Remodulin

Hazard statements (CLP)

H361d, H372

Code

Statements

H361d

Suspected of damaging the unborn child

SECTION 2: Hazards identification

WHMIS 2015 Classification of the substance or mixture Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Consult prescribing/packaging information. The classification and labeling listed below is for bulk drug product Reproductive toxicity, Category 2 Suspected of damaging the unborn child Specific target organ toxicity – Repeated exposure, Category 1 Causes damage to organs (lungs, lymphoid organs, testes, and hematological system) through prolonged or repeated exposure

Signal word

Danger

Hazard statements

H361d - Suspected of damaging the unborn child. H372 - Causes damage to organs (lungs, lymphoid organs, testes, and hematological system) through prolonged or repeated exposure.

Precautionary statements

P201 - Obtain special instructions before use. P202 - Do not handle until all safety precautions have been read and understood. P260 - Do not breathe mist, spray. P264 - Wash hands, forearms and face thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P280 - Wear protective gloves/protective clothing/eye protection/face protection. P308+P313 - If exposed or concerned: Get medical advice/attention P405 - Store locked up. P501 - Dispose of contents/container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

2.3 Other hazards

Treprostinil is a synthetic analog of the naturally occurring prostaglandin, prostacyclin indicated for the treatment of pulmonary arterial hypertension and pulmonary hypertension due to lung diseases. Treprostinil is a direct-acting vasodilator of pulmonary and systemic arterial vascular beds that also inhibits platelet aggregation, thereby alleviating pulmonary hypertension. The most commonly reported adverse systemic effects with therapeutic use of treprostinil include headache, dizziness, flushing, hypotension (which may result in dizziness, light-headedness, blurred vision or fainting), bleeding, gastrointestinal discomfort (nausea, vomiting, diarrhea), pain in the extremities, and jaw pain. In studies of inhaled forms of treprostinil, cough, sore throat, and increased respiratory infections were reported. Redness/swelling of the skin may occur with dermal contact. Prostaglandins can cause uterine contractions, and thus may pose a risk to workers exposed during pregnancy. However, treprostinil has been used to treat PAH in pregnant women and does not have a direct effect on fetal development. Note This substance is classified as hazardous under GHS as implemented by Regulation EC No

2.1 Classification of the substance or mixture

Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Consult prescribing/packaging information. The classification and labeling listed below is for bulk drug product. Reproductive toxicity, Category 2 Suspected of damaging the unborn child. Specific target organ toxicity – Repeated exposure, Category 1 Causes damage to organs (lungs, lymphoid organs, testes, and hematological system) through prolonged or repeated exposure.