Duosol
Italy
Table of Contents
Patient Information Leaflet
Duosol without potassium solution for haemofiltration
Please read this leaflet carefully before this medicine is administered to you, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Duosol without potassium is and what it is used for
- What you need to know before you are administered Duosol without potassium
- How to use Duosol without potassium
- Possible side effects
- How to store Duosol without potassium
- Contents of the pack and other information
1. What Duosol without potassium is and what it is used for
Duosol without potassium is a solution for hemofiltration. It is used in patients with acute renal failure, when the kidneys are no longer able to remove waste products from the blood. Continuous hemofiltration is a procedure used to remove waste products from the body that are normally excreted by the kidneys in urine. The solution corrects fluid balance and ensures that missing salts (electrolytes) are replenished during treatment.
2. What you should know before being given Duosol without potassium
Duosol without potassium must not be administered if
- blood potassium levels are too low (hypokalaemia)
- the blood has abnormally low acid levels (metabolic alkalosis).
The haemofiltration procedure itself must not be performed if
- renal failure is associated with a high metabolic turnover (hypercatabolic state), in which case the accumulation of waste products in the body cannot be corrected by haemofiltration
- there is poor blood flow at the site where the cannula is inserted into the vein
- there is a high risk of bleeding because you are receiving medications to prevent blood clotting (systemic anticoagulation).
Warnings and precautions
Talk to your doctor or pharmacist before you are given Duosol without potassium.
Before and during haemofiltration therapy, your blood pressure, fluid balance, electrolyte balance (salts), acid-base balance, and kidney function will be monitored. Blood sugar and phosphate levels will be regularly checked.
In addition, serum potassium concentration will be monitored before and during haemofiltration.
Other medicines and Duosol without potassium
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood levels of other medicines may be reduced during haemofiltration, and your doctor will take this into account.
Interactions with other medicines can be avoided by using the correct dose of haemofiltration solution and ensuring careful monitoring.
The following interactions will be considered:
- Infusions administered in intensive care may alter blood composition and hydration status.
- The toxic effects of certain medicines used to treat heart failure (digitalis-containing medicines) may not be apparent if potassium or magnesium levels are too high or calcium levels are too low. If these levels are corrected by haemofiltration, toxic effects may emerge and cause, for example, cardiac arrhythmia. If you have low potassium levels or high calcium levels in the blood, digitalis may produce toxic effects at doses lower than those normally used in therapy.
- Vitamin D and calcium-containing medicines may increase the risk of a significant rise in blood calcium levels (hypercalcaemia).
- Additional use of sodium hydrogen carbonate may increase the risk of abnormally low acid levels in the blood (metabolic alkalosis).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before being given this medicine.
Currently, there are no available data on the use of haemofiltration solutions during pregnancy. However, since all components of this medicine are natural substances intended solely to replace those substances lost during haemofiltration, no risk to the unborn child during pregnancy or to the breastfed infant during breastfeeding is expected, nor any effects on fertility.
Driving and using machines
This medicine is normally administered to immobile patients in a hospital or dialysis unit. Therefore, driving vehicles or operating machinery is not possible.
3. How to use Duosol without potassium
This medicinal product will be administered to you exclusively under the supervision of a physician experienced in
hemofiltration techniques.
Your doctor will determine the appropriate dose for you, taking into account your clinical condition, body weight, and
metabolic status. Unless otherwise prescribed, a filtration rate of 20–25 ml/kg body weight per hour is recommended for patients of any age to remove substances normally excreted in urine.
The ready-to-use hemofiltration solution will be administered via hemofiltration devices (called extracorporeal circuits) using an infusion pump.
Treatment of acute renal failure is performed for a limited period of time and ends when kidney function is fully restored.
If you are administered more Duosol without potassium than recommended
There are no reports of life-threatening situations following administration of prescribed doses of this medicinal product. If necessary, administration can be stopped immediately.
