AVONEX SOLUTION FOR INJECTION

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

INTERFERON BETA 1A

Fáanlegur frá:

MEDISON PHARMA LTD

ATC númer:

L03AB07

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

INTERFERON BETA 1A 30 MCG / 0.5 ML

Stjórnsýsluleið:

I.M

Gerð lyfseðils:

Required

Framleitt af:

BIOGEN IDEC LTD, UK

Meðferðarhópur:

INTERFERON BETA-1A

Lækningarsvæði:

INTERFERON BETA-1A

Ábendingar:

Treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and to decrease the frequency of clinical exacerbations. 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 diagnosis have been excluded, including the prescence of MRI abnormalities characteristic of MS and if they are determined to be at high risk of developing clinically definite multiple sclerosis. Safety and efficacy in patients with chronic progressive multiple sclerosis has not been evaluated.

Leyfisdagur:

2017-11-30

Upplýsingar fylgiseðill

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a physician’s prescription only
.
AVONEX SOLUTION FOR INJECTION
SOLUTION FOR INJECTION IN A PRE-FILLED PEN/PRE-FILLED SYRINGE
COMPOSITION:
Each 0.5 ml syringe/ pen contains interferon beta-1a 30 µg
* See inactive ingredients in section 6 (“Additional information”)
in this leaflet
READ THIS PACKAGE INSERT IN ITS ENTIRETY BEFORE USING THIS MEDICINE.
This leaflet includes
concise information about this medicine. If you have additional
questions, please consult
your doctor or pharmacist. This medicine was prescribed for the
treatment of your ailment.
Do not pass it to others as it may harm them even if they seem to have
a similar disease.
AVONEX SOLUTION FOR INJECTION is not intended for use in children and
adolescents under the
age of 16.
1. INTRODUCTION:
The active ingredient in AVONEX SOLUTION FOR INJECTION is a protein
called interferon beta 1a.
Interferons are substances that are naturally produced by the human
body to protect it from
infections and diseases. The protein in AVONEX SOLUTION FOR INJECTION
is made from the
same ingredients as interferon beta-1a found in the human body.
WHAT IS AVONEX SOLUTION FOR INJECTION USED FOR?
AVONEX SOLUTION FOR INJECTION is used to treat symptoms of relapsing
multiple sclerosis.
AVONEX SOLUTION FOR INJECTION can help reduce the occurrence of
relapses and slow down
the disabling effects of the disease.
This medicine works best when injected regularly at the same time,
once a week. Do not
stop treatment with AVONEX SOLUTION FOR INJECTION without first
consulting your neurologist.
THERAPEUTIC GROUP: interferons.
2. BEFORE YOU USE THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:
• You are sensitive (allergic) to interferon beta or to any of the
other ingredients in AVONEX
SOLUTION FOR INJECTION (SEE SECTION 6, ‘ADDITIONAL INFORMATION’)
• You have severe depression or suicidal thoughts.
SPECIAL WARNINGS CONCERNING USE OF THIS MEDICINE:
CONSULT YOUR DOCT

Vara einkenni

1
1.
NAME OF THE MEDICINAL
PRODUCT
AVONEX 30 micrograms/0.5 ml solution for injection. in pre-filled
syringe/pen.
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each 0.5 ml single use pre-filled syringe/pen contains 30 micrograms
(6 million IU) of interferon
beta-1a.
The concentration is 30 micrograms per 0.5
ml.
Using the World Health Organisation (WHO) International Standard for
Interferon, 30
micrograms of AVONEX contains 6 million IU of antiviral activity. The
activity against other
standards is not known.
Excipient(s) with known effect
For -the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Solution for
injection.
Clear and colourless
solution.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Avonex is indicated for the treatment of relapsing forms of multiple
sclerosis to slow the
accumulation of physical disability and to decrease the frequency of
clinical exacerbations.
Avonex is also indicated for the 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 diagnosis
have been excluded, including
the prescence of MRI abnormalities characteristic of MS and if they
are determined to be at high
risk of developing clinically definite multiple sclerosis. Safety and
efficacy in patients with
chronic progressive multiple sclerosis has not been evaluated.
4.2
POSOLOGY AND METHOD OF
ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the treatment
of
the disease.
Posology
_Adults: _The recommended dosage for the treatment of relapsing MS is
30 micrograms (0.5
ml
solution), administered by intramuscular (IM) injection once a week
(see section 6.6). No
2
additional
benefit has been shown by administering a higher dose (60 micrograms)
once a
week.
_Titration: _To help patients reduce the incidence and severity of
flu-like symptoms (see
section
4.8),
titration can be performed at the initiation of treatment. Titration