Remicade

Schering Corporation

Revision date : 2008-03-21

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Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

57-50-1

Name of the chemical

Sucrose, pure C12H22O11

Concentration

80-90

EC/CAS

9005-65-6

Name of the chemical

polyethyleneglycol sorbitan monooleate

Concentration

N/A

General Information

Revision date

2008-03-21

Product name

Remicade

Product Synonyms

Remicade (chimeric anti-TNF monoclonal antibody)

Emergency telephone

+44 (0)208 762 8322, +1 (908) 473-3371

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Company Information

company name

Schering Corporation

Section 2

SECTION 2: Hazards identification

EMERGENCY OVERVIEW White Powder Odor unknown May cause allergic reactions in susceptible individuals. May cause effects to: skin

Potential health effects

Infliximab is a large protein that is a chimeric monoclonal antibody to tumor necrosis factor alpha (TNFa), a pro-inflammatory mediator. Elevated levels of TNF have been found in the affected tissues and fluids of people with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, and ulcerative coliti. Elevated TNF levels are also found in psoriatic plaques. Infliximab is used in the management for the above medical conditions and is given by intravenous infusion. Common acute adverse effects in patients treated with infliximab during 1 to 2 hours of infusion include fever, chills, itching, hives, shortness of breath, chest pain, and changes in blood pressure. Delayed reactions have occurred 3 to 12 days after treatment and include muscular or joint pain, fever, and rash. Other common clinical effects include nausea, vomiting, abdominal pain, diarrhea, fatigue, dizziness, headache, and back pain. Antibodies to infliximab may develop and may increase the incidence of hypersensitivity reactions including anaphylaxis. Rare cases of severe liver effects (e.g. acute liver failure, jaundice, hepatitis) and blood effects (e.g. drastic changes in blood cells and counts) have also been reported. LISTED CARCINOGENS No carcinogens or potential carcinogens listed by IARC or EU Directive 90/394 (Annex I) in this mixture.

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