MIFEGYNE Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Mifegyne 200 mg tablets.
Qualitative and quantitative composition
Each tablet contains 200-mg mifepristone. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Light yellow, cylindrical, bi-convex tablets, with a diameter of 11 mm with 167 B engraved on one side.
Therapeutic indications
Medical termination of developing intra-uterine pregnancy.In sequential use with a prostaglandin analogue, up to 63 days of amenorrhea (see section 4.2). Softening and dilatation of the cervix uteri ...
Posology and method of administration
Posology Medical termination of developing intra-uterine pregnancy The method of administration will be as follows: <u>Up to 49 days of amenorrhea:</u> Mifepristone is taken as a single 600 mg (i.e. 3 ...
Contraindications
This product SHOULD NEVER be prescribed in the following situations. <u>In all indications:</u> chronic adrenal failure, hypersensitivity to mifepristone or to any of the excipients listed in section 6.1, ...
Special warnings and precautions for use
Warnings Because of its abortifacient properties, mifepristone should never be used in a woman with an ongoing pregnancy who wants to complete it. The age of the pregnancy must be determined from the questioning ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. On the basis of this drugs metabolism by CYP3A4, it is possible that ketoconazole, itraconazole, erythromycin, and grapefruit juice may inhibit its metabolism ...
Fertility, pregnancy and lactation
Pregnancy In animals (see section 5.3 Pre-clinical safety data), the abortifacient effect of mifepristone precludes the proper assessment of any teratogenic effect of the molecule. With subabortive doses, ...
Effects on ability to drive and use machines
No data showing an effect on the ability to drive or using machines are known. Dizziness could occur as a side effect inherent of the abortion process. When driving or using machines one should take this ...
Undesirable effects
The frequencies of occurrence of side effects are classified as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), ...
Overdose
No case of overdose has been reported. In the event of accidental massive ingestion, signs of adrenal failure might occur. Signs of acute intoxication may require specialist treatment including the administration ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other sex hormone and modulation of the reproductive function/antiprogestogen ATC code: GO3XB01 Mifepristone is a synthetic steroid with an antiprogestational action as a result ...
Pharmacokinetic properties
Absorption After oral administration of a single dose of 600 mg mifepristone is rapidly absorbed. The peak concentration of 1.98 mg/l is reached after 1.30 hours (means of 10 subjects). After oral administration ...
Preclinical safety data
In toxicological studies in rats and monkeys up to a duration of 6 months, mifepristone produced effects related to its antihormonal (antiprogesterone, antiglucocorticoid and antiandrogenic) activity. ...
List of excipients
Silica, colloidal anhydrous (E551) Maize starch Povidone (E1201) Magnesium stearate (E572) Cellulose microcrystalline (E460)
Incompatibilities
Not applicable.
Shelf life
4 years.
Nature and contents of container
PVC/aluminium perforated unit dose blister packs of 1, 3 1, 15 1 or 30 1 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Nordic Group B.V., Siriusdreef 22, 2132 WT Hoofddorp, The Netherlands
Marketing authorization number(s)
PL 40621/0022
Date of first authorization / renewal of the authorization
30/04/2017
Date of revision of the text
18/04/2019
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