General Information
Revision date
2012-12-06
Product name
Flucelvax
Product Synonyms
Inactivated Influenza Vaccine (Surface Antigen), suspension for Injection
Chemical name
and Company
1.2.1 Relevant identified uses
Vaccine to prevent influenza How Supplied: 1-80 liter container, 1-10 milliter Vial, 0.5-5 milliter Syringe
Emergency telephone
+49 (0) 17 26 74 07
Icons in SDS
Company Information
company name
Novartis Vaccines and Diagnostics GmbH
e-mail address of the competent person responsible for the Safety Data Sheet
pedro.diaz@novartis.com
Section 2
SECTION 2: Hazards identification
Directive 67/548/EEC: EU Labeling/Classification: According to Article 1 of European Union Council Directive 92/32/EEC, medical products in the finished state for human use (as defined by European Union Council Directives 67/548/EEC and 87/21/EEC) are not subject to the regulations and administrative provisions of European Union Council Directive 92/32/EEC. This material does not meet the definitions of any hazard class as defined by the European Union Council Directive 67/548/EEC or subsequent Directives. Emergency Overview 0 1 0 Novartis Corporation Laboratory Labeling Codes: Health: 1 Flammability: 0 Reactivity: 0 Special: None
Product definition
Flucelvax vaccine is a suspension of protein in water. This material is an opalescent, odorless liquid. Health Hazards Exposure of this material to the eyes may cause irritation. Flammability This material presents no significant flammability hazards. Reactivity Hazards: This material presents no significant reactivity hazards. Emergency Response Recommendations: Emergency Responders must wear appropriate personal protective equipment suitable for the situation to which they are responding. Numbering Guidelines Based upon a nationally recognized color-coded 0-4 scale Blue represents Health, Red represents flammability, Yellow represents reactivity and White represents a “special” hazard. 0 represents no hazard and 4 represents the most severe hazard for each category. Examples one might see in the “special” category include CA=potential carcinogen, COR=corrosive, I=irritant, T=toxic, OXY=Oxidizer, PF=Peroxide Former, W=Water reactive, SEN=sensitizing agent, REP=reproductive hazard, and TER=harmful to the fetus