Betaferon

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Interferon beta-1b 0.25mg (20% excess in quantity filled)

Verfügbar ab:

Bayer New Zealand Limited

INN (Internationale Bezeichnung):

Interferon beta-1b 0.25 mg (20% excess in quantity filled)

Dosierung:

8 MIU

Darreichungsform:

Injection with diluent

Zusammensetzung:

Active: Interferon beta-1b 0.25mg (20% excess in quantity filled) Excipient: Albumin Hydrochloric acid Mannitol Sodium hydroxide Hydrochloric acid Sodium chloride Water for injection

Einheiten im Paket:

Combination pack, 1 (pwdr+diluent syringe+adapter+needle+wipes), 1 dose unit

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Boehringer Ingelheim RCV GmbH & Co KG

Anwendungsgebiete:

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 characterised by at least two attacks of neurological dysfunction over a two year period followed by complete or incomplete recovery. · the reduction of frequency and severity of clinical relapses and for slowing the progression of disease in patients with secondary progressive multiple sclerosis

Produktbesonderheiten:

Package - Contents - Shelf Life: Combination pack, 1 (pwdr+diluent syringe+adapter+needle+wipes) - 1 dose units - 24 months from date of manufacture stored at or below 30°C 3 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 15 (pwdr+diluent vial/syringe) - 15 dose units - 24 months from date of manufacture stored at or below 30°C 3 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, diluent - 1.2 mL - 36 months from date of manufacture stored at or below 30°C - Vial, powder - 0.3 mg - 24 months from date of manufacture stored at or below 30°C 3 hours reconstituted stored at or below 30°C - Vial, diluent - 1.2 mL - 36 months from date of manufacture stored at or below 25°C

Berechtigungsdatum:

1995-01-30

Gebrauchsinformation

BETAFERON
®
Single Use Pack CMI vx2.0
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

Fachinformation

BETAFERON DS VX3.0; CCDS V16
Page 1 of 2
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
BETAFERON® Interferon beta-1b 8 MIU Injection with diluent
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lyophilisate and solvent for solution for injection.
BETAFERON® Recombinant Interferon beta-1b 0.25 mg (8.0 million IU)
per mL when reconstituted.
1 mL of the reconstituted solution for injection contains 8 million IU
(0.25 mg) of interferon beta-1b.
1 mL solution for injection contains 5.4 mg sodium chloride.
Interferon beta-1b is produced in Escherichia coli cells by
recombinant DNA technology from a strain
of _Escherichia coli_ that bears a genetically engineered plasmid
containing a modified human interferon
beta gene.
BETAFERON contains mannitol. For the full list of Excipients, see
section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
BETAFERON is presented as a sterile lyophilised white to off-white
cake or powder and solvent for
solution for injection.
4
CLINICAL PARTICULARS
4.1
Therapeutic 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 neurological dysfunction over
a two year period
followed by complete or incomplete recovery.
•
the reduction of frequency and severity of clinical relapses and for
slowing the progression of
disease in patients with secondary progressive multiple sclerosis
4.2
Dose and method of administration
General
Treatment with BETAFERON should be initiated under the supervision of
a physician experienced in
the treatment of multiple sclerosis. There are follow-up data under
controlled clinical trial conditions
for patients with relapsing–remitting multiple sclerosis for up to 5
years and for patients with
secondary progressive mult