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.
You have achieved a lot in the last few weeks and months.
Together with your physician and your family, you have decided on a therapy modality and have started a new chapter in your life. After the initial acclimatisation and discovery of a new routine, the focus is now on your daily life again.
You may notice that the routine you have established gives you more freedom to deal with other questions again. What activities did you enjoy before starting the treatment? What was helpful for your overall well-being? You now realise that life on dialysis requires concessions and that you had to restructure some areas of your everyday life. However, try to keep in mind that dialysis gives you the energy you need to cope with your everyday tasks and enjoy your life.
It is important for your well-being to find ways to combine hobbies and social contacts with dialysis.
Talk to your physician or healthcare professional about how to continue to integrate them into your everyday life.
I need support
Perhaps it was clear to you from the start that you needed more support in carrying out your treatment. Perhaps you decided on a home therapy option and have noticed that dealing with dialysis by yourself at home is overwhelming. Listen to your body carefully; there is nothing wrong with asking for help.
For example, support may be available in the form of assisted dialysis for home dialysis. A family member or close friend may assist you with the treatment. If a family member or friend takes on the role of an assistant, that person will also receive extensive training from the supervising dialysis centre. In some countries, a nursing service may be able to assist you with the treatment. However, it is important that you also understand your treatment and the related responsibilities.
Individualisation of therapy
You are already familiar with the different forms of therapy and have a new everyday life with your chosen treatment. However, in addition to medical factors, your individual lifestyle also plays a role in the choice of therapy. This may change during the course of your life or there might be complications which require switching to another form of treatment or adjusting your current treatment prescription. Many patients do not undergo just one form of treatment in their lifetimes. For example, you may begin with peritoneal dialysis and then get the opportunity to have a transplantation. If the transplant is unsuccessful, you may switch to home haemodialysis. A change in the therapy modality can therefore be reasonable in some cases.
Your physician will explain which options are available that best fit your individual needs.
Simple ordering process for materials
As a home dialysis patient, the materials required for the treatment will be delivered to your home. For example, these include bandages or solution bags for peritoneal dialysis and dialysers and disposables for home haemodialysis. Your dialysis centre will help you compile a list of all the materials you will need and show you how to fill out the order form.
Having an adequate inventory is essential for your treatment to be carried out. You should therefore adhere to the following guidelines:
- Please check the stocks of each product regularly. Also, think of accessories you might need, such as bandages and disinfectants.
- Order the required quantities for a certain period of time. You should also ensure that someone is at home when the delivery is made and can receive the goods.
Even as a home patient, you are not on your own! Have self-confidence and view dealing with therapy independently as an opportunity to take control of your life with dialysis.
As with any medical treatment, there may be problems related to dialysis. We want you to be aware of some of the possible problems related to the dialysis treatment that may occur and how to manage them.
There are various potential symptoms of kidney disease. In the following, you can find some symptoms you might experience:
- Tiredness and weakness
You may feel tired and weak. As a result, it might feel difficult to walk up a flight of stairs or take a walk around the block. You may feel the need to sleep more than usual.
- Feeling of having the flu
- Lack of concentration and forgetfulness
Concentrating might be difficult and you may forget things more often than usual. These symptoms are most often due to anaemia, a shortage of red blood cells which can be treated.
A person with kidney disease has kidneys that aren’t removing fluid. Therefore, swelling may occur in the feet, ankles, hands or face and putting on shoes is difficult. Extra fluid in the lungs can make it hard to breathe, which sometimes is mistaken for asthma or pneumonia. Having too much fluid can strain the heart, especially in someone whose heart is already weak due to congestive heart failure or other problems.
- Restless legs, insomnia, itching
Many problems are treatable. Talk to your physician and ask for help.
Complications of dialysis
Complications may be due to different reasons: they may be related to dialysis, the underlying kidney disease itself or the medications that are taken. As the most important member of your healthcare team, you play the key role when it comes topreventing or correcting problems that can lead to long-term and even life-threatening complications. You can help prevent complications by:
- Taking steps to prevent complications, such as practicing good hygiene at your blood access site by disinfecting your haemodialysis machine system as advised, or at the catheter exit site and when performing a PD exchange.
- Following the diet your physician and dietician recommend for you.
- Following your physician’s advice on daily fluid intake.
- Taking your medication as prescribed. Reporting any side effects to your physician.
- Being diligent about your dialysis. Skipping dialysis or not doing it according to your prescription may lead to complications.
- Reporting complications or the development of unusual signs or symptoms to your physician or nurse. Keep in touch with your physician and nurse! Show up at appointments and call them in case of questions or complication.
In the following text, you can find the most common potential problems for PD and HD. During training, your nurse will explain these problems in more detail.
In haemodialysis, a potential problem is an unsuccessful cannulation.
After unsuccessful cannulation, a haematoma may appear. A haematoma is a localised collection of blood, usually clotted, in the tissue. Blood may seep into the surrounding tissue, e.g. after an unsuccessful needle placement. If possible, do not place the needle in the area with the haematoma and give the area several days’ rest.
Light exercise and sport have a positive influence on your well-being, circulation and sleep at any age. Many sports are suitable for dialysis patients if you protect your catheter and vascular access well. However, please clarify with your dialysis centre which sports you can do, and to what extent.
More information can be found here
To prevent this from happening, you or your nurse will firmly attach the dialysis needle to your skin at the beginning of the treatment. Check this from time to time by yourself. In case it falls out, you can contact the clinical staff or stop the treatment. For home haemodialysis patients, there may also be warning sensors which detect a needle falling out. After the treatment, the needle is removed, the bleeding is stopped by applying a small swab and then the site is covered with a plaster.
You have to take immunosuppressives every day for as long as you have the kidney transplant. This is important to prevent rejection, as the transplanted kidney is a foreign organ to your body. You must continue to see your nephrologist regularly after the transplant. It is closely monitored how well the transplanted kidney is doing its job and whether the immunosuppressive medication may have to be adjusted. Under no circumstances should you stop taking the medication yourself! This can lead to the rejection of the transplanted kidney.