Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL

Hazard statements (CLP)

H351, H360FD

Code

Statements

H351

Suspected of causing cancer

SECTION 2: Hazards identification

1999/45/EC Emergency Short Term: Not an eye irritant; Not a skin irritant; Not acutely toxic (based on animal Overview data). Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on blood and blood forming organs, reproductive system, the developing fetus. Occupational studies have shown that males working with estrogen-like compounds have shown clinical signs of hyperestrogenism including enlarged breasts and milk secretion. Loss of libido, breast tenderness, and changes in sex hormone levels have also occurred. Occupational exposure in females has resulted in menstrual irregularities (breakthrough bleeding, menstrual flow changes, spotting and amenorrhea).

Hazard statements

H351 - Suspected of causing cancer H360FD - May damage fertility. May damage the unborn child. P202 - Do not handle until all safety precautions have been read and understood P281 Use personal protective equipment as required. P308+P313 - If exposed or concerned: Get medical attention/advice P405 - Store locked up P501 - Dispose of contents/container in accordance with all local and national regulations SDS Name: Medroxyprogesterone Acetate Injectable Approved By/Date: Suspension USP, 150 mg/mL 010918 Potential Health Known Clinical Effects: Adverse effects associated with therapeutic use of Effect medroxyprogesterone acetate include menstrual irregularities, abdominal pain or discomfort weight changes, dizziness, headache, weakness or fatigue, and nervousness. Clinical use of this drug has caused loss of libido impotence development of male characteristics in the female fetus. This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace. Classification of the

Signal word

Danger Precautionary P201 - Obtain special instructions before use

2.1 Classification of the substance or mixture

Reproductive Toxicity: Category 1A Substance or Carcinogenicity: Category 2 Mixture

EU Classification

EU Indication of danger: Toxic to reproduction: Category 1 Carcinogenic: Category 2 EU Risk Phrases: R45 - May cause cancer. R60 - May impair fertility. R61 - May cause harm to the unborn child. Directive Carcinogenicity (Category 2), H351 - Directives R40-48: Limited evidence of a carcinogenic 64/578/EEC (substances) or 1999/45/EC effect. Danger of serious damage to health (mixtures) by prolonged exposure.