Amikacin Sulfate Injection, USP

SECTION 2: Hazards identification

EMERGENCY OVERVIEW: Material is a clear, colorless to straw-colored, odorless liquid. Eye and skin irritant. Overexposure may cause damage to hearing, nervous system and kidneys. May cause allergic skin and respiratory reactions. Avoid contact with eyes, skin and clothing. Do USP supervision of physicians. not taste or swallow. Wash thoroughly after handling. Symptoms of Overexposure by Route of Exposure: This material is intended for injection under the Inhalation: Inhalation of significant amounts of the product is not anticipated to occur because of the small size of individual containers. Contact with Skin or Eyes: Contact may cause irritation. Effects may include stinging, watering, redness and swelling of the eyes and redness, itching, burning and skin damage. May cause an allergic skin reaction. Ingestion: Ingestion is not an anticipated route of occupational exposure. However, it is considered slightly toxic based on animal data. Symptoms similar to those identified under injection may occur. Ingestion may also cause allergic reaction due to the bisulfite present in the solution. Injection: Local redness and pain are the primary symptoms of accidental injection in an occupational Injection, setting. Medical personnel are not anticipated to experience over-exposures to the therapeutic doses of this product. However, effects including coughing, sneezing, runny nose, nausea, vomiting, dizziness, loss of balance and hearing loss may occur. See package insert for other adverse reactions associated with therapeutic doses of this product.

Potential health effects

or Risks From Exposure (An explanation in lay terms) Acute: The primary health effects anticipated in an occupational setting include irritation of eyes and skin as well as redness and local swelling after accidental injection. In case of over-exposure by Sulfate injection, effects such as coughing, sneezing, runny nose, nausea, vomiting, dizziness, loss of balance and hearing loss may occur. Amikacin Cancer: No long-term carcinogenicity studies were identified. See Section 11 for carcinogenicity attention. information for the non-active ingredient. Chronic: Overexposure may cause damage to hearing, kidneys and nervous system (see Section 11). Pre-Existing Medical Conditions: Conditions aggravated by exposure may include skin, kidney, nervous system and hearing disorders.