Consumer medicine information

multiBic® potassium-free and multiBic® 4 mmol/L potassium solutions for haemofiltration


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


1. Why am I using multiBic®?

multiBic® solutions contain the active ingredients Potassium chloride (multiBic® 4 mmol/L potassium only), Sodium chloride, Sodium bicarbonate, Calcium chloride dihydrate, Magnesium chloride hexahydrate and Glucose monohydrate. multiBic® is used as a substitution solution in haemofiltration therapy.

For more information, see Section 1. Why am I using multiBic®? in the full CMI.

2. What should I know before I use multiBic®?

Do not use if you have ever had an allergic reaction to multiBic® or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use multiBic®? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with multiBic® and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use multiBic®?

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. More instructions can be found in Section 4. How do I use multiBic®? in the full CMI.

5. What should I know while using multiBic®?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using multiBic®.
Things you should not do
  • 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.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how multiBic® affects you.
Drinking alcohol
  • Tell your doctor if you drink alcohol
Looking after your medicine
  • Follow the instructions in the carton on how to take care of your medicine properly
  • Store it in a cool dry place away from moisture, heat or sunlight.

For more information, see Section 5. What should I know while using multiBic®? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

multiBic® potassium-free and multiBic® 4 mmol/L potassium solutions for haemofiltration

Active ingredient(s): Potassium chloride (multiBic® 4 mmol/L potassium only), Sodium chloride, Sodium bicarbonate, Calcium chloride dihydrate, Magnesium chloride hexahydrate and Glucose monohydrate


Consumer Medicine Information (CMI)

This leaflet provides important information about using multiBic® potassium-free and multiBic® 4 mmol/L potassium solutions. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using multiBic® potassium-free and 4 mmol/L potassium solutions.

Where to find information in this leaflet:

1. Why am I using multiBic®?
2. What should I know before I use multiBic®?
3. What if I am taking other medicines?
4. How do I use multiBic®?
5. What should I know while using multiBic®?
6. Are there any side effects?
7. Product details

1. Why am I using multiBic®?

multiBic® solutions contain the active ingredients Sodium chloride, Sodium bicarbonate, Calcium chloride dihydrate, Magnesium chloride hexahydrate and Glucose monohydrate. In addition, multiBic® 4mmol/L potassium solution also contains Potassium chloride.

multiBic® potassium-free and multiBic® 4 mmol/L potassium are solutions for haemofiltration. This is a process where the blood is cleaned and replaced in the body. It is used for patients whose kidneys do not function as well as they should. multiBic® is a (high risk) registered medicine which is used only in hospitals.

multiBic® potassium-free and multiBic® 4mmol/L potassium solutions are used to treat patients with acute kidney (renal) failure requiring continuous haemofiltration. It is administered intravenously in ICU units of a hospital

2. What should I know before I use multiBic®?

Warnings

Do not use multiBic® potassium-free and multiBic® 4 mmol/L potassium if:

  • You are allergic to Potassium chloride (multiBic® 4 mmol/L potassium only), Sodium chloride, Sodium bicarbonate, Calcium chloride dihydrate, Magnesium chloride hexahydrate and Glucose monohydrate or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • You have or have had any of the following:
    – You suffer from high (for multiBic® 4 mmol/L potassium) or low (for multiBic® potassium-free mmol/L potassium) 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
  • 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.

Check with your doctor if:

  • You have allergies to:
    – any other medicines
    – any other substances, such as foods, preservatives or dyes.
  • You have or have had any medical conditions, especially the following:
    – End Stage Renal Disease
    – Chronic Kidney Disease
    – Hypertension
    – Cardiovascular disease
  • You are planning to have surgery or an anaesthetic.
  • You are currently receiving or are planning to receive dental treatment.
  • 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.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not take this medicine whilst breast-feeding until you and your doctor have discussed the risks and benefits involved.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with multiBic® potassium-free and multiBic® 4 mmol/L potassium solutions and affect how they work.

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.

Haemofiltration treatments like multiBic® may reduce the blood concentration of certain medicines. Your doctor may need to revise the dose of these medicines.

Toxic effects of digitalis (a medication for certain heart conditions) may be masked by high levels of electrolytes, particularly potassium, magnesium or calcium. The correction of these electrolytes by haemofiltration with multiBic® may initiate signs and symptoms of digitalis toxicity e.g. cardiac arrhythmia.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect multiBic® potassium-free and 4 mmol/L potassium solutions or if multiBic® affects the waythese medicines work.

4. How do I use multiBic®?

How much to take / use

  • multiBic® solutions are given as IV infusions and will be administered to you by your doctor or nurse while you are in hospital. They will determine how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

When to take / use multiBic® solutions

  • multiBic® potassium-free and multiBic® 4mmol/L potassium are given as IV infusions using a special pump so can only be given while you are in hospital.
  • Your doctor will tell you when you should attend the ICU unit for administration of the solutions

If you forget to use multiBic® solutions

Your doctor will tell you when these solutions are required. This solution is administered only by healthcare professionals in a hospital. You must make sure you keep all your appointments.

If you use too much multiBic® solutions

As multiBic® is given to you by your doctor it is unlikely that you will be given too much. If you think that you have used too much multiBic® solution you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using multiBic®?

Things you should 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.

Call your doctor straight away if you:

  • Experience any adverse reactions such as nausea, vomiting, muscle cramps, low blood pressure and high blood pressure.
  • Experience serious side-effects, including seizures, breathlessness and swelling of ankles and legs.

Remind any doctor, nurses, dentist or pharmacist you visit that you are using multiBic® potassium-free or multiBic® 4 mmol/L potassium solution.

Things you should not do

  • 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.

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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how multiBic® affects you.

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

multiBic® potassium-free and multiBic® 4 mmol/L potassium solutions may cause dizziness in some people

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Storage

As your medicine will be administered to you while you are in hospital, the hospital pharmacist will be responsible for ensuring the product is stored correctly.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects What to do

Common side effects:

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

Fluid-related side effects:

  • 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)
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do

Rare side-effects

  • Vomiting

Very serious side-effects:

  • Seizures
  • Breathlessness
  • Swelling of ankles and legs
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects that you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What multiBic® potassium-free and multiBic® 4 mmol/L potassium contains

Active ingredient
(main ingredient)
1000 mL of the mixed solution contain: 6.136 g of Sodium chloride, 0 or 0.2982 g of Potassium chloride, 2.940 g of Sodium bicarbonate, 0.2205g of Calcium chloride, 0.1017 g of Magnesium chloride; 1.100 g of Glucose monohydrate (as 1.000g of Glucose anhydrous) as the active ingredients.
Other ingredients
(inactive ingredients)
  • Water for injections
  • Hydrochloric acid 25%
  • Carbon dioxide
  • Monobasic sodium phosphate dihydrate
Potential allergens This medicine is gluten-free, lactose-free, tartrazine-free and free of other azo dyes

Do not take this medicine if you are allergic to any of these ingredients.

What multiBic® potassium-free and multiBic® 4 mmol/L potassium looks like

multiBic® potassium-free and multiBic® 4 mmol/L potassium are 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.

multiBic® potassium-free Solution for Haemofiltration

AUST R 357591

multiBic® 4 mmol/L potassium Solution for Haemofiltration

AUST R 357590

Who distributes multiBic® potassium-free and multiBic® 4 mmol/L potassium

multiBic® is supplied in Australia by:

Fresenius Medical Care Australia Pty Ltd
Level 3, 78 Waterloo Road
Macquarie Park, NSW 2113
AUSTRALIA

This leaflet was prepared in July 2023

Published by MIMS October 2023