Vincristine Sulphate 1 mg/ml Solution for Injection or Infusion

*
Pharmacy Only: Prescription
  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal 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 November 2023

File name

Reg PIL gxVC 19_0 1mgml IE clean.pdf

Reasons for updating

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

Updated on 13 November 2023

File name

Reg PIL gxVC 19_0 1mgml IE clean.pdf

Reasons for updating

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

Updated on 28 September 2023

File name

Reg SPC gxVC 10_1 1mgml IE clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Updated on 28 September 2023

File name

Reg PIL gxVC 18_1 1 mg ml IE clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 23 September 2022

File name

RegSPCgxVC811mgmlIEClean.pdf

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • 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)

Updated on 23 September 2022

File name

RegPILgxVC1611mgmlIEclean.pdf

Reasons for updating

  • 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 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 30 June 2022

File name

Reg PIL gx VC 15_0 1mg ml IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 30 June 2022

File name

Reg SPC gx VC 60_1 mg ml IE clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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)

Updated on 11 May 2022

File name

Reg PIL gxVC 11_1 (1mg-ml) IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 01 November 2021

File name

Reg SPC gxVC 4_3 (1mg-ml) 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
  • Change to section 6.2 - Incompatibilities
  • 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

The SPC has been updated as follows:

Sections 4.2 and 4.4 have been updated to align with the CDS in respect of administration instructions and avoidance of potential fatal medication errors.

Scetion 6.2 and 6.6 have been updated to refer to compatible diluents. Section 6.6 also includes a recommendation to label infusion bags for intravenous use only, fatal if given by other routes.

Updated on 01 November 2021

File name

Reg PIL gxVC 8_3 (1mg-ml) IE-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 31 August 2021

File name

Reg PIL gxVC 7_0 (1mg-ml) IE-clean.pdf

Reasons for updating

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

Updated on 12 February 2021

File name

DEC202109384_Reg PIL gxVC 6_0 (1mg-ml) IE-clean.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 19 January 2021

File name

DEC202103146_Reg SPC gxVC 3_3 (1mg-ml) IE-clean.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 19 January 2021

File name

DEC202103146_Reg PIL gxVC 5_1 (1mg-ml) IE-clean.pdf

Reasons for updating

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

Updated on 04 May 2020

File name

DEC202028791_Reg PIL gxVC 4_1 (1mg-ml) IE-clean.pdf

Reasons for updating

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

Updated on 22 November 2018

File name

Reg PIL gxVC 3_0 (1mg-ml) IE clean.pdf

Reasons for updating

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

Updated on 02 November 2018

File name

Reg PIL gxVC 2_2 (1mg-ml) IE clean.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 - use in children and adolescents
  • 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 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • 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 name of medicinal product
  • Correction of spelling/typing errors

Updated on 02 November 2018

File name

Reg SPC gxVC 2_2 (1mg-ml) IE clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • 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

Please update medicines.ie

SmPC section 1 – product name changed ‘Vincristine Sulfate  1 mg/ml solution for injection or infusion’

SmPC sections 2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1,5.2,  5.3, 6.2,  6.5 – QRD updates

SmPC section 10 – revision date

Updated on 05 October 2018

File name

Reg PIL gxVC 2_0 (1mg-ml) IE clean.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 gxVC 2_0 (1mg-ml) IE clean.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 11 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 11 September 2017

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



 

Existing SPC re-submitted - Active ingredient on system updated to Vincristine Sulfate (previously listed incorrectly as Vincristine)

Updated on 07 September 2017

File name

PIL_17115_456.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 September 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 March 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 10 March 2017

Reasons for updating

  • New PIL for medicines.ie