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Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 04/07/2011
SPC BeneFIX

When a pharmaceutical company changes an SPC or PIL, 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 04/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   23-Jun-2011
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 26/04/2011 and displayed until 04/07/2011
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   30-Mar-2011
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 17/09/2010 and displayed until 26/04/2011
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Aug-2010
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 01/03/2010 and displayed until 17/09/2010
Reasons for adding or 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
Date of revision of text on the SPC:   29-Oct-2009
Legal Category:   Product subject to restricted prescription (C)

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 29/05/2008 and displayed until 01/03/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Correction of data in table in section 5.2
Updated on 04/04/2008 and displayed until 29/05/2008
Reasons for adding or 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
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

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 09/01/2008 and displayed until 04/04/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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