Zinbryta
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
28-06-2018
Valmisteyhteenveto
(SPC)
28-06-2018
Julkisesta arviointikertomuksesta
(PAR)
02-05-2018
Aktiivinen ainesosa:
daclizumab
Saatavilla:
Biogen Idec Ltd
ATC-koodi:
L04AC01
INN (Kansainvälinen yleisnimi):
daclizumab
Terapeuttinen ryhmä:
Immunosuppressants
Terapeuttinen alue:
Multiple Sclerosis
Käyttöaiheet:
Zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Tuoteyhteenveto:
Revision: 8
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2016-07-01
Pakkausseloste
36
B. PACKAGE LEAFLET
Medicinal product no longer authorised
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINBRYTA 150 MG
solution for injection in pre-filled syringe
ZINBRYTA 150 MG
solution for injection in pre-filled pen
DACLIZUMAB BETA
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
IN ADDITION TO THIS LEAFLET YOU WILL BE GIVEN A PATIENT CARD BY YOUR
DOCTOR. THIS HAS IMPORTANT
SAFETY INFORMATION THAT YOU NEED TO KNOW BEFORE AND DURING TREATMENT
WITH ZINBRYTA.
•
Keep this leaflet and the Patient Card. You may need to read them
again. Keep the leaflet and
Card with you during treatment and for 6 months after the last dose of
Zinbryta, since side
effects may occur even after you have stopped treatment.
•
If you have any further questions, ask your doctor.
•
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zinbryta is and what it is used for
2.
What you need to know before you use Zinbryta
3.
How to use Zinbryta
4.
Possible side effects
5.
How to store Zinbryta
6.
Contents of the pack and other information
7.
Instructions for injecting Zinbryta
1.
WHAT ZINBRYTA IS AND WHAT IT IS USED FOR
The active substance in Zinbryta is daclizumab beta. This is a type of
medicine called a monoclonal
antibody.
WHAT ZINBRYTA IS USED FOR
Zinbryta is used to treat relapsing forms of multiple sclerosis (MS)
in adults who have failed to
respond despite therapy with at least two MS treatment and who cannot
be given other treatments.
In MS, the body’s immune system
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Zinbryta 150 mg solution for injection in pre-filled syringe
Zinbryta 150 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL
solution for injection.
Each pre-filled pen contains a pre-filled syringe, containing 150 mg
of daclizumab beta in
1 mL solution for injection.
Daclizumab beta is produced in a mammalian cell line (NS0) by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Colourless to slightly yellow, clear to slightly opalescent liquid
with pH 6.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zinbryta is indicated for the treatment of adult patients with
relapsing forms of multiple sclerosis
(RMS) who have had an inadequate response to at least two disease
modifying therapies (DMTs) and
for whom treatment with any other DMT is contraindicated or otherwise
unsuitable (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the
management of multiple sclerosis.
Posology
The recommended dose of Zinbryta is 150 mg injected subcutaneously
once a month.
In case a dose is missed and it is within 2 weeks of the missed dose,
patients should be instructed to
inject without delay their missed dose and then remain on their
original monthly dosing schedule.
If a dose is missed and it is more than 2 weeks from the missed dose,
patients should skip the missed
dose, wait until their next scheduled dose, and then remain on their
original monthly dosing schedule.
Only one dose should be administered a
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