Neupogen Singleject 48 MU/0.5 ml solution for injection in a pre-filled syringe
*Company:
Amgen Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 May 2024
File name
ie_neupogen_approved_leaflet_pfs_v152.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 03 May 2024
File name
ie_neupogen_approved_spc_pfs_48_v152.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 be renewed (B)
Updated on 11 October 2022
File name
ie_neupogen_approved_spc_pfs_48_v151.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 September 2022
File name
ie_neupogen_approved_leaflet_pfs_v146.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 23 September 2022
File name
ie_neupogen_approved_spc_pfs_48_v146.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
- Other
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 March 2022
File name
uk-ie_neupogen_approved_leaflet_pfs_v149.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to name of medicinal product
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
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Package leaflet: Information for the User |
Change of product name to: Neupogen Singleject 48 MU/0.5 ml solution for injection in a pre-filled syringe. |
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Section 7 Instructions for injecting Neupogen |
Correction to UK MAH address. |
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Date of revision of the text |
December 2021 |
Updated on 23 March 2022
File name
ie_neupogen_approved_spc_pfs_48_v149.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
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Section 1 Name of the medicinal product |
Change of product name to: Neupogen Singleject 48 MU/0.5 ml solution for injection in a pre-filled syringe. |
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Section 2 Qualitative and quantitative composition
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Change in abbreviation of 'microgram' from µg to mcg. Editorial updates. |
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Section 4.2 Posology and method of administration
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Change in abbreviation of 'microgram' from µg to mcg. Editorial updates. |
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Section 4.4 Special warnings and precautions for use |
Change in abbreviation of 'microgram' from µg to mcg. Editorial updates. |
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Section 5.1 Pharmacodynamic properties |
Change in abbreviation of 'microgram' from µg to mcg. Editorial updates. |
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Section 5.3 Preclinical safety data |
Change in abbreviation of 'microgram' from µg to mcg. Editorial updates. |
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Section 6.6 Special precautions for disposal and other handling |
Change in abbreviation of 'microgram' from µg to mcg. Editorial updates. |
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Section 10 Date of revision of the text |
22 March 2022 |
Updated on 15 April 2021
File name
ie_neupogen_approved_spc_pfs_48_v144.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 May 2019
File name
uk-ie_neupogen_approved_leaflet_pfs_v137.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 May 2019
File name
ie_neupogen_approved_spc_pfs_48_v137.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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Section 4.4 Special Warnings and Precautions for use |
Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI). Medicines (containing sorbitol/fructose) given intravenously may be life-threatening and should be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available. A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product. Neupogen contains less than 1 mmol (23 mg) sodium per 0.6 mg/ml, |
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Section 4.6 Fertility, pregnancy and lactation |
Removal of the following in both the pregnancy and breast-feeding sub headings:
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Section 10 Date of revision of the text |
March 2019 |
Updated on 06 February 2019
File name
ie_neupogen_approved_spc_pfs_48_r04.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The following is the changes to the SmPC:
- Section 9 Date of First Authorisation/Renewal of the Authorisation - Date of latest renewal: 21 December 2018
- Section 10 Date of revision of the text - 21 December 2018
Updated on 14 August 2018
File name
uk-ie_neupogen_approved_leaflet_pfs_v136.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 - manufacturer
- Change to section 6 - date of revision
Updated on 14 August 2018
File name
ie_neupogen_approved_spc_pfs_48_v136.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 be renewed (B)
Free text change information supplied by the pharmaceutical company
- In section 4.4 special warnings and precautions for use - a new section for aortitis has been added
- In section 4.8 undesirable effects - addition of aortitis as a rare adverse reaction (vascular disorder)
- In section 10 date of revision - the date of revision has been amended to 09 August 2018
File name
PIL_7894_738.pdf
Updated on 15 March 2018
File name
PIL_7894_738.pdf
Reasons for updating
- New PIL for new product
Updated on 15 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 March 2018
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
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Section 4.4 Special warnings and precautions for use |
Addition of subheadings for clarity; addition of heading for thrombocytopenia |
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Section 4.7 Effects on ability to drive and use machines |
Reworded to include minor influence from dizziness
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Section 4.8 Undesirable effects |
ADR tables amalgamated for all indications. Revision to reflect updated frequencies New common event of dizziness |
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Section 10 Date of revision of the text |
March 2018 |
Updated on 15 March 2018
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
Updated on 24 April 2017
Reasons for updating
- Change to section 6 - manufacturer
Updated on 19 October 2015
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Addition of glomerulonephitis to adverse reaction tables, change in frequency of "pain" in cancer patients (uncommon to very common)
Updated on 19 October 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 15 June 2015
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 02 March 2015
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 28 January 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 27 January 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.4 - Addition of text on hypersensitivity/immunogenicity; addition of sickle cell trait to section on sickle cell disease
4.8 - Addition of sickle cell crisis as an uncommon event to tables for PBPC mobilisation in normal donors, SCN patients and HIV patients
6.4 - Addition of instruction to keep in container to protect from light
Updated on 09 December 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 09 December 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 19 November 2014
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 October 2014
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 October 2014
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 04 February 2014
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
In patients treated with myeloablative therapy followed by bone marrow transplantation
Revision of text to now state that “The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.”
