magnesium chloride hexahydrate, sodium chloride, sodium bicarbonate, potassium chloride, disodium phosphate dihydrate 

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: 
1. What Biphozyl, Hemodialysis / Hemofiltration Fluid is and what it is used for 
2. What you need to know before you use Biphozyl, Hemodialysis / Hemofiltration Fluid  
3. How to use Biphozyl, Hemodialysis / Hemofiltration Fluid  
4 . Possible side effects 
5. How to store Biphozyl, hemodialysis/haemofiltration fluid 6. Contents of the pack 
and other information 

What Biphozyl Hemodialysis / Hemofiltration Fluid is and what it is used for

This medicine is a fluid for dialysis treatment ( hemofiltration, hemodialysis, and hemodiafiltration) which is used to remove waste products from the blood when the kidneys are not working. This medicine is used in hospitals during intensive care with continuous kidney replacement therapy (CRRT).

This medicine is especially used to treat critically ill patients with acute kidney injury who have:

  • a normal potassium content (normal kalemi) in the blood
  • a normal pH in the blood
  • a normal phosphate level (normal phosphatemia) in the blood
  • a high calcium content ( hypercalcemia ) in the blood.

This medicine can also be used

  • when other bicarbonate sources are available or when citrate is used to prevent blood clotting in the extracorporeal pathway.
  • in case of drug poisoning or intoxication of dialyzable or filterable substances.

The active substances contained in Biphozyl may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

2. What you need to know before you use Biphozyl, a hemodialysis/haemofiltration fluid 

Do not use Biphozyl, a hemodialysis/haemofiltration fluid 

Do not use Biphozyl if you have:

  • allergy to any of the active substances or any of the other ingredients (listed in section 6)
  • a low calcium level (hypocalcemia) in the blood
  • a high potassium content ( hyperkalemia ) in the blood
  • a high phosphate level ( hyperphosphatemia ) in the blood.

Warnings and cautions

Warnings

Talk to your doctor, pharmacist, or nurse before using Biphozyl.

Biphozyl should not be used in patients with high blood potassium levels. The potassium content in your blood will be monitored regularly before and during treatment.

Because Biphozyl contains potassium, high levels of potassium in the blood may occur shortly after starting treatment. Your doctor will slow down the infusion rate and check that the potassium level has returned to the desired level. If the condition does not resolve, the doctor must immediately stop administering one. A potassium-free fluid may be used briefly to restore blood potassium levels.

Because Biphozyl contains phosphate, a high level of phosphate in the blood may occur shortly after starting treatment. Your doctor will slow down the infusion rate and check that the phosphate content has returned to the desired level. If the condition does not resolve, the doctor must immediately stop administering one.

Because Biphozyl does not contain glucose, low blood glucose levels may occur during treatment. Blood glucose levels will be monitored regularly. If low blood glucose levels occur, your doctor may use a fluid that contains glucose. Other corrective measures may be necessary to maintain the desired blood glucose level.

Your doctor will regularly check the electrolyte and acid/base parameters of patients treated with Biphozyl. Biphozyl contains hydrogen phosphate which is a weak acid that can affect your acid/base balance. If a decrease in blood bicarbonate levels develops or worsens during treatment with Biphozyl, your doctor will slow down the infusion rate. If the condition does not resolve, the doctor must immediately stop administering one.

The user instructions must be strictly followed.

The liquids in the two chambers must be mixed before use.

Use only with a CRRT dialysis machine.

Use only if the cover and fluid bag are undamaged. All seals must be intact. The use of contaminated fluid may cause sepsis and shock.

Use only with a suitable system for extracorporeal kidney replacement.

Caution

This medicine is calcium-free and may cause hypocalcemia. Infusion of calcium may be necessary.

Biphozyl can be heated to 37 ° C to increase patient comfort. Heating of the liquid before use must be carried out before preparation with only dry heat. Liquids must not be heated in water or in a microwave oven. Biphozyl should be visually inspected visually for particulate matter and discoloration prior to administration. Do not administer if the liquid is not clear or if the seal is not intact.

Your doctor will closely monitor the balance between your blood pressure and blood flow (hemodynamic status), fluid balance, electrolyte and acid/base balance throughout the procedure, including all fluid ( intravenous infusion ) and all fluid withdrawals (urine production), including those not directly related to CRRT.

This medicinal product has a hydrogen carbonate content that is in the low direction within the normal range of hydrogen carbonate content in the blood. This is suitable when citrate is used to prevent the blood from clotting because citrate is broken down into bicarbonate, or when pH values ​​(measures of the body’s acidity) have been restored to normal. The need for buffer should be evaluated by repeated measurements of the blood acid/base parameter and examination of the overall treatment. A liquid with a higher hydrogen carbonate content may be necessary.

In case of abnormally high fluid volume in the body ( hypervolemia ), the rate of net ultrafiltration prescribed for the CRRT unit may be increased, and/or the rate of administration of fluids other than replacement fluids and/or dialysis fluid may be reduced.

In case of abnormally low fluid volume in the body ( hypovolemia ), the rate of net ultrafiltration prescribed for the CRRT unit may be reduced, and / or the rate of administration of fluids other than replacement fluids and / or dialysis fluid may be increased.

Children and young people

No specific side effects are expected in children when using this medicine.

