FEIBA 50 U/ml powder and solvent for solution for infusion *
Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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 16 December 2020
File name
ie-spc-feiba50u-ml-ib056-clean-2Dec2020_1608115737.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- 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
|
Section |
Changes (in red) |
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2. Qualitative and Quantitative Composition
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Excipients with known effect 500 U FEIBA contains approximately 1000 U FEIBA contains approximately 2500 U FEIBA contains approximately For |
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4.4.Special warnings and precautions for use |
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
500 U FEIBA contains approximately 40 mg sodium per vial, equivalent to 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 1000 U FEIBA contains approximately 80 mg sodium per vial, equivalent to 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 2500 U FEIBA contains approximately, 200 mg sodium per vial, equivalent to 10% of the WHO recommended maximum daily intake of 2 g sodium for an adult. |
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4.8 Reporting of side effects |
Updated |
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10 Date of revision of the text |
2nd December 2020 |
Updated on 16 December 2020
File name
ie-pl-feiba50u-ml-ib056-clean-Oct2020_1608115281.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 July 2019
File name
ie-spc-pa-2004-1-2-8Mar19_1562939555.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 9 corrected with the correct renewal date
Updated on 06 June 2019
File name
ie-spc-pa-2004-1-2-5Jun19_1559829848.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 6.5 (Nature and contents of container), new primary packaging material (container and closure Type II change) for 50 mL sWFI
Updated on 11 March 2019
File name
ie-pl-pa-2004-1-2-clean_1552067001.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 08 March 2019
File name
ie-spc-pa-2004-1-2-clean_1552067194.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.5, addition of isohemagglutinins and their possible interference with serological tests and to add the risk of thrombotic microangiopathy (TMA) with FEIBA used in patients receiving emicizumab prophylaxis in sections 4.4 and 4.5 of the SmPC. Plus minor editorial changes.
Updated on 09 August 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
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), add the sodium content for the 500 U presentation.
Updated on 09 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 August 2017
File name
PIL_16628_543.pdf
Reasons for updating
- New PIL for new product
Updated on 08 August 2017
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to other sources of information section
Updated on 16 November 2016
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 16 November 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 - sub-section Precautions - information on the elderly has been added.
In section 4.6 - information on parvovirus B19 has been added.
Throughout the SmPC updates have been made to align with the current QRD template, and mentions of "Sterilised Water for Injections" has been replaced with "Water for Injections".
Updated on 12 February 2016
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 February 2016
Reasons for updating
- New PIL for medicines.ie