Unbalanced administration may result in excessive or insufficient body fluids (overhydration or dehydration). This condition may become evident through changes in blood pressure or pulse.
An overdose of bicarbonate may occur if too large a volume of hemofiltration solution is administered. This may lead to abnormally low levels of acid in the blood (metabolic alkalosis), reduced levels of ionized calcium in the blood (decreased ionized calcium), or muscle cramps (tetany).
An overdose could cause heart failure and/or pulmonary congestion and may lead to disturbances in electrolyte and acid-base balance.
Your doctor will decide on the appropriate treatment.
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
At present, no side effects have been reported for this medicine; however, the following side effects are possible.
The frequency of these side effects is unknown (frequency cannot be estimated from the available data):
Excess or lack of fluids in the body (hyperhydration or dehydration), incorrect amounts of salts (electrolytes), low levels of phosphates in the blood (hypophosphatemia), high blood sugar levels (hyperglycemia), abnormally low levels of acid in the blood (metabolic alkalosis), high or low blood pressure (hypertension or hypotension), nausea, vomiting, and muscle cramps.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Duosol without potassium
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bag and on the box after “Exp”. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 30 °C.
Do not refrigerate or freeze.
Storage conditions after preparation of the ready-to-use solution
The mixed product must be used immediately. The mixed product is physically and chemically stable for 24 hours at 25 °C.
6. Package contents and other information
What Duosol without potassium contains
| The active ingredients are: | Electrolyte solution in the small compartment | Bicarbonate-containing solution in the large compartment | ||
| 555 ml contain | per 1000 ml | 4445 ml contain | per 1000 ml | |
| Sodium chloride | 2.34 g | 4.21 g | 27.47 g | 6.18 g |
| Calcium chloride dihydrate | 1.10 g | 1.98 g | ||
| Magnesium chloride hexahydrate | 0.51 g | 0.91 g | ||
| Glucose monohydrate equivalent to anhydrous glucose | 5.49 g 5.0 g | 9.90 g 9.0 g | ||
| Sodium hydrogen carbonate | 15.96 g | 3.59 g | ||
| Electrolytes: | [mmol/bag] | [mmol/l] | [mmol/bag] | [mmol/l] |
| Na+ | 40.0 | 72 | 660 | 149 |
| Ca2+ | 7.5 | 13.5 | ||
| Mg2+ | 2.5 | 4.5 | ||
| Cl- | 75.0 | 135 | 470 | 106 |
| HCO3- | 190 | 42.8 | ||
| Theoretical osmolarity [mOsm/l] | 275 | 297 | ||
Composition of the ready-to-use haemofiltration solution after mixing:
1000 ml of ready-to-use haemofiltration solution contain [mmol/l]:
Na 140
Ca 1.5
Mg 0.5
Cl 109
HCO₃ 35.0
Anhydrous glucose 5.6 (equivalent to 1.0 g)
Theoretical osmolarity [mOsm/l] 292
pH 7.0–8.0
Other components are:
Electrolyte solution (small compartment)
Hydrochloric acid 25% (for pH adjustment), water for injections
Bicarbonate solution (large compartment)
Carbon dioxide (for pH adjustment), water for injections
Description of the appearance of Duosol without potassium and contents of the pack
Haemofiltration solution
Clear, colourless solution, free from visible particles
This medicinal product is supplied in a two-compartment bag. Mixing of the two solutions following rupture of the seal between the compartments produces the ready-to-use haemofiltration solution.
