Rebif
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
01-06-2023
Karatteristiċi tal-prodott
(SPC)
01-06-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
20-12-2019
Ingredjent attiv:
interferon beta-1a
Disponibbli minn:
Merck Europe B.V.
Kodiċi ATC:
L03AB07
INN (Isem Internazzjonali):
interferon beta-1a
Grupp terapewtiku:
Immunostimulants,
Żona terapewtika:
Multiple Sclerosis
Indikazzjonijiet terapewtiċi:
Rebif is indicated for the treatment of:patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years.Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.
Sommarju tal-prodott:
Revision: 41
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
1998-05-03
Fuljett ta 'informazzjoni
151
B. PACKAGE LEAFLET
152
PACKAGE LEAFLET: INFORMATION FOR THE USER
REBIF 22 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
interferon beta-1a
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Rebif is and what it is used for
2.
What you need to know before you use Rebif
3.
How to use Rebif
4.
Possible side effects
5.
How to store Rebif
6.
Contents of the pack and other information
1.
WHAT REBIF IS AND WHAT IT IS USED FOR
Rebif belongs to a class of medicines known as interferons. These are
natural substances that transmit
messages between cells. Interferons are produced by the body and play
an essential role in the immune
system. Through mechanisms that are not totally understood,
interferons help to limit the damage of
the central nervous system associated with multiple sclerosis.
Rebif is a highly purified soluble protein that is similar to the
natural interferon beta that is produced
in the human body.
Rebif
_ _
is used for the treatment of multiple sclerosis. It has been shown to
reduce the number and the
severity of relapses and to slow the progression of disability.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE REBIF_ _
DO NOT USE REBIF_ _
•
if you are allergic to natural or recombinant interferon beta or any
of the other ingredients of
this medicine (listed in section 6).
•
if you are severely depressed at present.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Rebif.
•
Rebif should only be used under the supervision of your
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rebif 22 micrograms solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU*) of
interferon beta-1a**.
* Million International Units, measured by cytopathic effect (CPE)
bioassay against the in-house
interferon beta-1a standard which is calibrated against the current
international NIH standard
(GB-23-902-531).
** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA
technology.
Excipient with known effect: Contains 2.5 mg benzyl alcohol per dose
of 0.5 mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to
450 mOsm/L.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rebif is indicated for the treatment of relapsing multiple sclerosis.
In clinical trials, this was
characterised by two or more acute exacerbations in the previous two
years (see section 5.1).
Efficacy has not been demonstrated in patients with secondary
progressive multiple sclerosis without
ongoing relapse activity (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the treatment of the
disease.
Rebif is available in three strengths: 8.8 micrograms, 22 micrograms
and 44 micrograms. For patients
initiating treatment with Rebif, Rebif 8.8 micrograms and Rebif 22
micrograms are available in a pack
that corresponds to the patient needs for the first month of therapy.
Posology
The recommended posology of Rebif is 44 micrograms given three times
per week by subcutaneous
injection. A lower dose of 22 micrograms, also given three times per
week by subcutaneous injection,
is recommended for patients who cannot tolerate the higher dose in
view of the treating specialist.
When first starting treatment with Rebif, the dose should be gradually
escalat
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