CAMPTO 20 mg/ml, concentrate for solution for 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 15 October 2024
File name
Reg PIL CF 25_0 20mg-ml IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 October 2024
File name
Reg SPC CF 24_0 20mg-ml (all presentations) 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 11 June 2024
File name
Reg SPC CF 23_0 20mg-ml (all presentations) 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 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 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- 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 11 June 2024
File name
Reg PIL CF 24_1 20mg-ml 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 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 13 February 2023
File name
Reg SPC CF 22_0 20mgml all presentations IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 April 2022
File name
Reg SPC CF 22_0 20mgml all presentations IE clean.pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 April 2022
File name
Reg PIL CF 23_0 20mgml IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 17 May 2021
File name
DEC202132133_Reg SPC CF 21_1 20mg-ml (all presentations) 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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 May 2021
File name
DEC202132133_Reg SPC CF 21_1 20mg-ml (all presentations) 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 May 2021
File name
DEC202132133_Reg PIL CF 22_0 20mg-ml IE-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 08 March 2021
File name
DEC202115250_Reg SPC CF 20_3 20mg-ml (all presentations) IE-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
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: - to update SmPC Sections 2 Qualitative and Quantitative composition and 4.4 Special warnings and precautions for use in line with EU Excipient Guidelines (Oct. 2017). - to update irinotecan hydrochloride EU ‘common’ SmPC sections 4.4 and 4.6 following current updates to the Company Core Data Sheet. These updates include:
- to include editorial revisions to change ‘ml’ to ‘mL’
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Updated on 08 March 2021
File name
DEC202115250_Reg PIL CF 21_3 20mg-ml IE-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- 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 17 October 2018
File name
Reg PIL CF 20_0 20mg-ml IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 17 October 2018
File name
Reg SPC CF 19_1 20mg-ml (all presentations) 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 is updated as follows:
Section 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK 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 30 August 2018
File name
Reg_SPC_CF_18_0_20mg_ml_(all_presentations)_IE_clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
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 in section 4.8 in line with PRAC recommendation to add 2 ADRs, Fungal infections and Viral infections and editorial in line with common SPC.
Updated on 22 August 2018
File name
Reg PIL CF 19_2 20mg-ml IE-clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to information for healthcare professionals
Updated on 14 May 2018
File name
Reg_SPC_CF_18_0_20mg_ml_(all_presentations)_IE_clean.docx
Reasons for updating
- Change to section 4.8 - Undesirable effects
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 in section 4.8 in line with PRAC recommendation to add 2 ADRs, Fungal infections and Viral infections and editorial in line with common SPC
Updated on 13 May 2018
File name
Reg PIL CF 18_0 20mg-ml IE-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 04 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2018
Reasons for updating
- Change to section 4.8 - Undesirable effects
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 in section 4.8
Updated on 03 April 2018
File name
PIL_12277_487.pdf
Reasons for updating
- New PIL for new product
Updated on 03 April 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
Updated on 13 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 March 2018
File name
PIL_12277_296.pdf
Reasons for updating
- New PIL for new product
Updated on 13 March 2018
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.5 - 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 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 SPC has been updated as Follow:
The SPC has been updated in all section
Updated on 13 March 2018
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 - warnings and precautions
- Change to section 2 - use in children and adolescents
- 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
Updated on 03 October 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 27 September 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 February 2016
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
The SPC has been updated as follows:
Section 6.3 - Shelf-life has been reduced from 36 months to 24 months for the 2mL vial presentation onlyUpdated on 27 April 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
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.
• To justify and update section 4.4 of the SmPC to include and/or update warnings in Haematology, Acute cholinergic syndrome, Renal function, Irradiation therapy and Vascular disorders, as agreed with the RMS upon completion of variation FR/H/108/002/II/033.
• To justify and update section 4.8 of the SmPC to include thromboembolic events, as agreed with the RMS upon completion of variation FR/H/108/002/II/033.
• Administrative changes to cross reference sections and section headings.
• In addition, minor formatting revisions were made throughout the SPC.
Updated on 30 April 2013
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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)
Free text change information supplied by the pharmaceutical company
To amend section 4.5 of the SmPC to remove the text around interaction with bevacizumab, as a lack of interaction has been demonstrated and its removal approved in the bevacizumab label.QRD updates to sections 4.1-4.6, 4.8, 5.1, 5.2, 6.5 and 6.6
Updated on 01 December 2011
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 29 November 2011
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 08 June 2011
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 Precautions for extravasation, cardiac disorders and increased susceptibility to infections added
Section 4.5 Additional interactions for atazanavir, and interactions common to all cytotoxics
Section 4.6 Section updated
Section 5.1 Section added on patients with reduced UGT1A1 activity
Section 5.3 Section on Reproduction added
Section 6.3 Minor revisions
Section 6.5 Minor revisions.
Updated on 06 June 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 11 February 2011
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 – typographical corrections
6.4 Delete statement “Product in glass vials and polypropylene vials
6.5 Delete reference to glass vials
8 – Remove reference to PA 19/53/1 & PA 19/53/2
9 Update to date of first authorisation to reflect PA 19/53/3 only
10 Update to revision date
Updated on 08 February 2011
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 01 October 2010
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 29 July 2009
Reasons for updating
- Change to name of manufacturer
Updated on 21 May 2009
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 - new text regarding dosage adjustments
Section 4.3 - minor text edit
Section 4.8 - new text regarding adverse drug reactions
Section 5.1 - new text regarding combination therapy
Updated on 15 May 2009
Reasons for updating
- Change to date of revision
- Changes to therapeutic indications
- Change to drug interactions
- Change of contraindications
- Change to instructions about missed dose
- Change to side-effects
Updated on 16 July 2008
Reasons for updating
- Addition of manufacturer
Updated on 28 February 2008
Reasons for updating
- Change of trade or active ingredient name
- Change to packaging
- Change to date of revision
- Change of special precautions for disposal
- Change due to harmonisation of patient information leaflet
Updated on 27 February 2008
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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)
Free text change information supplied by the pharmaceutical company
6.1 – List of excipients: Addition of the sentence ‘hydrochloric acid (for ph adjustment) used for
the product in polypropylene vials’
and ‘store below 25 degrees C’
describing the instructions for use in more detail to be consistent with the SPC
Updated on 04 January 2008
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 August 2007
Reasons for updating
- New PIL for medicines.ie
Updated on 08 August 2007
Reasons for updating
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
4.1 and 4.2: Indications and Posology and method of administration: Information on combination with cetuximab and bevacuzimab
4.3: Contraindications: Reference made to product information for cetuximab and bevacuzimab for information on contraindications associated with these products
4.5: Interactions: Information on use of Campto with cetuximab and bevacuzimab
4.8: Adverse events: Update to adverse events section
5.1: Pharmacodynamic properties: Information on use in combination with cetuximab and bevacuzimab
10: Update to date of revision of text
Updated on 04 October 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 September 2005
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)