MATERIAL SAFETY DATA SHEET

Revision date: 22-Jul-2009 Version: 1.3 Page 1 of 5

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING

Pfizer Inc Pfizer Ltd

Pfizer Pharmaceuticals Group Ramsgate Road
235 East 42nd Street Sandwich, Kent
New York, New York 10017 CT13 9NJ
1-212-573-2222 United Kingdom
+00 44 (0)1304 616161
Emergency telephone number: Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300 International CHEMTREC (24 hours): +1-703-527-3887
Contact E-Mail: pfizer-MSDS@pfizer.com

Material Name: Tranexamic Acid Solution for Injection

Trade Name: CYKLOKAPRON®
Chemical Family: Mixture
Intended Use: Pharmaceutical product used as blood clotting agent

2. HAZARDS IDENTIFICATION

Appearance: Colorless solution

Statement of Hazard: Non-hazardous in accordance with international standards for workplace safety.

Additional Hazard Information:

Short Term: May cause eye irritation; Not acutely toxic (based on animal data) . May produce allergic
reactions after systemic administration.
Known Clinical Effects: Adverse effects most commonly reported in clinical use include skin rash and gastrointestinal
disturbances. Effects on blood and blood-forming organs have also occurred. Effects on
vision have been seen during clinical use.
EU Indication of danger: Not classified

Australian Hazard Classification Non-Hazardous Substance. Non-Dangerous Goods.

(NOHSC):

Note: This document has been prepared in accordance with standards for workplace safety, which
require the inclusion of all known hazards of the active substance or its intermediates
regardless of the potential risk. The precautionary statements and warnings included may not
apply in all cases. Your needs may vary depending upon the potential for exposure in your
workplace.

3. COMPOSITION/INFORMATION ON INGREDIENTS

Hazardous
Ingredient CAS Number EU EINECS/ELINCS List EU Classification %
Tranexamic Acid 1197-18-8 214-818-2 Not Listed 10

Ingredient CAS Number EU EINECS/ELINCS List EU Classification %

Water 7732-18-5 231-791-2 Not Listed *
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Additional Information: * Proprietary

Ingredient(s) indicated as hazardous have been assessed under standards for workplace
safety.

4. FIRST AID MEASURES

Eye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention
immediately.

Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek
medical attention.

Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not
induce vomiting unless directed by medical personnel. Seek medical attention immediately.

Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.

Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - Hazards
Identification and/or Section 11 - Toxicological Information.

5. FIRE FIGHTING MEASURES

Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.

Hazardous Combustion Products: Carbon monoxide, carbon dioxide, and oxides of nitrogen may be generated in a fire.

Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including self-
contained breathing apparatus.

Fire / Explosion Hazards: Not applicable

6. ACCIDENTAL RELEASE MEASURES

Health and Safety Precautions: Personnel involved in clean-up should wear appropriate personal protective equipment (see
Section 8). Minimize exposure.

Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill
area thoroughly.

Measures for Environmental Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to
Protections: avoid environmental release.

Additional Consideration for Large Non-essential personnel should be evacuated from affected area. Report emergency
Spills: situations immediately. Clean up operations should only be undertaken by trained personnel.

7. HANDLING AND STORAGE

General Handling: Avoid contact with eyes, skin and clothing. Wash thoroughly after handling.
Storage Conditions: Store in a cool, dry place away from light.

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Tranexamic Acid
Pfizer OEL TWA-8 Hr: 1500µg/m3
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION

The exposure limit(s) listed for solid components are only relevant if dust may be generated.

Engineering Controls: Engineering controls should be used as the primary means to control exposures.
Environmental Exposure Controls: Refer to specific Member State legislation for requirements under Community environmental
legislation.
Personal Protective Equipment: Refer to applicable national standards and regulations in the selection and use of personal
protective equipment (PPE).

Hands: Not required for the normal use of this product. Wear protective gloves when working with
large quantities.
Eyes: Not required under normal conditions of use. Wear safety glasses or goggles if eye contact is
possible.
Skin: Not required for the normal use of this product. Wear protective clothing when working with
large quantities.
Respiratory protection: If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate
respirator with a protection factor sufficient to control exposures to below the OEL.

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical State: Aqueous solution Color: Colorless

Molecular Formula: Mixture Molecular Weight: Mixture

pH: 6.5 - 8.0

10. STABILITY AND REACTIVITY

Chemical Stability: Stable under normal conditions of use.

Conditions to Avoid: Heat and light
Incompatible Materials: As a precautionary measure, keep away from strong oxidizers

11. TOXICOLOGICAL INFORMATION

General Information: The information included in this section describes the potential hazards of the active ingredient

Acute Toxicity: (Species, Route, End Point, Dose)

Tranexamic Acid
Rat Oral LD 50 >10,000 mg/kg
Mouse Oral LD 50 >10,000 mg/kg
Rat Intravenous LD 50 1,330 mg/kg
Mouse Intravenous LD 50 1,350 mg/kg
Rat Subcutaneous LD 50 4,620 mg/kg
Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable
at the highest dose used in the test.

Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)

Tranexamic Acid
6 Month(s) Rat Oral 4,000 mg/kg/day LOAEL Gastrointestinal system, Spleen

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11. TOXICOLOGICAL INFORMATION

Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))

Tranexamic Acid
Embryo / Fetal Development Rat Oral 300 mg/kg/day NOAEL Not teratogenic
Embryo / Fetal Development Mouse Oral 300 mg/kg/day NOAEL Not Teratogenic
Reproductive & Fertility Rat Rabbit Mouse No route specified No effects at maximum dose

Genetic Toxicity: (Study Type, Cell Type/Organism, Result)

Tranexamic Acid
In Vivo Not specified Negative
In Vitro Not specified Negative

Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))

Tranexamic Acid
Not specified Mouse Oral 5 g/kg/day LOAEL Immune system, Bone marrow

Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.

12. ECOLOGICAL INFORMATION

Environmental Overview: The environmental characteristics of this mixture have not been fully evaluated. Releases to
the environment should be avoided.

13. DISPOSAL CONSIDERATIONS

Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member State
specific and Community specific provisions must be considered. Considering the relevant
known environmental and human health hazards of the material, review and implement
appropriate technical and procedural waste water and waste disposal measures to prevent
occupational exposure and environmental release. It is recommended that waste minimization
be practiced. The best available technology should be utilized to prevent environmental
releases. This may include destructive techniques for waste and wastewater.

14. TRANSPORT INFORMATION

The following refers to all modes of transportation unless specified below.

Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.

15. REGULATORY INFORMATION

EU Indication of danger: Not classified

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15. REGULATORY INFORMATION

OSHA Label:
Non-hazardous in accordance with international standards for workplace safety.

Canada - WHMIS: Classifications

WHMIS hazard class:
None required
This product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the information
required by the CPR.

Tranexamic Acid
Standard for the Uniform Scheduling Schedule 4
for Drugs and Poisons:
EU EINECS/ELINCS List 214-818-2

Water
Inventory - United States TSCA - Sect. 8(b) Present
Australia (AICS): Present
REACH - Annex IV - Exemptions from the Present
obligations of Register:
EU EINECS/ELINCS List 231-791-2

16. OTHER INFORMATION

Data Sources: Publicly available toxicity information. Pfizer proprietary drug development information.

Reasons for Revision: Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information on
Ingredients. Updated Section 4 - First Aid Measures. Updated Section 13 - Disposal
Considerations.

Prepared by: Product Stewardship Hazard Communication

Pfizer Global Environment, Health, and Safety Operations

Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it
is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known
information at this time.

End of Safety Data Sheet

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