Betaferon

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

interferon beta-1b

Available from:

Bayer AG 

ATC code:

L03AB08

INN (International Name):

interferon beta-1b

Therapeutic group:

Immunostimulants,

Therapeutic area:

Multiple Sclerosis

Therapeutic indications:

Betaferon is indicated for the treatment ofpatients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

Product summary:

Revision: 36

Authorization status:

Authorised

Authorization date:

1995-11-30

Patient Information leaflet

41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAFERON 250 MICROGRAM/ML, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
interferon beta-1b
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 Betaferon is and what it is used for
2.
What you need to know before you use Betaferon
3.
How to use Betaferon
4.
Possible side effects
5.
How to store Betaferon
6.
Contents of the pack and other information
Annex – self injection procedure
1.
WHAT BETAFERON IS AND WHAT IT IS USED FOR
WHAT BETAFERON IS
Betaferon is a type of medicine known as interferon used to treat
multiple sclerosis. Interferons are
proteins produced by the body that help fight against attacks on the
immune system such as viral
infections.
HOW BETAFERON WORKS
MULTIPLE SCLEROSIS (MS)
is a long-term condition that affects the central nervous system
(CNS),
particularly the functioning of the brain and spinal cord. In MS,
inflammation destroys the protective
sheath (called
_myelin_
) around the nerves of the CNS and stops the nerves from working
properly. This
is called demyelination.
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.
THE DAMAGE TO THE CNS
can occur within an MS attack
_(relapse)_
. It can cause disability temporarily,
such as difficulty walking. Symptoms may disappear completely or
partly.
Interferon beta-1b has been shown to change the response of the immune
system and to help to reduce

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1._ _
NAME OF THE MEDICINAL PRODUCT
Betaferon 250 microgram/ml, powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Recombinant interferon beta-1b
*
250 microgram (8.0 million IU) per ml when reconstituted.
Betaferon contains 300 microgram (9.6 million IU) of recombinant
interferon beta-1b per vial.
For the full list of excipients, see section 6.1.
*
produced by genetic engineering from a strain of
_Escherichia coli_
.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Sterile white to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Betaferon is indicated for the treatment of
•
patients with a single demyelinating event with an active inflammatory
process, if it is severe
enough to warrant treatment with intravenous corticosteroids, if
alternative diagnoses have been
excluded, and if they are determined to be at high risk of developing
clinically definite multiple
sclerosis (see section 5.1).
•
patients with relapsing-remitting multiple sclerosis and two or more
relapses within the last two
years.
•
patients with secondary progressive multiple sclerosis with active
disease, evidenced by
relapses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment with Betaferon should be initiated under the supervision
of a physician experienced in
the treatment of the disease.
Posology
_ _
_Adults _
The recommended dose of Betaferon is 250 microgram (8.0 million IU),
contained in 1 ml of the
reconstituted solution (see section 6.6), to be injected
subcutaneously every other day.
_Paediatric population _
No formal clinical trials or pharmacokinetic studies have been
conducted in children or adolescents.
However, limited published data suggest that the safety profile in
adolescents from 12 to 16 years of
age receiving Betaferon 8.0 million IU subcutaneously every other day
is similar to that seen in adults.
There is no information on the use of Betaferon in children under 12
years of age. Therefo