Two bags of 5000 ml (two-compartment bags, 4445 ml and 555 ml) per box
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
B. Braun Avitum AG
Schwarzenberger Weg 73–79
34212 Melsungen
Germany DE
Manufacturer
B. Braun Avitum AG
Kattenvenner Straße 32
49219 Glandorf
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic: Duosol bez kalia
Estonia: Duosol ilma kaaliumita, hemofiltratsioonilahus
Finland: Duosol sine Kalium hemofiltraationeste
Italy: Duosol senza potassio soluzione per emofiltrazione
Latvia: Duosol bez kālija šķīdums hemofiltrācijai
Lithuania: Duosol K 0 hemofiltracijos tirpalas
Germany, Luxembourg: Duosol ohne Kalium Hämofiltrationslösung
Poland: Duosol nie zawierający potasu
Slovenia: Duosol brez kalija raztopina za hemofiltracijo
Spain: Priosol sin Potasio solución para hemofiltración
Netherlands: Duosol zonder Kalium, oplossing voor hemofiltratie
United Kingdom: Duosol without Potassium solution for haemofiltration
03/2018
The following information is intended exclusively for healthcare professionals:
Instructions for preparing the ready-to-use haemofiltration solution
The container and solution must be visually inspected before use. The haemofiltration solution
should only be used if the container (outer wrapper and dual-compartment bag), the intermediate seal,
and connectors are intact and undamaged, and if the solution is clear, colourless, and free from visible particles.
Remove the outer wrapper only immediately before use.
- Remove the outer wrapper.
- Flatten the bag and place it on a clean, flat surface.
- Apply pressure with both hands on the small compartment of the bag until the intermediate seal opens completely along its entire length.
- Ensure thorough mixing by rotating the bag forward and backward five times.
Administration of the ready-to-use haemofiltration solution
The haemofiltration solution must be warmed to approximately body temperature using an integrated or external
warmer. Under no circumstances should the solution be infused if its temperature is below room temperature.
In rare cases, during administration of the medicinal product, white precipitates of calcium carbonate have been observed in the tubing, particularly near the pump and heating unit. Therefore, during haemofiltration, the solution in the tubing must be visually inspected every 30 minutes to ensure that the solution in the tubing system remains clear and free from precipitate. Precipitates may also appear significantly delayed after the start of treatment. If precipitate is observed, the solution and tubing must be replaced immediately, and the patient must be closely monitored.
For single use only. Any unused portions of the solution and any damaged containers must be discarded.
Patient information leaflet: information for the patient
Duosol with 2 mmol/l of potassium solution for haemofiltration
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Duosol with 2 mmol/l of potassium is and what it is used for
- What you need to know before you are administered Duosol with 2 mmol/l of potassium
- How to use Duosol with 2 mmol/l of potassium
- Possible side effects
- How to store Duosol with 2 mmol/l of potassium
- Contents of the pack and other information
1. What Duosol with 2 mmol/l of potassium is and what it is used for
Duosol with 2 mmol/l of potassium is a haemofiltration solution. It is used in patients with acute renal failure, when the kidneys are no longer able to remove waste products from the blood. Continuous haemofiltration is a procedure used to remove waste products from the body that are normally excreted by the kidneys in the urine. The solution corrects fluid balance and ensures replacement of missing salts (electrolytes) during treatment.
2. What you need to know before you are given Duosol with 2 mmol/l of potassium
Duosol with 2 mmol/l of potassium must not be administered if
- your blood potassium level is too low (hypokalaemia)
- your blood contains abnormally low levels of acid (metabolic alkalosis).
The haemofiltration procedure itself should not be performed if
- renal failure is associated with high metabolic turnover (hypercatabolic state), in which case the accumulation of waste products in the body cannot be corrected by haemofiltration
- there is poor blood flow at the site of venous cannula insertion
- there is a high risk of bleeding because you are receiving medication to prevent blood clotting
(systemic anticoagulation).
Warnings and precautions
Talk to your doctor or pharmacist before you are given Duosol with 2 mmol/l of potassium.
Blood pressure, fluid balance, electrolyte balance, acid-base balance and kidney function are monitored before and during haemofiltration therapy. Blood glucose and phosphate levels will be regularly checked.
In addition, serum potassium concentration will be monitored before and during haemofiltration.
