hemodialysis fluid/hemofiltration fluid.
Sodium chloride / calcium chloride dihydrate / magnesium chloride hexahydrate / lactic acid / sodium bicarbonate

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
  • If you get any side effects , talk to your doctor, pharmacist or nurse. 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 Hemosol B0 is and what it is used for
2. What you need to know before using Hemosol B0
3. How to use Hemosol B0
4. Possible side effects
5. How to store Hemosol B0
6. Contents of the packaging and other information

1. What Hemosol B0 is and what it is used for

Hemosol B0 is used in hospitals in intensive care to correct chemical imbalances in the blood caused by kidney failure. The treatments have the task of removing residual products from the blood that have accumulated when the kidneys are not working.

Hemosol B0 is used in the following types of treatment in adults and children of all ages

  • hemofiltration ,
  • hemodiafiltration and
  • hemodialysis .

2. What you need to know before using Hemosol B0

Do not use Hemosol B0

If you are allergic to any of the active substances or any of the other ingredients (listed in section 6). 

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Hemosol B0.

Hemosol B0 should be used in hospitals and should only be administered by healthcare professionals. They make sure that the medicine is used safely.

Before and during treatment, your blood condition will be checked and, for example, the acid/base balance and salt concentration in the blood ( electrolytes ) will be monitored, including any fluid that you are given ( intravenous infusion ) and that you produce (urine production), including the fluid that is not is directly related to the treatment.

Because Hemosol B0 is potassium-free, the potassium levels in your blood will be closely monitored. If you have a low potassium content, extra potassium supplements may be needed.

Children

There are no special warnings or precautions when using the drug in children.

Other medicines and Hemosol B0

Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription.

The reason is that the level (concentration) in the blood of some other medicines taken may decrease during treatment with Hemosol B0. Your doctor will decide if other medicines you are taking should be changed.

It is especially important that you tell your doctor if you use any of the following:

  • Digitalis drugs (for the treatment of certain heart diseases), as the risk of irregular or rapid heartbeat ( cardiac arrhythmia ) caused by digitalis increases with low potassium concentration in the blood ( hypokalaemia ).
  • Vitamin D and drugs that contain calcium as they may increase the risk of high calcium levels in the blood ( hypercalcemia ).

The addition of bicarbonate (or other buffer sources) may increase the risk of excess bicarbonate in the blood ( metabolic alkalosis ).

When citrate is used as a blood-thinning drug, it can lower plasma calcium levels.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. No effects are expected on fertility, pregnancy, or breastfeeding newborns/infants. If you are pregnant or breastfeeding, your doctor will decide if you should receive Hemosol B0.

Driving and using machines

Hemosol B0 will not affect your ability to drive or use machines.

3. How to use Hemosol B0

Hemosol B0 should be used in hospitals and should only be administered by healthcare professionals.

The hemosol B0 volume, and thus the dose used, will depend on your condition. The dose-volume will be determined by the doctor responsible for your treatment.

Hemosol B0 can be administered directly into the bloodstream ( intravenously ) or via hemodialysis where the solution flows on one side of a dialysis membrane while the blood flows on the other side.

If you use more Hemosol B0 than you should 

Hemosol B0 should be used in a hospital and should only be administered by healthcare professionals, and your fluid balance and electrolyte and acid/base balance will be closely monitored.
Therefore, it is unlikely that you will use too much Hemosol B0.

If this is unlikely to happen and you get an overdose, your doctor will take the necessary steps and adjust your dose.

Overdose can lead to:

  • too much fluid in the blood
  • elevated levels of bicarbonate in the blood ( metabolic alkalosis )
  • and / or decreased levels of salts in the blood ( hypophosphatemia , hypokalaemia )

Instructions for use can be found in the section “The following information is only intended for healthcare professionals”.

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

4. Possible side effects

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

The following side effects have been reported (affects an unknown number of users):

  • Changes in salinity in the blood (disturbed electrolyte balance such as hypophosphatemia , hypokalaemia )
  • Increase in plasma hydrogen carbonate concentration ( metabolic alkalosis ) or decrease in plasma hydrogen carbonate concentration (metabolic acidosis )
  • Abnormally high or low fluid level in the body (hyper- or hypovolemia )
  • Nausea
  • Vomiting
  • Muscle cramps
  • Low blood pressure ( hypotension )

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Hemosol B0

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 back of the sachet and on the label after EXP. The expiration date is the last day of the specified month.

Do not store below 4 ° C.

For the reconstituted solution, chemical and physical in-use stability have been demonstrated for 24 hours at 22 ° C. From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to administration are the responsibility of the user and should not exceed 24 hours, including the time of treatment.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances before and after mixing are shown below.

1000 ml solution from the small chamber (A) contains:
Calcium chloride, 2H 2 O 5.145 g
Magnesium chloride, 6 H 2 O 2,033 g
Lactic acid 5.4 g

1000 ml solution from the large chamber (B) contains:
Sodium bicarbonate 3.09 g
Sodium chloride 6.45 g

Active substances after mixing: The
solutions in chambers A (250 ml) and B (4750 ml) are mixed into a finished solution (5000 ml) with the following composition:

  mmol / l
Calcium Ca 2+ 1.75
Magnesium Mg 2+ 0.5
Sodium, Na + 140
Chloride, Cl  109.5
Lactate 3
Hydrogen carbonate, HCO  32

Theoretical osmolarity: 287 mOsm / l

The other ingredients are carbon dioxide (E 290) and water for injections.

What the medicine looks like and contents of the pack

Hemosol B0 consists of a bag with two chambers. The bag is covered with a transparent film.

The final mixed solution is obtained by breaking the seal and mixing the two solutions. 

The mixed solution is clear and colorless. Each bag (A + B) contains 5,000 ml of haemofiltration fluid, haemodiafiltration fluid, and/or hemodialysis fluid.

Each carton contains two bags and a package leaflet.

Marketing Authorisation Holder

Baxter Holding BV

Kobaltweg 49

3542CE Utrecht

Netherlands

Manufacturer

Bieffe Medital SpA, Via Stelvio 94, 23035 Sondalo (SO), Italy

Baxter Healthcare SA, Moneen Road, Castlebar, County Mayo, F23 XR63, Ireland

Local representative

Baxter Medical AB

Box 63

164 94 Kista

This medicinal product is authorized under the European Economic Area under the names:

Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Iceland, Ireland, Croatia, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the United Kingdom, Czech Republic, Germany, Austria: Hemosol B0.

Hungary: Hemosol potassium mentes

Muhammad Nadeem

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