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KANJINTI

*
Pharmacy Only: Prescription

  • Company:

    Amgen Ireland Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Trastuzumab

    *Additional information is available within the SPC or upon request to the company

Updated on 07 February 2023

File name

en_kanjinti_approved_pil_renewal.pdf

Reasons for updating

  • 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 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 07 February 2023

File name

en_kanjinti_approved_spc_renewal.pdf

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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Updated on 03 February 2023

File name

en_kanjinti_approved_spc_v20_med error.pdf

Reasons for updating

  • Document format updated

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

Updated on 24 November 2021

File name

en_kanjinti_approved_pil_v20_med error.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • 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 - date of revision
  • Change to information for healthcare professionals

Updated on 24 November 2021

File name

en_kanjinti_approved_spc_v20_med error.pdf

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 Posology and method of administration

In order to prevent medication errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is KANJINTI (trastuzumab) and not another trastuzumab-containing product (e.g. trastuzumab emtansine or trastuzumab deruxtecan).

 

Method of administration

 

KANJINTI is for intravenous use only. The loading dose should be administered as a 90‑minute intravenous infusion. Do not administer Administration as an intravenous push or bolus is prohibited. KANJINTI intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available. Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion‑related symptoms (see sections 4.4 and 4.8). Interruption or slowing the rate of the infusion may help control such symptoms. The infusion may be resumed when symptoms abate.

 

Updated on 25 August 2021

File name

en_kanjinti_approved_spc_v18 IE & NI.pdf

Reasons for updating

  • 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

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

Updated on 25 August 2021

File name

en_kanjinti_approved_pil_v18 IE & NI.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 19 January 2021

File name

en_kanjinti_approved_spc_v17 IE.pdf

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

SPC

Summary Of Changes

Section 4.4 Special warnings and precautions for use

Add statement regarding sodium content

Section 4.7 Effects on ability to drive and use machines

Add “dizziness and somnolence” to the recommendations on the effects on the patient's ability to drive and use machines.

Section 4.8 Undesirable effects

Remove the following adverse drug reactions: herpes zoster, erysipelas, cellulitis, sepsis, thinking abnormal, ataxia, paresis, brain oedema, pericarditis, bradycardia and hepatic failure as adverse drug reactions.

 

Update to frequencies of adverse reactions: anaphylactic reaction and anaphylactic shock is changed to frequency rare; wheezing is changed to frequency uncommon, pneumonitis is changed to frequency uncommon and palpitation is changed to frequency common.

 

Section 10 Date of Revision

January 2021

Updated on 19 January 2021

File name

en_kanjinti_approved_pil_v17 IE.pdf

Reasons for updating

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

Updated on 13 November 2019

File name

en_kanjinti_approved_spc_v13.pdf

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

File name

en_kanjinti_approved_pil_v13.pdf

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

File name

en_kanjinti_approved_pil_psur1.pdf

Reasons for updating

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

Updated on 30 July 2019

File name

en_kanjinti_approved_spc_psur1.pdf

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

File name

en_kanjinti_approved_pil_v05.pdf

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

File name

en_kanjinti_approved_spc_v05.pdf

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

 

File name

en_kanjinti_approved_pil_maa.pdf

Updated on 25 July 2018

File name

en_kanjinti_approved_spc_v002.pdf

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

File name

en_kanjinti_approved_pil_maa.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 May 2018

File name

en_kanjinti_approved_spc_maa.docx

Reasons for updating

  • New SPC for new product

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