Consumer medicine information

Multibic

Calcium chloride dihydrate; Glucose; Magnesium chloride hexahydrate; Potassium chloride; Sodium chloride; Sodium bicarbonate

BRAND INFORMATION

Brand name

Multibic

Active ingredient

Calcium chloride dihydrate; Glucose; Magnesium chloride hexahydrate; Potassium chloride; Sodium chloride; Sodium bicarbonate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Multibic.

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about MULTIBIC potassium-free & 4 mmol/l potassium Solutions for Haemofiltration. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor, nurse or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about being administered this medicine, or
  • to obtain the most up-to-date information.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet when your medicine is administered to you. You may want to read it again.

What this medicine is used for

The name of your medicine is MULTIBIC potassium-free &4 mmol/l potassium Solutions for Haemofiltration. It contains the active ingredients Calcium chloride, Glucose, Magnesium chloride, Potassium chloride, Sodium chloride, Sodium bicarbonate.

It is used to treat patients with acute renal failure requiring continuous haemofiltration. It is administered intravenously in ICU units.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor's prescription.

How it works

It helps remove toxins from your blood and correct your fluid balance. It also increases the buffer capacity of your blood and thus prevents metabolic acidosis that is your blood becoming too acidic.

Use in children

This medicine should not be used in children unless your doctor has prescribed it.

Before you take this medicine

When you must not take it

Take special care with this medicine

  • Do not use MultiBic potassium-free or 4 mmol/L potassium before mixing the two solutions in the double chamber (two-compartment) bag.
  • The tubing lines used to apply MultiBic solution should be inspected every 30 minutes. If precipitate is observed within these tubing lines, bag and tubing lines must be replaced immediately and the patient carefully monitored.

Do not take this medicine if:

You have or have had any of the following:

  • You suffer from high (for MULTIBIC 4 mmol/l postassium) or low (for MULTIBIC potassium-free) levels of potassium
  • If you have metabolic alkalosis (a condition where there is too much bicarbonate in the blood)
  • If haemofiltration is in general the wrong treatment in your situation for the following reasons:
    - excessive protein metabolism (hypercatabolism)
    - an impossibility to achieve a sufficient blood flow through the haemofilter
    - a high risk of bleeding related to medications required to prevent clotting in the haemofilter
  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.
  • You have had an allergic reaction to any of the ingredients listed in this leaflet.
    Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin; fainting or hayfever-like symptoms.
    If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

If your laboratory results show that your serum levels of sodium, calcium, magnesium, phosphate, glucose, acid-base balance, urea and creatinine, body weight and fluid balance are outside of safe levels, you must stop taking this medicine immediately.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

  1. You have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. You have or have had any medical conditions, especially the following:
  • End Stage Renal Disease
  • Chronic Kidney Disease
  • Hypertension
  • Cardiovascular disease
  1. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
  2. You are currently breast-feeding or you plan to breast-feed. Do not take this medicine whilst breast-feeding until you and your doctor have discussed the risks and benefits involved.
  3. You are planning to have surgery or an anaesthetic.
  4. You are currently receiving or are planning to receive dental treatment.
  5. You are taking or are planning to take any other medicines, this includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with this medicine. These include:

  • Electrolyte substitution solutions
  • Parenteral nutrition and other infusions

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with this medicine.

How to take this medicine

Follow carefully all directions given to you by your doctor, nurse or pharmacist. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor, nurse or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Haemofiltration in patients with acute renal failure including the prescription of substitution solutions should be conducted under the direction of a physician with experience in this treatment.

MultiBic solutions containing 0 and 4 mmol/l potassium are exclusively used intravenously.

When to take it

Your doctor will tell you when these solutions are required.

How long to take it for

In acute renal failure treatment is carried out for a limited period and is discontinued when renal function is fully restored.

Continue taking your medicine for as long as your doctor tells you.

If you forget to take it

Your doctor will tell you when these solutions are required.

This solution is administered only by healthcare professionals.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you are pregnant or are planning to become pregnant
  • you are breast-feeding or are planning to breast-feed
  • you are about to have any blood tests
  • you are going to have surgery or an anaesthetic or are going into hospital.

