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).
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.
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
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.
It is perfectly understandable if you are initially nervous about the decisions that need to be done. Try to realise that neither your loved one nor you have to walk the path alone in finding a suitable therapy.
You can get a lot of information from the care team and other contacts at the dialysis centre. Other patients can share their own experiences and give insights into life with chronic kidney disease with their own personal stories.
Together with your loved one, you will find ways to live a fulfilling family life despite having the disease.