Duosol Solution

Duosol 02 is a solution for haemofiltration. It is intended for use in patients with acute kidney failure, when the kidneys are no longer able to remove waste products from the blood. Continuous haemofiltration is a procedure which is used to remove the waste products from the body which would otherwise be excreted via the kidneys in urine. The solution corrects the fluid balance and ensures that salt (electrolyte) losses are replaced following treatment.

Duosol 02 should not be given if:

• you have an abnormally low blood potassium level (hypokalaemia)
• your blood contains abnormally low acid levels (metabolic alkalosis)

The haemofiltration procedure itself should not be used if:

• you have kidney failure in combination with a very high metabolic turnover (hypercatabolic state), in which situation the accumulation of waste products in your body can no longer be corrected by haemofiltration
• you have poor blood flow from the site of insertion of the cannula of the vein
• you have a high risk of bleeding because you receive medicine to prevent blood clotting (systemic anticoagulation).

Warnings and precautions

Tell your doctor or health care provider before you are given Duosol 02. Before and during haemofiltration your blood pressure, fluid balance, salt (electrolyte) balance, acid-base balance and kidney function will be monitored. Your blood sugar and phosphate levels will regularly be checked. Furthermore serum potassium concentration will be monitored before and during haemofiltration.

Other medicines and Duosol 02

Always tell your health care provider if you are taking any other medicine (This includes all complementary or traditional medicines). The level of other medicines in your blood may be reduced during haemofiltration and your doctor will take this into account. Interactions with other medicines can be avoided by ensuring that the correct dose of the solution for haemofiltration is used and by careful monitoring.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself Duosol 02. You will only be given this medicine under the direction of a person with experience in haemofiltration techniques. Your doctor will decide on the proper dose for you, taking into account your clinical status, your body weight and your metabolic condition. Unless otherwise prescribed, a filtration rate of ca.600 – 1200 mL per hour is recommended for patients of all ages for the removal of those substance which are normally excreted in the urine. Nevertheless a maximum filtration rate of 75 L per day should not be exceeded.

You are given the ready-to-use solution for haemofiltration via the tubing of the haemofiltration apparatus (the so-called extracorporeal circulation) using an infusion pump.

If you are given more Duosol 02 than recommended

There have been no reports of life-treatening situations following the administration of the prescribed dose of this medicine. The administration can be stopped immediately, if required.

Unbalanced administration can result in too much or too little fluid being present in the body (hyperhydration or dehydration). This situation can become apparent through changes in blood pressure or pulse. Hydrogen carbonate overdose can occur if a too large volume of solution for haemofiltration is given. This can lead to abnormally low acid levels in the blood (metabolic alkalosis), less calcium dissolved in the blood (decrease of ionised calcium) or muscle cramps (tetany). An overdosage can be the cause of a heart failure and/or congested lung and can cause changes in the salt (electrolyte) balance and acid-base balance. Since a health care provider will administer Duosol 02, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

Duosol 02 can have side effects. Not all side effects reported for Duosol 02 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while given Duosol 02, please consult your health care provider for advice. The following side effects may occur, but the frequency of these side effects is not known (cannot be estimated from available data):

• Too much or too little fluid in the body (hyperhydration or dehydration),
• abnormal salt (electrolyte) levels,
• low blood phosphates levels (hypophosphataemia),
• high blood sugar levels (hyperglycaemia),
• abnormally low acid levels in the blood (metabolic alkalosis),
• high or low blood pressure (hypertension or hypotension),
• feeling sick (nausea),
• being sick (vomiting)
• and muscle cramps.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your health care provider. You can also report side effects to SAHPRA via the "6.04 Adverse Drug Reaction Reporting Form", found online under SAHPRA's publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Duosol 02.

Store all medicines out of reach of children. You should not be given this medicine after the expiry date which is stated on the bag and on the carton after "EXP". The expiry date refers to the last day of that month.

Storage conditions:

• Store at or below 25 ˚C.
• Do not refrigerate or freeze.

Storage conditions after preparation of the ready-to-use solution.

• The mixed product should be used immediately.
• The mixed product is physically and chemically stable for 24 hours at 25 ˚C.