Neulasta Pre-Filled Syringe
- Name:
Neulasta Pre-Filled Syringe
- 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: 11/01/21

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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 11 January 2021 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
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 11 January 2021 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 27 November 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 Warnings and Precautions |
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta. Stop using Neulasta and seek medical attention immediately if you notice any of the symptoms described in section 4. |
Section 4 Side Effects |
Rare side effects (may affect up to 1 in 1000 people):
|
Date of revision of the text |
November 2019 |
Updated on 27 November 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
Section 4.4 Special Warnings and Precautions |
Stevens-Johnson syndrome Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time. |
Section 4.8 Undesirable Effects |
Stevens-Johnson syndrome added as a Rare ADR in Table of ADRs |
Section 10 Date of revision of the text |
November 2019 |
Updated on 5 April 2019 PIL
Reasons for updating
- New PIL for new product
Updated on 5 April 2019 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)