Your doctor will check your hydration status (the amount of water in your body), the levels of potassium, other salts, certain waste products, and your blood sugar levels. Your doctor also might advise you about your diet.

The following parameters should be monitored before and during haemofiltration:
Serum potassium, serum sodium, serum calcium, serum magnesium serum phosphate, serum glucose, acid-base status, levels of urea and creatinine, body weight and fluid balance (for the early recognition of hyper- and dehydration).

The correct dosing of substitution solutions and strict monitoring of clinical chemistry parameters and vital signs will avoid interactions with other drugs.

Go to your doctor regularly for a check-up.

Tell any other doctors, nurses. dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:

  • Give this medicine to anyone else, even if their symptoms seem similar to yours
  • Take your medicine to treat any other condition unless your doctor, nurse or pharmacist tells you to
  • Stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

Your doctor will tell you whether to be careful when driving or operating machinery until you know how this medicine affects you.

Possible side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are taking this medicine or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you.

This list includes the more common side effects. Mostly, these are mild:

  • nausea (feeling sick)
  • muscle cramps
  • changes in blood pressure

Some side effects might be caused by too much or too little fluid. These are:

  • shortness of breath
  • swelling of the ankles and legs
  • dehydration (e.g. dizziness, muscle cramps, feeling thirsty)
  • blood disorders (e.g. abnormal salt concentrations in your blood)

Tell your doctor as soon as possible if you notice any of the following.

These may be serious side effects. You may need medical attention. Most of these side effects are rare.

  • Vomiting

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

These are very serious side effects and are usually very rare. You may need urgent medical attention or hospitalisation.

  • Seizures
  • Breathlessness
  • Swelling of ankles and legs

Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

  • cough, shortness of breath, wheezing or difficulty breathing.
  • swelling of the face, lips, tongue, or other parts of the body
  • rash, itching or hives on the skin
  • fainting
  • hayfever-like symptoms

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor, nurse or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What MULTIBIC potassium-free & 4 mmol/l potassium Solutions for Haemofiltration look like

MULTIBIC potassium-free & 4 mmol/L potassium is provided in a two-compartment bag with 4.75 l of an alkaline hydrogen carbonate solution in one compartment and 0.25 l of an acidic electrolyte, glucose solution in the other compartment.

The clear and colourless solutions are intended for haemofiltration administration.

Ingredients

1000 ml of the mixed solution contain: 6.136 g of Sodium chloride, 0 to 0.2982 g of Potassium chloride, 2.940 g of Sodium hydrogen carbonate, 0.2205 g of Calcium chloride, 0.1017 g of Magnesium chloride; 1.100 g of Glucose as the active ingredients.

It also contains the following inactive ingredients:

  • Water for injection
  • Hydrochloric acid 25%
  • Carbon dioxide

This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

MULTIBIC potassium-free & 4 mmol/l potassium Solutions for Haemofiltration. AUST R 206331, and AUST 206330.

Sponsor

Fresenius Medical Care Pty Ltd
305 Woodpark Road
Smithfield NSW 2164 Australia

This leaflet was last updated to Rev2 in: July 2019

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Multibic

Active ingredient

Calcium chloride dihydrate; Glucose; Magnesium chloride hexahydrate; Potassium chloride; Sodium chloride; Sodium bicarbonate

Schedule

Unscheduled

 

Name of the medicine

Multibic solutions for haemofiltration are mixtures of the following active ingredients: calcium chloride, glucose, magnesium chloride, potassium chloride, sodium chloride, sodium bicarbonate.

Excipients.

Compartment A.

Water for injections, hydrochloric acid 25%.

Compartment B.

Water for injections, carbon dioxide.

Description

Calcium chloride.

Molecular formula: CaCl2.2H2O. MW: 147.0. CAS: 10035-04-8.

Glucose.

Molecular formula: C6H12O6.H2O. MW: 198.17. CAS: 14431-43-7.

Magnesium chloride.

Molecular formula: MgCl2.6H2O. MW: 203.3. CAS: 7791-18-6.

Potassium chloride.

Molecular formula: KCl. MW: 74.55. CAS: 7447-40-7.

Sodium chloride.

