BeneFIX
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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
Updated on 13 February 2023
File name
DEC202070893_Adv SPC BF 17_0 IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 October 2022
File name
Adv PIL BF 17_0 IE NI clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 04 January 2022
File name
Adv PIL BF 16_0 IE NI clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 23 October 2020
File name
DEC202070893_Adv SPC BF 17_0 IE clean.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.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.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.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.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.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
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The following changes to the labelling have been approved. Please refer to attached copy/copies of labelling documentation for full details.
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The PI is not affected: The new strength is not launched. The PI will be updated upon launch. |
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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. |
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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.”
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
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
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
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
"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
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
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
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
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 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 4.4 – 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 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 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
Updated on 29 May 2008
Reasons for updating
- Change to dosage and administration
- Change to storage instructions
- Change to further information section
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
5.1 Pharmacodynamic properties
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.
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)