Fingolimod Devatis 0,5 mg, harde capsules

국가: 네덜란드

언어: 네덜란드어

출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

유효 성분:

FINGOLIMODHYDROCHLORIDE 0,56 mg/stuk SAMENSTELLING overeenkomend met ; FINGOLIMOD 0,5 mg/stuk

INN (국제 이름):

FINGOLIMODHYDROCHLORIDE 0,56 mg/stuk SAMENSTELLING overeenkomend met ; FINGOLIMOD 0,5 mg/stuk

약제 형태:

Capsule, hard

구성:

AMMONIA (E 527) ; CARMELLOSE CALCIUM (E 466) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; NATRIUMSTEARYLFUMARAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; TARTRAZINE (E 102) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110) ; ZWARTE INKT

관리 경로:

Oraal gebruik

승인 날짜:

1900-01-01

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FINGOLIMOD DEVATIS 0,25 MG, HARDE CAPSULES
FINGOLIMOD DEVATIS 0,5 MG, HARDE CAPSULES
fingolimod
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, 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 Fingolimod Devatis is and what it is used for
2.
What you need to know before you take Fingolimod Devatis
3.
How to take Fingolimod Devatis
4.
Possible side effects
5.
How to store Fingolimod Devatis
6.
Contents of the pack and other information
1.
WHAT FINGOLIMOD DEVATIS IS AND WHAT IT IS USED FOR
WHAT FINGOLIMOD DEVATIS IS
Fingolimod Devatis contains the active substance fingolimod.
WHAT FINGOLIMOD DEVATISIS USED FOR
Fingolimod Devatis is used in adults and in children and adolescents
(10 years of age and above) to
treat relapsing-remitting multiple sclerosis (MS), more specifically
in:
-
Patients who have failed to respond despite treatment with an MS
treatment.
or
-
Patients who have rapidly evolving severe MS.
Fingolimod Devatis does not cure MS, but it helps to reduce the number
of relapses and to slow down
the progression of physical disabilities due to MS.
WHAT IS MULTIPLE SCLEROSIS
MS is a long-term condition that affects the central nervous system
(CNS), comprised of the brain and
spinal cord. In MS inflammation destroys the protective sheath (called
myelin) around the nerves in
the CNS and stops the nerves from working properly. This is called
demyelination.
Relapsing-remitting MS is characterised by repeated attacks (relapses)
of nervous system symptoms
that reflect inflammation within the CNS. Symp

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fingolimod Devatis 0.25 mg, harde capsules
Fingolimod Devatis 0.5 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fingolimod Devatis 0.25 mg hard capsules
Each hard capsule contains 0.25 mg fingolimod (as hydrochloride).
Fingolimod Devatis 0.5 mg hard capsules
Each hard capsule contains 0.5 mg fingolimod (as hydrochloride).
Excipients with known effect:
Each hard capsule contains 0.028 mg of Tartrazine (E102) and 0.003 mg
of Sunset yellow FCF
(E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Fingolimod Devatis 0.25 mg hard capsules
Size ‘3’ hard gelatin capsules with ivory opaque cap and body,
imprint with black ink “F 0.25” on cap,
containing white to off-white powder mixture.
Fingolimod Devatis 0.5 mg hard capsules
Size ‘3’ hard gelatin capsules with yellow opaque cap and white
opaque body, imprint with black ink
“F 0.5” on cap, containing white to off-white powder mixture.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fingolimod Devatis is indicated as single disease modifying therapy in
highly active relapsing
remitting multiple sclerosis for the following groups of adult
patients and paediatric patients aged 10
years and older:
-
Patients with highly active disease despite a full and adequate course
of treatment with at least one
disease modifying therapy (for exceptions and information about
washout periods see sections 4.4
and 5.1).
or
-
Patients with rapidly evolving severe relapsing remitting multiple
sclerosis defined by 2 or more
disabling relapses in one year, and with 1 or more Gadolinium
enhancing lesions on brain MRI or a
significant increase in T2 lesion load as compared to a previous
recent MRI.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by a physician
experienced in multiple sclerosis.
Posology
2
In adults, the recommended dose of fingolimod is one 0.5 mg capsule
taken orally once daily.
In paediatri