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Fluorouracil 25 mg/ml Solution for Injection or Infusion *
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Fluorouracil sodium

    *Additional information is available within the SPC or upon request to the company

Updated on 16 May 2022

File name

628274a1b9cb8.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

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

Updated on 16 May 2022

File name

6282744999770.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 December 2021

File name

Reg SPC gxFU 10_1 25mg-ml IE_clean_1640189636.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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:

Section 3 - Update to description

Section 4.2 - Update to 'Method of Administration', and addition of 'Dose Reduction in Certain Situations' and 'Impaired Hepatic or Renal Function'

Section 4.3 - Amendments to Contraindications

Section 4.4 – Updates and rewording throughout, and addition of sub-headings

Section 4.5 - Updates and rewording throughout

Section 4.6 – Updated throughout

Section 4.8 - Updated to include AE Table according to MedDRA classifications

Section 4.9 - Updates throughout

Section 5.1 - Rewording of information on RNA

Section 5.2 - Addition of subheadings and information on Absorption

Section 5.3 - Updated

Section 10 – revised date of revision

 

Updated on 22 December 2021

File name

Reg PIL gxFU 11_1 25mg-ml IE_clean_1640189453.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 30 April 2021

File name

DEC202128827_Reg PIL gxFU 10_0 25mg-ml IE clean_1619782923.pdf

Reasons for updating

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

Updated on 10 December 2020

File name

DEC202082695_Reg SPC gxFU 9_0 25mg-ml IE_clean_1607602086.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 - 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)

Updated on 10 December 2020

File name

DEC202082695_Reg PIL gxFU 9_0 25mg-ml IE_clean_1607602021.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 03 March 2020

File name

DEC201956426_Reg SPC gxFU 4_2 25mg-ml IE_clean_1583249340.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 22 October 2019

File name

DEC201956426_Reg SPC gxFU 4_2 25mg-ml IE_clean_1571730384.

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • 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:

Section 4.3 – addition of information on patients with complete absence of DPD activity

Section 4.4 – addition of information on Cardiotoxicity, Encephalopathy, Dihydropryimidine dehydrogenase deficiency (DPD)

Section 4.8 – addition of AEs: infections, febrile neutropaenia, pericarditis, hyperammonaemic encephalopathy; addition of AE Reporting details

Section 4.9 – removal of no specific antidotal therapy exists

Section 5.2 – updated with information on DPD

Section 10 – revised dated of revision

Updated on 11 October 2019

File name

DEC201956426_Reg PIL gxFU 5_1 25mg-ml IE_clean_1570783641.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

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

Updated on 24 October 2018

File name

Reg PIL gxFU 4_0 25mg-ml IE_clean_1540361884.pdf

Reasons for updating

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

Updated on 01 October 2018

File name

Reg SPC gxFU 3_1 25mg-ml IE_clean_1538390558.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 28 September 2018

File name

Reg PIL gxFU 3_0 25mg-ml IE_clean_1538134268.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 September 2018

File name

Reg SPC gxFU 3_1 25mg-ml IE_clean_1538134114.pdf

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

The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 28 September 2018

File name

Reg SPC gxDP 2_0_clean_1538133838.pdf

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

The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 05 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 05 March 2018

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • 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

The SPC was updated with:
Section 4.2 QRD update to headings
Section 4.3 QRD update to excipient sentence
Section 4.4 warning on concomitant use with phenytoin, warning on photosensitivity after use
Section 4.5 QRD update
Section 4.8 cardiac disorder side-effects added and a typo corrected

Updated on 02 March 2018

File name

PIL_17083_697.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 March 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 03 May 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

We implemented artwork on the 26th of April 2017 by signing off updated production artwork for Irish Fluorouracil 25mg/ml Solution for Injection or Infusion, to include the Hurley address update to the MAH and Batch Release site. All presentations within PA 437/11/1 are affected. m32p31 is also affected, and there was also an update to slightly alter the Mulgrave finished product manufacturing site details to fully match the site’s GMP Certificate.

Updated on 28 April 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 15 February 2017

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 14 February 2017

Reasons for updating

  • New PIL for medicines.ie