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(at)fmc-ag.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.
Complete and thorough documentation is necessary for home dialysis patients so that your nephrologist and the dialysis team can get an idea of your health status and the course of your dialysis treatment. You can find out what you should document in your treatment instructions, which you will receive from your treating physician and dialysis team. Storing all your health records in an easily accessible folder may support conversations with your physicians.
If you want to know more about how and why to document vital signs, click here
Having restricted kidney function usually requires corresponding dietary measures. This may be less necessary for home dialysis patients, depending on the type of therapy received.
The composition of important food components such as fats, proteins and carbohydrates should be adapted to the changed needs of your body. The same applies to your fluid intake, as you may no longer be able to excrete as much fluid through your kidneys. A nutrition counsellor can discuss all the important aspects of a diet that suits you and work out an individual diet and hydration plan for you. Since diet and fluid balance are important elements of your therapy, it is necessary that you regularly check your body weight and the amount of urine you are still excreting. Talk to your dialysis centre about this.
Contact your dialysis centre or the national emergency hotline if you are having an emergency. Competent help is available on call. Ask for important telephone numbers from your unit and post them next to the telephone so that all family members can see them. Over time, you will gain experience and confidence so that you will know when to contact your dialysis centre.
Once the surrounding skin has healed after catheter implantation, it must be well cared for. Hygiene and cleanliness are essential for avoiding infections. You will learn how to care for your catheter exit site from your dialysis team in a detailed training session. Most patients cover the exit site with a small bandage after care. This way, nothing can move and the catheter usually does not interfere with your daily activities.
Generally, there are some clear signs that peritonitis is occurring. If the dialysis fluid discharge is cloudy or you experience abdominal pain and/or fever, you should call your dialysis centre immediately.
Nausea and vomiting may also indicate peritonitis. If the discharge is slower than usual or the ultrafiltration decreases, it could also indicate peritonitis. Your dialysis centre will inform you about the possible signs of peritonitis and how to treat it in detail. Your dialysis centre is also the first point of contact if you suspect peritonitis.
There are several signs that indicate a catheter site infection:
- Pain and
are all symptoms of an infected catheter exit site.
The color of the pus can be very different (brown, yellow, white or green), depending on which pathogen caused the infection. If you suspect an infection of your catheter exit site, please contact your dialysis centre immediately.
A permanent vascular access is also called a graft or fistula. It is a surgical procedure that connects a vein and an artery (usually in the forearm) to create a permanent access, which is punctured with a needle during each HD treatment. This access is necessary to permanently perform haemodialysis. The graft is visible as a small bulge under the skin.
There are different dialysis needles available for haemodialysis treatment. In order to adapt them to individual conditions such as blood flow, type of insertion and position of your arteriovenous fistula or arteriovenous graft, different lengths, types and strengths are available.