DEPO-PROVERA; DEPO-PRODASONE; FARLUTAL; FARLUTAL DEPO; ONCO-PROVERA

Pfizer Inc

Revision date : 2012-03-02

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

25322-68-3

Name of the chemical

polyethyleneglycol

Concentration

*

EC/CAS

202-785-7/99-76-3

Name of the chemical

4-hydroxybenzoic acid, methyl ester

Concentration

N/A

EC/CAS

202-307-7/94-13-3

Name of the chemical

Propylparaben; propyl 4-hydroxybenzoate

Concentration

N/A

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

EC/CAS

9005-65-6

Name of the chemical

polyethyleneglycol sorbitan monooleate

Concentration

N/A

General Information

Version

4.0

Revision date

2012-03-02

Product name

DEPO-PROVERA; DEPO-PRODASONE; FARLUTAL; FARLUTAL DEPO; ONCO-PROVERA

Product Synonyms

Medroxyprogesterone Suspension, For Injection, IM

Icons in SDS

Company Information

company name

Pfizer Inc

e-mail address of the competent person responsible for the Safety Data Sheet

pfizer-MSDS@pfizer.com

GHS Information

Signal word

DANGER

Section 2

SECTION 2: Hazards identification

Appearance: White to off-white suspension

Signal word

DANGER

Hazard statements

May cause cancer. May damage fertility or the unborn child. Toxic to aquatic life with long lasting effects.

Additional information

Short Term: Not an eye irritant ; Not a skin irritant ; Not acutely toxic (based on animal 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). Known Clinical Effects: Adverse effects associated with therapeutic use of 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

EU Classification

EU Indication of danger: Toxic to reproduction: Category 1 Carcinogenic: Category 2 Dangerous for the Environment EU Hazard Symbols: _______________________________________________________________________________________________________ PZ01162 101 EU Risk Phrases: R45 - May cause cancer. R60 - May impair fertility. R61 - May cause harm to the unborn child. R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Australian Hazard Classification

Hazardous Ingredients

Non-Dangerous Goods (NOHSC): Note: 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.

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