Other medicines and Duosol with 2 mmol/l of potassium
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Blood levels of other medicines may be reduced during haemofiltration, and your doctor will take this into account.
Interactions with other medicines can be avoided by using the correct dose of haemofiltration solution and ensuring careful monitoring.
The following interactions will be considered:
- Infusions administered in intensive care therapy may alter blood composition and hydration status.
- The toxic effects of certain medicines used to treat heart failure (digitalis-containing medicines) may not be evident if potassium or magnesium levels are too high or calcium levels are too low. If these levels are corrected by haemofiltration, toxic effects may become apparent and may cause, for example, cardiac arrhythmia. If you have low potassium levels or high calcium levels in the blood, digitalis may produce toxic effects at doses lower than normally used in therapy.
- Vitamin D and medicines containing calcium may increase the risk of a significant rise in blood calcium levels (hypercalcaemia).
- Additional use of sodium hydrogen carbonate may increase the risk of abnormally low acid levels in the blood (metabolic alkalosis).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, please consult your doctor or pharmacist before receiving this medicine.
Currently, there are no data available on the use of haemofiltration solutions during pregnancy. However, since all components of this medicine are natural substances intended only to replace those substances lost during haemofiltration, no risk to the unborn child during pregnancy or to the infant during breastfeeding is expected, nor any effects on fertility.
Driving and using machines
This medicine is normally administered to immobile patients in a hospital/dialysis unit. Therefore, driving vehicles and operating machinery are not permitted.
3. How to use Duosol with 2 mmol/l of potassium
This medicinal product will be administered to you exclusively under the supervision of a physician experienced in haemofiltration techniques.
Your physician will determine the appropriate dose for you, taking into account your clinical condition, body weight, and metabolic status. Unless otherwise prescribed, a filtration rate of 20–25 ml/kg body weight per hour is recommended for patients of any age, for the removal of substances normally excreted in urine.
The ready-to-use haemofiltration solution is administered via haemofiltration devices (called extracorporeal circuits) using an infusion pump.
Treatment of acute renal failure is performed for a limited period of time and ends when renal function is fully restored.
If you are administered more Duosol with 2 mmol/l of potassium than recommended
There are no reports of life-threatening situations following administration of prescribed doses of this medicinal product. If necessary, administration can be immediately discontinued.
Unbalanced administration may result from excessive or insufficient fluid volumes in the body (overhydration or dehydration). This condition may become evident through changes in blood pressure or pulse.
An overdose of bicarbonate may occur if too high a volume of haemofiltration solution is administered. This may lead to abnormally low levels of acids in the blood (metabolic alkalosis), reduced levels of ionized calcium in the blood (decreased ionized calcium), or muscle cramps (tetany).
An overdose could also cause heart failure and/or pulmonary congestion, and may induce disturbances in electrolyte and acid-base balance.
Your physician will decide on the appropriate treatment.
If you have any doubts about how to use this medicinal product, consult your physician or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Currently, no side effects have been reported for this medicine; however, the following side effects are possible.
The frequency of these side effects is unknown (frequency cannot be estimated from the available data):
Excess or lack of body fluids (overhydration or dehydration), abnormal levels of salts (electrolytes), low levels of phosphates in the blood (hypophosphatemia), high blood sugar levels (hyperglycaemia), blood acid levels too low (metabolic alkalosis), high or low blood pressure (hypertension or hypotension), nausea, vomiting, and muscle cramps.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide further information on the safety of this medicine.
5. How to store Duosol with 2 mmol/l of potassium
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bag and
on the outer box after “Exp”. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 30 °C.
Do not refrigerate or freeze.
Storage conditions after preparation of ready-to-use solution
The mixed product must be used immediately. The mixed product is physically and
chemically stable for 24 hours at 25 °C.
