SDS Number 4305 Approved/Revised 15-Aug-2005 Version 9
PARNATE TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material PARNATE TABLETS
PARNATE TABLETS 10 MG * NDC NO 0007-4471-20 * NDC NO
Synonyms
0007-4471-64 * TRANYLCYPROMINE SULPHATE, 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
TRANYLCYPROMINE SULFATE 7.5
13492-01-8
NON-HAZARDOUS INGREDIENTS 92.5
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
* Health Caution - Pharmaceutical agent.
Exposure might occur via ingestion skin eyes.
Harmful by ingestion.
May produce allergic skin reactions.
Possible effects of overexposure in the workplace include: increased heart
rate; sweating; hallucinations; restlessness; agitation; 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
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SDS Number 4305 Approved/Revised 15-Aug-2005 Version 9
PARNATE TABLETS
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 Treat according to locally accepted protocols. For additional guidance, refer
to the current prescribing information or to the local poison control
information centre. Medical treatment in cases of overexposure should be
treated as an overdose of tranylcypromine .
Medical Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product. Ocular
Caused or Aggravated
symptoms may be indicative of allergic reaction.
by Exposure
Health Surveillance Exposed individuals are encouraged to report symptoms of skin and
respiratory irritation to an occupational health professional or line
Procedures
management. These symptoms may include, but are not limited to, skin
conditions, bronchitis, asthma, or nasal irritation.
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, dry powder or foam extinguishers are recommended. Carbon
dioxide extinguishers may be ineffective.
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 Water can be used for clean-up and decontamination operations. No
specific decontamination or detoxification procedures have been identified
Procedures
for this product.
7. HANDLING AND STORAGE
HANDLING
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SDS Number 4305 Approved/Revised 15-Aug-2005 Version 9
PARNATE 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
TRANYLCYPROMINE SULFATE
INGREDIENT
3
GSK Occupational
Hazard Category
GSK Occupational 30 MCG/M3 (8 HR TWA)
Exposure Limit
* Other Equipment or Wear appropriate clothing to avoid skin contact.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Geranium red.
Colour
Sugar-coated 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 Adverse effects might occur 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; central nervous system.
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 Insufficient information available to classify for reproductive toxicity.
* Pharmacological Effects This preparation contains ingredient(s) with the following activity: a
monoamine oxidase inhibitor.
* Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary No information is available about the potential of this product 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.
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SDS Number 4305 Approved/Revised 15-Aug-2005 Version 9
PARNATE TABLETS
Material
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.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 15-Aug-2005 SDS Version Number 9
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
EXPOSURE CONTROLS / PERSONAL PROTECTION Other Equipment or Procedures
HAZARDS IDENTIFICATION Health
REGULATORY INFORMATION
TOXICOLOGY INFORMATION Other Adverse Effects
Pharmacological 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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