GyMiso misoprostol 200 microgram oral tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

misoprostol, Quantity: 200 microgram

Tersedia dari:

MS Health Pty Ltd

INN (Nama Internasional):

Misoprostol

Bentuk farmasi:

Tablet

Komposisi:

Excipient Ingredients: hypromellose; microcrystalline cellulose; sodium starch glycollate; hydrogenated castor oil

Rute administrasi :

Oral

Unit dalam paket:

Four (4) tablets per pack

Kelas:

Medicine Registered

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

GyMiso is indicated in females of childbearing age for the medical termination of a developing intrauterine pregnancy in sequential combination with a mifepristone 200 mg tablet, up to 49 days of gestation.

Ringkasan produk:

Visual Identification: White, flat round tablet, "ML" debossed on one side, "200" on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2012-08-29

Selebaran informasi

GyMiso® misoprostol 200 µg tablets
Page 1 of 3
GYMISO®
EACH TABLET CONTAINS MISOPROSTOL 200 MICROGRAMS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some common
questions about GyMiso® tablets. It
does not contain all the available
information. It does not take the place
of talking to your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being given GyMiso® tablets
against the expected benefits it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT GYMISO® IS USED
FOR
GyMiso® contains misoprostol. It
belongs to a group of medicines called
prostaglandins. It acts like
prostaglandin E
1
. GyMiso® induces
contractions of the smooth muscle and
relaxation of the cervix. These
properties help open the cervix and
push out the contents of the uterus.
GyMiso® can therefore be used to
terminate a pregnancy.
GyMiso® is recommended for the
medical termination of pregnancy. It is
recommended for use up to 49 days
after your last menstrual period. It is
given in combination with another
medicine called mifepristone, which
blocks progesterone, a hormone that is
needed for pregnancy to continue.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY GYMISO® HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
_ _
This medicine is available only with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
GYMISO®
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN GYMISO® IF:

you are pregnant and wish to carry
your pregnancy to term

you have any allergies to
misoprostol, or any other
prostaglandins or any of the other
ingredients listed at the end of this
leaflet
YOU SHOULD NOT BE GIVEN A MIFEPRISTONE
TABLET AND GYMISO® TABLETS IF:

you cannot take mifepristone or
have any allergies to mifepristone

you suffer from chronic adrenal
failure

you suffer from severe disease
where it is necessary to take
st

Karakteristik produk

PRODUCT INFORMATION - GYMISO®
_Version: 18-09-2012 _
_ _
_Page 1 of 13 _
NAME OF THE MEDICINE
GyMiso
®
, misoprostol 200 microgram tablet
Australian Approved Name (AAN): Misoprostol
Chemical Structure:
O
C
H
3
OH
OMe
O
O
H
(±)
Molecular formula: C
22
H
38
O
5
Molecular weight: 382.5
The CAS Registry Number:
_ _
59122-46-2
_ _
DESCRIPTION
White, flat round tablet with ‘ML’ debossed on one side and
‘200’ on the other side.
Each tablet contains 200 micrograms of misoprostol as a 1% dispersion
of misoprostol-
hypromellose. Misoprostol is a clear, colourless or yellowish oily
liquid.
GyMiso® contains the following excipients: hypromellose, cellulose -
microcrystalline,
sodium starch glycollate type A and castor oil - hydrogenated.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Other gynecological medicines –
prostaglandins. ATC code:
G02AD06
_ _
Misoprostol is a synthetic analogue of prostaglandin E1. At the
recommended dosages,
misoprostol induces contractions of the smooth muscle fibers in the
myometrium and
relaxation of the uterine cervix. The uterotonic properties of
misoprostol should facilitate
cervical opening and evacuation of intrauterine debris.
In the event of an early termination of pregnancy, the combination of
GyMiso® used in a
sequential regimen after mifepristone leads to an increase in the
success rate and accelerates
the expulsion of the conceptus.
PRODUCT INFORMATION - GYMISO®
_Version: 18-09-2012 _
_ _
_Page 2 of 13 _
Pharmacodynamic studies in early pregnancy have found an increase in
uterine tone around 8
minutes after oral and 40 minutes after buccal misoprostol, with
sustained contractions
achieved by a mean of around 90 minutes and uterine activity peaking
prior to 5 hours.
Following oral administration uterine activity rises earlier than
other routes, but is lower
overall. Pretreatment with mifepristone has previously been shown to
increase uterine
contractility in response to misoprostol.
PHARMACOKINETIC PROPERTIES
ABSORPTION
When administered orally, mis