haemofiltration fluid 

Read all of this leaflet carefully before you are given this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Duosol Potassium 2 mmol / l is and what it is used for 
2. What you need to know before you are given Duosol Potassium 2 mmol / l 
3. How to use Duosol Potassium 2 mmol / l 
4 Possible side effects 
5. How to store Duosol Potassium 2 mmol / l 
6. Contents of the packaging and other information 

What Duosol Potassium 2 mmol / l is and what it is used for

Duosol Potassium 2 mmol / l is a haemofiltration fluid. It is used for patients with acute renal failure, ie. as the kidneys can no longer eliminate waste products from the blood. Continuous haemofiltration is a method of eliminating the waste products that are normally excreted via the kidneys into the urine. The fluid corrects the fluid balance and replaces salts ( electrolytes ) lost in connection with the treatment.

2. What you need to know before you are given Duosol Potassium 2 mmol / l

You will not be given Duosol Potassium 2 mmol / l

  • if you have an abnormally low level of potassium in your blood ( hypokalaemia )
  • if you have an abnormally low level of acid in your blood ( metabolic alkalosis ).

Hemofiltration should not be used:

  • if you have kidney failure in combination with very high metabolic turnover (hypercatabolism) where haemofiltration can no longer eliminate slag products that accumulate in the blood
  • if you have poor blood circulation around the venous cannula
  • if you have a high risk of bleeding due to the use of drugs that prevent the blood from clotting (systemic anticoagulation).

Warnings and cautions

Talk to your doctor or pharmacist before giving Duosol Potassium 2 mmol / l.

Before and during hemofiltration, your blood pressure, fluid, salt ( electrolyte ) and acid-base balance, and kidney function are checked. Blood glucose and phosphate levels are monitored regularly.

Also, the concentration of potassium in serum is checked before and during hemofiltration.

Other medicines and Duosol Potassium 2 mmol / l

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your doctor will consider that the concentration of other drugs in your blood may decrease during hemofiltration.

Effects on other and other drugs ( interactions ) can be avoided with proper dosing of haemofiltration fluid and close monitoring of treatment.

The following interactions should be considered:

  • Infusion given in intensive care can change the composition of your blood and fluid balance.
  • The toxic effects of certain medicines used to treat heart failure (medicines containing digitalis ) may not be detected if the potassium or magnesium levels in your blood are too high or the calcium levels in your blood are too low. If these levels are corrected by hemofiltration, toxic effects can appear and cause, for example, abnormal heart rhythms. If you have low levels of potassium or high levels of calcium in your blood, digitalis can cause toxic effects at lower doses than those commonly used for treatment.
  • D vitamins and medicines containing calcium may increase the risk of abnormally high blood calcium ( hypercalcemia ).
  • Additional use of sodium bicarbonate may increase the risk of abnormally low levels of acid in the blood ( metabolic alkalosis ).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

At present, there is no information on the use of haemofiltration fluids during pregnancy. However, as all the ingredients in this medicine are naturally occurring substances that only replace substances lost by the body during haemofiltration, no risks to the baby during pregnancy and breastfeeding or any effects on fertility are expected.

Driving and using machines

This medicine is usually given to patients in a hospital/dialysis unit and this excludes the possibility of driving and using machines.

How to use Duosol Potassium 2 mmol / l

You will only be given this medicine under the guidance of a doctor who has experience in haemofiltration treatment.

Your doctor will prescribe the appropriate dose for you based on your clinical condition, your weight, and your metabolic condition. Unless otherwise specified, the recommended filtration rate is 20-25 ml/kg body weight/hour for patients of all ages to remove slag products normally excreted in the urine.

The ready-to-use liquid is given to you via a tubing system and with an infusion pump that belongs to the haemofiltration device (so-called extracorporeal circulation).

Acute renal failure is treated for a limited time and treatment is stopped when normal renal function has been restored.

If you take more Duosol Potassium 2 mmol / l then you should

No life-threatening events have been reported with the use of prescribed doses. Administration can be discontinued immediately if necessary.

Too much or too little can lead to too much or too little fluid in the body (hyperhydration or dehydration ). This can be detected by changes in blood pressure or heart rate.

Hydrocarbonate overdose may occur if too much hemofiltration fluid is given.

This can lead to abnormally low levels of acid in the blood ( metabolic alkalosis ), decreased amount of dissolved calcium in the blood (decrease in ionized calcium ), or muscle cramps.

Overdose can cause heart failure and/or blood clotting in the lungs and lead to changes in the salt balance (electrolyte balance) and acid-base balance.

The doctor prescribes appropriate treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them

do not need to get them.

At present, no side effects associated with this medicine have been reported, but the following side effects are still possible. The frequency of these side effects is not known (can not be calculated from the available data):

Too much or too little fluid in the body (hyperhydration or dehydration ), an abnormal amount of salts ( electrolytes ), low phosphate level in the blood ( hypophosphatemia), high blood sugar ( hyperglycemia ), abnormally low level of acid in the blood ( metabolic alkalosis ), high or low blood pressure ( hypertension or hypotension ), nausea, vomiting, and muscle cramps.

5. How to store Duosol Potassium 2 mmol / l

Keep this medicine out of the sight and reach of children.

You will not be given this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Storage

Do not store above 25 ° C.

Store in a cold place. Do not freeze.

Storage 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.

6. Contents of the packaging and other information

Content declaration


Small chamber 
Electrolyte solution
Large chamber 
Bicarbonate solution
The active substances are 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 corresponding to anhydrous glucose 5.49 g5.0 g 9.90 g9.0 g
Sodium bicarbonate 15.96 g 3.59 g

Electrolytes: [mmol / chamber] [mmol / l] [mmol / chamber] [mmol / l]
Na + 40.0 72 660 149
+ 10.0 18.0
Ca 2+ 7.5 13.5
Mg 2+ 2.5 4.5
Cl  85.0 153 470 106
HCO  190 42.8
Theoretical osmolarity [mOsm / l] 311 297

Composition of the ready-to-use haemofiltration fluid after mixing:

1000 ml of ready-to- use haemofiltration fluid contains [mmol / l]:
Na + 140
+ 2.0
Ca 2+ 1.5
Mg 2+  0.5
Cl  111
HCO  35.0
Glucose , anhydrous 5.6 (= 1.0 g)


Theoretical osmolarity[mOsm / l] 296
pH 7.0-8.0

Other ingredients are:

Electrolyte solution (small chamber)

Hydrochloric acid 25% (for pH adjustment ), water for injections

Bicarbonate solution (large chamber)

Carbon dioxide (for pH adjustment ), water for injections

What the medicine looks like and contents of the pack

Hemofiltration fluid

Clear and colorless liquid, no visible particles

This medicine is packaged in a double chamber sachet. The ready-to-use hemofiltration liquid is obtained by breaking the seal between the chambers and mixing the two liquids.

Two bags of 5000 ml (double chamber bag, 4445 ml and 555 ml) in one package.

Marketing Authorization Holder and Manufacturer

B. Braun Avitum AG

Schwarzenberger Weg 73–79

34212 Melsungen

Germany

Local representative:

B. Braun Medical AB

Box 110

182 12 Danderyd

Muhammad Nadeem

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