Avonex
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-09-2023
Charakterystyka produktu
(SPC)
18-09-2023
Sprawozdanie z oceny publicznego
(PAR)
19-12-2019
Składnik aktywny:
interferon beta-1a
Dostępny od:
Biogen Netherlands B.V.
Kod ATC:
L03AB07
INN (International Nazwa):
interferon beta-1a
Grupa terapeutyczna:
Immunostimulants,
Dziedzina terapeutyczna:
Multiple Sclerosis
Wskazania:
Avonex is indicated for the treatment of:patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; Avonex slows the progression of disability and decreases the frequency of relapses;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 MS.Avonex should be discontinued in patients who develop progressive MS.
Podsumowanie produktu:
Revision: 37
Status autoryzacji:
Authorised
Data autoryzacji:
1997-03-13
Ulotka dla pacjenta
36
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION
AVONEX 30 micrograms/0.5 ml solution for injection
Interferon beta-1a
IM
2.
METHOD OF ADMINISTRATION
See package leaflet.
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
0.5 ml
6.
OTHER
37
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON
1.
NAME OF THE MEDICINAL PRODUCT
AVONEX 30 micrograms/0.5ml solution for injection in pre-filled pen
Interferon beta-1a
2.
STATEMENT OF ACTIVE SUBSTANCE (S)
Each pre
-
filled pen of 0.5 ml contains 30 micrograms (6 million IU) of
interferon beta
-
1a.
3.
LIST OF EXCIPIENTS
Sodium acetate trihydrate, acetic acid glacial, arginine
hydrochloride, polysorbate 20, water for
injections.
4.
PHARMACEUTICAL FORM AND CONTENTS
Solution for injection in pre-filled pen
4 pre-filled pens. Each single pack contains 1 Avonex pen, injection
needle and pen cover.
12 pre-filled pens. Each single pack contains 1 Avonex pen, injection
needle and pen cover.
5.
METHOD AND ROUTE (S) OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before use.
For single use only.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.
OTHER SPECIAL WARNING (S), IF NECESSARY
38
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator.
Do not freeze.
The Avonex pen can be stored at room temperature (between 15°C -
30°C) for up to one week.
Sensitivity to light. Store the Avonex pen in the original package to
protect from light.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
12.
MARKETING AUTHORISATION NUMBER (S)
EU/1/97/033/005 4 pack
EU/1/97/033/006 12 pack
13.
BATCH NUMBER
Lot
14.
GENERAL CLASSIFIC
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AVONEX 30 micrograms/0.5 ml solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml pre-filled syringe 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 contain 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 in adults for the treatment of
•
Patients diagnosed with relapsing multiple sclerosis (MS). In clinical
trials, this was
characterised by two or more acute exacerbations (relapses) in the
previous three-years without
evidence of continuous progression between relapses; AVONEX slows the
progression of
disability and decreases the frequency of relapses.
•
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).
AVONEX should be discontinued in patients who develop progressive MS.
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 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 ca
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