Molecular formula: NaCl. MW: 58.44. CAS: 7647-14-5.

Sodium bicarbonate.

Molecular formula: NaHCO3. MW: 84.01. CAS: 144-55-8.
Multibic haemofiltration (HF) solution is a solution comprised of electrolytes needed for continuous renal replacement therapies (CRRT). It is used as a substitution solution in haemofiltration therapy.
It is used to help remove uraemic toxins and correct the patient's fluid balance; Multibic HF solution also corrects the patient's acid/ base balance. Renal failure leads to the buffer systems being exhausted which causes metabolic acidosis, and so administration of buffer base is required. Bicarbonate buffered hemofiltration solutions result in a direct increase of the buffer capacity in blood.
Multibic HF solution is provided in a two compartment bag with 4.75 L of an alkaline bicarbonate solution in one compartment (compartment B) and 0.25 L of an acidic electrolyte, glucose solution in the other compartment (compartment A) to give a total volume of 5 L after mixing.
The clear and colourless solution is intended for haemofiltration administration.
Before mixing, each 1000 mL Multibic solution contains the following. See Tables 1 and 2.
After mixing, 1000 mL of the ready to use Multibic solution contains the following. See Table 3.

Theoretical osmolarity.

Multibic potassium free: 292 mOsm/L; Multibic 4 mmol/L potassium: 300 mOsm/L. pH ≈ 7.2.
In addition, each bag with haemofiltration solution contains the following excipients:
In compartment A: Water for injections, Hydrochloric acid, 25%.
In compartment B: In compartment B: Water for injections, Carbon dioxide.

Pharmacology

Pharmacodynamics.

During continuous haemofiltration water and solutes such as uremic toxins, electrolytes, and bicarbonate are removed from the blood by ultrafiltration. The ultrafiltrate is replaced by a substitution solution (Multibic), with a balanced electrolyte and buffer composition.
The ready to use Multibic solution is a bicarbonate buffered substitution solution for intravenous administration for the treatment of acute renal failure, of any origin, by continuous haemofiltration.
The electrolytes Na+, K+, Mg2+, Ca2+, Cl-, and bicarbonate are essential for the maintenance and correction of fluids and electrolyte homeostasis (blood volume, osmotic equilibrium, acid/ base balance). The pharmacodynamic effects of the haemofiltration solution result from the additive physiological effects of the well balanced single components.

Pharmacokinetics.

The ready to use Multibic solutions must only be administered intravenously.
The distribution of electrolytes and bicarbonate is regulated in accordance with requirements and the metabolic status and residual renal function. The active substances of the substitution solution are not metabolized except for glucose. The elimination of water and electrolytes depends on cellular requirements, metabolic status, residual renal function, and on other routes of fluid losses (e.g. gut, lung, and skin).
No pharmacokinetic interactions between the individual ingredients of Multibic are known.

Absorption; distribution; metabolism; excretion.

Bioavailability of substitution solutions is 100% as they are administered intravenously.
The distribution of substitution solutions depends on the osmotic gradient between extracellular and intracellular space, whereas the distribution of dissolved electrolytes is regulated according to their intracellular and extracellular concentration gradients. Glucose freely distributes in the extracellular space and subsequently enters the cells under the assistance of insulin.
The active substances of Multibic are not metabolized except for glucose.

Special populations.

No studies have been conducted on special target patient groups.

