Inflectra 100 mg powder for concentrate for solution for infusion

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

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 18 March 2021

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 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 18 March 2021

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 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 05 October 2020

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 follows:

Section 4.8: Kaposi's sarcoma has been added to Not known frequency of Neoplasms benign, malignant and unspecified (including cysts and polyps) category.

Updated on 05 October 2020

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 16 December 2019

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 follows:

In section 4.8, the adverse reaction “Cerebrovascular accidents in close temporal association with infusion ” has been added with a Not Known frequency.

Updated on 16 December 2019

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 June 2019

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 18 June 2019

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life

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

Updated on 02 May 2019

Reasons for updating

  • 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 12 April 2019

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 April 2019

Reasons for updating

  • 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 11 April 2019

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 April 2019

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 follows:

In section 4.8, the adverse reaction “Lichenoid reactions” has been added to the Rare Skin and subcutaneous tissue disorder section

Updated on 26 February 2019

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 26 February 2019

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 06 November 2018

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to information for healthcare professionals

Updated on 06 November 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 4.4 - update the warning on screening tests for tuberculosis to align it with current medical practice

Section 4.4 - Update of the current warning on colon cancer and dysplasia of Section 4.4 of the SmPC based on final report of the OPUS Registry (Prospective, Observational, Non-Interventional, Post-marketing Safety Surveillance Program in Subjects with UC; P04808) as per MEA 121.

Section 4.8 – Change from ”……..Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn’s disease……” to ”……..Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn’s disease……”

Section 10 – Reference update

Updated on 31 October 2018

Reasons for updating

  • Change to section 6 - date of revision

Updated on 31 October 2018

Reasons for updating

  • 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 10.

DATE OF REVISION OF THE TEXT – 10/2018

Updated on 02 October 2018

Reasons for updating

  • 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 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to information for healthcare professionals

Updated on 02 October 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 SPC has been updated as follows:
Section 4.4 – update to Advice on Vaccination

Section 4.8 – Addition of rare ADR (Linear IgA Bullous Dermatosis (LABD))

Section 5.2 – Editorial changes to table (lower case now used in the word “week”

Section 6.6 – Advice when using volumes greater than 250ml

Updated on 03 August 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 03 August 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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 7 – Change to MAH

SECTION 9 – Inclusion of Date of first authorization

SECTION 10 – Date of revision of text

Updated on 04 July 2018

Reasons for updating

  • 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 4.9 - Overdose

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:
Deletion of inverted black triangle (tbc)

Section 3 – pharmaceutical form now reads: Powder for concentrate for solution for infusion (powder for concentrate)

Section 4 – format changes and the use of infliximab and not Inflectra in many instances, addition of a statement on Sodium content

Section 6.3 has been reworded

Updated on 04 July 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 - contraindications
  • 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 - excipient warnings
  • Change to section 3 - dose and frequency
  • 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 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • Removal of Black Inverted Triangle

Updated on 06 March 2018

Reasons for updating

  • New PIL for new product

Updated on 06 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 06 March 2018

Reasons for updating

  • 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 - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • 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

 

The SPC has been updated as follows: 4.2 (readability corrections and updates), 4.4 (readability update), 4.6 (readability update, information on risk of birth defects for women exposed to Infliximab during pregnancy, warning to only use Infliximab during pregnancy if clearly needed), 4.8 (readability correction), 5.1 (2 spelling updates (‘z’ to ‘s’), 6.6 (readability and spelling updates), 10 (revision date).

Updated on 06 March 2018

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to information for healthcare professionals

Updated on 17 November 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 11 July 2017

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 07 July 2017

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

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

None provided

Updated on 05 October 2016

Reasons for updating

  • New PIL for medicines.ie