Imraldi 40mg solution for injection in pre-filled pen

  • Name:

    Imraldi 40mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    adalimumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/09/19

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Summary of Product Characteristics last updated on medicines.ie: 11/9/2019
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.

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Biogen Idec Ltd

Biogen Idec Ltd

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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 11 September 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency

Free text change information supplied by the pharmaceutical company

Reference to Imraldi being only available as a 40mg pre filled syringe and pre filled pen has been deleted, as Imraldi is now available in a 40mg/0.8ml vial presentation and can be administered as a less than full 40mg dose. 

Also, section 1 has been updated as follows:

  • non-infectious uveitis affecting the back of the eye.

 

Updated on 11 September 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency

Free text change information supplied by the pharmaceutical company

Reference to Imraldi being only available as a 40mg pre filled syringe and pre filled pen has been deleted, as Imraldi is now available in a 40mg/0.8ml vial presentation and can be administered as a less than full 40mg dose. 

Also, section 1 has been updated as follows:

  • non-infectious uveitis affecting the back of the eye.

 

Updated on 11 September 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 of the SPC has been updated. Reference to Imraldi being only available as a 40mg pre filled syringe and pre filled pen has been deleted, as Imraldi is now available in a 40mg/0.8ml vial presentation and can be administered as a less than full 40mg dose.  

Updated on 30 April 2019 PIL

Reasons for updating

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

Updated on 30 April 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 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: The Patient Alert card has been renamed as 'Patient Reminder Card'

Section 4.4:The Patient Alert card has been renamed as 'Patient Reminder Card'

Updated on 16 April 2019 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 16 April 2019 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

The previous version of this SPC uploaded was not a consolidated version, and did not include the approved updates of the paed. uveitis indication. This version corrects the error.

Updated on 2 April 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 2 April 2019 SmPC

Reasons for updating

  • 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 6.4 - the storage conditions at room temperature (25C) have been extended from a maximum of 14 to a maximum of 28 days.

Updated on 11 March 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents
  • Change to further information section

Updated on 11 March 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

- Section 4.1 has been updated to include the following text:

Paediatric Uveiti

Imraldi is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

 - Section 4.2 been updated to include the following text:

Paediatric uveitis

 The recommended dose of Imraldi for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5). Imraldi is administered via subcutaneous injection.

 In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate.

 

Table 5 Imraldi Dose for Paediatric Patients with Uveitis

 

Patient Weight

Dosing Regimen

< 30 kg

-

≥ 30 kg

40 mg every other week in combination with methotrexate

- Not applicable, Imraldi is only available as 40 mg pre-filled syringe and pre-filled pen

 

When Imraldi therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy. No clinical data are available on the use of an adalimumab loading dose in children < 6 years of age (see section 5.2).

 There is no relevant use of adalimumab in children aged less than 2 years in this indication.

 It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).

 - Section 4.8 been updated to include the following text:

No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.

  - Section 5.1 been updated to include the following text:

Paediatric Uveitis

 The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment. Patients received either placebo or 20 mg adalimumab (if < 30 kg) or 40 mg adalimumab (if ≥ 30 kg) every other week in combination with their baseline dose of methotrexate.

 The primary endpoint was ‘time to treatment failure’. The criteria determining treatment failure were worsening or sustained non-improvement in ocular inflammation, partial improvement with development of sustained ocular co-morbidities or worsening of ocular co-morbidities, non-permitted use of concomitant medications, and suspension of treatment for an extended period of time.

 Clinical Response

 Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P < 0.0001 from log rank test). The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure. Adalimumab significantly decreased the risk of treatment failure by 75 % relative to placebo, as shown by the hazard ratio (HR = 0.25 [95 % CI:  0.12, 0.49]).

  -Section 5.2 been updated to include the following text:

Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn’s disease, and enthesitis-related arthritis). No clinical exposure data are available on the use of a loading dose in children < 6 years. The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic exposure.

 

Updated on 27 November 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 November 2018 SmPC

Reasons for updating

  • New SmPC 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

New product.