Zavesca
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
02-03-2022
Valmisteyhteenveto
(SPC)
02-03-2022
Julkisesta arviointikertomuksesta
(PAR)
30-07-2013
Aktiivinen ainesosa:
miglustat
Saatavilla:
Janssen Cilag International NV
ATC-koodi:
A16AX06
INN (Kansainvälinen yleisnimi):
miglustat
Terapeuttinen ryhmä:
Other alimentary tract and metabolism products,
Terapeuttinen alue:
Gaucher Disease; Niemann-Pick Diseases
Käyttöaiheet:
Zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type-C disease.
Tuoteyhteenveto:
Revision: 33
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2002-11-20
Pakkausseloste
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZAVESCA 100 MG CAPSULES
miglustat
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects,talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zavesca is and what it is used for
2.
What you need to know before you take Zavesca
3.
How to take Zavesca
4.
Possible side effects
5.
How to store Zavesca
6.
Contents of the pack and other information
1.
WHAT ZAVESCA IS AND WHAT IT IS USED FOR
Zavesca contains the active substance miglustat which belongs to a
group of medicines that affect
metabolism. It is used to treat two conditions:
ZAVESCA IS USED TO TREAT MILD TO MODERATE TYPE 1 GAUCHER DISEASE IN
ADULTS.
In type 1 Gaucher disease, a substance called glucosylceramide is not
removed from your body. It
starts to build up in certain cells of the body’s immune system.
This can result in liver and spleen
enlargement, changes in the blood, and bone disease.
The usual treatment for type 1 Gaucher disease is enzyme replacement
therapy. Zavesca is only used
when a patient is considered unsuitable for treatment with enzyme
replacement therapy.
ZAVESCA IS ALSO USED TO TREAT PROGRESSIVE NEUROLOGICAL SYMPTOMS IN
NIEMANN-PICK TYPE C
DISEASE IN ADULTS AND IN CHILDREN.
If you have Niemann-Pick type C disease, fats such as
glycosphingolipids build up in the cells of your
brain. This can result in disturbances in neurological functions such
as slow eye movements, balance,
swallowing, and memory, and in seizures.
Zavesca works by inhibiting the enzyme called ‘glucosylceramide
synthase’ which
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zavesca 100 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg miglustat.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
White capsules with “OGT 918” printed in black on the cap and
“100” printed in black on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zavesca is indicated for the oral treatment of adult patients with
mild to moderate type 1 Gaucher
disease. Zavesca may be used only in the treatment of patients for
whom enzyme replacement therapy
is unsuitable (see sections 4.4 and 5.1).
Zavesca is indicated for the treatment of progressive neurological
manifestations in adult patients and
paediatric patients with Niemann-Pick type C disease (see sections
4.4, and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be directed by physicians who are knowledgeable in the
management of Gaucher
disease or Niemann-Pick type C disease, as appropriate.
Posology
_Dosage in type 1 Gaucher disease_
_Adult_
The recommended starting dose for the treatment of adult patients with
type 1 Gaucher disease is
100 mg three times a day.
Temporary dose reduction to 100 mg once or twice a day may be
necessary in some patients because
of diarrhoea.
_Paediatric population_
The efficacy of Zavesca in children and adolescents aged 0-17 years
with type 1 Gaucher disease has
not been established. No data are available.
_Dosage in Niemann-Pick type C disease_
_Adult_
The recommended dose for the treatment of adult patients with
Niemann-Pick type C disease is
200 mg three times a day.
3
_Paediatric population_
The recommended dose for the treatment of adolescent patients (12
years of age and above) with
Niemann-Pick type C disease is 200 mg three times a day.
Dosing in patients under the age of 12 years should be adjusted on the
basis of body surface area as
illustrated below:
Body surface area (m
2
)
Recommended dose
1.25
200 mg three times a day
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