Inflectra 100 mg powder for concentrate for solution for infusion
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal 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 22 April 2024
File name
Adv SPC bIF 16_0 IE clean.pdf
Reasons for updating
- 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)
Updated on 22 April 2024
File name
Adv PIL bIF 19_0 IE NI clean - Copy.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 05 May 2022
File name
AdvSPCbIF150IEclean.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 May 2022
File name
AdvPILbIF180IENIclean.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 6 - date of revision
Updated on 23 November 2021
File name
Adv SPC bIF 14_0 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
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: Addition of information on lactation i.e., infant exposure via breast milk
Section 4.5: Addition of update regarding interaction of Inflectra with live vaccines
Section 4.6: Update of information to Breast-feeding
Section 4.8: Addition of “Dyslipidaemia” as an uncommon adverse reaction
Updated on 23 November 2021
File name
Adv PIL bIF 17_0 IE & NI_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 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 23 September 2021
File name
DEC202162861_Adv PIL bIF 16_0 IE & NI_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 18 March 2021
File name
DEC202118689_Adv SPC bIF 13_0 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 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
File name
DEC202118689_Adv PIL bIF 15_0 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 5 - how to store or dispose
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 05 October 2020
File name
DEC202065867_clean Adv SPC bIF 12_0 IE.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 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
File name
DEC202065867_clean Adv PIL bIF 14_0 IE.pdf
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
File name
DEC201970506_clean Adv SPC bIF 11_0 IE.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 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
File name
DEC201970506_clean Adv PIL bIF 12_0 UK IE_2.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 June 2019
File name
DEC201932108_clean Adv PIL bIF 12_0 UK IE.pdf
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
File name
DEC201932108_clean Adv SPC bIF 10_0 IE.pdf
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
File name
DEC201919354_clean Adv SPC bIF 9_0 IE.pdf
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
File name
DEC201919354_clean Adv PIL bIF 11_0 UK IE_1.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 April 2019
File name
DEC201919354_clean Adv SPC bIF 9_0 UK.pdf
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
File name
DEC201919069_clean Adv PIL bIF 10_0 UK IE_1.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 11 April 2019
File name
DEC201919069_clean Adv SPC bIF 8_0 IE.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 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
File name
clean Adv PIL bIF 9_0 UK IE.pdf
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
File name
clean Adv SPC bIF 7_0 IE (2).pdf
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
File name
clean Adv PIL bIF 8_0 UK IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
Updated on 06 November 2018
File name
clean Adv SPC bIF 6_0 IE.pdf
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
File name
clean Adv PIL bIF 7_0 UK IE.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 31 October 2018
File name
clean Adv SPC bIF 4_0 IE_1.pdf
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
File name
clean Adv PIL bIF 6_0 UK IE.pdf
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
File name
clean Adv SPC bIF 4_0 IE.pdf
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
File name
clean Adv PIL bIF 4_0 UK IE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 August 2018
File name
clean Adv SPC bIF 3_0 IE.pdf
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
File name
clean_Adv_SPC_bIF_2_0_IE_1.docx
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
File name
clean_Adv_PIL_bIF_4_0_uk_IE.pdf
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 SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 March 2018
File name
PIL_16938_230.pdf
Reasons for updating
- New PIL for new product
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
Updated on 05 October 2016
Reasons for updating
- New PIL for medicines.ie