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FEIBA 50 U/ml powder and solvent for solution for infusion *
Pharmacy Only: Prescription

Updated on 19 January 2022

File name

ie-pl-feiba50u-ml-BR name chg-clean-Dec2021_1642595538.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

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)

 

2. Qualitative and Quantitative Composition

 

Excipients with known effect

500 U

FEIBA contains approximately 1.80 mmol sodium 40 mg sodium per vial.

1000 U

FEIBA contains approximately 3.6 mmol sodium 80 mg sodium per vial.

2500 U

FEIBA contains approximately 8.9 mmol sodium 200 mg sodium per vial.

For a the full list of excipients, see section 6.1.

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.

It is strongly recommended that every time that FEIBA is administered to the patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

FEIBA 50 U/ml contains approximately 4 mg sodium (calculated) per ml; it is approx. 40 mg sodium for the presentation 500 U FEIBA, approx. 80 mg sodium for the presentation 1000 U FEIBA and approx. 200 mg sodium for the presentation 2500 U FEIBA.  This is to be taken into consideration in patients on a low sodium diet

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.

4.8 Reporting of side effects

Updated

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

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

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 2 (QUALITATIVE AND QUANTITATIVE COMPOSITION), add the additional presentation 500 U.
- In section 4.4 (Special warnings and precautions for use), add the sodium content for the 500 U presentation.

 

 

 

 

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 - 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

The main changes are to the following sections:

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 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 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

None provided

Updated on 12 February 2016

Reasons for updating

  • New PIL for medicines.ie