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.
Section 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION
Updated to include information regarding the excipient sodium
Section 3 - PHARMACEUTICAL FORM
Inclusion of the text ‘Clear, colourless solution’
Section 4.2 - Posology and method of administration
Updated with minor formatting changes and addition of the sub-section ‘Method of administration’
Section 4.4 - Special warnings and precautions for use
Section 4.5 - Interaction with other medicinal products and other forms of interaction
Updated with minor formatting changes and clarifications
Section 4.7 - Effects on ability to drive and use machines
Updated to state that ‘Aranesp has no or negligible influence on the ability to drive and use machines’.
Section 4.8 - Undesirable effects
Table heading revised from ‘Incidence of undesirable effects considered related to treatment with Aranesp from controlled clinical studies are:’ to ‘Incidence of adverse reactions from controlled clinical studies are:’
Section 5.1 - Pharmacodynamic properties
Clarification of the Pharmacotherapeutic group
Section 6.5 Nature and contents of container
Revision of the text describing nature and contents of containers
Section 6.6 Special precautions for disposal and other handling
Addition of ‘and other handling’ to the sub title and other minor changes
Section 10 - DATE OF REVISION OF THE TEXT
Date of revision changed from 20 December 2010 to 28 February 2011
In addition, there have been updates throughout the SPC to bring in line with SmPC Guideline Rev.2.
For patients with Chronic Renal Failure the following sections of the Aranesp® SPC have been updated to incorporate results from the clinical study “Trial to Reduce Cardiovascular Events with Aranesp® Therapy”
· 4.4 “Special warnings and precautions for use” · 4.8 “Undesirable effects” (this section includes the addition of stroke as a common adverse drug reaction in Chronic Renal Failure patients) · 5.1 ‘Pharmacodynamic properties’ Section 4.4 “Special warnings and precautions for use” has been updated to add a warning to specify that cases of severe hypertension have been seen in Chronic Renal Failure patients treated with Aranesp® therapy, including cases of hypertensive crisis, hypertensive encephalopathy and seizures.
· 4.8 “Undesirable effects” (this section includes the addition of stroke as a common adverse drug reaction in Chronic Renal Failure patients) · 5.1 ‘Pharmacodynamic properties’ Section 4.4 “Special warnings and precautions for use” has been updated to add a warning to specify that cases of severe hypertension have been seen in Chronic Renal Failure patients treated with Aranesp® therapy, including cases of hypertensive crisis, hypertensive encephalopathy and seizures.
· 5.1 ‘Pharmacodynamic properties’ Section 4.4 “Special warnings and precautions for use” has been updated to add a warning to specify that cases of severe hypertension have been seen in Chronic Renal Failure patients treated with Aranesp® therapy, including cases of hypertensive crisis, hypertensive encephalopathy and seizures.
Section 4.4 “Special warnings and precautions for use” has been updated to add a warning to specify that cases of severe hypertension have been seen in Chronic Renal Failure patients treated with Aranesp® therapy, including cases of hypertensive crisis, hypertensive encephalopathy and seizures.
Change to section 4.4 Special warnings and precautions for use
The SPC has been updated to provide guidance to physicians on ensuring appropriate identification and traceability of the product used.
Changes to section 4.8 Undesirable effects
To include hypertension as an undesirable effect identified in the post-marketing setting in patients.
To provide clarification that frequency cannot be estimated for undesirable effects identified in the post-marketing setting.
Change to section 10 Date of revision of the text
Change of date
In order to reflect the need for traceability of specific products ‘darbepoetin alfa’ and ‘Aranesp’ are referred to appropriately throughout the SPC. The following sections have been updated:
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.8 Undesirable effects
4.9 Overdose
5.3 Preclinical safety data
Section 4.4 Special Warnings & Precautions for Use
The needle cover of the syringe contains dry natural rubber which may cause allergic reactions. This text is repeated in section 6.5.
Specifically relating to CRF patients - Aranesp should be used in caution in patients with epilepsy. Convulsions have been reported in patients with CRF receiving Aranesp.
Section 4.8 Undesirable Effects
The rare cases of convulsion in CRF patients is repeated in this section.
Section 6.4 Special Precautions for storage
If the drug has been removed from the fridge and has reached room temperature it must be used within 7 days or disposed of.