Dilantin ; Dilantin-125 ; Epanutin ; Epamin ; Epelin

Pfizer Inc

Revision date : 2007-01-18

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General Information

Version

1.0

Revision date

2007-01-18

Product name

Dilantin ; Dilantin-125 ; Epanutin ; Epamin ; Epelin

Chemical name

Mixture

1.2.1 Relevant identified uses

Pharmaceutical product used for seizures and epilepsy

Emergency telephone

1-800-424-9300, +44 (0)208 762 8322

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Company Information

company name

Pfizer Inc

Section 2

Additional information

* Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. 3. HAZARDS IDENTIFICATION Appearance: Orange suspension Signal Word: WARNING Statement of Hazard: Harmful if swallowed. Suspected of causing cancer. Suspected of damaging the unborn child. May cause damage to central nervous system through prolonged or repeated exposure. Additional Hazard Information: Short Term: May cause eye irritation (based on components) . Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on blood and blood forming organs, gastrointestinal system and liver. Known Clinical Effects: The most common adverse effects observed with clinical use of phenytoin are lack of appetite, headache, dizziness, transient nervousness, ataxia, slurred speech, decreased coordination, mental confusion, insomnia, and GI disturbances (nausea, vomiting, and constipation). IV administration has been associated with hypotension and CNS depression. Mild hypersensitivity reactions (skin rashes) are common. Effects on blood- forming organs and the liver have occurred rarely. Other less common effects include swollen lymph nodes, sore mouth and symptoms of dependence/withdrawal. There is an unconfirmed association between the use of anticonvulsants during pregnancy and an increased risk of birth defects. This material has been shown to be secreted in low concentrations in human breast milk. EU Indication of danger: Carcinogenic: Category 3 EU Hazard Symbols: EU Risk Phrases: R40 - Limited evidence of a carcinogenic effect Australian Hazard Classification Hazardous Substance. Non-Dangerous Goods. (NOHSC): Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.

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