情報リーフレット
SABRIL
®
_vigabatrin_
CONSUMER MEDICINES INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sabril.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits.
Your doctor has weighed the risks of
you taking Sabril against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SABRIL IS USED
FOR
Sabril is a medicine used to help
control epilepsy, a condition where
you have repeated fits or
convulsions. Sabril is used in
addition to other medicines to treat
epilepsy.
Sabril is an anticonvulsant. It works
by stopping the breakdown of an
important chemical transmitter
("messenger") in the brain and this
helps reduce seizure activity.
Your doctor, however, may have
prescribed Sabril for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SABRIL IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT TAKE IT IF YOU ARE PREGNANT
OR INTEND TO BECOME PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT TAKE IT IF YOU ARE BREAST-
FEEDING OR PLANNING TO BREAST-FEED.
Sabril passes into breast milk and
there is a possibility your baby may
be affected.
DO NOT TAKE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK.
If you take this medicine after the
expiry date has passed, it may not
work as well.
DO NOT TAKE IT IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF TAMPERING.
_BEFORE YOU START TO TAKE IT_
TELL YOUR
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製品の特徴
Sabril PI
CCDSv11 PIv9 1 Oct 13
Page 1
PRODUCT INFORMATION
SABRIL
®
TABLETS 500 MG / SABRIL
®
SACHETS 500 MG
NAME OF THE MEDICINE
NON-PROPRIETARY NAME
Vigabatrin
CHEMICAL STRUCTURE
H
2
C =
CH ─ CH ─ CH
2
─ CH
2
─ COOH
|
NH
2
CAS NUMBER
60643-86-9
DESCRIPTION
Sabril sachets contain the inactive ingredient povidone EP.
Sabril tablets contain the following inactive
ingredients: povidone BP, cellulose microcrystalline EP,
sodium starch glycollate USNF, magnesium stearate EP, hydroxypropyl methylcellulose EP,
titanium dioxide BP and polyethylene glycol 8000.
PHARMACOLOGY
CLASS
Actions: Anticonvulsant
PHARMACODYNAMICS
The mechanism of action is attributed to dose-dependent enzyme inhibition of GABA-
transaminase (GABA-T) and consequent increased levels of the inhibitory neurotransmitter,
GABA. In mice, decreased GABA-T levels in the brain persisted for 5 days following a single
intraperitoneal dose (1500 mg/kg) and was accompanied by a marked rise in brain GABA
concentration.
Animal safety studies carried out in rat, mouse, dog and monkey have indicated that vigabatrin
has no significant adverse effects on the liver, kidney, lung, heart or gastrointestinal tract. In the
brain, microvacuolation has been observed in white matter tracts of rat, mouse and dog at doses
of 30-50 mg/kg/day. This effect is caused by a separation of the outer lamellar sheath of
myelinated fibres, a change
characteristic of intramyelinic oedema.
In both rat and dog (mouse, not tested), the intramyelinic oedema was reversible on stopping
vigabatrin tre
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