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Neulasta Pre-Filled Syringe

*
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):

    Pegfilgrastim

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

Updated on 03 July 2023

File name

en_neulasta_approved_pil_v122_obi_deregistration.pdf

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

Free text change information supplied by the pharmaceutical company

OBI (OnPro KIt) De-registered and all the references removed.

Updated on 03 July 2023

File name

en_neulasta_approved_spc_v122_obi_deregistration.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • 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

OBI (OnPro KIt) De-registered and all the references removed.

Updated on 03 February 2023

File name

en_neulasta_approved_spc_v114 IE and XI (1).pdf

Reasons for updating

  • Document format updated

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

Updated on 26 January 2022

File name

en_neulasta_approved_pfs_pil_euvar116_clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 27 April 2021

File name

en_neulasta_approved_spc_v114 IE and XI.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 11 January 2021

File name

en_neulasta_approved_spc_v113.pdf

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

File name

en_neulasta_approved_pil_pfs_v113.pdf

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

File name

en_neulasta_approved_pil_pfs_PSURv20.pdf

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):

  • inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
  • bleeding from the lung (pulmonary haemorrhage).
  • Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Neulasta if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

Date of revision of the text

November 2019

Updated on 27 November 2019

File name

en_neulasta_approved_spc_PSURv20.pdf

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 05 April 2019

File name

en_neulasta_approved_pil_pfs_v107.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 April 2019

File name

en_neulasta_approved_spc_v107.pdf

Reasons for updating

  • New SPC for new product

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