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Vinblastine Sulfate 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):

    Vinblastine Sulfate

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

Updated on 01 November 2023

File name

Reg PIL gx VS 12 01 mg ml IE clean.pdf

Reasons for updating

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

Updated on 14 February 2023

File name

RegSPCgxVS421mgmlIEclean.pdf

Reasons for updating

  • Document format updated

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

Updated on 09 June 2022

File name

Reg PIL gxVS 9_0 (1mg-ml IE) clean.pdf

Reasons for updating

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

Updated on 03 February 2022

File name

RegPILgxVS811mgmlIEclean.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 4 - possible side effects
  • 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 03 February 2022

File name

RegPILgxVS811mgmlIEclean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 03 February 2022

File name

RegSPCgxVS421mgmlIEclean.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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 SPC has been updated as follows:  

Section 4.2:

- additional dosage information for testicular tumours

- additional information on method of administration

- information added on use in hepatic impairment and renal impairment

Section 4.3

- clarification added to the contraindication in patients who are leuocopenic

Section 4.4

- strengthening of the warning relating to intravenous use only

- addition of reported cases of phlebitis and cellulitis 

- deletion of the statement relating to possible carcinogenic effects

Section 4.5

- addtion of fatal acute respiratory distress or failure and pulmonary infiltration or pulmonary oedema when used in combination with mitomycin

- addition of dyspnoea and severe bronchospasm especially when used in combination with mytomycin-C

- strengthening of the wording relating to combination treatment with bleomycin and cisplatin

- strengthening of the wording relating to combination treatment with erythromycin

Section 4.8

- addition of new side effects

Section 4.9

- additional information on treatment of overdose

Section 6.5

- updated to refer to the marketed container only (vials in ONCOTAIN protective sleeve).

 

Updated on 03 February 2022

File name

RegPILgxVS811mgmlIEclean.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 4 - possible side effects
  • 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 28 July 2021

File name

Reg PIL gxVS 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 31 March 2021

File name

DEC202109359_Reg PIL gxVS 6_0 (1mg-ml IE)-clean.pdf

Reasons for updating

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

Updated on 26 November 2020

File name

Reg PIL gxVS 5_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 15 October 2020

File name

DEC202068727_Reg SPC gxVS 3_1 1mg-ml IE-clean.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 - how to report a side effect

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

Updated on 15 October 2020

File name

DEC202068727_Reg PIL gxVS 4_1 1mg-ml IE-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 21 November 2018

File name

Reg PIL gxVS 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 gxVS 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
  • Correction of spelling/typing errors

Updated on 02 November 2018

File name

Reg SPC gxVS 2_2 1mg-ml IE clean.pdf

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

SmPC sections 2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.1, 6.2, 6.4, 6.6, 9 – QRD updates

SmPC section 10 – revision date

Updated on 05 October 2018

File name

Reg PIL gxVS 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 gxVS 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 Vinblastine Sulfate (previously listed incorrectly as Vinblastine)

Updated on 28 October 2016

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 27 October 2016

File name

PIL_16971_529.pdf

Reasons for updating

  • New PIL for new product