PLEGRIDY 125

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PEGINTERFERON BETA 1A

Available from:

MEDISON PHARMA LTD

ATC code:

L03AB13

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PEGINTERFERON BETA 1A 125 MCG / 0.5 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

BIOGEN IDEC LTD, UK

Therapeutic area:

PEGINTERFERON BETA-1A

Therapeutic indications:

Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis

Authorization date:

2020-11-30

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) 1986
This medicine is to be supplied by physician’s prescription only
PLEGRIDY 63 MCG
PLEGRIDY 94 MCG
PLEGRIDY 125 MCG
SOLUTION IN A PRE-FILLED PEN
COMPOSITION:
Each pen of PLEGRIDY 63 contains peginterferon beta-1a 63 µg
Each pen of PLEGRIDY 94 contains peginterferon beta-1a 94 µg
Each pen of PLEGRIDY 125 contains peginterferon beta-1a 125 µg
Inactive ingredients and allergens in this medicine: see section 2
under
‘Important information about
some of this medicine’s ingredients’, and section 6 ‘Additional
information’
.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
essential information about this medicine. If you have any further
questions, refer to the physician or
the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar.
This medicine is intended for the treatment of adults aged 18 or over.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
PLEGRIDY is intended for the treatment of symptoms of
relapsing-remitting multiple sclerosis.
THERAPEUTIC GROUP: Interferons.
Multiple sclerosis (MS) is a chronic illness that affects the central
nervous system (CNS), including
the brain and spinal cord. In this illness the body
’
s immune system 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. In
relapsing-remitting MS there
are periods when the disease is not active (remission) in between
flare-ups of symptoms (relapses).
The disease can be manifested in various forms in different patients.
The symptoms of multiple
sclerosis include:
•
Feeling off-balance or light headed, walking problems, stiffness and
muscle spasms, tiredness,
numbness in the face, arms or legs
•
Acute or chronic pain, bladder and bowel problems, sexual prob

Summary of Product characteristics

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Plegridy 63 micrograms solution for injection in pre -filled pen or
syringe.
Plegridy 94 micrograms solution for injection in pre -filled pen or
syringe.
Plegridy 125 micrograms solution for injection in pre filled pen or
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 63 microgram pre -filled pen or syringe contains 63 micrograms of
peginterferon beta -1a* in 0.5 mL
solution for injection.
Each 94 microgram pre -filled pen or syringe contains 94 micrograms of
peginterferon beta -1a* in 0.5 mL
solution for injection.
Each 125 microgram pre filled pen or syringe 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 substance, peginterferon beta-1a, is a covalent conjugate
of interferon beta-1a, produced in
Chinese Hamster Ovary cells, with 20,000 Dalton (20 kDa) methoxy
poly(ethyleneglycol) using an
O-2-methylpropionaldehyde linker.
The potency of this medicinal product should not be compared to the
one of another pegylated or
non-pegylated protein of the same therapeutic class. For more
information see section 5.1.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless solution with pH 4.5-5.1.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plegridy is indicated in adult patients for the treatment of relapsing
remitting multiple sclerosis (see section
5.1)._ _
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the treatment of multiple
sclerosis.
Efficacy of Plegridy has been demonstrated over placebo. Direct
comparative data for Plegridy
versus non-pegylated interferon beta or data on efficacy of Plegridy
after switching from a non-
pegylated interferon beta are not available. This should be considered
w