CAMPTO 20 mg/ml, concentrate for solution for infusion *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 17 May 2021

File name

DEC202132133_Reg SPC CF 21_1 20mg-ml (all presentations) IE-clean_1621249168.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_1620997584.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_1620996979.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_1615202494.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:

  • Addition of text regarding the need for effective contraception in women of childbearing potential and in men during and after treatment with irinotecan,

 

  • Addition of text regarding the presence of irinotecan and its active metabolite SN-38 in human milk and advice regarding breast-feeding.

- to include editorial revisions to change ‘ml’ to ‘mL’

 

Updated on 08 March 2021

File name

DEC202115250_Reg PIL CF 21_3 20mg-ml IE-clean_1615202426.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_1539778774.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_1539778933.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_1535635197.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_1534934343.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 as Follow:
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

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

  • New SPC for new product

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

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 only

Updated 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

SmPC Update to sections 6.3, 6.4, 6.5 and 6.6 to update storage instructions, and stability following dilution

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 4.3 Minor amendments to section cross reference

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 4.1 - new text regarding indications

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

the reasons for the submission are:
6.1 – List of excipients: Addition of the sentence ‘hydrochloric acid (for ph adjustment) used for
the product in polypropylene vials’
6.3 – Shelf-Life: Information for polypropylene (plastic) vials
6.4 – Special precautions for storage: Addition of the sentence ‘products in glass vials and polypropylene vials’
and ‘store below 25 degrees C’
6.5- Nature and content of Container: Addition of information on pack sizes for glass and polypropylene vials.
6.6-Instructions for use and handling, and disposal (if applicable), under ‘preparation for the intravenous infusion administration section’ there is a replacement of dextrose with ‘glucose’ and a paragraph
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

In Section 4.3 the words ‘or bevacizumab’ has been amended to ‘or bevacizumab’ (i.e. without underlining)

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)