CAMPTO 20 mg/ml, concentrate for solution for infusion

  • Name:

    CAMPTO 20 mg/ml, concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Irinotecan hydrochloride trihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/10/18

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Summary of Product Characteristics last updated on medicines.ie: 17/10/2018

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name Atorvastatin Pfizer 10 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 20 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 40 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 80 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
1 - 0 of 231 items.Total: Infinity pages

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 October 2018 PIL

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 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to information for healthcare professionals

Updated on 14 May 2018 SmPC

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 4 April 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 April 2018 SmPC

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 3 April 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 April 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 13 March 2018 PIL

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 13 March 2018 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 3 October 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 27 September 2017 PIL

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 9 February 2016 SmPC

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 SmPC

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 SmPC

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 1 December 2011 SmPC

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 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 8 June 2011 SmPC

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 6 June 2011 PIL

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 SmPC

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 8 February 2011 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 1 October 2010 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 29 July 2009 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 21 May 2009 SmPC

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 PIL

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 PIL

Reasons for updating

  • Addition of manufacturer

Updated on 28 February 2008 PIL

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 SmPC

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 4 January 2008 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 8 August 2007 SmPC

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 4 October 2005 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 21 September 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

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