ZAVESCA miglustat 100 mg capsules blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

miglustat, Quantity: 100 mg

제공처:

Janssen-Cilag Pty Ltd

INN (국제 이름):

Miglustat

약제 형태:

Capsule, hard

구성:

Excipient Ingredients: magnesium stearate; povidone; sodium starch glycollate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid; potassium hydroxide; industrial methylated spirit; ammonia; sorbitan monolaurate; Gelatin; sodium lauryl sulfate

관리 경로:

Oral

패키지 단위:

90 capsules

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Zavesca is indicated for the oral treatment of patients with mild to moderate Type 1 Gaucher disease, for whom enzyme replacement therapy is not a therapeutic option. ZAVESCA is indicated for the treatment of the progressive neurological manifestations in adult and paediatric patients with Niemann-Pick type C disease.

제품 요약:

Visual Identification: White capsule with "OGT918" printed in black on the cap and "100" printed on the body.; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

승인 상태:

Registered

승인 날짜:

2007-10-23

환자 정보 전단

ZAVESCA (220217) ACMI
1
This leaflet was prepared in February 2022. Please check with your
pharmacist if an updated version of this leaflet has been
made available.
ZAVESCA
®
_Miglustat 100 mg capsules _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZAVESCA.
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 ZAVESCA
against the benefits he/she expects it
will 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 ZAVESCA IS
USED FOR
ZAVESCA is a medicine that is used
to treat mild to moderate Type 1
Gaucher disease in adults and it is
also used to treat Niemann-Pick type
C (NP-C) disease in children,
adolescents and adults.
Type 1 Gaucher disease is an
inherited disease that you get from
both of your parents. People with
Type 1 Gaucher disease are partially
missing an enzyme that breaks down
a chemical in the body called
glucosylceramide. Too much
glucosylceramide causes an increase
in the size of the liver and spleen. It
also causes bone disease and changes
in the blood.
ZAVESCA reduces the formation of
glucosylceramide to a level the
partially missing enzyme can cope
with.
You may be prescribed ZAVESCA if
your doctor decides other treatments
for this disease are not right for you.
Niemann-Pick disease is an inherited
disease that you get from both
parents. If you have NP-C, fats
(glycosphingolipids) build up in the
cells of your brain. This can result in
disturbances in neurological
functions such as eye movements,
balance, swallowing, and memory,
and in seizures.
ZAVESCA works by inhibiting the
enzyme called 'glucosylceramide
synthase' which is responsible for the
first step in the synthesis of most
glycosphingolipids.
Your doctor may have prescribed
ZAVESCA for another reason. Ask
your

제품 특성 요약

3.210402
Page 1
ZAVESCA (220527) API
AUSTRALIAN PRODUCT INFORMATION
ZAVESCA
®
MIGLUSTAT
100 MG CAPSULES
1
NAME OF THE MEDICINE
Miglustat
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active: 100 mg miglustat
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Hard capsules.
White capsule with "OGT918" printed in black on the cap and "100"
printed on the body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
ZAVESCA
®
is indicated for the oral treatment of patients with mild to moderate
Type 1 Gaucher
disease, for whom enzyme replacement therapy is not a therapeutic
option.
ZAVESCA
®
is indicated for the treatment of progressive neurological
manifestations in adult
and paediatric patients with Niemann-Pick type C disease.
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
Therapy should be directed by physicians who are experienced in the
management of Gaucher
disease or Niemann-Pick type C disease.
DOSAGE IN TYPE 1 GAUCHER DISEASE
_ADULTS _
The recommended starting dose for the treatment of adult patients with
Type 1 Gaucher disease
is 100 mg three times a day.
As there has been no formal food interaction study performed, it is
recommended to take
ZAVESCA
®
without food.
Patients should be instructed to reduce the intake of foods which are
high in disaccharides (e.g.
lactose or sucrose) or to take ZAVESCA
®
away from food, as these actions have been shown
during the clinical studies to reduce the risk and/or intensity of
gastrointestinal adverse events.
3.210402
Page 2
ZAVESCA (220527) API
Also, the use of medications such as loperamide have been demonstrated
to be effective in
patients experiencing diarrhoea on ZAVESCA
®
. Temporary dose reduction of ZAVESCA
®
to
100 mg once or twice a day may be necessary in some patients because
of diarrhoea.
_CHILDREN, ADOLESCENTS AND THE ELDERLY _
There is currently no relevant experience with the use of ZAVESCA
®
in patients under the age
of 18 and over the age of 70. The use of ZAVESCA
®
is therefore not recommended in children
or adolescents with