Fingolimod Vivanta 0,5 mg harde capsules

Maa: Alankomaat

Kieli: hollanti

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

Aktiivinen ainesosa:

FINGOLIMODHYDROCHLORIDE 0,6 mg/stuk SAMENSTELLING overeenkomend met ; FINGOLIMOD 0,5 mg/stuk

Saatavilla:

Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)

INN (Kansainvälinen yleisnimi):

FINGOLIMODHYDROCHLORIDE 0,6 mg/stuk SAMENSTELLING overeenkomend met ; FINGOLIMOD 0,5 mg/stuk

Lääkemuoto:

Capsule, hard

Koostumus:

AMMONIA (E 527) ; FUMAARZUUR (E 297) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL, GEPREGELATINEERD ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; FUMAARZUUR (E 297) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL, GEPREGELATINEERD ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Antoreitti:

Oraal gebruik

Valtuutus päivämäärä:

2020-09-10

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FINGOLIMOD VIVANTA 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 Vivanta is and what it is used for
2.
What you need to know before you take Fingolimod Vivanta
3.
How to take Fingolimod Vivanta
4.
Possible side effects
5.
How to store Fingolimod Vivanta
6.
Contents of the pack and other information
1.
WHAT FINGOLIMOD VIVANTA IS AND WHAT IT IS USED FOR
WHAT FINGOLIMOD VIVANTA IS
Fingolimod Vivanta contains the active substance fingolimod.
WHAT FINGOLIMOD VIVANTA IS USED FOR
Fingolimod Vivanta is used in adults 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 Vivanta 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.
Fingolimod Vivanta contains the active substance fingolimod, which is
also used in the treatment of
conditions not listed in this leaflet. Please contact your doctor or
pharmacist if you have any questions.
_ _
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 characte

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fingolimod Vivanta 0,5 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mg capsule contains 0.5 mg fingolimod (as hydrochloride)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Hard capsules, size 3, with a white cap imprinted “0.5 mg” and a
white body imprinted “MF” with black
ink. The capsules contain a white to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fingolimod Vivanta is indicated as single disease modifying therapy in
highly active relapsing
remitting multiple sclerosis for the following groups of adult
patients:
-
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.
For paediatric patients aged 10 years and older a fingolimod
containing drug product from a different
company is registered in the European Union.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by a physician
experienced in multiple sclerosis.
Posology
In adults, the recommended dose of Fingolimod Vivanta is one 0.5 mg
capsule taken orally once daily.
Fingolimod Vivanta can be taken with or without food.
The capsules should always be swallowed intact, without opening them.
The same first dose monitoring as for treatment initiation is
recommended when treatment is
interrupted for:
-
1 day or more during the first 2 weeks of treatment.
-
more than 7 days during weeks 3 and 4 of treatment.
-
more than 2 weeks after one month of treatment.
If the treatment interruption is of shorter duration than the above,
the treat