Updated on 03/11/2011 and displayed until Current
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.2 (Posology and Method of Administration)- An alternative titration strategy has been included. Further information on the manual titration device has been provided.
In section 4.8 (Undesirable Effects)- Information on titration on a reduction in incidence and severity of flu-like symptoms has been included
In section 10 (Date of Revision of Text)- Date amended.
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Updated on 18/05/2010 and displayed until 03/11/2011
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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change to paediatric information
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| Date of revision of text on the SPC: 01-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Previous Text
4.2 Posology and method of administration
Children and adolescents: 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 AVONEX 30 micrograms IM once per week is similar to that seen in adults.
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 AVONEX 30 micrograms IM once per week is similar to that seen in adults.
There is no information on the use of AVONEX in children under 12 years of age and therefore AVONEX should not be used in this population.
New Approved Text
4.2 Posology and method of administration
Paediatric population: The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established. Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established. Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
The safety and efficacy of AVONEX in children below 12 years of age have not yet been established.
No data are available.
4.8 Undesirable effects
Paediatric population: Limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
Limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paediatric population: Limited data of the efficacy/safety of AVONEX 15 micrograms IM once per week (n=8) as compared to no treatment (n=8) with follow up for 4 years showed results in line to those seen in adults, although the EDSS scores increased in the treated group over the 4 year follow-up thus indicating disease progression. No direct comparison with the dose currently recommended in adults is available.
Limited data of the efficacy/safety of AVONEX 15 micrograms IM once per week (n=8) as compared to no treatment (n=8) with follow up for 4 years showed results in line to those seen in adults, although the EDSS scores increased in the treated group over the 4 year follow-up thus indicating disease progression. No direct comparison with the dose currently recommended in adults is available.
10. DATE OF REVISION OF THE TEXT
03/2010
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
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Updated on 09/01/2009 and displayed until 18/05/2010
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Change to section 4.2 - Posology and method of administration
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 (posology and method of administration)
At the initiation of treatment, patients may either be started on a full dose of 30 micrograms (0.5 ml solution) or on approximately half the dose once a week to help them to adjust to treatment and thereafter increased to the full dose of 30 micrograms (0.5 ml solution). In order to obtain adequate efficacy, a dose of 30 micrograms (0.5 ml solution) once a week should be reached and maintained after the initial titration period. A manual titration device to enable delivery of approximately half the dose is available for patients initiating AVONEX treatment.
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Updated on 31/07/2008 and displayed until 09/01/2009
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Change to section 2 - Qualitative and quantitative composition
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 Qualitative And Quantitative Composition has been updated with the standard reference variation as follows;
Using the World Health Organisation (WHO) natural interferon beta standard, Second International Standard for Interferon, Human Fibroblast (Gb-23-902-531), 30 micrograms of AVONEX contains 6 million IU of antiviral activity. The activity against other standards is not known.
Section 7. Marketing Authorisation Holder address has been updated as follows
BIOGEN IDEC LIMITED
5 Roxborough Way Innovation House
Foundation Park 70 Norden Road
Maidenhead
Berkshire
SL6 4AY SL6 3UD
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Updated on 27/05/2008 and displayed until 31/07/2008
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3 Shelf life has been extended from 18 months to 2 years
Section 10 Date of revision of text is 04/2008
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Updated on 25/03/2008 and displayed until 27/05/2008
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Change to section 4.1 - Therapeutic indications
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 03/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Biogen Idec requested an update to therapeutic indication (section 4.1) and pharmacodynamic properties (section 5.1) to align them with the current medical practice, taking into account the McDonald criteria for the diagnosis of multiple sclerosis.
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Updated on 11/12/2007 and displayed until 25/03/2008
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Correction of spelling/typing errors
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Updated on 08/03/2007 and displayed until 11/12/2007
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Change to section 4.1 - Therapeutic indications
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Incusion of paediatric indication and 5 year renewal
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Updated on 13/09/2006 and displayed until 08/03/2007
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 Contraindication " pregnant patients" removed from being in the contraindications section
Section 4.4 Special warnings and Special Precautions for Use " or other mood disorders, conditions that are common with MS . Depression has been reported in association with Avonex use and it may occur at any time during treatment" removed from the section
“Patients with current severe depression and / or suicidal ideation” added to the above section
“ Epileptic patients with a history of seizures not adequately controlled by treatment” removed from the above section
“Patients with a history of hypersensitivity to natural or recombinant interferon - b or to any excipient “ added
"Caution should be exercised when administering AVONEX to patients with pre existing seizure disorder. For patients without a pre existing seizure disorder who develop seizures during therapy with AVONEX, an etiologic basis should be established and appropriate anti-convulsant therapy instituted prior to resuming AVONEX treatment" removed from the above section
Section 4.6 - Pregnancy and Lactation “Because of the potential hazards to the foetus, AVONEX is contraindicated in pregnancy. There are no studies of interferon beta 1a in pregnant women. At high doses, in rhesus monkeys, abortifacient effects were observed. It cannot be excluded that such side effects will be observed in humans" - removed
"Fertile women receiving AVONEX should take appropriate contraceptive measures. Patients planning for pregnancy and those becoming pregnant should be informed of the potential hazards and AVONEX should be discontinued" - removed
" Breast feeding " Changed to Lactation .
“Breast fed” - removed
“to discontinue” = removed
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Updated on 20/06/2006 and displayed until 13/09/2006
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 03/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of date of revision of the SPC to March 2006
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Updated on 03/10/2005 and displayed until 20/06/2006
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 03/10/2005 and displayed until 03/10/2005
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 01/10/2004 and displayed until 03/10/2005
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Change to section 4.8 - Undesirable Effects
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Updated on 29/09/2004 and displayed until 01/10/2004
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Addition of separate SPCs covering individual presentations
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Updated on 30/09/2004 and displayed until 29/09/2004
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Change to section 4.8 - Undesirable Effects
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Updated on 29/09/2004 and displayed until 30/09/2004
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 25/09/2003 and displayed until 29/09/2004
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Change to section 3 - pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 8 - MA number
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Updated on 04/04/2003 and displayed until 25/09/2003
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Transferred from eMC version 1
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Updated on 17/08/2001 and displayed until 04/04/2003
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Updated on 31/07/2001 and displayed until 17/08/2001
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Updated on 10/04/2001 and displayed until 31/07/2001
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Updated on 06/09/1999 and displayed until 10/04/2001
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