1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Material Name: AVIGRA (Sildenafil Citrate) TabletsTrade Name: ViagraSynonyms: Sildenafil citrate tabletsChemical Family: MixtureIntended Use: Pharmaceutical product used for male erectile dysfunction
2. HAZARDS IDENTIFICATION
Appearance: Blue film-coated tablets
Statement of Hazard: Non-hazardous in accordance with international standards for workplace safety.
Additional Hazard Information:Short Term: Active ingredient may be harmful if swallowed. May cause eye irritation (based on
components) .Long Term: Animal studies indicate that this material may cause adverse effects on the cardiovascular
system.Known Clinical Effects: Adverse effects most commonly reported in clinical use include difficult digestion (dyspepsia),
nose bleed, headache, flushing, insomnia, abnormal redness of skin (erythema), difficultybreathing, muscle pain, fever, gastrointestinal irritation, tingling/itching (paresthesia), transientchanges in light perception and color vision, effects on hearing, and effects on vision.
EU Indication of danger: Not classified
Australian Hazard Classification(NOHSC):
Non-Hazardous Substance. Non-Dangerous Goods.
Note: This document has been prepared in accordance with standards for workplace safety, whichrequire the inclusion of all known hazards of the product or its ingredients regardless of thepotential 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
HazardousIngredient CAS Number EU EINECS/ELINCS List EU Classification %
Sildenafil citrate 171599-83-0 Not Listed Xn;R22 23
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Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222
Pfizer LtdRamsgate RoadSandwich, KentCT13 9NJUnited Kingdom+00 44 (0)1304 616161
Emergency telephone number:1-877-777-3180
Revision date: 06-Dec-2011
Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887
Contact E-Mail: [email protected]
Version: 1.0
MATERIAL SAFETY DATA SHEET
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3. COMPOSITION/INFORMATION ON INGREDIENTSMicrocrystalline cellulose 9004-34-6 232-674-9 Not Listed *Titanium dioxide 13463-67-7 236-675-5 Not Listed *Magnesium stearate 557-04-0 209-150-3 Not Listed *
Ingredient CAS Number EU EINECS/ELINCS List EU Classification %FD & C Blue No. 2, Aluminum lake 16521-38-3 240-589-3 Not Listed *Lactose Monohydrate 64044-51-5 Not Listed Not Listed *Triacetin 102-76-1 203-051-9 Not Listed *Calcium phosphate dibasic, anhydrous 7757-93-9 231-826-1 Not Listed *Croscarmellose sodium 74811-65-7 Not Listed Not Listed *Hydroxypropyl methylcelluslose 9004-65-3 Not Listed Not Listed *
Additional Information: * ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety.
For the full text of the R phrases mentioned in this Section, see Section 16
4. FIRST AID MEASURES
Eye Contact: Immediately flush eyes with water for at least 15 minutes. If irritation occurs or persists, getmedical attention.
Skin Contact: Wash skin with soap and water. Remove contaminated clothing and shoes. If irritation occursor persists, get medical attention. This material may not be completely removed byconventional laundering. Consult professional laundry service. Do not home launder.
Ingestion: Get medical attention immediately. Do not induce vomiting unless directed by medicalpersonnel. Never give anything by mouth to an unconscious person.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. Get medical attentionimmediately.
Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological Information.
5. FIRE FIGHTING MEASURES
Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.
Hazardous Combustion Products: Formation of toxic gases is possible during heating or fire.
Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.
Additional Information: Not applicable
6. ACCIDENTAL RELEASE MEASURES
Health and Safety Precautions: Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8). Minimize exposure.
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Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spilled material by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area thoroughly.
Measures for EnvironmentalProtections:
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken toavoid environmental release.
Additional Consideration for LargeSpills:
Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
General Handling: Minimize dust generation and accumulation. If tablets or capsules are crushed and/or broken,avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, useappropriate personal protective equipment (see Section 8). Wash thoroughly after handling.Releases to the environment should be avoided. Review and implement appropriate technicaland procedural waste water and waste disposal measures to prevent occupational exposure orenvironmental releases. Potential points of process emissions of this material to theatmosphere should be controlled with dust collectors, HEPA filtration systems or otherequivalent controls. Refer to Section 12 - Ecological Information, for information on potentialeffects on the environment.
Storage Conditions: Store as directed by product packaging.
8. EXPOSURE CONTROLS / PERSONAL PROTECTIONRefer to available public information for specific member state Occupational Exposure Limits.
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France OEL - TWA 10 mg/m3
Sildenafil citrate
Ireland OEL - TWAs 10 mg/m34 mg/m3
Version: 1.0
Latvia OEL - TWA 2 mg/m3
Pfizer OEL TWA-8 Hr: 350g/m3
OSHA - Final PELS - TWAs: 15 mg/m3
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Portugal OEL - TWA 10 mg/m3
Microcrystalline cellulose
Romania OEL - TWA 10 mg/m3
Calcium phosphate dibasic, anhydrous
Spain OEL - TWA 10 mg/m3
Titanium dioxide
ACGIH Threshold Limit Value (TWA) 10 mg/m3
ACGIH Threshold Limit Value (TWA) 10 mg/m3
Revision date: 06-Dec-2011
Australia TWA 10 mg/m3
Australia TWA
Austria OEL - MAKs 5 mg/m3
10 mg/m3
Belgium OEL - TWA 10 mg/m3
Latvia OEL - TWA
Bulgaria OEL - TWA 10.0 mg/m3
Belgium OEL - TWA 10 mg/m3
Denmark OEL - TWA 6 mg/m3
10 mg/m3
Estonia OEL - TWA 10 mg/m3
Material Name: AVIGRA (Sildenafil Citrate) Tablets
MATERIAL SAFETY DATA SHEET
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Analytical Method: Analytical method available for Sildenafil. Contact Pfizer Inc for further information.Engineering Controls: Engineering controls should be used as the primary means to control exposures. General
room ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this section.
Environmental Exposure Controls: Refer to specific Member State legislation for requirements under Community environmentallegislation.
Personal Protective Equipment: Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).
Hands: Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing operations.
Eyes: Wear safety glasses or goggles if eye contact is possible.Skin: Impervious protective clothing is recommended if skin contact with drug product is possible and
for bulk processing operations.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
10. STABILITY AND REACTIVITY
Chemical Stability: Stable under normal conditions of use.Conditions to Avoid: None knownIncompatible Materials: As a precautionary measure, keep away from strong oxidizers
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