Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Haemofiltration Replacement Fluid (AHB7864). It does not contain all the available information.

It does not take the place of talking to your doctor or nurse.

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

If you have any concerns about being given this medicine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may want to read it again.

What this medicine is used for

The name of your medicine is Haemofiltration Replacement Fluid (AHB7864). It contains the active ingredients calcium chloride, glucose, magnesium chloride, potassium chloride, sodium chloride and sodium lactate.

It is used in continuous renal replacement therapy (CRRT) to treat patients with serious kidney malfunction. It is administered by injection into the vein, using specialised equipment in intensive care units.

Your doctor or nurse are best positioned to answer any questions you may have about why AHB7864 has been prescribed for you.

How it works

AHB7864 is used to purify your blood of waste products and correct the chemistry and mineral levels in your blood.

As a replacement fluid, it can also be used to improve the hydration status of your blood.

Before you are given this medicine

When you must not be given this medicine

You must not be given this medicine if you have or have had any of the following:

• if you have a low level of potassium in your blood
• if your body has trouble metabolising lactate, such as due to liver failure or heart failure
• if the access to your veins and/or arteries is not good.
• if you have an excessive risk of bleeding
• circulatory shock.

Your doctor or nurse should verify whether any of the above concerns apply to you.

You must not be given this medicine if:

• The expiry date (EXP) printed on the bag has passed.
• The packaging is damaged, leaking or shows signs of prior use or tampering.

Your nurse should verify the above before you are given AHB7864.

Before you are given it

Prior to your CRRT therapy with AHB7864, your doctor should be told if you:

• take any regular medications or other types of medicines from your pharmacy, supermarket or health food shop.
• are pregnant or breast-feeding. Your doctor will determine the benefits versus the risks of using AHB7864.
• are diabetic, as your blood glucose level will need to be carefully measured. Your insulin dose or blood glucose levels may also need to be adjusted.
• take vitamin D or medicines containing calcium, as your blood calcium levels may be adjusted.
• take medicines for your heart known as cardiac glycosides, your blood potassium levels may need to be modified.

How to take this medicine

AHB7864 must only be prescribed by a doctor and used in an intensive care unit experienced in CRRT treatment.

AHB7864 is normally administered by way of the tubing connected to specialised CRRT equipment. Your doctor and nurse will be experienced in the particulars of the administration techniques.

AHB7864 is supplied in specialised medicinal plastic bags.

Your nurse will replace the bag and tubing if any particles are observed in the solution prior to or during use.

How much and how often?

Your doctor will determine the flow rate and quantity of solution you need to best treat your condition.

For acute kidney injury, CRRT therapy with AHB7864 is carried out for a limited period and stopped when your kidney function has improved.

Overdose

As AHB7864 is given to you under the direction of an experienced doctor and intensive care team, it is very unlikely that you will receive too much. However, if you think side effects have occurred after receiving AHB7864 (see 'Side Effects' section below), your doctor or nurse should be told immediately.

While you are taking this medicine

Things you must do

If it appears that your condition or symptoms are getting worse, your doctor or nurse should be told immediately.

During CRRT therapy, your doctor or nurse will carefully check your hydration status (the amount of water in your body), the levels of potassium, other minerals, certain waste products and glucose in your blood.

Your nurse will also check for the very rare possibility of particle formation occurring during CRRT therapy. If any particles are observed in the fluid or tubing during use of AHB7864, your nurse will replace the bag and tubing.

Side effects

If it appears your condition or symptoms are getting worse while you are receiving AHB7864, your doctor or nurse should be told immediately.

All medicines can have side effects. They may not be due to the use of AHB7864. As CRRT therapy with AHB7864 is used to treat serious kidney injury, it is important to monitor whether your condition and symptoms are getting worse.

Your doctor or nurse should monitor the following possible side effects to AHB7864 or to CRRT therapy:

• disturbances in various mineral blood levels (e.g. sodium, potassium, calcium)
• low phosphate blood levels
• changes in blood pressure

Tell your doctor or the nurse should be told if you notice any of the following possible side effects to AHB7864 or to CRRT therapy:

• dizziness or light-headedness
• nausea
• vomiting
• bleeding or clotting problems
• infection

Your doctor or nurse should be told if you notice any other unusual symptoms.

Storage

AHB7864 will be stored in the pharmacy or in the intensive care unit where the temperature stays below 30°C.

Product Description

What it looks like

AHB7864 is a clear and colourless solution supplied in a specialised plastic bag.

AHB7864 is available as 5000 mL bag.

Ingredients

Active ingredients:

• sodium chloride
• sodium lactate
• calcium chloride dihydrate
• magnesium chloride hexahydrate
• glucose
• potassium chloride

It also contains the following inactive ingredients:

• water for injections
• sodium hydroxide (for pH adjustment)

Australian Registration Number

Haemofiltration Replacement Fluid (AHB7864): AUST R 19432

Distributed in Australia by

Nikkiso Australia Pty Ltd
Unit 9, 11 Brookhollow Avenue
Baulkham Hills NSW 2153
Telephone: +61 1300 277 828

This leaflet was prepared October 2019.

Published by MIMS December 2019

Notes

Distributed by Nikkiso Australia Pty Ltd

1 Name of Medicine

Calcium chloride dihydrate, Glucose, Magnesium chloride hexahydrate, Potassium chloride, Sodium chloride and Sodium lactate.

2 Qualitative and Quantitative Composition

Haemofiltration Replacement Fluid (AHB7864) is a large volume solution used undiluted as a replacement fluid in continuous renal replacement therapy (CRRT), a therapeutic technique that effects rapid corrections to fluid, electrolyte and acid-base balance in patients with acute kidney injury. The composition of the solution is described in Table 1.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/HAEMRF01.gif Equivalent to the following ionic composition. See Table 2.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/HAEMRF02.gif For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Haemofiltration Replacement Fluid is a sterile, non-pyrogenic, clear and colourless replacement fluid solution for injection. It is a ready-to-use solution that is lactate-buffered and contains no added antimicrobial preservative.

4 Clinical Particulars

4.9 Overdose

Overdose with Haemofiltration Replacement Fluid should not occur if CRRT procedures and monitoring are carried out correctly by experienced personnel. Moreover, the administration of replacement fluids can be discontinued at any time.
Of course, if 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, so ultrafiltration should be increased, and the rate and volume of replacement fluid infused reduced. In cases of marked hypohydration, ultrafiltration should be decreased or discontinued, and the volume of replacement fluid infused increased as appropriate.
Overdose may result in disturbances of electrolyte concentrations and the acid-base-balance or if an inappropriate large volume of replacement fluid is infused/administered. This could possibly lead to metabolic alkalosis, decrease of ionized calcium or tetany.
For advice on the management of overdose, please contact the Poisons Information Centre on 13 11 26.

5 Pharmacological Properties

5.3 Preclinical Safety Data

All ingredients are physiological components in human plasma.
Genotoxicity. Given the nature of its components, Haemofiltration Replacement Fluid is not considered to pose a genotoxic hazard.
Carcinogenicity. Given the nature of its components, Haemofiltration Replacement Fluid is not considered to pose a carcinogenic hazard.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

See Table 4.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/HAEMRF04.gif

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/HAEMRFST.gif