Methylprednisolone Acetate Injectable Suspension, USP (Multi-Dose)

Teva Parenteral Medicines, Inc

Revision date : 2000-11-27

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Note: Ingredients listed on restricted chemical lists

EC/CAS

100-51-6

Name of the chemical

Benzyl Alcohol

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

EC/CAS

1310-73-2

Name of the chemical

sodium hydroxide

Concentration

N/A

EC/CAS

7647-01-0

Name of the chemical

Hydrochloric acid

Concentration

5ppm

General Information

Revision date

2000-11-27

Product name

Methylprednisolone Acetate Injectable Suspension, USP (Multi-Dose)

Product Synonyms

Depo-Medrol™

Chemical name

pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6- methyl-,(6α,11β)-

CAS No.

53-36-1

1.2.1 Relevant identified uses

Medical Treatment; Corticosteroid (anti-inflammatory)

Manufacturer Name

Teva Parenteral Medicines, Inc

Emergency telephone

1-800-424-9300 (United States

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Company Information

company name

Teva Parenteral Medicines, Inc

Section 2

SECTION 2: Hazards identification

EMERGENCY OVERVIEW: Material is a white suspension. May cause allergic reactions. Overexposure may cause damage to the kidneys, pituitary, cardiovascular, immune and nervous Injectable and redness of the eyes and redness and a burning sensation on the skin. Hypersensitive (allergic) systems. Avoid breathing vapor. Avoid contact with eyes, skin and clothing. Do not taste or swallow. Wash thoroughly after handling. Symptoms of Overexposure by Route of Exposure: This material is intended for intravenous injection under the supervision of physicians. 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 mild irritation. Effects may include stinging, watering, reactions have been observed following clinical use of the product. Acetate product. USP Injection: Local redness and pain are the primary symptoms of accidental injection in an occupational Ingestion: Although ingestion is not an anticipated route of occupational exposure, this material has a low degree of toxicity. Harmful effects from swallowing are not expected. Symptoms similar to those identified under injection may occur. setting. Medical personnel are not anticipated to experience over-exposures to the therapeutic doses of Suspension, Cancer: Methylprednisolone acetate was negative in the DNA-cell-binding (DCB) assay. Ingredients this product. See package insert for adverse reactions associated with therapeutic doses of this Methylprednisolone

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 injection, effects such as hypertension, headaches, abdominal pain, pancreatitis, visual disturbances (including cataracts, glaucoma and blindness), muscle weakness and fatigue, acne, menstrual disorders, peptic ulcers, fluid retention, heart failure, susceptibility to infection, and fluctuation in electrolyte levels may occur. are not listed as carcinogenic by NTP, IARC or OSHA. Chronic: Corticosteroids are generally teratogenic in laboratory animals (see Section 11). Target Organs: This product may produce adverse effects on the kidneys, pituitary, cardiovascular, immune and nervous systems. (see Section 11). Other: This product contains benzyl alcohol which is potentially toxic when administered locally to neural tissues. Multi-dose use from a single vial requires special care to avoid contamination. See package insert for additional information. 2 cont Pre-Existing Medical Conditions: Conditions aggravated by exposure may include kidney, pituitary, Injectable cardiovascular, immune and nervous systems disorders. Corticosteroids may increase susceptibility to infection (including reactivation of latent tuberculosis and enhancement of secondary eye infections due to fungi or viruses) or mask some signs of infection. Recent immunization procedures may result in a lack of antibody response and neurological disorders. This material is contraindicated for intrathecal administration, systemic fungal infections and in patients with clinically significant hypersensitivity to it. Corticosteroids exhibit enhanced effects on persons with hypothyroidism or cirrhosis.

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