KANJINTI

  • Name:

    KANJINTI

  • Company:
    info
  • Active Ingredients:

    Trastuzumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/11/19

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Summary of Product Characteristics last updated on medicines.ie: 13/11/2019
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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Amgen Ireland Ltd

Amgen Ltd

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Medicine Name Blincyto Active Ingredients Blinatumomab
Medicine Name Imlygic Active Ingredients Talimogene laherparepvec
Medicine Name KANJINTI Active Ingredients Trastuzumab
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Medicine Name Mimpara tablets Active Ingredients cinacalcet hydrochloride
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Medicine Name Neulasta On Body Injector Active Ingredients Pegfilgrastim
Medicine Name Neulasta Pre-Filled Syringe Active Ingredients Pegfilgrastim
Medicine Name Neupogen 30 MU (0.3 mg/ml) solution for injection Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 30 MU (0.6 mg/ml) Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 48 MU (0.96 mg/ml) Active Ingredients Filgrastim
Medicine Name Nplate Active Ingredients Romiplostim
Medicine Name Nplate reconstitution kit Active Ingredients Romiplostim
Medicine Name Otezla 10mg, 20mg, 30mg Active Ingredients Apremilast
Medicine Name Parsabiv Active Ingredients etelcalcetide
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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 13 November 2019 SmPC

Reasons for updating

  • 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
  • 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 13 November 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Information for healthcare professionals

Addition of wording around appropriate aseptic technique for reconstitution and dilution procedures. Stability and storage conditions included, as well as in-use storage times and conditions. Addition of wording around aseptic preparation, handling and storage.

 

Date of revision of the text

November 2019

Updated on 31 July 2019 PIL

Reasons for updating

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

Updated on 30 July 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 Undesirable effects

Addition of tumour lysis syndrome as an adverse reaction (frequency not known)

 

Section 10 Date of revision of the text

July 2019

Updated on 18 September 2018 PIL

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 September 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

  • In section 4.4, the following paragraph has been amended:

Traceability

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

  • In section 4.7, the following paragraph has been amended:  Trastuzumab may have a minor influence on the ability to drive or use machines (see section 4.8). Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.

 

  • In Section 4.8 (undesirable effects), the following paragraph has been amended:

Immunogenicity

In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab. Neutralising anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the trastuzumab intravenous arm.

The clinical relevance of these antibodies is not known. The presence of anti-trastuzumab antibodies had no impact on the pharmacokinetics, efficacy (determined by pathological complete response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.

  • In Section 10, the date of revision has been amended to September 2018

 

Updated on 3 August 2018

Updated on 25 July 2018 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

  • In section 6.3, the shelf-life has been changed from 30 months to 3 years
  • In section 10, the date of revision has been updated to 20 July 2018

Updated on 29 May 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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