Country: Израел
Језик: Енглески
Извор: Ministry of Health
MIFEPRISTONE
A. LAPIDOT PHARMACEUTICALS, LTD
G03XB01
TABLETS
MIFEPRISTONE 200 MG
PER OS
Required
EXELGYNE LABORATORIES, FRANCE
MIFEPRISTONE
MIFEPRISTONE
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.
2014-07-31
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 Прочитајте комплетан документ
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 Прочитајте комплетан документ