Note: Ingredients listed on restricted chemical lists
EC/CAS
231-791-2/7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
limit (SCL
EC/CAS
9003-11-6
Name of the chemical
poly(ethylene propylene) glycol
Concentration
N/A
General Information
Revision date
2024-04-23
Product name
Fidanacogene elaparvovec Solution for Infusion
Product name
Fidanacogene elaparvovec Solution for Infusion
Identification on the label/Trade name
BEQVEZ
Product Synonyms
FidaVec; Spark-Factor IX; GTx-FIX; FIX-GTx; Modified Adeno Associated Viral Vector; SPK9001; SPK-9001
Chemical name
Not determined
1.2.1 Relevant identified uses
Modified Adeno Associated Viral Vector (GTx FIX) for gene therapy treatment
Emergency telephone
1-800-424-9300, +1-703-527-3887
Icons in SDS
Company Information
company name
Pfizer Inc
e-mail address of the competent person responsible for the Safety Data Sheet
pfizer-MSDS@pfizer.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H341, H360FD, H373
Hazard statements
Code
Statements
H341
Suspected of causing genetic defects
Section 2
SECTION 2: Hazards identification
1272/2008 Modes of Transmission: Transmission routes may include parenteral, respiratory, gastrointestinal, mucous membrane or ocular exposure.
2.1 Classification of the substance or mixture
GHS - Classification Regulated
Signal word
Danger
Hazard statements
H341 - Suspected of causing genetic defects H373 - May cause damage to organs through prolonged or repeated exposure H360FD - May damage fertility. May damage the unborn child
Precautionary statements
P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P281 - Use personal protective equipment as required P308 + P313 - IF exposed or concerned: Get medical attention/advice P405 - Store locked up P501 - Dispose of contents/container in accordance with all local and national regulations
Supplemental label elements
Compound, not fully tested, additional hazards may exist.
2.3 Other hazards
Short term Not determined, however, this is an experimental research program. The physical, chemical, toxicological and ecological properties have not been thoroughly investigated. Exposure by any route should be avoided. Early research experimental data may be available that drives this substance into a hazard class that requires additional precautions to be taken when handling this material. In case of accidental exposure, seek medical advice immediately. Long Term: This material may cause adverse effects on fertility, the developing fetus, cardiovascular system, or blood.
Other hazards
An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8). Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients 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.
