Plegridy

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

peginterferon beta-1a

Διαθέσιμο από:

Biogen Netherlands B.V.

Φαρμακολογική κατηγορία (ATC):

L03AB13

INN (Διεθνής Όνομα):

peginterferon beta-1a

Θεραπευτική ομάδα:

Immunostimulants,

Θεραπευτική περιοχή:

Multiple Sclerosis

Θεραπευτικές ενδείξεις:

Treatment of relapsing remitting multiple sclerosis in adult patients.

Περίληψη προϊόντος:

Revision: 24

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-07-18

Φύλλο οδηγιών χρήσης

50
B. PACKAGE LEAFLET
51
PACKAGE LEAFLET: INFORMATION FOR THE USER
PLEGRIDY 63 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
PLEGRIDY 94 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
PLEGRIDY 125 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
peginterferon 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 PLEGRIDY IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PLEGRIDY
3.
HOW TO USE PLEGRIDY
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PLEGRIDY
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
7.
INSTRUCTIONS FOR INJECTING PLEGRIDY PRE-FILLED SYRINGE
1.
WHAT PLEGRIDY IS AND WHAT IT IS USED FOR
WHAT PLEGRIDY IS
The active substance in Plegridy is peginterferon beta-1a.
Peginterferon beta-1a is a modified
long-acting form of interferon. Interferons are natural substances
made in the body to help protect
from infections and diseases.
WHAT PLEGRIDY IS USED FOR
THIS MEDICINE IS USED TO TREAT RELAPSING-REMITTING MULTIPLE SCLEROSIS
(MS) IN ADULTS AGED 18 OR
OVER.
MS is a long term illness that affects the central nervous system
(CNS), including the brain and spinal
cord, in which the body’s immune system (its natural defences)
damages the protective layer (myelin)
that surrounds the nerves in the brain and spinal cord. This disrupts
the messages between the brain
and other parts of the body, causing the symptoms of MS. Patients with
relapsing-remitting MS have
periods when the disease is not active (remission) in between
flare-ups of symptom

Αρχείο Π.Χ.Π.

1_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Plegridy 63 micrograms solution for injection in pre-filled syringe
Plegridy 94 micrograms solution for injection in pre-filled syringe
Plegridy 125 micrograms solution for injection in pre-filled syringe
Plegridy 63 micrograms solution for injection in pre-filled pen
Plegridy 94 micrograms solution for injection in pre-filled pen
Plegridy 125 micrograms solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plegridy 63 micrograms solution for injection in pre-filled syringe
(for subcutaneous use)
Each pre-filled syringe contains 63 micrograms of peginterferon
beta-1a* in 0.5 mL solution for
injection.
Plegridy 94 micrograms solution for injection in pre-filled syringe
(for subcutaneous use)
Each pre-filled syringe contains 94
micrograms of peginterferon beta-1a* in 0.5 mL solution for
injection.
Plegridy 125 micrograms solution for injection in pre-filled syringe
(for subcutaneous use)
Each pre-filled syringe contains 125 micrograms of peginterferon
beta-1a* in 0.5 mL solution for
injection.
Plegridy 125 micrograms solution for injection in pre-filled syringe
(for intramuscular use)
Each pre-filled syringe contains 125 micrograms of peginterferon
beta-1a* in 0.5 mL solution for
injection.
Plegridy 63 micrograms solution for injection in pre-filled pen (for
subcutaneous use)
Each pre-filled pen contains 63 micrograms of peginterferon beta-1a*
in 0.5 mL solution for injection.
Plegridy 94 micrograms solution for injection in pre-filled pen (for
subcutaneous use)
Each pre-filled pen contains 94 micrograms of peginterferon beta-1a*
in 0.5 mL solution for injection.
Plegridy 125 micrograms solution for injection in pre-filled pen (for
subcutaneous use)Each pre-filled
pen contains 125 micrograms of peginterferon beta-1a* in 0.5 mL
solution for injection.
The dose indicates the quantity of the interferon beta-1a moiety of
peginterferon beta-1a without
consideration of the PEG moiety attached.
*The active sub