BeneFIX

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 23 October 2020

File name

DEC202070893_Adv SPC BF 17_0 IE clean_1603452593.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 23 October 2020

File name

DEC202070893_Adv PIL BF 15_0 IE clean_1603452442.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 25 September 2020

File name

Adv SPC BF 16_0 IE clean_1601023009.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 25 September 2020

File name

Adv PIL BF 14_0 IE clean_1601022950.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 12 December 2018

File name

Adv PIL BF 13_0 UK_IE-clean_1544623112.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 December 2018

File name

Adv SPC BF 15_0 UK_IE-clean_1544623249.pdf

Reasons for updating

  • 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 SPC has been updated as follows: Revision date only.  NO content change

Updated on 10 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 10 July 2017

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

·         The SPC has been updated as follows:Impacts section 5.1 (Pharmacodynamic properties) of the EU SPC.  ATC Code change from B02BD09 to B02BD04

Updated on 05 July 2017

File name

PIL_12768_675.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 July 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 29 March 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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 following changes to the labelling have been approved.  Please refer to attached copy/copies of labelling documentation for full details.

The SPC has been updated as follows:

Sections 1, 2, 3, 6.5, 8 and 10

The PIL has been updated to reflect the SPC changes. See PIL tick list for sections updated.

 

The PI is not affected: The new strength is not launched.  The PI will be updated upon launch.

The packaging (label/carton) has been updated: Please note at this time Pfizer Above Country Regulatory Affairs are still in dialogue with the EMA mock-ups and specimens group to agree the colour for the carton and vial label.  Some of the existing BeneFIX EU packaging components are impacted by the review of the 1500 IU mock-ups.  Details will follow from ALIM.

Updated on 27 March 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Introduction of new strength

Updated on 18 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 23 June 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

The changes concern a re-wording only to consolidate the CP Annexes in to one SPC for all presentations. 

Our local SPC Content has not changed  except for addition of Malta ADR reporting details in section 4.8.

Our local SPC sections 1, 2, 3 and 6.5 have been re-worded to align exactly with the Annex and the addition of Maltese ADR reporting details in section 4.8.

Updated on 21 June 2016

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 19 November 2015

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

The following wording has been added to SmPC section 5.1, section 5.2 has also been updated.
“In two open-label studies BeneFIX was found to be safely administered at 100 IU/kg once weekly. However, the half-life of the product (see section 5.2) and the limited pharmacokinetic study data for the once weekly regimen do not allow recommending this regimen in general for long term prophylaxis in severe haemophilia B patients.”

Other changes are editorial: PK written in full as Pharmacokinetic in Table 2 and withdrawal of the change from “ml” to “mL” in Annexes IIIA and IIIB

Updated on 03 September 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Updates to Sections: 4.1, 4.2, 4.4, 4,5, 4.7, 4.8, 4.9.

Updated on 01 September 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 03 February 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2. Posology and method of administration, Paediatric  population – mean dosage for prophylaxis corrected to 3-7 days, from 3-74 days.

Other minor grammar/punctuation updates to align with current approved EMA Annex.

Updated on 23 December 2013

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

change to version number

Updated on 06 December 2013

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Update to Section 6.6

Updated on 30 October 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Update to section 4.8

Updated on 23 October 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 24 July 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 08 May 2013

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

remove the following wording from sections 4.2 and 5.1 of the BeneFIX SmPC:

"There are insufficient data to recommend the use of BeneFIX in children less than 6 years of age."

Additional wording was included in Sections 4.2, 4.8, 5.1 and 5.2.



Updated on 03 May 2013

Reasons for updating

  • Change to date of revision

Updated on 01 May 2013

Reasons for updating

  • Improved electronic presentation

Updated on 29 October 2012

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Section 9 – update to date of renewal 

Updated on 03 October 2012

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • 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 8 - MA number
  • Introduction of new strength

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

Free text change information supplied by the pharmaceutical company

Section 1 – Name of the medicinal product updated to add new strength.

Section 2 – Qualitative and Quantitative Composition updated to add new strength.

Section 3 – Pharmaceutical form : Addition of, “ Powder and solvent for solution for injection”.

Section 4.2 -  Posology and method of administration : Updated with sub-sections for ease of readability.

 Section 4.4 – Special warnings and precautions for use: Updated with sub-sections for the ease of readability.