6. Contents of the pack and other information
What Duosol with 2 mmol/l of potassium contains
| The active ingredients are: | Electrolyte solution in the small compartment | Bicarbonate-containing solution in the large compartment | ||
| 555 ml contains | per 1000 ml | 4445 ml contains | per 1000 ml | |
| Sodium chloride | 2.34 g | 4.21 g | 27.47 g | 6.18 g |
| Potassium chloride | 0.74 g | 1.34 g | ||
| Calcium chloride dihydrate | 1.10 g | 1.98 g | ||
| Magnesium chloride hexahydrate | 0.51 g | 0.91 g | ||
| Glucose monohydrate equivalent to anhydrous glucose | 5.49 g 5.0 g | 9.90 g 9.0 g | ||
| Sodium hydrogen carbonate | 15.96 g | 3.59 g | ||
| Electrolytes: | [mmol/bag] | [mmol/l] | [mmol/bag] | [mmol/l] |
| Na+ | 40.0 | 72 | 660 | 149 |
| K+ | 10.0 | 18.0 | ||
| Ca2+ | 7.5 | 13.5 | ||
| Mg2+ | 2.5 | 4.5 | ||
| Cl- | 85.0 | 153 | 470 | 106 |
| HCO3- | 190 | 42.8 | ||
| Theoretical osmolarity [mOsm/l] | 311 | 297 | ||
Composition of the ready-to-use haemofiltration solution after mixing:
1000 ml of ready-to-use haemofiltration solution contain [mmol/l]:
Na 140
K 2.0
Ca 1.5
Mg 0.5
Cl 111
HCO₃ 35.0
Anhydrous glucose 5.6 (equivalent to 1.0 g)
Theoretical osmolarity [mOsm/l] 296
pH 7.0–8.0
Other components are:
Electrolyte solution (small compartment)
Hydrochloric acid 25% (for pH adjustment), water for injections
Solution with bicarbonate (large compartment)
Carbon dioxide (for pH adjustment), water for injections
Description of the appearance of Duosol with 2 mmol/l potassium and contents of the pack
Haemofiltration solution
Clear, colourless solution, free from visible particles
This medicinal product is supplied in a two-compartment bag. Mixing of the two solutions following the opening of the seal between the two compartments produces the ready-to-use haemofiltration solution.
Two bags of 5000 ml (two-compartment bags, 4445 ml and 555 ml) per box
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
B. Braun Avitum AG
Schwarzenberger Weg 73–79
34212 Melsungen
Germany
Manufacturer
B. Braun Avitum AG
Kattenvenner Straße 32
49219 Glandorf
Germany
This medicinal product is authorised in the European Economic Area Member States under the following names:
Czech Republic: Duosol s 2 mmol/l kalia
Estonia: Duosol koos 2 mmol/l kaaliumiga, hemofiltratsioonilahus
Finland: Duosol cum 2 mmol/l Kalium hemofiltraationeste
Italy: Duosol con 2 mmol/l di potassio soluzione per emofiltrazione
Latvia: Duosol ar 2 mmol/l kālija šķīdums hemofiltrācijai
Lithuania: Duosol K 2 hemofiltracijos tirpalas
Germany, Luxembourg: Duosol mit 2 mmol/l Kalium Hämofiltrationslösung
Poland: Duosol zawierający 2 mmol/l potasu
Slovenia: Duosol z 2 mmol/l kalija raztopina za hemofiltracijo
Spain: Priosol con 2 mmol/l de Potasio solución para hemofiltración
Netherlands: Duosol met 2 mmol/l Kalium, oplossing voor hemofiltratie
United Kingdom: Duosol with 2 mmol/l Potassium solution for haemofiltration
03/2018
The following information is intended for healthcare professionals only:
Instructions for preparing the ready-to-use hemofiltration solution
The container and solution must be visually inspected before use. The hemofiltration solution
should be used only if the container (outer wrapper and dual-compartment bag), the intermediate seal,
and connectors are intact and undamaged, and if the solution is clear, colorless, and free from visible particles.
