ALPROLIX powder and solvent for solution for injection
- Name:
ALPROLIX powder and solvent for solution for injection
- Company:
Swedish Orphan Biovitrum Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/03/19
(Click to Download)Click on this link to Download PDF directly
Swedish Orphan Biovitrum Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name ALPROLIX powder and solvent for solution for injection | Active Ingredients Eftrenonacog Alfa |
| Medicine Name ELOCTA powder and solvent for solution for injection | Active Ingredients efmoroctocog alfa |
| Medicine Name Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe | Active Ingredients Anakinra |
| Medicine Name Orfadin 2mg, 5mg, 10mg and 20mg Capsules | Active Ingredients Nitisinone |
| Medicine Name Orfadin 4mg/ml Oral Suspension | Active Ingredients Nitisinone |
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 28 March 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 28 March 2019 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update the sections 4.8 and 5.1 with data from the extension study BYOND.
Updated on 24 July 2018 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 13 July 2018 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC Changes:
4.4 Special warnings and precautions for use
Hypersensitivity
Allergic type hypersensitivity reactions are possible have been reported with ALPROLIX.
4.8 Undesirable effects
Post Marketing Experience
In post-marketing experience, FIX inhibitor development and hypersensitivity (including anaphylaxis) have been observed.
10. DATE OF REVISION OF THE TEXT
23/06/2017 06/07/2018
Updated on 6 July 2017 SmPC
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
4. Clinical particulars
4.2 Posology and method of administration
Inserted (additional text highlighted in bold): 100 IU/kg once every 10 days, adjust interval based on individual response. Some patients who are well-controlled on a once every 10 days regimen might be treated on an interval of 14 days or longer.
4.8 Undesirable effects
Inserted: Post Marketing Experience: In post-marketing experience, FIX inhibitor development and hypersensitivity have been observed.
10. DATE OF REVISION OF THE TEXT
Deleted: 30th Sept 2016
Inserted: 23rd June 2017
Updated on 6 July 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 3 July 2017 PIL
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 3 July 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 25 October 2016 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Summary of Product Characteristics changes:
7. MARKETING AUTHORISATION HOLDER
Biogen removed as MAH & Swedish Orphan Biovitrum inserted.
10. DATE OF REVISION OF THE TEXT
Revision of text updated from 12th May 2016 to 30th September 2016.
Updated on 17 October 2016 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
- Change to marketing authorisation holder
Updated on 11 July 2016 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 July 2016 PIL
Reasons for updating
- New PIL for new product