Depo-Provera

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Medroxyprogesterone acetate 150 mg/mL

Available from:

Pfizer New Zealand Limited

INN (International Name):

Medroxyprogesterone acetate 150 mg/mL

Dosage:

150 mg/mL

Pharmaceutical form:

Injection (depot)

Composition:

Active: Medroxyprogesterone acetate 150 mg/mL Excipient: Hydrochloric acid Macrogol 3350 Methyl hydroxybenzoate Polysorbate 80 Propyl hydroxybenzoate Sodium chloride Sodium hydroxide

Units in package:

Syringe, Disposable, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Valdepharm

Therapeutic indications:

Adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma

Product summary:

Package - Contents - Shelf Life: Syringe, Disposable - 1 mL - 60 months from date of manufacture stored at or below 25°C - Vial, glass, 1ml - 1 mL - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1969-12-31

Patient Information leaflet

DEPO-PROVERA
®
1
DEPO-PROVERA
®
_Medroxyprogesterone acetate 150 mg/mL injection(depot)_
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 being treated with
DEPO-PROVERA against the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DEPO-
PROVERA IS USED FOR
The active ingredient of DEPO-
PROVERA, medroxyprogesterone
acetate, is a chemical similar to the
natural hormone progesterone.
Progesterone is produced by your
ovaries 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 the eggs
from the 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 the cells found
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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's pre

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DEPO-PROVERA
®
150 mg/mL Injection (depot)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL vial contains 150 mg/mL Medroxyprogesterone acetate
Each 1 mL disposable syringe contains 150 mg/mL Medroxyprogesterone
acetate
Excipients with known effects:
•
Sodium
•
Methyl hydroxybenzoate,
•
Propyl hydroxybenzoate,
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
DEPO-PROVERA 150 mg/mL Injection (depot) is a white, aqueous,
suspension containing
medroxyprogesterone acetate (MPA) as the active ingredient.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DEPO-PROVERA is indicated for:
•
ovulation suppression.
Since loss of bone mineral density (BMD) may occur in pre-menopausal
women who use
DEPO-PROVERA, particularly if treated long-term (greater than 2
years), women should be
assessed for risk factors for low BMD including a review of their
medical history, to determine
the risk of developing osteoporosis. This should be conducted before
the commencement of
treatment. A careful re-evaluation of the risks and benefits of
treatment beyond 2 years should
be carried out in those patients who need to remain on DEPO-PROVERA.
Women under the age of 18 years may be at risk of failing to achieve
their predicted peak BMD
(see section 4.4).
•
the treatment of endometriosis.
•
adjunctive and/or palliative treatment of recurrent and/or metastatic
endometrial or
renal carcinoma.
•
the treatment of hormonally-dependent recurrent breast cancer in
post-menopausal
women.
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Page 2 of 18
4.2 DOSE AND METHOD OF ADMINISTRATION
OVULATION SUPPRESSION
DEPO-PROVERA should be vigorously shaken just before use to ensure
that the dose being
administered represents a uniform suspension. The IM suspension is not
formulated for
subcutaneous injection.
The recommended dose is 150 mg of DEPO-PROVERA every 3 months
administered by IM
injection in the gluteal or