SDS Number 110559 Approved/Revised 23-Nov-2004 Version 08
Material IMITREX INJECTION
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material IMITREX INJECTION
IMITREX INJECTION 6MG/0.5ML * IMITREX STATDOSE SYSTEM * IMITREX
Synonyms
STATDOSE PEN * IMITREX INJECTION CATRIDGE PACK * IMITREX
SINGLE DOSE VIAL 6MG * IMIGRAN SUBJECT TREATMENT PACK 0.5ML *
IMIGRAN SUBJECT REFILL PACK 0.5ML * NDC NO 0173-0449-02 * NDC NO
0173-0449-00 * NDC NO 0173-0449-03 * NDC NO 0173-0449-01 * NDC NO
0173-0479-00 * NDC NO 0173-0478-00 * NDC NO 0173-0486-00 *
SUMATRIPTAN SUCCINATE, 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
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
SUMATRIPTAN SUCCINATE 1.7
103628-48-4
NON-HAZARDOUS INGREDIENTS 98.3
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
* Health Caution - Pharmaceutical agent.
Skin irritant. Eye irritant.
Exposure might occur via eyes; skin; ingestion.
Health effects information is based on hazards of components.
* Environment Dangerous for the environment. Harmful to aquatic organisms. May cause
long-term adverse effects in the environment.
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SDS Number 110559 Approved/Revised 23-Nov-2004 Version 08
Material IMITREX INJECTION
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 a 5-hydroxytryptamine 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
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.
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SDS Number 110559 Approved/Revised 23-Nov-2004 Version 08
Material IMITREX INJECTION
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
SUMATRIPTAN SUCCINATE
INGREDIENT
3
GSK Occupational
Hazard Category
GSK Occupational 100 mcg/m3 (15 MIN STEL)
Exposure Limit 50 mcg/m3 (8 HR TWA)
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.
PERSONAL PROTECTIVE EQUIPMENT
* Eye Protection Wear approved safety glasses with side shields or cover goggles if eye
contact is possible.
* Other Equipment or Wear appropriate clothing to avoid skin contact. Wash hands and arms
thoroughly after handling. An eye wash station should be available.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Liquid.
Physical Form
4.5 to 5
pH of Aqueous Solutions
10. STABILITY AND REACTIVITY
Stability DO NOT FREEZE - dispose of properly if frozen.
Conditions to Avoid None for normal handling of this product.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
* Inhalation Toxicity Overexposure may result in irritation of the respiratory tract.
* Skin Effects Irritation might occur following direct contact.
* Eye Effects 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 US
OSHA.
* Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
* Pharmacological Effects This product contains active ingredient(s) with the following activity: a
5-hydroxytryptamine agonist.
Other Adverse Effects None known for occupational exposure.
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SDS Number 110559 Approved/Revised 23-Nov-2004 Version 08
Material IMITREX INJECTION
12. ECOLOGICAL INFORMATION
* 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: > 750 mg/l, 3 Hours, Activated sludge
* Algal This material contains an active pharmaceutical ingredient that is harmful to
algae.
IC50: 36 mg/l, 72 Hours, Scenedesmus subspicatus,
green algae
NOEL: 12.5 mg/l, 72 Hours, Scenedesmus subspicatus,
green algae
* Daphnid This material contains an active pharmaceutical ingredient that is not toxic
to daphids.
EC50: 290 mg/l, 48 Hours, Daphnia pulex, Static test
NOEL: 200 mg/l, 48 Hours, Daphnia pulex, Static test
* Fish This material contains an active pharmaceutical ingredient that is not toxic
to fish.
Juvenile Oncorhyncus mykiss, rainbow trout
EC50: > 100 mg/l, 96 Hours, Measured
Juvenile Oncorhyncus mykiss, rainbow trout
NOEL: 100 mg/l, 96 Hours, Measured
MOBILITY
* Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
* Adsorption This material contains an active pharmaceutical ingredient that is likely to
adsorb to soil or sediment. This material contains an active pharmaceutical
ingredient that is likely to adsorb to sludges and other biomass.
Soil Sediment Sorption 3.52 to 3.57, Measured
(log Koc):
* 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 stable in water. Hydrolysis is unlikely to be a
significant depletion mechanism.
Half-Life, Neutral: > 1 Years, Measured
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SDS Number 110559 Approved/Revised 23-Nov-2004 Version 08
Material IMITREX INJECTION
* Photolysis This mixture contains an active pharmaceutical ingredient that is likely to
undergo photodegradation.
UV/Visible Spectrum: 290 nm
* Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable but is inherently biodegradable (as defined by 1993
OECD Testing Guidelines) and is not expected to persist in the
environment.
Aerobic - Ready
Percent Degradation: 1 %, 28 days
Aerobic - Inherent
Percent Degradation: 100 %, 16 days, Modified Zahn-Wellens, primary
biodegradation, loss of parent., Activated sludge
Percent Degradation: 17 %, 28 days, Modified Zahn-Wellens, DOC
removal., Activated sludge
Aerobic - Soil
Percent Degradation: 32 to 40 %, 64 days, , Soil
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 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.
For waste disposal purpose, this product should be classified in line with the European Waste Catalogue
criteria.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This product is classified as hazardous according to the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 23-Nov-2004 SDS Version Number 8
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SDS Number 110559 Approved/Revised 23-Nov-2004 Version 08
Material IMITREX INJECTION
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
Algal
Algal Degradation
Bioaccumulation
Biodegradation
Daphnid
Distribution
Earthworm
Ecotoxicity
Fish
Hydrolysis
Microbial Growth Inhibition
Microtox
Mobility
Other Adverse Effects
Other Species - Aquatic
Other Species - Terrestrial
Partitioning
Persistence/Degradation
Photolysis
Solubility
Summary
Volatility
EXPOSURE CONTROLS / PERSONAL PROTECTION Administrative
Containment
Exposure Controls
Eye Protection
Gloves
Occupational Hygiene Air Monitoring Methods
Occupational Hygiene Surface Monitoring Methods
Other Equipment or Procedures
Other Exposure Limits
Other Information
Other Protective Equipment
Respirators
Surface Exposure Target
Ventilation
FIRST-AID MEASURES Antidotes
Eye Contact
Health Surveillance Procedures
Ingestion
Inhalation
Medical Conditions Caused or Aggravated by
Exposure
Medical Treatment
Skin Contact
HAZARDS IDENTIFICATION Conditions Aggravated by Exposure
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SDS Number 110559 Approved/Revised 23-Nov-2004 Version 08
Material IMITREX INJECTION
SDS Sections Updated
Sections Subsections
HAZARDS IDENTIFICATION Environment
Eye Contact
Health
Ingestion
Inhalation
Overview
Skin Contact
Summary
TOXICOLOGY INFORMATION Carcinogenicity
Eye Effects
Genetic Toxicity
Inhalation Toxicity
Oral Toxicity
Other Adverse Effects
Pharmacological Effects
Reproductive Effects
Sensitisation
Skin Toxicity
Target Organ 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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