Adverse Events Reporting 

Adverse events should be reported. Reporting forms and information can be found at 

https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple app store. Adverse events should also be reported to Fresenius Medical Care on 01623 445100.

UK/HEMA/FME/0922/0005 Date of Preparation: November 2022

What is an Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment [Dir 2001/20/EC Art 2(m)].

An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product (Annex 4 Guideline on good pharmacovigilance practices (GVP) Rev 4).

Reporting Side Effects

If you get any side effects, talk to your Doctor, Pharmacist or Nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

Report an Adverse Event

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Fresenius Medical Care on 01623 445 215 and via medinfo-uk@freseniusmedicalcare.com

Medical Information

Call 01623 445 100 (please choose option 5). Opening times are Monday - Friday 9am - 5pm.

UK/HEMA/FME/0922/0002 – Date of Preparation September 2022.