Folinic Acid (as Calcium Folinate) 10mg/ml Solution for Injection

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 28 May 2021

File name

DEC202127216_Reg PIL gxFO 10_0 10mg-ml inj IE-clean_1622197244.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 22 April 2021

File name

DEC202127216_Reg SPC gxFO 4_2 10mg-ml IE - clean_1619074708.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

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 2 - sodium content per presentation added; section 4.4 - sodium excipient content per presentation updated; section 4.8 – ADR reporting updated; date of revision and Ref number.

 

Updated on 22 April 2021

File name

DEC202127216_Reg PIL gxFO 8_1 10mg-ml inj IE - clean_1619074658.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 03 March 2021

File name

DEC202114577_Reg PIL gxFO 9_0 10mg-ml inj IE - clean_1614767836.pdf

Reasons for updating

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

Updated on 14 September 2020

File name

Reg PIL gxFO 7_0 10mg-ml inj IE - clean_1600095155.pdf

Reasons for updating

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

Updated on 25 March 2020

File name

DEC202019081_Reg SPC gxFO 3_2 10mg-ml IE-clean_1585160442.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 and including QRD updates as follows:

Injections: sections 2, 4.1, 4.2 (added method of administration), 4.3, 4.4 (added monitoring patients and sodium excipient quanitities), 4.5 (added other antibiotics, methotrexate, fluoropyrimidine and chloramphenicol), 4.6 (added fertility), 4.8 (added blood disorders, neurological disorders and HPRA ADR reporting), 4.9, 5.1, 6.1 (added pH adjustors), 6.3, 6.6 (added diluents), 10.

Updated on 25 March 2020

File name

DEC202019081_Reg PIL gxFO 6_1 10mg-ml inj IE-clean_1585160168.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • 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 11 September 2019

File name

Reg PIL gxFO 5_0 10mg-ml inj IE - clean_1568215893.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 05 October 2018

File name

Reg PIL gxFO 4_0 10mg-ml inj IE - clean_1538731791.pdf

Reasons for updating

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

Updated on 05 October 2018

File name

Reg SPC gxFO 2_0 10mg-ml IE - clean_1538732017.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 14 September 2018

File name

Reg PIL gxFO 3_0 10mg-ml inj IE - clean_1536923092.pdf

Reasons for updating

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

Updated on 18 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 17 August 2017

File name

PIL_17260_726.pdf

Reasons for updating

  • New PIL for new product