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Cisatracurium besylate

SDS Number 126688 Approved/Revised 23-Mar-2007 Version 6
NIMBEX
Material

SAFETY DATA SHEET

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material NIMBEX
NIMBEX FORTE * NIMBEX INJECTION 2 MG/ML * NIMBEX INJECTION 5
Synonyms
MG/ML * NIMBEX INJECTION 10 MG/ML * NIMBIUM INJECTION *
CIS-ATRACURIUM BESYLATE, 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
CIS-ATRACURIUM BESYLATE 0.2 to 1.05
96946-42-8
NON-HAZARDOUS INGREDIENTS 98.95 to 99.80
Unassigned

3. HAZARDS IDENTIFICATION
This product is classified as non-flammable.
Fire and Explosion
Health Caution - Pharmaceutical agent.
Pharmacological effects may occur following skin absorption.
Exposure might occur via ingestion; skin; eyes.
Possible effects of overexposure in the workplace include: symptoms of
hypersensitivity (such as skin rash, hives, itching, and difficulty breathing).
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 126688 Approved/Revised 23-Mar-2007 Version 6
NIMBEX
Material

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 neuromuscular blocking agent. 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 Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product.
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 No special requirements needed.
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.
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.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.

SDS Number 126688 Approved/Revised 23-Mar-2007 Version 6
NIMBEX
Material

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
CIS-ATRACURIUM BESYLATE
INGREDIENT
3
GSK Occupational
Hazard Category
GSK Occupational 35 mcg/m3 (15 MIN STEL)
Exposure Limit
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields 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
3.3 to 3.8
pH of Aqueous Solutions

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 Pharmacological effects may occur following skin absorption. Irritation is not
expected following direct contact.
Eye Effects Direct contact with eyes might produce evidence of pharmacological
effects. Irritation is not expected following direct contact with eyes.
Target Organ Effects No specific target organ effects have been identified.
Sensitisation Allergic skin reactions might occur following dermal exposure.
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
muscle relaxant for use during anaesthesia.
Other Adverse Effects None known for occupational exposure.

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.

SDS Number 126688 Approved/Revised 23-Mar-2007 Version 6
NIMBEX
Material

ECOTOXICITY
Aquatic
Ecotoxicity This material contains an active pharmaceutical ingredient that may be
harmful to aquatic organisms.
Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
IC50: > 4000 mg/l, 3 Hours, Activated sludge, Nominal
NOEC: 320 mg/l
Microbial Growth This material contains an active pharmaceutical ingredient that is not toxic
to these microorganisms.
Inhibition
Minimum Inhibition 300 mg/l, , Azotobacter chroococcum
Concentration: > 1000 mg/l, , Pseudomonas fluorescens
> 1000 mg/l, , Chaetomium globosum
> 1000 mg/l, , Bacillus megaterium
> 1000 mg/l, , Anabaena flos-aquae
> 1000 mg/l, , Aspergillus clavatus
> 1000 mg/l, , Penicillium canescens
Daphnid This material contains an active pharmaceutical ingredient that is harmful to
daphnids.
EC50: 14 mg/l, 48 Hours, Daphnia magna, Nominal
NOEL: 5.6 mg/l
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
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: 6.4 Hours, Measured
Half-Life, Acidic: 19 Days, Measured
Half-Life, Basic: < 4 Minutes, Measured
Photolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water when exposed to light. Aqueous
photolysis may be a significant depletion mechanism.
Half-Life, Aqueous: 2.45 Days, Measured, pH 5 Buffer Solution
UV/Visible Spectrum: 280 nm
Biodegradation This material is readily biodegradable (as defined by 1993 OECD Testing
Guidelines) and is not expected to persist in the environment.
Aerobic - Ready
Percent Degradation: 82.26 %, 28 days, Modified Sturm test.
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.

SDS Number 126688 Approved/Revised 23-Mar-2007 Version 6
NIMBEX
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.
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-Mar-2007 SDS Version Number 6

SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AN OF COMPANY
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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