When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
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
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.