Flucelvax

Novartis Vaccines and Diagnostics GmbH

Revision date : 2012-12-06

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Environmental risk rating

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

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