DEPO-PROVERA 150 MGML

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

MEDROXYPROGESTERONE ACETATE

Disponible desde:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Código ATC:

G03AC06

formulario farmacéutico:

SUSPENSION FOR INJECTION

Composición:

MEDROXYPROGESTERONE ACETATE 150 MG/ML

Vía de administración:

I.M

tipo de receta:

Required

Fabricado por:

PFIZER MANUFACTURING BELGIUM NV/SA

Grupo terapéutico:

MEDROXYPROGESTERONE

Área terapéutica:

MEDROXYPROGESTERONE

indicaciones terapéuticas:

For contraception where medically indicated and oral administration is inapplicable.

Fecha de autorización:

2020-12-31

Información para el usuario

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with
a doctor’s prescription only
DEPO-PROVERA
®
150 MG/ML
SUSPENSION FOR INJECTION
MEDROXYPROGESTERONE ACETATE 150
MG/ML
Inactive and allergenic ingredients: see
section 2 under “Important information
about some of the ingredients of the
medicine” and section 6 “Further
information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to 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 to
yours.
The effectiveness of Depo-Provera
®
in the
prevention of pregnancy depends on your
adherence to receiving an injection of the
preparation once every 12 weeks.
1. WHAT IS THE MEDICINE INTENDED
FOR?
• Depo-Provera
®
is a contraceptive agent,
when there is a medical indication for
this and oral contraceptives (taken by
mouth) cannot be used.
THERAPEUTIC GROUP:
PROGESTOGENS
A progesterone derivative – Depo-
Provera
®
contains the active ingredient
medroxyprogesterone acetate, which is
chemically similar to the natural hormone
progesterone. Progesterone is produced
by the ovaries during the second half of the
menstrual cycle. Depo-Provera
®
prevents
the eggs in the ovaries from maturing,
thereby preventing their passage from
the ovaries into the womb, and therefore,
fertilization is not possible and pregnancy
is prevented. Depo-Provera
®
also acts by
changing the lining of the womb, which
makes it less likely for pregnancy to
occur, and by thickening the mucosa at
the entrance of the womb, making it more
difficult for sperm to enter.
Depo-Provera
®
is
given
as
an
intramuscular injection ONCE EVERY 12
WEEKS.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
x You are sensitive (allergic) to the active
ingredient or to any of the a

Ficha técnica

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