Fosphenytoin Sodium Injection, USP

Hazard statements (CLP)

H314, H317, H318, H334, H360, H362

Code

Statements

H314

Causes severe skin burns and eye damage

Signal word

DANGER. GHS Class Serious Eye Damage. category 1. Skin corrosion. category 1. Respiratory sensitisation. category 1. Reproductive toxicity. Category 1A. Skin Sensitization. category 1. Reproductive toxicity. Effects on or via lactation.

Hazard statements

Causes serious eye damage. Causes severe skin burns and eye damage. May cause allergy or asthma symptoms or breathing difficulties if inhaled. May damage fertility or the unborn child. May cause an allergic skin reaction. May cause harm to breast-fed children.

Precautionary statements

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Do not breathe dust/fume/gas/mist/vapours/spray. Avoid breathing dust/fume/gas/mist/vapours/spray. Avoid contact during pregnancy and while nursing. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. Contaminated work clothing should not be allowed out of the workplace. Wear protective gloves/protective clothing/eye protection/face protection. In case of inadequate ventilation wear respiratory protection. IF SWALLOWED: Rinse mouth. Do not induce vomiting. IF ON SKIN: Wash with plenty of water. IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. IF exposed or concerned: Get medical advice/attention. Immediately call a POISON CENTER or doctor/physician. Specific treatment (see ... on this label). If skin irritation or rash occurs: Get medical advice/attention. If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. Take off contaminated clothing and wash it before reuse. Wash contaminated clothing before reuse. Store locked up. Dispose of contents/container in accordance with Local, State, Federal and Provincial regulations. Emergency Overview This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert.

Principle Routes of Exposure

Inhalation Ingestion Eye contact Skin Absorption. Injection.

Potential health effects

Eye Contact with eyes may cause irritation. Signs/Symptoms Potential adverse reactions from prescribed doses are described in the package insert and include: nausea, vomiting, lethargy, tachycardia, bradycardia, asystole, cardiac arrest, hypotension, syncope, hypocalcemia, metabolic acidosis, and death have been reported in cases of overdosage with fosphenytoin. Treatment is nonspecific since there is no known antidote to Fosphenytoin Sodium or phenytoin overdose. Occupational exposure has not been fully investigated. Aggravation of Pre-Existing Individuals with hypersensitivity to Fosphenytoin Sodium Injection or its ingredients or to phenytoin or Conditions other hydantoins. Individuals with sinus bradycardia, sino-atrial block, second and third degree A-V block, and Adams- Strokes syndrome.