Clinical Trials

Multibic solution is a replacement fluid, which is administered intravenously in patients with acute renal failure in intensive care units.
The clinical trial program showed that Multibic solution is effective for the target population of patients.
An open randomised multicentre trial was conducted which compared the bicarbonate buffered haemofiltration solution with a lactate solution in the continuous venovenous haemofiltration (CVVH) therapy of patients with acute renal failure. Patients were treated in parallel groups with bicarbonate (n = 61) or lactate (n = 56) buffered haemofiltration solution. The bicarbonate buffered solutions contained 0 or 2 mmol potassium depending on the serum potassium values of individual patients. The normal dosage rate was 1000 mL/h (range 600-1200 mL/h).
Both solutions produced statistically equivalent serum bicarbonate concentrations. The lactate buffered solution resulted in serum bicarbonate and base excess levels below the optimum with a trend towards acidosis. The bicarbonate buffered solution resulted in statistically higher serum bicarbonate and base excess levels but still below alkolotic values. The lactate buffered solution produced a trend towards higher serum lactate concentrations (see Table 4).
No adverse events or side effects specifically related to the bicarbonate buffered solutions were recorded.
Both solutions were adequate and therapeutically equivalent with respect to the treatment of acute renal failure.
An open label multicentre trial was conducted using bicarbonate buffered haemofiltration solution in continuous haemofiltration therapy of patients with acute renal failure and lactacidemia (N = 25). Patients were treated with bicarbonate buffered haemofiltration solution until either renal function was restored or the patient was removed from the study. The bicarbonate buffered solutions contained 0 or 2 mmol potassium depending on the serum potassium values of individual patients. The normal dosage rate was 1000 mL/h (range 600-1200 mL/h).
The solution produced physiological serum bicarbonate concentrations and acidosis was balanced within the first day of treatment. The bicarbonate buffered solution did not produce any shift to alkolotic serum bicarbonate and base excess levels. Serum bicarbonate was at optimum levels (approx. 24 mmol/L) from day 2 of treatment (see Table 5).
Haemofiltration mean duration of treatment was 5.8 ± 0.91 days (range 1 to 17 days). On day 5, mean daily ultrafiltration volume was 28.9 ± 3.17 L (range 18.7 to 55.0 L). The corresponding mean substitution volume was 26.9 ± 2.98 L (range 16.0 to 52.0 L).
No adverse events or side effects specifically related to the bicarbonate buffered solutions were recorded. The reported adverse events were complications of the severe underlying disease.
The solutions were adequate with respect to the treatment of acute renal failure and the bicarbonate buffered solution normalised the acidosis without risk for alkalosis or side effects.

Indications

Replacement fluid, which is administered intravenously in patients with acute renal failure in intensive care units.

Contraindications

Contraindications are dependent on the solutions used in patients.
Contraindications of Multibic solutions containing 0 mmol/L potassium (potassium free) are that this solution not be used with patients suffering from:
1. Hypokalaemia.
2. Metabolic alkalosis.
Contraindications of Multibic solution containing 4 mmol/L potassium are that this solution not be used with patients suffering from:
1. Hyperkalaemia.
2. Metabolic alkalosis.
Haemofiltration dependent contraindications that are due to the technical procedure itself:
1. Renal failure with increased hypercatabolism in cases where uraemic symptoms can no longer be relieved by haemofiltration.
2. Inadequate blood flow from vascular access.
3. If there is a high risk of haemorrhage on account of systemic anticoagulation.

Precautions

The haemofiltration solution should be warmed prior to infusion with appropriate equipment to approximately body temperature and must not be infused under any circumstances below room temperature.
The warming of this solution to approximately body temperature must be carefully controlled verifying that the solution is clear and without particles.
During application of Multibic in CRRT, white calcium carbonate precipitation has been observed in the tubing lines in rare cases, particularly close to the pump unit and the heating unit warming Multibic. Precipitations particularly can occur if the temperature of the Multibic solution at the inlet of the pump unit is already higher than 25°C.
Therefore, the Multibic solution in the tubing lines should be closely visually inspected every 30 min during CRRT in order to ensure, that the solution in the tubing system is clear and free from precipitate.
Precipitations may occur also with substantial delay after start of treatment.
If precipitate is observed, Multibic solution and CRRT tubing lines must be replaced immediately and the patient carefully monitored.
The serum potassium concentration must be checked regularly before and during haemofiltration. The potassium status of the patient and its trend during haemofiltration must be considered. If hypokalaemia is present or tends to develop, supplementation of potassium and/or changing to a Multibic solution with higher potassium concentration may be required.

Precautions for Multibic potassium free solution.

If hyperkalaemia tends to develop, an increase in the filtration rate may be indicated as well as usual measures of intensive care medicine.

Precautions for Multibic solution containing 4 mmol/L potassium.