Section 4.6 – Fertility, pregnancy and lactation: New statement added, “ The effect of BeneFIX on fertility has not been established”.

Section 4.7 - Effects on ability to drive and use machines: new statement added, “On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions BeneFIX has no or negligible influence on the ability to drive or use machines”.

 

Section 4.8 – Undesirable Effects: Summary of safety profile updated. No new side effects added.

Section 6.3 – Shelf life: Section updated to specify that the product does not contain a preservative.

Section 6.4 – Special precautions for storage: Updated to read, “Store below 30°C. Do not freeze”.

Section 6.5 – Nature and content of container: Updated with new strength.

Section 6.6 - Special precautions for disposal and other handling: Section updated for ease of readability.

Section 8 – New MA number added for new strength.

Updated on 26 September 2012

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details
  • Introduction of new strength

Updated on 04 July 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7: Marketing authorisation holder

Updated on 30 June 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 26 April 2011

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3 Storage conditions: change the storage conditions from 2-8 oC to 2-30 oC and reduce the shelf life from 3 to 2 years

Updated on 21 April 2011

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 23 February 2011

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 17 September 2010

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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

EMEA/H/C/139/IB/091/G Change in Short Term Room Temperature Label Claim for the drug product and Changes to  Stability Studies for the Process Qualification and Supporting Post Approval Commitment of the Drug product

Updated on 10 September 2010

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 01 March 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to MA holder contact details

Updated on 01 March 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Section 4.2 - Administration by continuous infusion has not been approved and is not recommended (see also sections 4.4, 4.8 and 6.6).

Section 4.4 – Addition of: bronchospasm, laryngospasm, wheezing, hypotension, blurred vision, and anaphylaxis.

Section 4.4 – Addition of: The safety and efficacy of BeneFIX administration by continuous infusion have not been established (see also sections 4.2 and 4.8). There have been post-marketing reports of thrombotic events, including life threatening superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous infusion BeneFIX through a central venous catheter (see also section 4.8).

Section 4.8 – Addition of: dyspnoea, urticaria and blurred vision to Immune system disorders

Section 4.8 – Addition of:
Thrombotic events

There have been post-marketing reports of thrombotic events, including life-threatening SVC syndrome in critically ill neonates, while receiving continuous-infusion BeneFIX through a central venous catheter. Cases of peripheral thrombophlebitis and deep venous thrombosis have also been reported; in most of these cases, BeneFIX was administered via continuous infusion, which is not an approved method of administration (see also sections 4.2 and 4.4).

Inadequate therapeutic response and inadequate factor IX recovery

Inadequate therapeutic response and inadequate factor IX recovery have been reported during the post marketing use of BeneFIX (see also section 4.2).

If any adverse reaction takes place that is thought to be related to the administration of BeneFIX, the rate of infusion should be decreased or the infusion stopped.

Section 6.6
Replacement of
The reconstituted solution should be used immediately or within 3 hours
With
The product does not contain a preservative, and the reconstituted solution should be used immediately or within 3 hours after reconstitution.

Updated on 29 May 2008

Reasons for updating

  • Change to dosage and administration
  • Change to storage instructions
  • Change to further information section

Updated on 29 May 2008

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

Correction of data in table in section 5.2

Updated on 04 April 2008

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • 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

4.5          Interaction with other medicinal products and other forms of interaction

 

No interactions studies have been performedof recombinant coagulation factor IX products with other medicinal products are known.
 

5.1           Pharmacodynamic properties

 

Pharmacotherapeutic group: antihaemorrhagic Blood Coagulation Factor IX; ATC code: B02BD049
 

6.6     Special precautions for disposal and other handling

 

BeneFIX is administered by intravenous (IV) injection after reconstitution of the lyophiliszed powder for injection with the supplied diluent solvent (0.234% w/v sodium chloride solution) in the pre-filled syringe.

 

BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of BeneFIX. It is important that the recommendations in section 4.2 be followed closely.

 

Any unused product or waste material should be disposed of in accordance with local requirements.

 

The reconstituted solution should be used immediately or within 3 hours.

 

Because the use of BeneFIX by continuous infusion has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.
 

10.     DATE OF REVISION OF THE TEXT

 

14 February 2008

Updated on 14 January 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 January 2008

Reasons for updating

  • New SPC for medicines.ie

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