EYSUVIS

Hazard statements (CLP)

H360D, H373

Code

Statements

H360D

May damage 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 1B May damage the unborn child Specific target organ toxicity (repeated exposure) Category 2 May cause damage to organs (immune system) through prolonged or repeated exposure

Signal word

Danger

Hazard statements

H360D - May damage the unborn child. H373 - May cause damage to organs (immune 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. P280 - Wear protective clothing, eye protection, face protection. P308+P313 - If exposed or concerned: Get medical advice/attention. P314 - Get medical advice/attention if you feel unwell. 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

Loteprednol etobonate is a synthetic corticosteroid with anti-inflammatory properties. Effects reported in clinical trials following ophthalmic use included blurry vision, dilation and redness of blood vessels in the eye, discomfort on instillation (burning, itching, pain) and sensitivity to light. With prolonged use there is a risk of developing glaucoma, increased intraocular pressure, eye infections, or delayed wound healing. Corticosteroids, as a class, have been associated with immunosuppression, as well as disturbances of the hypothalmic-pituitary-adrenal (HPA) axis. They have also been associated with fetal growth retardation if administered late in pregnancy. Malformations were also frequently reported with systemic exposure in non-clinical studies. Although loteprednol etobonate is considered a "soft steroid" (designed to be rapidly inactivated upon entering circulation) and it appears to act more locally, a potential for the drug to adversely affect pregnancty outcomes if accidentally inhaled or ingested in a workplace setting cannot be excluded. Note This mixture 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 1B May damage the unborn child. Specific target organ toxicity (repeated exposure) Category 2 May cause damage to organs (immune system) through prolonged or repeated exposure