Mifegyne

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Mifepristone 200mg;  ;  

Доступна з:

Istar Limited

ІПН (Міжнародна Ім'я):

Mifepristone 200 mg

Дозування:

200 mg

Фармацевтична форма:

Tablet

Склад:

Active: Mifepristone 200mg     Excipient: Colloidal silicon dioxide Magnesium stearate Maize starch Microcrystalline cellulose Povidone

Одиниць в упаковці:

Blister pack, PVC-Al, 3 tablets

Клас:

Prescription

Тип рецепту:

Prescription

Виробник:

VLG Chem SAS

Терапевтичні свідчення:

1. As a medical alternative to surgical termination of intra-uterine pregnancy 2. Softening and dilatation of the cervix uteri prior to surgical pregnancy termination 3. Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons 4. Labour induction for the expulsion of a dead fetus (fetal death in utero).

Огляд продуктів:

Package - Contents - Shelf Life: Blister pack, PVC-Al - 1 tablets - 48 months from date of manufacture stored at or below 30°C - Blister pack, PVC-Al - 3 tablets - 48 months from date of manufacture stored at or below 30°C

Дата Авторизація:

2000-06-14

Характеристики продукта

1
1.
NAME OF THE MEDICINAL PRODUCT
Mifegyne 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200-mg mifepristone.
_For the 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,
the
anti-progesterone
mifepristone
and
the
prostaglandin
analogue can only be prescribed and administered in accordance with
New Zealand’s abortion
laws and regulations.
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 (see section
4.2).
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 FETAL DEATH IN UTERO.
In patients where prostaglandin or oxytocin cannot be used.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
1-
MEDICAL TERMINATION OF DEVELOPING INTRA-UTERINE PREGNANCY
The method of administration will be as follows:
→
Up to 49 days of amenorrhea:
Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg
each) oral dose, followed 36 to
48 hours later, by the administration of the prostaglandin analogue:
misoprostol 400 µg orally or
per vaginum.
2
→
Between 50-63 days of amenorrhea
Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg
each) oral dose, followed 36 to
48 hours later, by the administration of misoprostol.
Alternatively, 200 mg of mifepristone (i.e. 1 tablet of 200 mg) can
also be used in a single oral
dose, followed 36 to 48 hours later, by the administration of
misoprostol. (see section 5.1.
pharmacodynamic properties).
Dose adjustment to a higher dose (600 mg) is needed with concomitant
treatment with CYP3A4
inducers (see section 4.5 Interact