Cisplatin 1 mg/ml Concentrate for Solution for Infusion (Latex-free vial stopper)
*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 24 March 2025
File name
Reg PIL gxCP 17_1 IE clean.pdf
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 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes.
Updated on 21 March 2025
File name
Reg PIL gxCP 17_1 IE clean.pdf
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 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes.
Updated on 21 March 2025
File name
Reg SPC gxCP 16_1 IE clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to improve clarity and readability
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 3: enhanced detail of product description.
Section 4.2: enhanced detail of posology and administration.
Section 4.4: additional information re toxicity (nephrotoxicity, neurotoxicity, ototoxicity), bone marrow function and immunosuppressant effects.
Section 4.5: additional information re antigout agents.
Section 4.8: additions, removals and changes to ADRs, ADR frequency and System Organ Class. Extended information on renal/urinary disorders, gastrointestinal disorders, eye disorders, ear/labyrinth disorders, nervous system disorders and metabolism/nutrition disorders.
Section 4.9: enhanced detail of overdosage and treatment.
Section 5.1: addition of target tissues.
Section 5.2: addition of absorption, distribution and biotransformation information.
Section 6.2: enhanced detail of incompatible products.
Section 6.6: enhanced details on dilution.
Minor editorial & typographical corrections throughout.
Updated on 16 October 2024
File name
Reg SPC gxCP 15_0 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)
Updated on 16 October 2024
File name
Reg PIL gxCP 16_0 IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 09 September 2024
File name
Reg SPC gxCP 14_2 IE_clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 September 2024
File name
Reg PIL gxCP 15_1 IE_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 06 December 2023
File name
Reg PIL gx CP 13 0 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 17 March 2023
File name
Reg SPC gxCP 12_1 IE clean.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 March 2023
File name
Reg PIL gx CP 12_1 IE clean.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 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 06 September 2022
File name
RegSPCgxCP101IEclean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC is has been updated as follows:
Section 4.4 – Removal of warning statement that the vial stopper contains dry natural rubber (latex).
Section 10 – Date of Revision
This product is the same as the existing Cisplatin on medicines.ie but has a Latex-free vial stopper
Updated on 06 September 2022
File name
RegPILgxCP111IEclean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
This is the same as the existing Cisplatin listed on medicines.ie but has a Latex-free vial stopper
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363