MIFEGYNE

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

MIFEPRISTONE

Mevcut itibaren:

A. LAPIDOT PHARMACEUTICALS, LTD

ATC kodu:

G03XB01

Farmasötik formu:

TABLETS

Kompozisyon:

MIFEPRISTONE 200 MG

Uygulama yolu:

PER OS

Reçete türü:

Required

Tarafından üretildi:

EXELGYNE LABORATORIES, FRANCE

Terapötik grubu:

MIFEPRISTONE

Terapötik alanı:

MIFEPRISTONE

Terapötik endikasyonlar:

Medical termination of developing intra-uterine pregnancy.- In sequential use with a prostaglandin analogue up to 63 days of amenorrhea.- Softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester.- Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (beyond the first trimester).- Labour induction in foetal death in utero.In patients where prostaglandin or oxytocin cannot be use.

Yetkilendirme tarihi:

2014-07-31

Bilgilendirme broşürü

PATIENT LEAFLET IN ACCORDANCE TO PHARMACIST'S REGULATIONS
(MEDICATIONS) 1986
The medicine is marketed by prescription only
Read this leaflet in its entirety before you use the medication. This
leaflet summarizes
information about the medication.
If you have any additional questions please contact your physician or
your nurse.
Afterwards, you must sign an informed consent form.
This medication has been prescribed for you. Do not give it to others,
as it may cause them
harm, even if it seems that their medical condition is similar to
yours.
MIFEGYNE
ORAL TABLETS
ACTIVE INGREDIENT: MIFEPRISTONE 200 MG
For a list of excipients see section 6 at the end of this leaflet.
1. WHAT THIS MEDICINE INTENDED FOR?
MIFEGYNE is recommended to be used:
1.
For the medical termination of a pregnancy:
•
no later than 63 days after the first day of your last menstrual cycle
(until
period is 35 days (5 weeks) late in a woman with regular menstrual
cycles).
•
in combination with a second medicine, a prostaglandin (a substance
that
triggers contraction of the womb and softens the cervix), which you
take 36
to 48 hours after taking Mifegyne.
2.
Softening and dilatation of the cervix before surgical termination of
pregnancy
within the first trimester (up to 84 days from the start of the last
period).
3.
Termination of pregnancy after the first trimester (for medical
reasons) as pre-
treatment before giving prostaglandins (which cause uterine
contractions).
4.
To induce labor in cases where the fetus has died in the womb and
where it is not
possible to use other medical treatments (prostaglandin or oxytocin).
THERAPEUTIC GROUP:
MIFEGYNE oral tablets include the active ingredient Mifepristone which
is anti-hormone, a
synthetic steroid that works by blocking the action of the hormone
progesterone (a
hormone which is needed for pregnancy to continue). Therefore,
MIFEGYNE can cause
termination of pregnancy. It can also be used to soften and open the
cervix.
The efficacy of the method is not perfect and in isolated cases
curettage (a regular

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
For use only in medical centers having approval to undertake
terminations of
pregnancies.
1. NAME OF THE MEDICINAL PRODUCT
MIFEGYNE®
Tablets 200 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200-mg mifepristone.
_For a full list of excipients, see section 6.1_
3. PHARMACEUTICAL FORM
Tablet.
Light yellow, cylindrical, bi-convex tablets,
with a diameter of 11 mm with
“167 B” engraved on one side.
4. CLINICAL PARTICULARS
For termination of pregnancy, MIFEGYNE® and the prostaglandin can
only be prescribed and
administered in accordance with the countries laws and regulations.
As a consequence, they can only be prescribed by a medical doctor and
in public or private hospital or
center (having approval to undertake termination of pregnancy). The
product will be administered in the
presence of the medical practitioner or of a delegated health
professional.
The signature of a letter of an informed consent by the patient would
certify that she has been fully
informed about the method and its risks.
4.1 THERAPEUTIC INDICATIONS
1) MEDICAL TERMINATION OF DEVELOPING INTRA-UTERINE PREGNANCY.
In sequential use with a prostaglandin analogue, up to 63 days of
amenorrhea.
2) SOFTENING AND DILATATION OF THE CERVIX UTERI PRIOR TO SURGICAL
TERMINATION OF
PREGNANCY DURING THE FIRST TRIMESTER.
3) PREPARATION FOR THE ACTION OF PROSTAGLANDIN ANALOGUES IN THE
TERMINATION OF
PREGNANCY FOR MEDICAL REASONS (_BEYOND THE FIRST TRIMESTER_)
4) LABOUR INDUCTION IN FOETAL DEATH IN UTERO.
In patients where prostaglandin or oxytocin cannot be used.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
MIFEGYNE® must not be administered if there is doubt as to the
existence and age of pregnancy, or in
case of extra-uterine pregnancy. The prescribing doctor should in any
case perform an ultrasound scan
and/or measure Beta-hCG before administration.
_POSOLOGY _
_ _
2
1)
MEDICAL TERMINATION OF DEVELOPING INTRA-UTERINE PREGNANCY.
The method of administration which will be prescribed by the physician
a