Cefazolin for Injection

SECTION 2: Hazards identification

EU Classification

R20, R61 Celestone Chronodose Injection (6 mg/mL) MSDS NUMBER: SP000225 Latest Revision Date: 19-Mar-2009 Page 1 of 7 EMERGENCY OVERVIEW Colorless Liquid Odor unknown May be harmful by inhalation, skin absorption or if swallowed. May cause sensitization by skin contact. May cause developmental effects. May cause reproductive effects. Causes effects to: skin endocrine system May cause effects to: muscoloskeletal system nervous system gastrointestinal tract immune system liver kidney reproductive system fetus

Potential health effects

The health hazard information presented below is for the active ingredient in this product. Betamethasone is an anti-inflammatory corticosteroid used in the treatment of various disease states. As a class, corticosteroids are know n to cause systemic effects such as reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, increased blood sugar, sugar in the urine, impairment of glucose tolerance, and changes in general metabolism, bone metabolism, w hite blood cell counts, and some blood serum chemistry levels. The clinical relevance of these changes in healthy adults is unknow n. Cushing's syndrome may occur from excessive exposure to corticosteroids. Use of aerosolized corticosteroid inhalers has caused nasal irritation or burning, occasional sneezing, runny or bloody nose. Rare instances of nasal ulceration, septum perforation and increased intraocular pressure have been reported follow ing prolonged use of or overexposure to aerosolized corticosteroids. Prolonged use of systemic steroids is also know n to be associated w ith the formation of cataracts and glaucoma. Corticosteroids may mask some signs of infection, and opportunistic infections may appear during their use due to effects on immune system. Persons w ith pre-existing skin conditions including dermatitis and acne, a history of asthma, or those taking or those w ith a history of taking systemic steroids are more susceptible to allergic reactions from exposure to steroids. Serious health effects including death have occured in asthmatic patients during transfer from systemic corticosteroid to topical corticosteroid clinical use. The most common side effects in studies w ith betamethasone-containing topical preparations w ere local, including erythema, steroid-induced rosacea (redness, acne-like reaction on face), mild burning, itching, skin dryness and irritation. Betamethasone has been show n to decrease collagen synthesis in human skin follow ing treatment w ith topical cream. Adverse reactions reported follow ing injection of betamethasone include effects on fluid and electrolytes, musculoskeletal, gastrointestinal, dermatologic, neurological, endocrine, ophthalmic and metabolic parameters. Corticosteroids are teratogenic in laboratory animals and may be considered teratogenic in non-human primates as w ell. Widespread clinical use of corticosteroids has resulted in very few reports of teratogenic activity in humans. There is no evidence of impaired fertility in humans treated w ith corticosteroids although hypo-adrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. LISTED CARCINOGENS No carcinogens or potential carcinogens listed by IARC or EU Directive 90/394 (Annex I) in this mixture.