Fingolimod Bluefish 0.5 mg hard capsules

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

FINGOLIMOD HYDROCHLORIDE

Prieinama:

Bluefish Pharmaceuticals AB

ATC kodas:

L04AA27

INN (Tarptautinis Pavadinimas):

FINGOLIMOD HYDROCHLORIDE

Vaisto forma:

Capsule, hard

Gydymo sritis:

fingolimod

Autorizacija statusas:

Not marketed

Leidimo data:

2022-03-25

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FINGOLIMOD BLUEFISH 0.5 MG HARD 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fingolimod Bluefish is and what it is used for
2.
What you need to know before you take Fingolimod Bluefish
3.
How to take Fingolimod Bluefish
4.
Possible side effects
5.
How to store Fingolimod Bluefish
6.
Contents of the pack and other information
1.
WHAT FINGOLIMOD BLUEFISH IS AND WHAT IT IS USED FOR
Fingolimod Bluefish contains the active substance fingolimod.
Fingolimod Bluefish 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 Bluefish 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. Symptoms vary from patient
to patient but typically involve
walking difficulties, num

Prekės savybės

Health Products Regulatory Authority
29 March 2022
CRN009W8X
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fingolimod Bluefish 0.5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fingolimod hydrochloride equivalent to 0.5
mg fingolimod.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Fingolimod Bluefish 0.5 mg hard capsules is presented as 15.9 mm
length hard capsules with yellow cap and white opaque
body; imprinted with black ink "FD 0.5 mg" on cap
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fingolimod Bluefish 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
In adults, the recommended dose of Fingolimod Bluefish is one 0.5 mg
capsule taken orally once daily.
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body weight:

Paediatric patients with body weight ≤40 kg: one 0.25 mg capsule
taken orally once daily.

Paediatric patients with body weight >40 kg: one 0.5 mg capsule taken
orally once daily.
Fingolimod Bluefish 0.5 mg hard capsules are not suitable for
paediatric patients with body weight ≤40 kg. Other
fingolimod-containing medicinal products are available in a lower