If hyperkalaemia tends to develop, an increase in the filtration rate and/or changing to a substitution solution with a lower potassium concentration may be indicated as well as usual measures of intensive care medicine.
In addition, the following parameters should be monitored before and during haemofiltration: serum sodium, serum calcium, serum magnesium, serum phosphate, serum glucose, acid/ base status, levels of urea and creatinine, body weight and fluid balance (for the early recognition of hyper- and hypohydration).
Prior to use the solution bag must be carefully inspected as described in detail in the section Special precautions for disposal and other handling below.
Do not use before mixing the two compartment solutions.

Effects on fertility.

No studies have been conducted to assess the effects of Multibic on fertility.

Use in pregnancy.

(Category Exempt)
There are no adequate and well controlled studies in pregnant women with Multibic. The bicarbonate buffered substitution solution must only be used after assessment of the potential risks and benefits for the mother and child.

Use in lactation.

At present no clinical experience of use of this medicine with patients in this target group is available. The bicarbonate buffered substitution solution must only be used after assessment of the potential risks and benefits for the mother and child.

Paediatric use.

At present no clinical experience of use of this medicine with patients in this target group is available.

Use in the elderly.

At present no clinical experience of use of this medicine with patients in this target group is available.

Genotoxicity.

Given the nature of its components, Multibic is not considered to pose a genotoxic hazard.

Carcinogenicity.

Given the nature of its components, Multibic is not considered to pose a carcinogenic hazard.

Effect on laboratory tests.

The effect on laboratory tests of this medicine has not been established.

Special precautions for disposal and other handling.

The haemofiltration solution should be administered in the following steps.

1. Removal of the overwrapping and careful inspection of the haemofiltration bag.

The overwrap should only be removed immediately before administration.
Plastic containers may occasionally be damaged during transport from the manufacturer to the dialysis clinic or within the clinic itself. This can lead to contamination and microbiological or fungal growth in the haemofiltration solution. Careful visual inspection of the container before connection and of the solution before use is therefore necessary. Particular attention should be paid to even the slightest damage to the closure, the welded seam and the corners of the container in view of a possible contamination.
The solution should only be used if clear and colourless and if the container and connectors are undamaged and intact.
In case of doubt, the treating physician should decide about the use of the haemofiltration solution.

2. Mixing of the two compartments.

The two compartment bag (the bicarbonate and the electrolytes + glucose compartments) are mixed immediately before use to obtain a ready for use solution. The mixed solution is clear and colourless. After mixing both compartments, it must be checked that the peel seam is completely open, that the solution is clear and colourless and that the container is not leaking.
Unfold the small compartment; roll up the solution bag starting from the corner opposite the small compartment until the peel seam between both compartments has opened along its entire length and the solutions from both compartments are mixed.

3. Ready to use solution.

Any addition to the substitution solution should only be done after the substitution solution has been thoroughly mixed (see also Incompatibilities). After such an addition, Multibic solution should again be thoroughly mixed prior to the start of the infusion.
The ready to use Multibic solution should be used immediately, but within a maximum of 48 hours after mixing is acceptable.
If not otherwise prescribed, the ready to use Multibic solution should be warmed immediately before infusion to 36.5°C-38.0°C. The exact temperature must be selected depending on clinical requirements and the technical equipment used.
The haemofiltration solution is for single use.
Partially used and/or damaged containers should be discarded.

Interactions

Interactions.

The correct dosing of substitution solutions and strict monitoring of clinical chemistry parameters and vital signs will limit interactions with other drugs.
The following interactions could occur.
1. Electrolyte substitution solutions, parenteral nutrition and other infusions, which are usually given in intensive care medicine, could interact with the serum composition and the fluid status of the patient. This must be considered when prescribing haemofiltration treatments.
2. Haemofiltration treatments may reduce the blood concentration of drugs, especially of drugs with a low protein binding capacity, with a small distribution volume, with molecular weight below the cut off of the haemofilter and of drugs adsorbed to the haemofilter. An appropriate revision of the dose of such drugs may be required.
3. Toxic effects of digitalis may be masked by hyperkalaemia, hypermagnesaemia and hypocalcaemia. The correction of these electrolytes by haemofiltration may initiate signs and symptoms of digitalis toxicity, e.g. cardiac arrhythmia.

