PROVERA 5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MEDROXYPROGESTERONE ACETATE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

G03AC06

Pharmaceutical form:

TABLETS

Composition:

MEDROXYPROGESTERONE ACETATE 5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PFIZER INC, USA

Therapeutic group:

MEDROXYPROGESTERONE

Therapeutic area:

MEDROXYPROGESTERONE

Therapeutic indications:

In cases requiring progesterone supplement.

Authorization date:

2022-11-30

Patient Information leaflet

Provera 5 mg PIL CC 281121 English_ _
0073740
-
2021
ULATIONS (PREPARATIONS)
' REG
HE PHARMACISTS
IN ACCORDANCE WITH T
NSERT
PATIENT PACKAGE I
1986
-
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This
PROVERA
® 5 MG
TABLETS
ACTIVE INGREDIENT
Medroxyprogesterone acetate 5 mg
A list of inactive and allergenic ingredients in the preparation is
provided in section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise
information about the medicine. If you have further questions, contact
the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar.
This medicine is intended to treat women over the age of 18 years.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
To treat cases requiring administration of exogenous progesterone.
THERAPEUTIC GROUP:
Progestogen, similar to the natural sex hormone progesterone.
2.
BEFORE USING THE MEDICINE
X DO NOT USE THE MEDICINE IF:
×
you are sensitive (allergic) to the active ingredient or to other
similar hormonal medicines
or to any of the other ingredients contained in the medicine (listed
in section 6).
×
you are pregnant or think you may be pregnant. The doctor may ask you
to perform a
pregnancy test before starting treatment or during the treatment if
your period is delayed.
×
you have breast cancer or have been diagnosed with breast cancer in
the past.
×
you suffer from or have suffered in the past from formation of venous
blood clots
(venous thrombosis).
×
you suffer from or have suffered in the past from formation of
arterial blood clots (arterial
thrombosis).
×
you suffer from liver problems.
×
you suffer from porphyria - when your body lacks the ability to
correctly produce certain
enzymes, and it manifests with either neurological complications or
with skin problems
(or occasionally both).
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
! Before treatment with the medicine, tell the do

Summary of Product characteristics

DEPO-PROVERA
® 500
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Depo-Provera
®
500
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Depot-medroxyprogesterone acetate injectable suspension is available
as 500 mg/3.3 ml vial.
Excipients with known effect:
Methyl paraben
Propyl paraben
Sodium chloride
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for intramuscular injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DEPO-PROVERA
® 500 is indicated for: Palliation of inoperable recurrent or
metastatic carcinoma
of endometrium, breast, ovary and kidney.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Injectable suspensions should be shaken well before use.
The site of injection should be cleansed using standard methods prior
to administration of the
injection.
_RECURRENT AND/OR METASTATIC BREAST CANCER_
INJECTABLE DMPA INITIAL DOSE 500 TO 1000 MG INTRAMUSCULARLY PER DAY
FOR 28 DAYS. THE
PATIENT SHOULD THEN BE PLACED ON A MAINTENANCE SCHEDULE OF 500 MG
TWICE WEEKLY AS
LONG AS SHE RESPONDS TO TREATMENT.
_RECURRENT AND/OR METASTATIC ENDOMETRIAL OR RENAL CANCER_
INJECTABLE DMPA 400 TO 1000 MG INTRAMUSCULARLY PER WEEK IS RECOMMENDED
INITIALLY. IF
IMPROVEMENT IS NOTED WITHIN A FEW WEEKS OR MONTHS AND THE DISEASE
APPEARS STABILIZED,
IT MAY BE POSSIBLE TO MAINTAIN IMPROVEMENT WITH AS LITTLE AS 400 MG
PER MONTH.
_LONG-TERM USE_
Since loss of bone mineral density (BMD) may occur in pre-menopausal
women who use DMPA
injection long-term (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE AND SECTION
5.1 PHARMACODYNAMIC PROPERTIES, _CLINICAL TRIALS RELATING TO BONE
MINERAL DENSITY_), a risk/
benefit assessment, which also takes into consideration the decrease
in BMD that occurs during
pregnancy and/or lactation, should be considered.
_USE IN CHILDREN_
DMPA IM is not indicated before menarche. Data are available in
adolescent females
(12-18 years) (SEE SECTION 5.1 PHARMACODYNAMIC PROPERTIES, _CLINICAL
TRIALS, CHANGES IN _
_BMD IN ADOLESCENT FEMALES (AGED