KANJINTI
- Name:
KANJINTI
- Company:
Amgen Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/01/21
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Amgen Ireland Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name AMGEVITA prefilled pen | Active Ingredients adalimumab |
| Medicine Name AMGEVITA prefilled syringe | Active Ingredients adalimumab |
| Medicine Name Aranesp PFS | Active Ingredients Darbepoetin alfa |
| Medicine Name ARANESP PFS with needle guard | Active Ingredients Darbepoetin alfa |
| Medicine Name Aranesp SureClick | Active Ingredients Darbepoetin alfa |
| Medicine Name Blincyto | Active Ingredients Blinatumomab |
| Medicine Name Imlygic | Active Ingredients Talimogene laherparepvec |
| Medicine Name KANJINTI | Active Ingredients Trastuzumab |
| Medicine Name Kyprolis | Active Ingredients Carfilzomib |
| Medicine Name Mimpara Granules | Active Ingredients cinacalcet hydrochloride |
| Medicine Name Mimpara tablets | Active Ingredients cinacalcet hydrochloride |
| Medicine Name MVASI | Active Ingredients Bevacizumab |
| 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 reconstitution kit | Active Ingredients Romiplostim |
| Medicine Name Nplate vial | Active Ingredients Romiplostim |
| Medicine Name Otezla 10mg, 20mg, 30mg | Active Ingredients Apremilast |
| Medicine Name Parsabiv | Active Ingredients etelcalcetide |
| Medicine Name Prolia | Active Ingredients Denosumab |
| Medicine Name Repatha SureClick | Active Ingredients Evolocumab |
| Medicine Name Vectibix | Active Ingredients Panitumumab |
| Medicine Name XGEVA | Active Ingredients Denosumab |
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 19 January 2021 SPC
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 PIL
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 SPC
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 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 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 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)