Elderly patients

No specific side effects are expected in elderly patients when using this medicine.

Other medicines and Biphozyl, hemodialysis/haemofiltration fluid 

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is important because the number of other medicines can be reduced in the body during dialysis treatment. Your doctor will decide if the dose of any of the medicines you are taking needs to be adjusted.

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

  • Additional sources of phosphate (eg nutritional fluids) may increase the risk of high phosphate levels in the blood ( hyperphosphatemia ).
  • Sodium bicarbonate may increase the risk of excess bicarbonate in the blood ( metabolic alkalosis ).
  • When citrate is used to counteract blood coagulation, as it can lower the calcium concentration in the blood.

Pregnancy, breastfeeding, and fertility

Pregnancy and breast-feeding:

There are no documented clinical data on the use of this medicine during pregnancy or lactation. This medicine should only be given to pregnant or lactating women if there is a clear need.

Fertility:

No effects on fertility are expected as sodium, potassium, magnesium, chloride, hydrogen phosphate and bicarbonate are normal components of the body.

Driving and using machines

Biphozyl has no known effect on the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Biphozyl, a hemodialysis/haemofiltration fluid 

For intravenous use and use in hemodialysis. This medicine should be used in a hospital and should only be given by healthcare professionals. The volume used, and thus the dose of the medicine depends on your condition. Dose one will be determined by the doctor.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

It is the doctor’s responsibility to determine if an added medicine can be mixed with this medicine by checking for any discoloration and/or precipitation. Before a drug is added, it must be confirmed that it dissolves and is stable together with this drug.

Dosage

When used as a replacement fluid in haemofiltration and haemodiafiltration, the range of flow rates is:

Adults: 500 – 3,000 ml / hour

Children <18 years old: 1,000 to 4,000 ml / hour / 1.73 m 2

When used as dialysate in continuous hemodialysis and continuous hemodiafiltration, the range of flow rates is:

Adults: 500 – 2,500 ml / hour

Children <18 years old: 1,000 to 4,000 ml / hour / 1.73 m 2

For adolescents (12‑18 years of age), the dose recommendation for adults should be used when the estimated pediatric dose exceeds the highest dose for adults.

Instructions for use

This medicine will be given to you in the hospital. Your doctor will know how to use it.


Instructions for use can be found at the end of this leaflet.

If you use more Biphozyl than you should Hemodialysis/haemofiltration fluid  

Contact a doctor or nurse immediately if you have taken a larger amount of this medicine than recommended in this leaflet or prescribed by a doctor and you experience discomfort.

Symptoms of overdose are fatigue, fluid retention in the body ( edema ), or shortness of breath.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your blood tests and your clinical condition will be checked regularly by a doctor or nurse in order to detect any side effects. Use of this liquid may cause:

  • Changes in salinity (disturbed electrolyte balance) such as low calcium (hypocalcemia), high potassium (hyperkalemia), and high phosphate ( hyperphosphatemia )
  • Reduction of blood bicarbonate concentration (metabolic acidosis )

There are also side effects that can be caused by dialysis treatments, such as:

  • Abnormally high ( hypervolemia ) or low fluid volume ( hypovolemia ) in the body
  • Lowered blood pressure
  • Nausea, vomiting
  • Muscle cramps.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Biphozyl, hemodialysis/haemofiltration fluid

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

No special storage instructions. 
Do not freeze.

Chemical and physical in-use stability of the mixed liquid has been demonstrated for 24 hours at +22 ° C. If not used immediately after mixing, the storage time and storage conditions before administration are the responsibility of the user and should not exceed 24 hours including the treatment time. The liquid can be flushed down the drain without harming the environment.

Do not use this medicine if the product is damaged or if you detect visible particles in the liquid. All seals must be intact.

6. Contents of the packaging and other information

Content declaration

Before preparation

In the small chamber, A (250 ml):

Magnesium chloride hexahydrate 3.05 g / l

In the Great Chamber, B (4,750 ml):

Sodium chloride 7.01 g / l

Sodium bicarbonate 2.12 g / l

Potassium chloride 0.314 g / l

Disodium phosphate dihydrate 0.187 g / l

After preparation

the ready-mixed liquid, A + B:

Active substances mmol / l mEq / l
Sodium, Na + 140 140
Potassium, K + 4 4
Magnesium, Mg 2+ 0.75 1.5
Chloride, Cl  122 122
Hydrogen phosphate, HPO 2- 1 2
Hydrogen carbonate, HCO  22 22

Theoretical osmolarity: 290 mOsm / l

pH = 7.0  8.0

Other ingredients are:

Dilute hydrochloric acid (for pH adjustment) E 507

Water for injection s

Carbon dioxide (for pH adjustment) E 290

What the medicine looks like and the contents of the pack

This medicine is a hemodialysis/haemofiltration fluid and is packaged in a two-chamber multilayer film bag containing polyolefins and elastomers. The final prepared liquid is obtained after the weld has been opened and the liquids in the small and large chambers have been mixed. The liquid is clear and colorless.

Each bag contains 5,000 ml of liquid and the bag has a transparent film cover.

Each box contains two bags and a package leaflet.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Bieffe Medical SpA

Via Stelvio, 94

230 35 Sondalo (SO)

Italy

Local representative

Baxter Medical AB

Box 63

164 94 Kista

Muhammad Nadeem

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