Zavesca

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Miglustat 100mg

थमां उपलब्ध:

Janssen-Cilag (New Zealand) Ltd

INN (इंटरनेशनल नाम):

Miglustat 100 mg

डोज़:

100 mg

फार्मास्यूटिकल फॉर्म:

Capsule

रचना:

Active: Miglustat 100mg Excipient: Gelatin Magnesium stearate Povidone Sodium starch glycolate Titanium dioxide

पैकेज में यूनिट:

Blister pack, 90 capsule blister. Thermoformed Aclar UltRx 2000 adhesive, PVC film pockets child-resistant foil, 90 capsules

वर्ग:

Prescription

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Lonza AG

चिकित्सीय संकेत:

ZAVESCA® is indicated for the treatment of progressive neurological manifestations in adult and paediatric patients with Niemann-Pick type C disease.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Blister pack, 90 capsule blister. Thermoformed Aclar UltRx 2000 adhesive, PVC film pockets child-resistant foil - 90 capsules - 5 years from date of manufacture stored at or below 30°C

प्राधिकरण की तारीख:

2009-02-13

सूचना पत्रक

ZAVESCA (201201) ACMI
Page 1 of 4
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
doctor if you have any questions
about why ZAVESCA has been
prescribed for you.
BEFORE YOU TAKE
ZAVESCA
_WHEN YOU MUST NOT _
_

उत्पाद विशेषताएं

CCDS210402
Page 1 of 16
ZAVESCA (220324) ADS
ZAVESCA
®
MIGLUSTAT
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
ZAVESCA 100 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active: 100 mg miglustat.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ZAVESCA® hard capsules are white with ‘OGT 918’ printed in black
on the cap and ‘100’ printed in
black on the body and contain 100 mg of miglustat.
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 ADMINISTRATION
Therapy should be directed by physicians who are experienced in the
management of Gaucher
disease or Niemann-Pick type C disease.
U
DOSAGE IN TYPE 1 GAUCHER DISEASE
ADULTS
The recommended starting dose for the treatment of 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 may 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. Also, the use of
medications such as loperamide have been demonstrated to be effective
in patients experiencing
CCDS210402
Page 2 of 16
ZAVESCA (220324) ADS
diarrhoea on ZAVESCA®. A 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