Summary of Product Characteristics
last updated on the eMC:
25/03/2011
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 25/03/2011 and displayed until Current
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 28-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Black triangle has been removed
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Updated on 25/10/2010 and displayed until 25/03/2011
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 28-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 has been updated from "As with any exogenous protein administration, local or systemic allergic reactions may occur. Parents and patients should be informed that such reactions are possible and that if an allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought" to "In post-marketing experience in patients treated with Increlex, cases of hypersensitivity, urticaria, pruritis and erythema have been reported. These have been observed both as local to the injection site and/or systemic. A small number of cases indicative of anaphylaxis requiring hospitaisation have been reported. Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought"
Section 4.8 has been updated from "As with all protein pharmaceuticals, some patients may develop antibodies to INCRELEX. Anti-IGF 1 antibodies were observed in 11 of 23 children with severe primary IGFD tested during the first year of therapy. However, no clinical consequences of these antibodies were observed (e.g., allergic reactions or attenuation of growth)" to "During clinical trials in other indications totalling approximately 300 patients, reports of local and/or systemic hypersensitivity were received for 8% of patients. All cases were mild or moderate in severity and none was serious. As with all protein pharmaceuticals, some patients may develop antibodies to Increlex. Anti-IGF‑1 antibodies were observed in 11 of 23 children with severe Primary IGFD tested during the first year of therapy. No attenuation of growth was observed as a consequence of the development of antibodies".
The following information has also been added:
The following adverse reactions have been identified during post approval use of Increlex. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
-Systemic hypersensitivity: anaphylaxis, generalised urticaria, angioedema, dyspnoea
The symptoms in the cases indicative of anaphylaxis included hives, angioedema and dyspnoea. Some patients required hospitalisation. Upon re-administration, symptoms did not re-occur in all patients.
-Local allergic reactions at the injection site: pruritis, urticaria.
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Updated on 08/04/2010 and displayed until 25/10/2010
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 14-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to MAH from Tercica to Ipsen Pharma
Update of ATC code
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Updated on 17/09/2009 and displayed until 08/04/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 17-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.3 - shelf life increased from 2 years to 3 years.
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Updated on 04/09/2007 and displayed until 17/09/2009
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Reasons for adding or updating:
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