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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 05/07/2011
SPC BeneFIX

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 05/07/2011 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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7: Marketing authorisation holder (Wyeth Europa, Taplow to Pfizer, Sandwich)
Updated on 26/04/2011 and displayed until 05/07/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to section 6.3: Storage conditions to change the storage conditions from 2-8 oC to 2-30 oC and reduce the shelf life from 3 to 2 years
Updated on 20/08/2010 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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4 Storage conditions changed as follows;

For the purpose of ambulatory use the product may be removed from refrigerated storage for one single period of maximum 16 months at room temperature (up to 3025 ºC).  At the end of this period, the product should not be put back in the refrigerator, but should be used or discarded.
Updated on 20/05/2010 and displayed until 20/08/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   05-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1
Sentance on authorisation under exceptional circumstances removed
Updated on 18/11/2009 and displayed until 20/05/2010
Reasons for adding or 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
Date of revision of text on the SPC:   28-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4
Blurred vision added to paragraph 3 -

........Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, bronchospasm, laryngospasm, wheezing, hypotension, blurred vision, and anaphylaxis.


Section 4.8
Blurred vision added to -

Immune system disorders

 

Uncommon:      Neutralising antibodies (factor IX inhibition)*

Rare:                Hypersensitivity/allergic reactions; such reactions may include anaphylaxis*, bronchospasm/respiratory distress, (dyspnoea), hypotension, angioedema, tachycardia, chest tightness, urticaria, hives, rash, burning sensation in jaw and skull, chills (rigors), tingling, flushing, lethargy, restlessness, dry cough/sneezing, blurred vision

 
Updated on 12/05/2009 and displayed until 18/11/2009
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 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   22-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2            Posology and method of administration

New paragraph on administration by continuous infusion

 

Section 4.4            Special warnings and precautions for use

Additional early signs of hypersensitivity reactions

 

New paragraph on safety and efficacy of continuous infusion

 

Section 4.8            Undesirable effects

Amendment to Rare Immune system disorders

 

New paragraphs on Thrombotic events and Inadequate therapeutic response and inadequate factor IX recovery

 

Section 5.2            Pharmacokinetic properties

Change to title of Table 1 and change to explanation

 

Section 6.6            Special precautions for disposal and other handling

Change to useage instructions
Updated on 23/10/2008 and displayed until 12/05/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   14-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 30/05/2008 and displayed until 23/10/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   14-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 04/04/2008 and displayed until 30/05/2008
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 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
  • SPC Retired pending re-submission
  • 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 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.5            Interaction with other medicinal products and other forms of interaction

 

No interaction studies have been performed.

 

5.1             Pharmacodynamic properties

 

Pharmacotherapeutic group: antihaemorrhagic Blood Coagulation Factor IX; ATC code: B02BD09

 

6.6       Special precautions for disposal and other handling

 

BeneFIX is administered by intravenous (IV) injection after reconstitution of the lyophilised powder for injection with the supplied 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 30/11/2007 and displayed until 04/04/2008
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
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