BETAFERON INJECTION

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

interferon beta-1b

Διαθέσιμο από:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (Διεθνής Όνομα):

interferon beta-1b

Μονάδες σε πακέτο:

15units Units

Κατασκευάζεται από:

BAYER AG

Φύλλο οδηγιών χρήσης

Reference: CCPI Version 16 , D3 Betaferon-CCDS 16_clean_08 Feb23.doc
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Betaferon is used for
2.
How Betaferon works
3.
Before you use Betaferon
4.
How to use Betaferon
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Betaferon
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BETAFERON IS USED FOR
Betaferon is indicated for patients with
►
a single clinical event suggestive of
multiple
sclerosis
(MS)
(‘Clinically
Isolated Syndrome’)
►
relapsing forms of multiple sclerosis
(MS) and
►
secondary
progressive
multiple
sclerosis
(MS)
with
active
disease,
evidenced by relapses or pronounced
neurological deterioration within the
last two years.
In patients with a single clinical event
suggestive
of
multiple
sclerosis
(‘Clinically
Isolated
Syndrome’),
Betaferon
is
indicated
to
delay
progression to definite multiple sclerosis.
In relapsing-remitting multiple sclerosis
Betaferon is indicated for the reduction
of frequency and degree of severity of
clinical relapses in ambulatory patients
(i.e.
patients
who
are
able
to
walk
unaided), characterized by at least two
attacks of neurological dysfunction over
the preceding two year period, followed
by complete or incomplete recovery.
In
secondary
progressive
multiple
sclerosis Betaferon is indicated for the
reduction of frequency and severity of
clinical
relapses
and
for
slowing
the
progression of disease.
Usage of Betaferon Injection in children
and adolescents 12 years and above
HOW BETAFERON WORKS
Multiple sclerosis (MS) is a disease of
the central nervous system (CNS) (i.e.
brain and spinal cord) but its exact cause
is unknown. An abnormal response by
the body's immune system is thought to
play
an
important
part
in
the
process
which damages the CNS.
Interferon
beta-1b
has
been
shown
to
modify the immune system response.
BEFORE YOU USE
Betaferon
-
_When you must not use it _
_ _
BEFORE YOU USE BETAFERON
DO NOT USE BET

Αρχείο Π.Χ.Π.

Reference : Betaferon / Powder and solvent for solution for injection
/ aCCDS / Version 16 / 31 Jan2022
BETAFERON
®
250 microgram/ml
Powder and solvent for solution for injection 1.
NAME OF THE MEDICINAL PRODUCT
Betaferon 250 microgram/mL powder and solvent for solution for
Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with powder for solution for injection contains 300 microgram
recombinant Interferon beta-1b.
When reconstituted, 1 mL solution for injection contains 250 microgram
recombinant Interferon beta-1b.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
Betaferon is indicated for patients with
►
a single clinical event suggestive of multiple sclerosis (MS)
(‘Clinically Isolated Syndrome’)
►
relapsing forms of multiple sclerosis (MS) and
►
secondary progressive multiple sclerosis (MS) with active disease,
evidenced by relapses or pronounced neurological
deterioration within the last two years.
In patients with a single clinical event suggestive of multiple
sclerosis (‘Clinically Isolated Syndrome’), Betaferon is indicated
to delay progression to definite multiple sclerosis.
In relapsing-remitting multiple sclerosis Betaferon is indicated for
the reduction of frequency and degree of severity of
clinical relapses in ambulatory patients (i.e. patients who are able
to walk unaided), characterized by at least two attacks of
neurological dysfunction over the preceding two year period, followed
by complete or incomplete recovery.
In secondary progressive multiple sclerosis Betaferon is indicated for
the reduction of frequency and severity of clinical
relapses and for slowing the progression of disease.
Usage of Betaferon Injection in children and adolescents 12 years and
above.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
Method of administration: Subcutaneous injection
_ADULTS _
The treatment with Betaferon should be initiated under the supervision
of a physician experienced in the treatment of the
disease.
The recommended dos