CYTOVENE IV (500 MG/VIAL)

SECTION 2: Hazards identification

EMERGENCY OVERVIEW: This product is a white to off-white lyophilized powder. The chief health hazard in an occupational setting in event of exposure is the potential for mild irritation of contaminated skin or eyes. In animal and in vitro studies Ganciclovir Sodium (the active component of this product) caused aspermatogenesis, mutagenicity, teratogenicity and carcinogenicity; therefore, it should be considered a potential teratogen and carcinogen in humans. This product must be substantially pre-heated before ignition can occur. If this product is ignited, the decomposition products generated will include irritating vapors and toxic gases (e.g., carbon oxides, nitrogen oxides, and sodium oxides). This product presents no significant reactivity hazards. Emergency responders must wear personal protective equipment suitable for the situation to which they are responding. SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The extent of entry into the body by most routes has not been fully investigated. Occupational exposures to this product may cause acute effects in humans, as described on the following page. INHALATION: Inhalation of airborne dusts of this product may slightly irritate the nose, throat, and lungs. Symptoms are generally alleviated upon breathing fresh air. CONTACT WITH SKIN or EYES: Skin contact may cause mild irritation, which is alleviated upon rinsing. Eye contact with airborne dusts of this product may cause mild to moderate irritation, redness, and tearing. SKIN ABSORPTION: The components of this product are not known to be absorbed through intact skin. (Continued) INJECTION: Accidental injection of this product can cause effects as described in “Other Potential Health Effects”. HAZARDO US MATERIAL IDENTIFICATION SYSTEM OTHER POTENTIAL HEALTH EFFECTS: Cytovene is a pharmacological product used for the treatment of cytomegalovirus retinitis in immunocompromised patients. The mo st common dose -

Health hazards

BLUE) 2 dependent adverse effects associated with therap eutic treatment s include decrease in the number of neutrophils in the blo od , decrease in the number of platelets in the blood, and elev a te d serum creatinine levels. Less common side effects incl ud e FLAMMABILITY HAZARD (RED) 1 enlarged abdomen, weakness, chest pain, swelling, headache , fatigue, pain, abnormal liver function test, c anker sores in th e m uth, constipation, in ge o di stion, pancytopenia, increased cough, d iculty iff breathing, ab ormal n dreams, a nxiety, confusion,

Physical hazards

YELLOW) 0 d pression, dizz ne e i ss, dr mouth y , insomnia, seizures, slee piness , tremor, hair loss, dry skin, abnormal vision, abnormal taste, ringing in the ears, weight loss, increased SGOT, increased SGPT, high PROTECTIVE EQUIPMENT blood pressure, kidney failure, abnormal kidney function, increased urination, joint pain, leg cramps, muscle pain, muscle weakness , EYES RESPIRATORY HANDS BODY gastrointestinal perforation, multiple organ failure, pancreatitis, and sepsis. In animal and in vitro studies Ganciclovir Sodium (the active component of this product)caused aspermatogenesis, mutagenicity SEE SECTION 8 , SEE SECTION 8 teratogenicity and carcinogenicity; therefore, it should be c on sidered a potential teratogen and carcinogen in humans. For Routine Use and Handling Applications H ALTH EFFECTS OR RISKS FROM EXPOSURE: An Ex E planation in Lay Terms. See Section 16 for Definition of Ratings ACUTE: The primary health effects that may be experienced by medical personnel exposed to this product are mild irritation of contaminated skin and eyes or pain, and redness. In the event of exposures via ingestion and injection of therapeutic doses of this product, effects described in “Other Potential Health Effects” may result. CHRONIC: In animal and in vitro studies Ganciclovir Sodium (the active component of this product) caused a spermatogenesis, mutagenicit y, teratogenicity and carcinogenicity; therefore, it sh ould be considered a potential teratogen and carcinogen in hu mans. Refer to Section 11 (Toxicological Informa tion) for additional information on this product. TARGET ORGANS: Skin, eyes (anticipated occupational exposures). Blood system (therapeutic doses). What should I do if a hazardous situation occurs?