Section 2 : For excipients see 6.1 changed to “For a full list of excipients, see section 6.1.”
Section 3 : addition of text – “Clear, colourless solution.”
Section 4.2 : addition of references to section 12; addition of “For instructions on disposal, see section 6.6”; addition of “Children:
There is no experience in children or adolescents below 18 years of age.”
Section 4.4 : Addition of various paragraphs of new information:
“Because the Zevalin therapeutic regimen includes the use of rituximab, see also the prescribing information of rituximab.”
“In most patients Zevalin administration results in severe and prolonged cytopenia which is generally reversible. “
“In a clinical trial in which Zevalin was administered as consolidation after prior first line chemotherapy a higher frequency of severe and prolonged neutropenia and thrombocytopenia was observed in patients who had received Zevalin within 4 months after a combination chemotherapy of fludarabine with mitoxantrone and/or cyclophosphamide compared to those patients who had received any other chemotherapy. Hence the risk of hematological toxicity may be increased when Zevalin is administered shortly (< 4 months) after fludarabine containing regimens.”
Additional information added to the paragraph relating to mucocutaneous reactions “The onset of the reactions varied from days to months. Patients experiencing a mucocutaneous reaction should not receive any further component of the Zevalin regimen.”
Section 4.5 : addition of “No interaction studies have been performed.” in place of “Formal drug interaction studies have not been carried out.”
Section 4.8 : System Organ Class classification reordered and addition of new text under the side effects table …
“* fatal outcome has been observed either in clinical trials or in post-marketing experience”
“The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.”
“Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.”
“Because the Zevalin therapeutic regimen includes the use of rituximab, see also the prescribing information of rituximab.”
Section 5.1 : addition of new text – “This medicinal product has been authorised under “Exceptional Circumstances”.
This means that for ethical reasons it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.”
Section 5.3 : addition of new text – “Non-clinical data reveal no special hazard for humans based on studies of single and repeated dose toxicity.”
Section 5.4 : the previous section 5.4 relating to dosimetry has been deleted and recreated in a new section, section 11.
Section 6.2 : new cross reference to section 12 added and addition of new text “No incompatibilities have been observed between Zevalin and infusion sets.”
Section 6.4 : rewording of text relating to storage conditions and cross reference to section 6.3
Section 6.6: addition of cross reference to section 12; addition of new text relating to risks of radiation to others “ … since the administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc”
Section 10 : date of revision changed to 14 November 2006
Section 11 : text from previous section 5.4 now included here under the heading Dosimetry.
Section 12: text previously included under section 6.6 relating to preparation of product now included in section 12 under the heading “Instructions for the preparation of radiopharmaceuticals”
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