DEPO-PROVERA medroxyprogesterone acetate 150 mg/mL aqueous suspension injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

medroxyprogesterone acetate, Quantity: 150 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: propyl hydroxybenzoate; methyl hydroxybenzoate; water for injections; sodium chloride; macrogol 3350; polysorbate 80

Administration route:

Intramuscular

Units in package:

1mL X 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Carcinoma: Palliative treatment of recurrent and/or metastatic breast or renal cell cancer and of inoperable recurrent or metastatic endometrial carcinoma. Endometriosis: For use in the treatment of visually proven (laparoscopy) endometriosis where the required end-point of treatment is pregnancy, or for the control of symptoms when surgery is contra- indicated or has been unsuccessful. Contraception (ovulation suppression): For long-term prevention of pregnancy in women when administered at 3-month intervals. Since loss of bone mineral density (BMD) may occur in pre-menopausal women who use DEPO-PROVERA long-term (greater than 2 years), women should be assessed, before starting treatment for contraception or endometriosis, regarding the risk of osteoporosis. Women under the age of 18 years may be at risk of failing to achieve their predicted peak bone mineral density (See WARNINGS). The 50 mg/1mL vial is not approved for the indication of contraception (ovulation suppression). The injection, DEPO-PROVERA 1

Product summary:

Visual Identification: White suspension; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

DEPO-PROVERA
®
_Medroxyprogesterone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DEPO-PROVERA.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking DEPO-
PROVERA against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DEPO-
PROVERA IS USED FOR
The active ingredient of DEPO-
PROVERA is a chemical similar to
the natural hormone progesterone.
Your ovaries produce progesterone
during the second half of your
monthly cycle.
There are several reasons why your
doctor may have prescribed DEPO-
PROVERA for you.
DEPO-PROVERA is used for the
following reasons.
CONTRACEPTION
DEPO-PROVERA is an injectable
form of contraception. Each injection
protects you from pregnancy for 3
months.
DEPO-PROVERA works by
inhibiting the hormones that are
needed for the release of eggs from
your ovaries.
ENDOMETRIOSIS
Endometriosis is a condition in
which cells from the lining of the
uterus (womb) grow in places outside
the uterus.
During your period, these cells may
grow and break down in the same
way as those in the lining of the
uterus. This causes pain and
discomfort. DEPO-PROVERA helps
to stop the growth of cells outside the
uterus.
CANCER
DEPO-PROVERA is also used in the
treatment of certain types of cancer
including cancer of the breast, kidney
and endometrium (lining of the
uterus). It works by inhibiting the
growth of these types of cancer cells.
DEPO-PROVERA is not a cure for
cancer.
Your doctor may have prescribed
DEPO-PROVERA for another
purpose. Ask your doctor if you have
any questions about why DEPO-
PROVERA has been prescribed for
you.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
DEPO-PROVERA
_WHEN YOU MUST NOT BE GIVEN_

Summary of Product characteristics

Version:pfpdepvi10420
Supersedes: pfpdepvi10220
Page 1 of 18
AUSTRALIAN
PRODUCT
INFORMATION
–
DEPO-PROVERA
®
(MEDROXYPROGESTERONE ACETATE)
1.
NAME OF THE MEDICINE
medroxyprogesterone acetate (MPA)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DEPO-PROVERA 150 mg/mL injection suspension contains 150 mg
medroxyprogesterone
acetate (MPA).
EXCIPIENT(S) WITH KNOWN EFFECT
DEPO-PROVERA contains methyl hydroxybenzoate, propyl hydroxybenzoate
and sodium
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Injection, suspension
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CARCINOMA
Palliative treatment of recurrent and/or metastatic breast or renal
cell cancer and of inoperable
recurrent or metastatic endometrial carcinoma.
ENDOMETRIOSIS
For use in the treatment of visually proven (laparoscopy)
endometriosis where the required
end-point of treatment is pregnancy, or for the control of symptoms
when surgery is
contraindicated or has been unsuccessful.
CONTRACEPTION (OVULATION SUPPRESSION)
For long-term prevention of pregnancy in women when administered at
3-month intervals.
Since loss of BMD may occur in pre-menopausal women, who use MPA
long-term (greater
than 2 years), women should be assessed before starting treatment for
contraception or
endometriosis, for the risk of osteoporosis. Women under the age of 18
years may be at risk
of failing to achieve their predicted peak BMD (see Section 4.4
Special warnings and
precautions for use).
1
Version:pfpdepvi10420
Supersedes: pfpdepvi10220
Page 2 of 18
4.2 DOSE AND METHOD OF ADMINISTRATION
INOPERABLE, RECURRENT, METASTATIC, ENDOMETRIAL & RENAL CARCINOMA
Initially, 600 mg to 1200 mg weekly followed by 450 mg to 600 mg every
1 to 4 weeks for
maintenance.
BREAST CARCINOMA
IM injection 500 mg daily for 4 weeks then 500 mg to 1000 mg at weekly
intervals for
maintenance.
ENDOMETRIOSIS
50 mg weekly or 100 mg every 2 weeks by IM injection for at least 6
months.
CONTRACEPTION (OVULATION SUPPRESSION)
150 mg every 3 months by deep IM injectio