Summary of Product Characteristics
last updated on the eMC:
12/08/2011
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 12/08/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Additions marked in red:
4.4 Special warnings and precautions for use
In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
4.8 Undesirable effects
There have been reports of Graft versus Host Disease (GvHD) and fatalities in patients receiving G‑CSF after allogeneic bone marrow transplantation (see section 5.1).
Pseudogout has been reported in patients with cancer treated with filgrastim.
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Updated on 18/04/2011 and displayed until 12/08/2011
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 date of revision of the text
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Change to separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 01-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 6.4: Addition of:
Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 72 hours. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Section 10: Change:
EMEA to EMA
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Updated on 04/05/2010 and displayed until 18/04/2011
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Reasons for adding or updating:
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Addition of link to EMEA website
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Introduction of new pack/pack size
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| Date of revision of text on the SPC: 26-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In section 8, additional packs added without needle guard.
In section 10, link to EMEA website.
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Updated on 29/11/2009 and displayed until 04/05/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 06-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In section 4.4 the following sentence and the bold words in the second paragraph have been added.
Transient cytogenetic modifications have been observed in normal donors following G-CSF use. The significance of these changes is unknown.
Long-term safety follow-up of donors is ongoing. Nevertheless, a risk of promotion of a malignant myeloid clone can not be excluded. It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
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Updated on 29/09/2009 and displayed until 29/11/2009
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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