BETAFERON interferon beta-1b rbe 0.25mg (8 million IU) powder for injection vial with diluent syringe

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

Interferon beta-1b, Quantity: 0.25 mg/mL

Prieinama:

Bayer Australia Ltd

Vaisto forma:

Injection, powder for

Sudėtis:

Excipient Ingredients: Albumin; mannitol

Vartojimo būdas:

Subcutaneous

Vienetai pakuotėje:

15 x 0.25mg powder for injection vials with 1.2mL diluent syringes

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Betaferon is indicated for the treatment of: - Ambulatory patients with relapsing-remitting multiple sclerosis (MS) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery. - Betaferon is also indicated for the reduction of frequency and severity of clinical relapses, and for the slowing of progression of disease in patients with secondary progressive multiple sclerosis. - The treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (MRI) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

Produkto santrauka:

Visual Identification: WHITE TO OFF WHITE CAKE OR POWDER.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizacija statusas:

Licence status A

Leidimo data:

2002-08-09

Pakuotės lapelis

BETAFERON
®
Single Use Pack CMI vx1.0
1
BETAFERON

(BEE·TA·FEER·ON)
_interferon beta-1b (rbe)_
CONSUMER MEDICINE INFORMATION_ _
_ _
CONTENTS:
What is in this leaflet ……….
1
What Betaferon is used for ….
1
Before you use Betaferon …...
2
How Betaferon is
given/used …………………..
3
While you are using
Betaferon …………………...
7
Side effects …………………
7
After Using Betaferon ………
8
Product Description …………
9
Further information …………
9
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Betaferon.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Betaferon
against the benefits it will have for
you.
If you have any concerns about
taking this medicine, ask your
doctor, nurse or pharmacist.
Keep this leaflet with your
medicine. You may need to read it
again.
WHAT BETAFERON IS
USED FOR
Betaferon belongs to a class of
medicines known as interferons.
Interferons are naturally occurring
proteins, produced by the body that
help fight against attacks on the
immune system such as viral
infections.
The active substance of Betaferon is
interferon beta-1b, a recombinant
human interferon beta produced
from a strain of
_Escherichia coli_
.
_HOW IT WORKS _
Multiple sclerosis (MS) is a long
term condition that affects the
central nervous system (CNS) i.e.
brain and spinal cord. The exact
cause of MS 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.
Betaferon has been shown to change
the response of the immune system
and to help reduce disease activity.
Single clinical event indicating high
risk of developing MS: Betaferon is
for use in patients who for the first
time have experienced symptoms
which indicate a high risk for
development of multiple sclerosis.
Your doctor will rule out any other
reasons which

Prekės savybės

BETAFERON PI V3.0; CCDS V15
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
BETAFERON
® (INTERFERON BETA-1B) POWDER FOR INJECTION VIAL WITH DILUENT SYRINGE
1
NAME OF THE MEDICINE
BETAFERON is interferon beta-1b (rbe), 8 million IU (0.25 mg).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of the reconstituted solution for injection contains 8 million IU
(0.25 mg) of interferon
beta-1b. 1 mL of solution for injection contains 5.4 mg sodium
chloride.
Interferon beta-1b is a purified, sterile lyophilised protein that has
165 amino acids and an
approximate
molecular
weight
of
18,500
daltons.
It
is
produced
by
recombinant
DNA
techniques from a strain of _ Escherichia coli_ that bears a
genetically engineered plasmid
containing a modified human interferon beta gene.
Interferon beta-1b differs structurally from natural human interferon
beta by the presence of
serine instead of cysteine in position 17, lack of methionine in
position 1 and absence of
carbohydrate moieties.
BETAFERON contains mannitol. For the full list of excipients, see
LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
BETAFERON is presented as a sterile lyophilised white to off-white
cake or powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
BETAFERON is indicated for
•
the treatment of patients with a single clinical event suggestive of
multiple sclerosis
and
at
least
two
clinically
silent
magnetic
resonance
imaging
(MRI)
lesions
characteristic of multiple sclerosis, if alternative diagnoses have
been excluded,
•
the treatment of ambulatory patients with relapsing-remitting multiple
sclerosis (MS)
characterised by at least two attacks of neurologic dysfunction over a
two year period
followed by complete or incomplete recovery,
•
the reduction of frequency and severity of clinical relapses, and for
the slowing of
progression of disease in patients with secondary progressive multiple
sclerosis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
G
ENERAL
Treatment with interferon beta-1b should be initiated under the
supervision of a
physician experienced in the