Cytarabine 20 mg/ml Solution for Injection or Infusion
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal 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 17 October 2024
File name
Reg PIL gxCY 12_0 20mg-ml inj IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- 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 change for the MAH name and address.
Updated on 17 October 2024
File name
Reg SPC gxCY 6_0 20mg-ml inj IE_clean.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 Change of MAH name and address
Updated on 14 December 2023
File name
Reg PIL gxCY 11_0 20 mgml inj IEclean.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 13 February 2023
File name
DEC202126497_Reg SPC gxCY 5_2 20mg-ml inj IE_clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 April 2021
File name
DEC202126497_Reg SPC gxCY 5_2 20mg-ml inj 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
- 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
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Updated on 20 April 2021
File name
DEC202126497_Reg PIL gxCY 7_1 20mg-ml inj IE_clean.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 20mg-ml inj 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 31 October 2018
File name
Reg PIL gxCY 4_0 20mg-ml inj IE_clean.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 20mg-ml inj 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 05 October 2018
File name
Reg SPC gxCY 3_1 20mg-ml inj 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 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
The changes are detailed below:
20mg/ml EMC 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: QRD updates
Section 6.6: QRD updates
Section 10: QRD heading update and new revision date.
Updated on 23 November 2017
File name
PIL_16941_290.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 09 October 2017
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
To increase the shelf life of the finished product from 12 months to 18 months.
Updated on 08 August 2017
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)
Free text change information supplied by the pharmaceutical company
Please implement in line with REG08-WI-GBR04 SPC release and withdrawal
Updated on 18 July 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - how to report a side effect
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
Updated on 06 October 2016
Reasons for updating
- New PIL for medicines.ie