Remove the outer wrapper only immediately before use.
- Remove the outer wrapper.
- Lay the bag flat and place it on a clean, flat surface.
- Apply pressure with both hands on the small compartment of the bag until the intermediate seal opens completely along its entire length.
- Ensure thorough mixing by gently rotating the bag forward and backward 5 times.
Administration of the ready-to-use hemofiltration solution
The hemofiltration solution must be warmed to approximately body temperature using an integrated or external
heater. Under no circumstances should the solution be infused if its temperature is below room temperature.
Rarely, during administration, white precipitates of calcium carbonate have been observed in the tubing, particularly near the pump and heating unit. Therefore, during hemofiltration, the solution in the tubing should be visually inspected every 30 minutes to ensure that it remains clear and free of precipitates. Precipitates may also appear significantly delayed after the start of treatment. If precipitates are observed, the solution and tubing must be replaced immediately, and the patient must be closely monitored.
For single use only. Any unused residue of the solution and any damaged containers must be discarded.
Patient information leaflet
Duosol with 4 mmol/l of potassium solution for haemofiltration
Please read this leaflet carefully before this medicine is administered to you, as it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Duosol with 4 mmol/l of potassium is and what it is used for
- What you need to know before Duosol with 4 mmol/l of potassium is administered to you
- How to use Duosol with 4 mmol/l of potassium
- Possible side effects
- How to store Duosol with 4 mmol/l of potassium
- Contents of the pack and other information
1. What Duosol with 4 mmol/l of potassium is and what it is used for
Duosol with 4 mmol/l of potassium is a solution for hemofiltration. It is used in patients with acute renal failure, when the kidneys are no longer able to remove waste products from the blood. Continuous hemofiltration is a procedure used to remove waste products from the body that are normally excreted by the kidneys in urine. The solution corrects fluid balance and ensures that missing salts (electrolytes) are replenished during treatment.
2. What you need to know before you are given Duosol with 4 mmol/l of potassium
Duosol with 4 mmol/l of potassium must not be administered if
- your blood potassium level is too high (hyperkalemia)
- your blood has abnormally low acid levels (metabolic alkalosis).
The hemofiltration procedure itself should not be performed if
- renal failure is associated with high metabolic turnover (hypercatabolic state), in which case the accumulation of waste products in the body cannot be corrected by hemofiltration
- there is poor blood flow at the site of venous cannula insertion
- there is a high risk of bleeding because you are receiving medications to prevent blood clotting (systemic anticoagulation).
Warnings and precautions
Talk to your doctor or pharmacist before you are given Duosol with 4 mmol/l of potassium.
Blood pressure, fluid balance, electrolyte balance, acid-base balance, and kidney function will be monitored before and during hemofiltration therapy.
Your blood sugar and phosphate levels will be regularly checked.
In addition, serum potassium concentration will be monitored before and during hemofiltration.
Other medicines and Duosol with 4 mmol/l of potassium
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood levels of other medicines may be reduced during hemofiltration, and your doctor will take this into account.
Interactions with other medicines can be avoided by using the correct dose of hemofiltration solution and ensuring careful monitoring.
The following interactions should be considered:
- Infusions used in intensive care therapy may alter blood composition and hydration status.
- The toxic effects of certain medicines used to treat heart failure (digitalis-containing medicines) may not be evident if potassium or magnesium levels are too high or calcium levels are too low. If hemofiltration corrects these levels, toxic effects may become apparent and may cause, for example, cardiac arrhythmia. If you have low potassium levels or high calcium levels in the blood, digitalis may produce toxic effects at lower doses than normally used in therapy.
- Vitamin D and calcium-containing medicines may increase the risk of a significant rise in blood calcium levels (hypercalcemia).
- Additional use of sodium hydrogen carbonate may increase the risk of abnormally low blood acid levels (metabolic alkalosis).
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, please consult your doctor or pharmacist before you are given this medicine.
