ANASTROZOLE FILM-COATED TABLET

SECTION 2: Hazards identification

67/548/EEC EU CLP REGULATION (EC) 1272/2008 LABELING AND CLASSIFICATION: According to Article 1, item 5 (a) of CLP Regulation (EC) 1272/2008, medicinal products in the finished state for human use, as defined in 2001/83/EC, are excepted from classification and other criteria of 1272/2008. EU 67/548/EEC LABELING AND 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. EMERGENCY OVERVIEW: WARNING! ANTINEOPLASTIC AGENT. EXPOSURE BY ALL ROUTES OF EXPOSURE MUST BE AVOIDED.

Product definition

This product is supplied as round, white to off-white, practically odorless tablets

Health hazards

CONTAINS ANTINEOPLASTIC AGENT. EXPOSURE BY ALL ROUTES OF EXPOSURE MUST BE AVOIDED. In the workplace, exposure to dusts from product via inhalation and skin contact may cause irritation. Eye contact from dusts can cause mechanical irritation. In therapeutic use, the most common adverse effects reported have included hot flashes, lack or loss of strength and energy, weakness, arthritis, pain, joint pain, pharyngitis, high blood pressure, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, difficulty breathing, increased cough, peripheral edema and blockage of the lymph vessels, with a resulting accumulation of lymphatic fluid in the interstitial tissues of the body. May cause serious allergic reactions, including anaphylaxis and angioedema. Therapeutic use can cause serious adverse effects to the skin and cardiovascular system. Can cause harm to fetus during pregnancy. May cause adverse effects on fertility, based on animal data. Limited evidence of carcinogenic effect, based on animal data. These effects may be possible as a result of workplace exposure. Refer to Section 11 (Toxicological Information) for additional information on adverse effects. Flammability Hazards: This product requires substantial pre-heating before ignition occurs. When involved in a fire, this product may decompose and produce irritating vapors and toxic compounds (including carbon, sodium, titanium and nitrogen oxides). Reactivity Hazards: This product is not reactive.

Environmental hazards

Large quantities of this product released to the aquatic and terrestrial environment may have an adverse effect. Emergency Considerations: Emergency responders should wear appropriate protection for the situation to which they respond.