4.4 Special warnings and precautions for use
Special precautions in cancer patients
· Addition of information regarding splenomegaly and splenic rupture
Special precautions in normal donors undergoing PBPC mobilisation
· Addition of the following information “Thrombocytopenia has been reported very commonly in patients receiving Neupogen. Platelet counts should therefore be monitored closely.”
Special precautions in SCN patients
· Addition of the following information “Thrombocytopenia has been reported commonly in patients receiving Neupogen.”
· Addition of information regarding splenomegaly and splenic rupture
Special precautions in patients with HIV infection
· Addition of information regarding splenomegaly and splenic rupture
4.8 Undesirable effects
Cancer patients
· Addition of splenic rupture as uncommon (≥ 1/1000 to < 1/100) adverse reaction
PBPC mobilisation in normal donors
· Addition of splenic rupture as uncommon (≥ 1/1000 to < 1/100) adverse reaction
SCN patients
· Addition of splenic rupture as a common (≥ 1/100 to < 1/10) adverse reaction
Additional information regarding splenomegaly and splenic rupture has been added under the sub-section “Description of selected adverse reactions” for all indications.
Information on where to report adverse reactions has been added
10. DATE OF REVISION OF THE TEXT
Date changed to January 2014
Updated on 04 February 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 30 August 2013
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use
The symptoms of capillary leak are described. Advice is also provided on monitoring and giving patients treatment.
Section 4.8 Undesirable effects
Capillary leak syndrome added as a post-marketing potentially life-threatening adverse drug reaction in cancer patients
Section 10 Date of revision of the text
Changed to 21 Aug 2013
Updated on 30 August 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 19 July 2013
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use
Special precautions in normal donors undergoing PBPC mobilisation:
· Text relating to the long term safety follow-up of normal donors has been deleted.
· To align with section 4.8 of the SmPC the frequency of splenic rupture has been changed from very rare to common.
· To align with section 4.8 of the SmPC dyspnoea has been assigned a frequency of common and the frequency of pulmonary events has been changed from very rare to uncommon.
Special precautions in SCN patients:
· To align with section 4.8 of the SmPC haematuria has been assigned a frequency of common.
Section 4.8 Undesirable effects
The Undesirable Effects section (section 4.8) of the SmPC has been revised according to the SmPC guideline (September 2009 version) for the following indications:
· PBPC mobilisation in normal donors
· SCN patients
· Patients with HIV
Section 10 Date of revision of the text
Date changed to 4 July 2013
Updated on 19 July 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 24 May 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use
Inclusion of information regarding vascular disorders
Section 4.8 Undesirable effects
Focusing on the chemotherapy induced neutropenia indication the Undesirable Effects section of the SmPC has been revised according to the SmPC guideline, September 2009 version and where necessary consequential changes have been made to the Special Warnings and Precautions for Use section of the SmPC.
Addition of a new sub-section
Paediatric SCN patients.
Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with Neupogen. The frequency is estimated as ‘common’ from clinical trial data.
Section 10 DATE OF REVISION OF THE TEXT
Changed to 17 April 2013
Minor administrative changes and corrections throughout the SmPC have also been made to ensure compliance with the latest Quality Review of Documents template (QRD template version 8.0).
Updated on 24 May 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 05 May 2011
Reasons for updating
- Change to date of revision
Updated on 14 April 2011
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The following changes have been made to the Summary of Product Characteristics
· Deletion of the statement in section 4.3 (Contraindications) “NEUPOGEN should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens“.
· Relocation of the statement “NEUPOGEN should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics“ that was in section 4.3 (Contraindications) to section 4.4 (Special Warnings and Precautions for Use) and to amend the statement.
· Deletion of the statement ‘If patients with SCN develop abnormal cytogenetics, the risks and benefits of continuing NEUPOGEN should be carefully weighed; NEUPOGEN should be discontinued if MDS or leukaemia occur’ from section 4.4, sub-section Transformation to leukaemia or myelodysplastic syndrome.
· Update to section 10 (date of revision of the text) to 4 April 2011
Updated on 14 April 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to date of revision
Updated on 23 July 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 - Updated to include information regarding the excipients sodium and sorbitol.
Section 4.4
Updated to include information regarding the excipients sodium and sorbitol.
Safety related terms have been amended in accordance to MedRA standard terms.
Information to record the trade name of the administered product has been included.
Section 4.8 – Text has been revised in accordance to MedRA standard terms and a subsection ‘Post-marketing experience’ under the frequency category ‘unknown’ has been introduced.
Section 6.1 now lists the E number for sorbitol (E420).
Section 10 - The date of revision of text has been updated.
Updated on 21 July 2010
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 July 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 22 December 2009
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Change due to harmonisation of patient information leaflet
Updated on 09 July 2008
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 15 May 2007
Reasons for updating
- Change to warnings or special precautions for use
Updated on 04 May 2006
Reasons for updating
- Change to warnings or special precautions for use
Updated on 07 February 2005
Reasons for updating
- Improved electronic presentation
Updated on 09 August 2004
Reasons for updating
- New PIL for medicines.ie