Currently, there are no available data on the use of hemofiltration solutions during pregnancy. However, since all components of this medicine are natural substances intended only to replace those lost during hemofiltration, no risk to the unborn child during pregnancy or to the breastfed infant, nor any effect on fertility, is expected.
Driving and using machines
This medicine is normally administered to immobile patients in a hospital/dialysis unit. Therefore, driving vehicles or operating machinery is not relevant.
3. How to use Duosol with 4 mmol/l of potassium
This medicine will be administered to you exclusively under the supervision of a physician experienced in
hemofiltration techniques.
Your doctor will determine the appropriate dose for you, taking into account your clinical condition, body weight, and metabolic status. If not otherwise prescribed, a filtration rate of 20–25 ml/kg body weight per hour is recommended for patients of any age, in order to remove substances normally excreted in urine.
The ready-to-use hemofiltration solution will be administered using hemofiltration devices (called extracorporeal circuits) and an infusion pump.
The treatment of acute renal failure is carried out for a limited period of time and ends when kidney function is fully restored.
If you are administered more Duosol with 4 mmol/l of potassium than recommended
There are no reports of life-threatening situations following administration of prescribed doses of this medicine. If necessary, administration can be stopped immediately.
Unbalanced administration may result in either excessive or insufficient fluid volumes in the body (overhydration or dehydration). This condition may become evident through changes in blood pressure or pulse.
An overdose of bicarbonate may occur if too large a volume of hemofiltration solution is administered. This may lead to abnormally low levels of acid in the blood (metabolic alkalosis), reduced levels of ionized calcium in the blood (decreased ionized calcium), or muscle cramps (tetany).
An overdose could cause heart failure and/or pulmonary congestion, and may lead to disturbances in electrolyte and acid-base balance.
Your doctor will decide on the appropriate treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody will experience them.
Currently, no side effects have been reported for this medicine; however, the following side effects are possible.
The frequency of these side effects is unknown (frequency cannot be estimated from the available data):
Excess or deficiency of fluids in the body (hyperhydration or dehydration), abnormal levels of salts (electrolytes), such as high levels of potassium in the blood (hyperkalaemia), low levels of phosphates in the blood (hypophosphataemia), high blood sugar levels (hyperglycaemia), abnormally low levels of acids in the blood (metabolic alkalosis), high or low blood pressure (hypertension or hypotension), nausea, vomiting, and muscle cramps.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Duosol with 4 mmol/l of potassium
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bag and on the box after “Exp”. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 30 °C.
Do not refrigerate or freeze.
Storage conditions after preparation of the ready-to-use solution
The mixed product must be used immediately. The mixed product is physically and chemically stable for 24 hours at 25 °C.
6. Contents of the pack and other information
What Duosol with 4 mmol/l of potassium contains
| The active ingredients are: | Electrolyte solution in the small compartment | Solution with bicarbonate in the large compartment | ||
| 555 ml contains | per 1000 ml | 4445 ml contains | per 1000 ml | |
| Sodium chloride | 2.34 g | 4.21 g | 27.47 g | 6.18 g |
| Potassium chloride | 1.49 g | 2.68 g | ||
| Calcium chloride dihydrate | 1.10 g | 1.98 g | ||
| Magnesium chloride hexahydrate | 0.51 g | 0.91 g | ||
| Glucose monohydrate equivalent to anhydrous glucose | 5.49 g 5.0 g | 9.90 g 9.0 g | ||
| Sodium hydrogen carbonate | 15.96 g | 3.59 g | ||
| Electrolytes: | [mmol/bag] | [mmol/l] | [mmol/bag] | [mmol/l] |
| Na+ | 40.0 | 72 | 660 | 149 |
| K+ | 20.0 | 36.0 | ||
| Ca2+ | 7.5 | 13.5 | ||
| Mg2+ | 2.5 | 4.5 | ||
| Cl- | 95.0 | 171 | 470 | 106 |
| HCO3- | 190 | 42.8 | ||
| Theoretical osmolarity [mOsm/l] | 347 | 297 | ||
Composition of the ready-to-use haemofiltration solution after mixing:
1000 ml of ready-to-use haemofiltration solution contain [mmol/l]:
Na 140
K 4.0
Ca 1.5
Mg 0.5
Cl 113
HCO₃ 35.0
Anhydrous glucose 5.6 (equivalent to 1.0 g)
Theoretical osmolarity [mOsm/l] 300
pH 7.0–8.0
Other components are:
Electrolyte solution (small compartment)
Hydrochloric acid 25% (for pH adjustment), water for injections
Bicarbonate solution (large compartment)
Carbon dioxide (for pH adjustment), water for injections
Description of the appearance of Duosol with 4 mmol/l potassium and package contents
Haemofiltration solution
Clear, colourless solution, free from visible particles
This medicinal product is supplied in a two-compartment bag. Mixing of the two solutions following rupture of the seal between the two compartments produces the ready-to-use haemofiltration solution.
