BETAFERON

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

INTERFERON BETA 1B

זמין מ:

BAYER ISRAEL LTD

קוד ATC:

L03AB08

טופס פרצבטיות:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

הרכב:

INTERFERON BETA 1B 0.3 MG/VIAL

מסלול נתינה (של תרופות):

S.C

סוג מרשם:

Required

תוצרת:

BAYER AG, GERMANY

קבוצה תרפויטית:

INTERFERON BETA-1B

איזור תרפויטי:

INTERFERON BETA-1B

סממני תרפויטית:

Use in ambulatory patients with relapsing-remitting multiple sclerosis (RRMS) and relapsing progressive M.S. to reduce the frequency of clinical exacerbations. Treatment of secondary progressive (SP) form of multiple sclerosis. Treatment of patients who have experienced 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, including the prescence of MRI abnormalities characteristic of M.S. and if they are determined to be at high risk of developing clinically definite multiple sclerosis.

תאריך אישור:

2020-12-31

עלון מידע

FILE NAME
Betaferon-ENG-D23-F.docx
PRODUCT
Betaferon
JOB NO.
SO23000468
LANGUAGE
English
ARTWORK
Patient Leaflet
DOCUMENT HISTORY
VER.
DATE
CHANGE DESCRIPTION
BY
27-Jun-23 11:22
Last save
_OUR EXPERTISE. YOUR SUCCESS._
2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
–
1986
This medicine is dispensed with a doctor's prescription only
BETAFERON
POWDER AND SOLVENT FOR SOLUTION FOR SUBCUTANEOUS INJECTION
ACTIVE INGREDIENT AND QUANTITY:
interferon beta-1b 0.3 mg/vial
After reconstitution, 1 ml contains 250 micrograms (8.0 million
international units) interferon beta-
1b.
Inactive ingredients and allergens
–
see section 2 ‘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
concise information about this medicine. If you have any further
questions, consult your doctor or
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 medical condition is similar
to yours.
ESSENTIAL INFORMATION ABOUT THE MEDICINE
This section presents a summary of the most essential information from
the leaflet about
treatment with Betaferon.
•
Before injection, prepare the Betaferon solution by using the vial
that contains Betaferon
powder and the pre-filled syringe that contains a solvent. This will
be prepared by your doctor
or nurse, or by you after you have received appropriate training.
•
Detailed instructions regarding preparation of the Betaferon solution
and self-injection under
the skin are provided in the Annex “Self
-injection instructions
.”
•
Routinely change the site of injection.
See section 2 ‘Special warnings
about using this
medicine’ and follow the instructions in the Annex, in part II
‘Rotating injection sites’.
1)
WHAT IS THIS MEDICINE INTENDED FOR?
•
For treatment of ambulatory patients suffering from multiple sclerosis

מאפייני מוצר

1.
NAME OF THE MEDICINAL PRODUCT
BETAFERON

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

Use in ambulatory patients with relapsing-remitting multiple sclerosis
(RRMS) and
relapsing progressive M.S. to reduce the frequency of clinical
exacerbations.

Treatment of secondary progressive (SP) form of multiple sclerosis.

Treatment of patients who have experienced 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, including
the presence of MRI abnormalities characteristic of M.S. and if they
are determined to
be at high risk of developing clinically definite multiple sclerosis.
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. Therefore Betaferon should not be u