Pred Forte

Hazard statements (CLP)

H361

Code

Statements

H361

Suspected of damaging fertility or the unborn child

SECTION 2: Hazards identification

OSHA Hazards Classification

2.2 Label elements

Emergency Overview Danger

Hazard statements

H362 - May cause harm to breast-fed children H361 - Suspected of damaging fertility or the unborn child (Bad file name) Appearance Liquid Chemical Name Prednisolone acetate Physical state Liquid Odor No information available Symptoms Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the antibacterial ingredient are allergic sensitizations. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sulfacetamide sodium may cause local irritation.The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical corticosteroids. Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriaisis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. Secondary Infection The development of secondary infection has occurred after use of combinations containing corticosteroids and antibacterials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs. Chemical Name Prednisolone acetate

Medical Conditions Generally Aggravated by Exposure

This ophthalmic ointment is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.This product is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids. (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.) Polysorbate 80 Hypersensitivity to the material.

Precautionary statements

P302 + P352 - IF ON SKIN Wash with plenty of soap and water P321 - Specific treatment (see supplemental first aid instructions on this label) P332 + P313 - If skin irritation occurs Get medical advice/attention P362 - Take off contaminated clothing and wash before reuse P337 + P313 - If eye irritation persists: Get medical advice/attention P202 - Do not handle until all safety precautions have been read and understood P405 - Store locked up P501 - Dispose of contents/ container to an approved waste disposal plant P280 - Wear protective gloves/protective clothing/eye protection/face protection P201 - Obtain special instructions before use P260 - Do not breathe dust/fume/gas/mist/vapors/spray P263 - Avoid contact during pregnancy/while nursing P264 - Wash face, hands and any exposed skin thoroughly after handling P270 - Do not eat, drink or smoke when using this product

Further information

Unknown Acute Toxicity 17.7% of the mixture consists of ingredient(s) of unknown toxicity

2.1 Classification of the substance or mixture

OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Reproductive toxicity Category 2 Effects on or via lactation Yes