AVONEX 30 micrograms/0.5ml solution for injection, in pre-filled pen
- Name:
AVONEX 30 micrograms/0.5ml solution for injection, in pre-filled pen
- Company:
Biogen Idec Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/09/19
(Click to Download)XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1 What AVONEX is and what it is used for
1 What AVONEX is and what it is used for
2. What you need to know before you use AVONEX
2. What you need to know before you use AVONEX
3. How to use AVONEX PEN
3. How to use AVONEX PEN
4. Possible side effects
4. Possible side effects
5. How to store AVONEX PEN
5. How to store AVONEX PEN
6. Contents of the pack and other information
6. Contents of the pack and other information
7. How to inject AVONEX PEN
7. How to inject AVONEX PEN
Click on this link to Download PDF directly
Biogen Idec Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name AVONEX 30 micrograms/0.5 ml solution for injection | Active Ingredients Interferon beta-1a |
| Medicine Name AVONEX 30 micrograms/0.5ml solution for injection, in pre-filled pen | Active Ingredients Interferon beta-1a |
| Medicine Name Fampyra 10 mg prolonged-release tablets | Active Ingredients Fampridine |
| Medicine Name Plegridy 63 mcg, 94 mcg and 125mcg solution for injection in pre-filled pen | Active Ingredients peginterferon beta-1a |
| Medicine Name Spinraza 12 mg solution for injection | Active Ingredients Nusinersen sodium |
| Medicine Name Tecfidera 120mg and 240mg gastro-resistant hard capsules | Active Ingredients Dimethyl fumarate |
| Medicine Name Tysabri 300mg concentrate for solution for infusion | Active Ingredients Natalizumab |
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 20 September 2019
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.3: Removal of contraindication related to pregnancy
Section 4.4: Inclusion of statement regarding batch traceability
Section 4.6: Updated guidance on pregnancy and breastfeeding following closure of INF pregnancy registry.
Updated on 20 September 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Removal of contraindication related to pregnancy, Inclusion of statement regarding batch traceability, Updated guidance on pregnancy and breastfeeding.
Updated on 8 April 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 8 April 2019
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
MAH transfer to Biogen Netherlands B.V.
Updated on 26 June 2017
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2017 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 14 June 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 14 June 2017 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 7 March 2016 PIL
Reasons for updating
- Change to date of revision
Updated on 6 January 2016 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Other minor editorial changes are included.
Updated on 5 January 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 6 November 2014 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 17 September 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 16 September 2014 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In Section 4.4, information has been added on the occurrence of thrombotic microangiopathy in multiple sclerosis patients treated with interferon beta products, including diagnosis of the condition and subsequent patient management
- In Section 4.8, thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome has been added as a rare adverse reaction (class label for interferon beta products)
- In Section 4.8, the contact details for the Irish Regulatory Agency have been updated, following their change of name from IMB to HPRA
- In Section 10, the date of revision of the text has been changed to August 2014
Updated on 9 June 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 9 June 2014 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.4 (Special warnings and precautions for use), the following text has been added:
Nephrotic Syndrome: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products. Events were reported at various time points during treatment and may occur after several years of treatment with interferon-beta. Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease. Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Avonex should be considered.
In Section 4.6 (Fertility, pregnancy and lactation), the following text has been added:
Fertility
Fertility and developmental studies in rhesus monkeys have been carried out with a related form of interferon beta 1a. At very high doses, anovulatory and abortifacient effects in test animals were observed (see section 5.3).
No information is available on the effects of interferon beta 1a on male fertility.
In Section 4.8 (Undesirable effects), nephrotic syndrome and glomerulosclerosis have been added as renal and urinary disorders reported rarely, and the following text has been added:
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
In Section 6.3, the shelf life has been increased from 2 years to 3 years.
Updated on 14 August 2013 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 10 January 2013 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 10 August 2012 SPC
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 10 (Date of Revision of Text)- the date has been updated.
Updated on 6 August 2012 PIL
Reasons for updating
- Change to date of revision
Updated on 4 November 2011 PIL
Reasons for updating
- Change to date of revision
- Change of distributor details
Updated on 4 November 2011 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 (Undesirable Effects)- Information on titration reducing the incidence and severity of flu-like symptoms has been included.
In section 10: (Date of Revision of Text)- Date amended.
Updated on 1 July 2011 PIL
Reasons for updating
- New PIL for new product
Updated on 30 June 2011 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)