THIS INFORMATION IS ADDRESSED TO HEALTHCARE PROFESSIONALS WHO TAKE CARE OF PATIENTS TREATED WITH
(biotin 100 mg, hard capsules)
(Educational material as described in the risk minimisation plan)
THERAPEUTIC INDICATION OF QIZENDAY
QIZENDAY is indicated in adults for the treatment of progressive multiple sclerosis (primary or secondary).
Some laboratory tests may potentially be distorted by QIZENDAY.
Alternatives are available:
Not all analysers use biotin/streptavidin method for immunoassays. This depends on the parameter analysed, the analyser manufacturer, the reagent cartridges used in the analyser, as showed in the following illustrative sample for some parameters needed in emergency setting:
Information to the physician prescribing/interpreting a laboratory test
Check with the laboratory if biotin interferes with the assay method used for this laboratory test.
The laboratory should be informed of the potential interferences between biotin and immunoassays.
Remind the patient to carry and transmit their card to any healthcare professional they see.
Information to the healthcare professionals from the laboratory
Check if biotin interferes with the assay method used for this laboratory tests.
Not all analysers use biotin/streptavidin method for immunoassays. This depends on the parameter analysed, the analyser manufacturer, the reagent cartridges used in the analyser.
If biotin interferes with the assay method used for this laboratory test, the test should be repeated using an assay not subject to interference by biotin.
When no alternative method is available, a 7-day wash-out period is required before collecting the samples.
TREATMENT WITH QIZENDAY MAY INTERFERE WITH SOME LABORATORY TESTS
SEPSIS / INFLAMMATION
DRUGS OF ABUSE/ TOXICOLOGY
For further information on this product, please refer to EMA Website
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions the national reporting system listed in Appendix V.
Please note that the information you will find in this website is for healthcare professionals who take care of patients treated with Qizenday®.
If you are a patient, this website contains important information for any healthcare professionals you may consult. Some laboratory tests may potentially be affected by using this medicine, including some that may be used in emergency situation. Therefore, you must always carry the card provided with the Qizenday leaflet and show it to any healthcare professional you see.