDC NO. 0007-4890-64 * NDC NO. 0007-4890-65 * NDC NO.
0007-4890-66 * NDC NO. 0007-4891-20 * NDC NO. 0007-4891-61 * NDC NO.
0007-4891-64 * NDC NO. 0007-4892-20 * NDC NO. 0007-4892-61 * NDC NO.
0007-4893-20 * NDC NO. 0007-4893-61 * NDC NO. 0007-4893-62 * NDC NO.
0007-4893-63 * NDC NO. 0007-4894-20 * NDC NO. 0007-4895-20 * NDC NO.
0007-4895-61 * NDC NO. 0007-4896-20 * ROPINIROLE HYDROCHLORIDE,
FORMULATED PRODUCT
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
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 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
ROPINIROLE 4
91374-20-8
NON-HAZARDOUS INGREDIENTS 96
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Caution - Pharmaceutical agent.
Exposure might occur via skin; eyes; ingestion.
Health effects information is based on hazards of components.
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SDS Number 2943 Approved/Revised 14-Feb-2007 Version 17
REQUIP TABLETS
Material
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 Physical form suggests that risk of inhalation exposure is negligible.
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 Medical treatment in cases of overexposure should be treated as an
overdose of D2-dopamine agonist. Treat according to locally accepted
protocols. For additional guidance, refer to the current prescribing
information or to the local poison control information centre.
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 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.
For larger amounts (multiple packages/pallets) of product: Since toxic,
Procedures
corrosive or 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.
Decontamination No specific decontamination or detoxification procedures have been
identified for this product.
Procedures
7. HANDLING AND STORAGE
HANDLING
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SDS Number 2943 Approved/Revised 14-Feb-2007 Version 17
REQUIP TABLETS
Material
General Requirements Avoid breaking or crushing tablets.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
ROPINIROLE
INGREDIENT
3
GSK Occupational
Hazard Category
REPRODUCTIVE HAZARD
GSK Occupational 20 MCG/M3 (8 HR TWA)
Exposure Limit
ENGINEERING CONTROLS
Containment Open handling may result in overexposure.
Ventilation Local exhaust ventilation (LEV) should be used in conjunction with other
control measures as a means of removing material incidentally released.
Administrative Entry to the working area should be controlled. Only authorised personnel
may enter the working area.
Other Equipment or None required for normal handling. Wear appropriate clothing to avoid skin
contact.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Tablet.
Physical Form
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 No studies have been conducted.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation is not expected following direct contact with eyes.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: cardiovascular system.
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 US
OSHA.
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions. Contains components which have been
classified as: Known or presumed to affect the quantity and quality of
breast milk in humans.
Pharmacological Effects This product contains active ingredient(s) with the following activity: a
dopaminergic agonist.
* Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
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SDS Number 2943 Approved/Revised 14-Feb-2007 Version 17
REQUIP TABLETS
Material
Summary This material contains an active pharmaceutical ingredient that has been
tested and which may be harmful if released directly to the environment.
Consult the MSDS of the active ingredient for specific information about
potential environmental effects. Appropriate precautions should be taken to
limit release of this material to the environment. Local regulations and
procedures should be consulted prior to environmental release.
Specific information on the active pharmaceutical ingredient is provided
below.
ECOTOXICITY
Aquatic
Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
IC50: 500 mg/L, 3 Hours, Residential sludge
Microtox Microtox is a general toxicity test which utilizes a sensitive marine photo
bacteria as the test species. This material contains an active
pharmaceutical ingredient that is not toxic to these microorganisms.
EC50: 362 mg/L, 15 Minutes
Algal This material contains an active pharmaceutical ingredient that is harmful to
algae.
IC50: 29.3 mg/L, 72 Hours, Selenastrum capricornutum,
green algae
NOEL: 8.8 mg/L, 72 Hours, Selenastrum capricornutum,
green algae
* Daphnid This material contains an active pharmaceutical ingredient that is harmful to
daphnids.
EC50: 41.1 mg/L, 48 Hours, Daphnia magna, Static test
NOEL: 4.4 mg/L, 48 Hours, Daphnia magna, Static test
Chronic EC50: 7.7 mg/L, 8 Days, Ceriodaphnia dubia, 7 day static
renewal
Chronic LOEC: 10 mg/l, 8 Days, Ceriodaphnia dubia
Chronic NOEC: 3.2 mg/L, 8 Days, Ceriodaphnia dubia
Fish This material contains an active pharmaceutical ingredient that is harmful to
fish.
Adult Lepomis macrochirus, bluegill sunfish
EC50: 11 mg/L, 96 Hours, Static test
Adult Lepomis macrochirus, bluegill sunfish
NOEL: 3.7 mg/L, 96 Hours, Static test
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into air from water.
Henry's Law Constant 5.67E-07 atm m^3/mol, Calculated
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SDS Number 2943 Approved/Revised 14-Feb-2007 Version 17
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Material
Adsorption This material contains an active pharmaceutical ingredient that is not likely
to adsorb to sludge or biomass if released directly to the environment.
Soil Sediment Sorption 0.74, Calculated at pH 7
(log Koc):
Sludge Biomass 1.92 Measured
Distribution Coefficient
(log Kd):
Partitioning This material contains an active pharmaceutical ingredient with
octanol/water partition coefficient data that suggests that for environmental
fate predictions the active pharmaceutical ingredient will not have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water. Hydrolysis may be a significant
depletion mechanism.
Half-Life, Neutral: 163 Days, Measured
Photolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically stable in water when exposed to light. Aqueous
photolysis is unlikely to be a significant depletion mechanism.
Half-Life, Aqueous: 433 to 13700 Days, Measured
Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable (as defined by 1993 OECD Testing Guidelines). It
may persist in the environment.
BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
Bioconcentration Factor: 1 Estimated
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
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal
product, 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 Hazard
Communication Standard.
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SDS Number 2943 Approved/Revised 14-Feb-2007 Version 17
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Material
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 14-Feb-2007 SDS Version Number 17
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
Algal
Algal Degradation
Bioaccumulation
Biodegradation
Crustacea
Daphnid
Distribution
Earthworm
Ecotoxicity
EHAC Notation
Fish
GSK Environmental Hazard Category
Hydrolysis
Microbial Growth Inhibition
Microtox
Mobility
Other Adverse Effects
Other Species - Aquatic
Other Species - Terrestrial
Partitioning
Persistence/Degradation
Photolysis
Solubility
Summary
Volatility
REGULATORY INFORMATION US Environmental (EPA) Requirements
TOXICOLOGY INFORMATION Other Adverse Effects
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.
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