Cytarabine 100 mg/ml Solution for Injection *
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 20 April 2021

File name

DEC202126497_Reg SPC gxCY 5_1 100mg-ml inj IE_clean_1618909190.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
  • 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 – Excipient update regarding sodium (20 mg/ml only)

Section 4.4 – Update concerning excipient information for sodium

Section 4.8 – Update to AE Reporting details

Section 10 – Revised date of revision

 

Updated on 20 April 2021

File name

DEC202126497_Reg PIL gxCY 7_1 100mg-ml inj IE_clean_1618909121.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 22 June 2020

File name

DEC202041589_Reg PIL gxCY 5_1 100mg-ml inj IE clean_1592804284.pdf

Reasons for updating

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

Updated on 31 October 2018

File name

Reg PIL gxCY 4_0 100mg-ml inj IE_clean_1540969983.pdf

Reasons for updating

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

Updated on 05 October 2018

File name

Reg PIL gxCY 3_0 100mg-ml inj IE_clean_1538730815.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 05 October 2018

File name

Reg SPC gxCY 3_1 100mg-ml inj IE_clean_1538730879.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 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 28 November 2017

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • 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

100mg/ml SPC update:

 

Section 2: QRD update

Section 4.1: changed the title by making the ‘I’ in indications a capital

Section 4.2: QRD updates
Section 4.3: QRD updates

Section 4.4: QRD updates
Section 4.6: QRD updates
Section 4.8: add side-effect ‘sinus bradycardia’

Section 5.1: QRD updates

Section 5.2: QRD updates
Section 6.4: v minor font update
Section 6.6: QRD updates
Section 10: QRD heading update and new revision date.

 

 

Updated on 23 November 2017

File name

PIL_16942_227.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 November 2017

Reasons for updating

  • 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 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 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
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 06 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 06 October 2016

Reasons for updating

  • New PIL for medicines.ie