Benepali 25mg solution for injection in pre-filled syringe

  • Name:

    Benepali 25mg solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Etanercept

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/04/21

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Summary of Product Characteristics last updated on medicines.ie: 13/4/2021

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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 13 April 2021 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Reporting of suspected adverse reactions sub section has been updated to include the following:

United Kingdom (Northern Ireland)
Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Updated on 2 April 2021 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to date of revision
  • Addition of information on reporting a side effect.

Free text change information supplied by the pharmaceutical company

In section 6, local representative contact details for United Kingdom (Northern Ireland) have been added;  Biogen Netherlands BV has been added as a manufaturer, and name and address of Biogen Hillerod  has been changed to FUJIFILM .

Updated on 27 November 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Removal of Black Inverted Triangle
  • Change to date of revision

Free text change information supplied by the pharmaceutical company

- Patient Alert Card' has been renamed to 'Patient Card'.

- Black triangle and explanation have been removed.

- In section 1, 'psoriasis' has been updated to 'plaque psoriasis'.

In section 4, the following changes have been made:

'Rare (may affect up to 1 in 1,000 people):
..
...opportunistic infections (infections that occur because of a weakened immune system); lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered), erythema multiforme (inflammatory skin rash), cutaneous vasculitis (inflammation of blood vessels in the skin); damage to nerves, including Guillain-Barré syndrome (a serious condition which can affect breathing and damage body organs).'

Very rare (may affect up to 1 in 10,000 people):
Failure of the bone marrow to produce crucial blood cells; damage to nerves, including Guillain-Barré syndrome (a serious condition which can affect breathing and damage body organs); toxic epidermal necrolysis (a life-threatening skin condition). 

Not known (frequency cannot be estimated from available data)
Merkel cell carcinoma (a type of skin cancer); Kaposi’s sarcoma (a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash); Llisteria (a bacterial infection).

 

 - Minor editorial changes have been made throughout the PL as requested and/or to align with reference product.

​​

Updated on 27 November 2020 SPC

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 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Removal of Black Inverted Triangle

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: 'Patient Alert Card' has been renamed to 'Patient Card'.

Section 4.4: 'Patient Alert Card' has been renamed to 'Patient Card'.

Formatting changes have also been made to this section, including the following:

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.


Benepali contains sSodium contents

No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin.

Section 4.8: Kaposi’s sarcoma was added to the tabulated list of adverse reactions, with unknown frequency to align with reference product.

 

Minor editorial changes have been made to other sections of the SPC as requested and/or to align with reference product.

​​

Updated on 18 June 2020 Ed-Ptnt

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Update to ADR reporting details for Ireland and UK.

Updated on 18 June 2020 Ed-HCP

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

ADR reporting details for Ireland and UK updated in HCP Slide Deck.

Updated on 9 June 2020 Ed-Ptnt

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Item number now reflects Irish pack.

Updated on 27 January 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Samsung Bioepis NL B.V has been added as a manufacturer responsible for batch release.

Updated on 9 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

Uncommon side effects section has been updated to include 'abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).'

Updated on 9 December 2019 SPC

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

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

​​Traceability

In order to improve the traceability of biological medicinal products, the trademark name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.

​​4.8     Undesirable effects section has been updated to include Inflammatory bowel disease in the tabulated list of adverse reactions.

Updated on 6 December 2019 Ed-Ptnt

Reasons for updating

  • Replace document

Updated on 1 November 2019 Ed-HCP

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Previous version was uploaded on website in error.

Updated on 30 September 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 30 September 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 30 September 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 23 May 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 23 May 2019 SPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 4.6:

Update to align with the reference product to add additional information to this section - the following text has been added:

The effects of etanercept on pregnancy outcomes have been investigated in two observational cohort studies.....In another observational multi‑country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy (n=425) to those exposed to non-biologic drugs (n=3497), there was no observed increased risk of major birth defects (crude odds ratio [OR]= 1.22, 95% CI: 0.79-1.90; adjusted OR = 0.96, 95% CI: 0.58-1.60 after adjusting for country, maternal disease, parity, maternal age and smoking in early pregnancy). This study also showed no increased risks of minor birth defects, preterm birth, stillbirth, or infections in the first year of life for infants born to women exposed to etanercept during pregnancy.

The following text has been updated to read: Benepali should only be used during pregnancy if clearly needed

Updated on 22 March 2019 PIL

Reasons for updating

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

Updated on 21 March 2019 SPC

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 include lichenoid skin reactions as a rare adverse event.

Updated on 16 November 2018 PIL

Reasons for updating

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

Updated on 16 November 2018 SPC

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)

Updated on 16 November 2018 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 29 May 2018 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 29 May 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 13 February 2018 PIL

Reasons for updating

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

Updated on 13 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 January 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 23 August 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 23 August 2017 SPC

Reasons for updating

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

$0 $0$0$0$06.5     Nature and contents of container$0$07.       MARKETING AUTHORISATION HOLDER$0

Updated on 22 August 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder

Updated on 9 August 2017 SPC

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

·         Summary of Product Characteristics (SmPC)

 

Location

Update

SmPC, section 4.8 Undesirable effects

Hepatobiliary disorders:

Uncommon:        Elevated liver enzymes*

Rare:      Elevated liver enzymes, aAutoimmune hepatitis

SmPC, section 4.8 Undesirable effects

Elevated liver enzymes

In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon). In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common).

PiL, section 4 Possible side effects

·         Uncommon (may affect up to 1 in 100 people):

elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common).

·         Rare (may affect up to 1 in 1,000 people):

elevated liver blood tests;

Updated on 25 July 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 June 2017 SPC

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 13 June 2017 PIL

Reasons for updating

  • New PIL for new product