Flixabi 100 mg powder for concentrate for solution for infusion

  • Name:

    Flixabi 100 mg powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Infliximab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/12/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 13/12/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Biogen Biosimilar

biogenbiosimilar_1576666433

Company Products

Medicine NameActive Ingredients
Medicine Name Benepali 25mg solution for injection in pre-filled syringe Active Ingredients Etanercept
Medicine Name Benepali 50 mg solution for injection in pre-filled pen Active Ingredients Etanercept
Medicine Name Benepali 50 mg solution for injection in pre-filled syringe Active Ingredients Etanercept
Medicine Name Flixabi 100 mg powder for concentrate for solution for infusion Active Ingredients Infliximab
Medicine Name Imraldi 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Imraldi 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
1 - 0 of 6 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 31 March 2020 Ed-Ptnt

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Changes made are as follows:

- The Patient Alert Card has been renamed to Patient Reminder Card

- The following information on heart failure has been removed from the Flixabi Patient Reminder Card, in order to be aligned with the reference product:

Before treatment with Flixabi

    • Tell your doctor if you have any heart problems such as mild heart failure.

During treatment with Flixabi

    • Tell your doctor straight away if you notice signs of a heart problem. Signs include shortness of breath, swelling of the feet or changes in your heartbeat.

Updated on 13 December 2019 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Possible side effects section has been updated as follows:

  • Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/or numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems

 

 

Updated on 13 December 2019 SmPC

Reasons for updating

  • 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

Section 4.8 has been updated to add the following to the tabulated list of adverse reactions, with a frequency of unknown:

'Cerebrovascular accidents in close temporal association with infusion.'

Also, the following paragraph has been expanded as shown below:

'Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have been reported, some in close temporal association with infusion of infliximab; cerebrovascular accidents have also been reported in close temporal association with infusion of infliximab.'

Updated on 1 November 2019 SmPC

Reasons for updating

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

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 ' Special warnings and precautions for use' has been updated as follows:

Traceability

In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.

 

Updated on 1 August 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 14 May 2019 PIL

Reasons for updating

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

Updated on 14 May 2019 SmPC

Reasons for updating

  • 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

Section 4.8

Acute generalised exanthematous pustulosis (AGEP) added as a rare skin and subcutaneous reaction.

Updated on 8 April 2019 PIL

Reasons for updating

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

Updated on 8 April 2019 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

Section 4.8:

Lichenoid reactions has been added to rare undesirable effects section.

Updated on 29 January 2019 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to date of revision

Updated on 29 January 2019 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

Section 6.5 has been updated from:

...

Flixabi is available in packs containing 1 vial and multipacks containing 2, 3, 4, and 5 (2, 3, 4, and 5 packs of 1) vials. Not all pack sizes may be marketed.

to:

...

Flixabi is available in packs containing 1, 2, 3, 4, and 5 vial(s). Not all pack sizes may be marketed.

Updated on 3 January 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to date of revision

Updated on 3 January 2019 SmPC

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 4.8 - 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

Section 4.2 has been updated to 'special alert card' to 'patient alert card'.

Section 4.4, sub section on Tuberculosis and Malignancies and lymphoproliferative disorders: wording on warning re colon cancer nd dysplasia has been updated. Also, the warning on screening test for tuberculosis was updated.

Section 4.8 has been updated as follows:

Neoplasms benign, malignant and unspecified (including cysts and polyps)

 

Rare:

Lymphoma, non-Hodgkin’s lymphoma, Hodgkin’s disease, leukaemia, melanoma, cervical cancer.

 

Not known:

Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn’s disease and ulcerative colitis), Merkel cell carcinoma.

Updated on 20 November 2018 PIL

Reasons for updating

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

Updated on 20 November 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

In section 7, the MA holder has been changed from:

​​

Samsung Bioepis UK Limited

5th floor

Profile West

950 Great West Road

Brentford

Middlesex TW8 9ES

United Kingdom

​​

to

​​

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

Updated on 4 October 2018 PIL

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 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 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to information for healthcare professionals

Updated on 3 October 2018 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 sections of the SPC outlined above have been updated in line with the reference product PI update.

Updated on 2 August 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 2 August 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

Section 6.3 has been updated as follows:

Before reconstitution:

36 months at 2°C – 8°C.

Flixabi may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date. The new expiry date must be written on the carton. Upon removal from refrigerated storage, Flixabi must not be returned to refrigerated storage.

After reconstitution:

Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used as soon as possible but within 3 hours of reconstitution and dilution. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.

Section 6.4 has been updated as follows:

Store in a refrigerator (2°C - 8°C).

For storage conditions up to 25°C before reconstitution of the medicinal product, see section 6.3.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

 

Updated on 15 May 2018 SmPC

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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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)

Updated on 23 April 2018 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 7 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 August 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7: MAH Address change

Updated on 25 July 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 25 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 June 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3$0Shelf life increase from 2 to 3 years$0

Updated on 13 June 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 24 October 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

  • Black inverted triangle is now in larger size font.
  • In section 6.3, the shelf life has been changed from 24 to 30 months.

Updated on 20 October 2016 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 30 September 2016 SmPC

Reasons for updating

  • New SPC for new product

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 28 September 2016 PIL

Reasons for updating

  • New PIL for new product