Incompatibilities.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. If an addition to the substitution solution is done, it should be done only after evaluating the compatibility with the substitution solution and only after the two compartments of the substitution solution have been thoroughly mixed.

Adverse Effects

Undesirable effects.

Adverse reactions, such as nausea, vomiting, muscle cramps, hypotension and hypertension, may result from the treatment mode itself or may be induced by the substitution solution.
In general, the tolerability of bicarbonate buffered haemofiltration solution is good. However, the following potential side effects of the treatment can be anticipated:
hyper- or hypohydration, electrolyte disturbances (e.g. hypokalaemia), hypophosphataemia, hyperglycaemia, and metabolic alkalosis.

Dosage and Administration

Haemofiltration in patients with acute renal failure including the prescription of Multibic solutions should be under the direction of a physician with experience in this treatment.
In acute renal failure treatment is carried out for a limited period and is discontinued when renal function is fully restored.
Multibic solutions containing 0 and 4 mmol/L potassium are exclusively indicated for intravenous use.
Infuse the ready to use Multibic solution into the extracorporeal circulation by means of a metering pump.
As blood serum is filtered off in haemofiltration, the filtered volume, minus the necessary ultrafiltration fluid, must be substituted in the form of Multibic solution.
The filtration rate is prescribed by the attending physician depending on the clinical status and the body weight of the patient. Unless otherwise prescribed a total filtration rate of 20-25 mL/kg/h is appropriate in adults to remove metabolic waste products depending on the metabolic status of the patient. A maximum filtration rate of 75 L per day is recommended.
There is no clinical experience on the use and dosing of this product in children.
For instructions on use of the product, see Special precautions for disposal and other handling.

Overdosage

No reports of emergency situations have arisen after using recommended doses. Moreover, the administration of the solution can be discontinued at any time. If the fluid balance is not accurately calculated and monitored, hyperhydration or hypohydration may occur resulting in associated circulatory reactions. These may be manifest through changes in blood pressure, central venous pressure, heart rate, and pulmonary arterial pressure. In cases of hyperhydration congestive cardiac failure and/or pulmonary congestion may be induced.
In cases of hyperhydration, ultrafiltration should be increased, and the rate and volume of substitution solution infused reduced. In cases of marked hypohydration, ultrafiltration should be decreased or discontinued, and the volume of substitution solution infused increased as appropriate.
Overdosage may result in disturbances of electrolyte concentrations and the acid-base-balance, e.g. an overdose of bicarbonate may occur if an inappropriate large volume of substitution solution is infused/administered. This could possibly lead to metabolic alkalosis, decrease of ionized calcium, or tetany.
Contact the Poisons Information Centre on 13 11 26 (Australia) for advice on the management of overdosage.

Presentation

Multibic potassium-free Solution for Haemofiltration. AUST R Number 206331.
Multibic 4 mmol/L potassium Solution for Haemofiltration. AUST R Number 206330.
The quantities and strengths of each therapeutically active ingredient are provided in the Description section.
The container consists of a double chamber bag. The contents of this bag are 4.75 L (alkaline bicarbonate solution) + 0.25 L (acidic electrolyte, glucose solution) = 5.0 L (ready-to-use solution).
The film used for the bag is made of polyethylene terephthalate (PET), which is coated with SiOx as a gas barrier, polyamide and a polypropylene-synthetic elastomer blend.
The double chamber bag is wrapped in a film made of a polyolefine-synthetic elastomer and/or plastomer blend.
In each carton are packed 2 bags each containing 5 L solution.

Storage

Store below 30°C. Do not store below 4°C.

Shelf life after mixing.

48 hours.
Product is for single use in one patient only. Discard any residue.
Chemical and physical in-use stability of the ready to use solution has been demonstrated for 48 hours at 25°C. Other in-use storage times and conditions prior to use (longer than 48 hours including the duration of the treatment, higher than 25°C prior to the inlet of the pump unit) are the responsibility of the user.
From a microbiological point of view, once connected to the haemofiltration circuit, and as bicarbonate is present, the product shall be used immediately. Other in-use storage times and conditions are the responsibility of the user.

Poison Schedule

Unscheduled.