Two 5000 ml bags (two-compartment bags, 4445 ml and 555 ml) per box
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
B. Braun Avitum AG
Schwarzenberger Weg 73–79
34212 Melsungen
Germany DE
Manufacturer
B. Braun Avitum AG
Kattenvenner Straße 32
49219 Glandorf
Germany
This medicinal product is authorised in the European Economic Area Member States under the following names:
Czech Republic: Duosol s 4 mmol/l kalia
Greece: Duosol with 4 mmol/l Potassium Διάλυμα αιμοδιήθησης
Estonia: Duosol koos 4 mmol/l kaaliumiga, hemofiltratsioonilahus
Finland: Duosol cum 4 mmol/l Kalium hemofiltraationeste
Italy: Duosol con 4 mmol/l di potassio soluzione per emofiltrazione
Latvia: Duosol ar 4 mmol/l kālija šķīdums hemofiltrācijai
Lithuania: Duosol K 4 hemofiltracijos tirpalas
Germany, Luxembourg: Duosol mit 4 mmol/l Kalium Hämofiltrationslösung
Poland: Duosol zawierający 4 mmol/l potasu
Slovenia: Duosol s 4 mmol/l kalija raztopina za hemofiltracijo
Spain: Priosol con 4 mmol/l de Potasio solución para hemofiltración
Netherlands: Duosol met 4 mmol/l Kalium, oplossing voor hemofiltratie
United Kingdom: Duosol with 4 mmol/l Potassium solution for haemofiltration
03/2018
The following information is intended exclusively for healthcare professionals:
Instructions for preparing the ready-to-use hemofiltration solution
The container and solution must be visually inspected before use. The hemofiltration solution
should be used only if the container (outer wrapper and dual-compartment bag), the intermediate seal,
and connectors are intact and undamaged, and if the solution is clear, colorless, and free of visible particles.
Remove the outer wrapper only immediately before use.
- Remove the outer wrapper.
- Lay the bag flat and place it on a clean, flat surface.
- Apply pressure with both hands over the small compartment of the bag until the intermediate seal opens completely along its entire length.
- Ensure thorough mixing by gently rotating the bag forward and backward five times.
Administration of the ready-to-use hemofiltration solution
The hemofiltration solution must be warmed to approximately body temperature using an integrated or external
heater. Under no circumstances should the solution be infused if its temperature is below room temperature.
In rare cases, white precipitates of calcium carbonate have been observed in the tubing during administration,
particularly near the pump and heating unit. Therefore, during hemofiltration, the solution in the tubing must be
visually inspected every 30 minutes to ensure that it remains clear and free of precipitate. Precipitates may appear
considerably delayed after the start of treatment. If precipitates are observed, the solution and tubing must be
replaced immediately, and the patient must be closely monitored.
For single use only. Any unused solution and any damaged containers must be discarded.