Consumer medicine information

Haemofiltration Replacement Fluid (AHB7864)

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

BRAND INFORMATION

Brand name

Haemofiltration Replacement Fluid (AHB7864)

Active ingredient

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

Schedule

Unscheduled

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

BRAND INFORMATION

Brand name

Haemofiltration Replacement Fluid (AHB7864)

Active ingredient

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

Schedule

Unscheduled

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.
Equivalent to the following ionic composition. See Table 2.
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

4.1 Therapeutic Indications

Haemofiltration Replacement Fluid is indicated as a replacement fluid in Continuous Renal Replacement Therapy (CRRT) in intensive care units to treat acute kidney injury.

4.2 Dose and Method of Administration

Haemofiltration Replacement Fluid should only be prescribed by physicians experienced in CRRT. Use of Haemofiltration Replacement Fluid is only recommended in clinical units with appropriate equipment and trained personnel.
CRRT replacement fluids are intended for intravenous infusion via the arterial or venous blood line with ultrafiltration equipment either in pre- and/or post-dilutional mode, according to the physician's prescription. Replacement fluids must be properly circulated from inlet to outlet, as in conventional haemodialysis.
Replacement fluids should be infused into the extracorporeal circulation by means of a metering pump. As the patient's blood serum is filtered off, the filtered volume minus the necessary ultrafiltration fluid is replaced with Haemofiltration Replacement Fluid as required. The specific volume of solution to be infused is determined by the physician according to the clinical status of each individual patient.
In CRRT, effluent volume expressed as total effluent volume per weight and unit time (mL/kg/h) is used as a surrogate for dose. Unless otherwise indicated, the effluent volume prescribed will be dependent on the patient's clinical status, body weight and the administration equipment ultrafiltration rate used, according to the following parameters:
Effluent volume: 20 - 35 mL/kg/h (to achieve delivered dose of 20 - 25 mL/kg/h).
Maximum effluent volume: 75 L/day.
In acute kidney injury, CRRT treatment is carried out for a limited period and is discontinued when renal function is fully restored.

Instructions for use and method of administration.

The replacement fluids should only be used where adequate equipment is available to monitor CRRT. Strict aseptic technique must be observed throughout the fluid preparation and delivery procedures, in accordance with all applicable intensive care practices and precautions:
Only remove the overwrap immediately before administration. Do not store the contents for a subsequent infusion.
Carefully inspect the bag before connection, particularly around the welded ports and container corners. Also check for minute leaks by squeezing the bag firmly. Any damage to the bag may compromise sterility. Only intact bags, with undamaged connectors and free of leaks, containing clear and colourless solutions that are free of any particulate matter should be used. If the bag is damaged or the port protector is prematurely removed, do not administer the solution and discard the bag. Occasionally condensation may occur between the overwrap and the bag due to the manufacturing process, and this is not necessarily indicative of a bag leak. In case of doubt of the integrity of the product, the treating physician should decide whether to use the replacement fluid.
If the resealable rubber plug on the medication port is missing or partially removed the bag should be discarded.
If concomitant medication is required, this must be added through the medication port. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before any admixture occurs (see Section 6.2 Incompatibilities). Any admixture must be thoroughly mixed. After addition, check for a possible colour change and/or the appearance of precipitates, insoluble complexes or crystals. Do not administer unless the solution is clear and free of precipitates. Solutions containing additives must be used immediately and not stored.
If not otherwise prescribed, the replacement fluid should be warmed immediately before infusion to 36.5 - 38.0°C (see Section 4.4 Special Warnings and Precautions for Use). The exact temperature must be selected depending on clinical requirements and the administration equipment used.
The product is for single-use in one patient only. Do not reconnect any partially used containers; discard any residue and/or damaged containers.

4.3 Contraindications

Contraindications are dependent on the CRRT technique and the Haemofiltration Replacement Solution used.

Solution-dependent contraindications.

Hypokalaemia, severe metabolic acidosis, impaired lactate metabolism or liver failure, circulatory shock.

CRRT-dependent contraindications.

Renal failure with pronounced protein catabolism in cases where uraemic symptoms cannot be corrected by CRRT.
Inadequate blood flow or arterial pressure from vascular access.
Any states where there is a high risk of haemorrhage, such as systemic anticoagulation.

4.4 Special Warnings and Precautions for Use

This solution is only recommended for use in appropriately equipped clinical units managed by trained intensive care personnel.
Replacement fluids should be warmed prior to infusion with appropriate CRRT equipment to approximate body temperature (37°C) and must not be infused under any circumstances below room temperature.
Prior to use the solution bag must be carefully inspected as described in detail, see Section 4.2 Dose and Method of Administration, Instructions for use and method of administration. Aseptic technique should be observed throughout preparation and delivery procedures.

Monitoring.

Serum potassium concentrations must be checked regularly before and during CRRT. The potassium status of the patient and its trend during therapy must be carefully considered. If hypokalaemia is present or tends to develop, usual measures of intensive care management is indicated including additional potassium supplementation. If hyperkalaemia occurs, usual measures of intensive care management including use of increased effluent rates and consideration of the use of an alternative replacement fluid to Haemofiltration Replacement Solution.
Consideration should be given to whether necessary lactate uptake may exceed the individual patient's metabolic capabilities to convert it into bicarbonate.
Special attention must be paid to acid-base equilibrium, especially in those patients with liver impairment and cardiogenic shock.
Serum lactate and pH must be closely monitored.
Very special care must be devoted to ensuring proper fluid balance for the early recognition of hyper- and hypohydration. Accurate fluid balance records and patient weight must be established and closely monitored to avoid fluid balance problems.
Fluid imbalance may cause life-threatening complications such as congestive heart failure, or excessive volume depletion resulting in hypovolaemic shock.
Similarly, electrolyte balance (chloraemia, phosphataemia, calcaemia, magnesaemia and natraemia), together with the levels of urea and creatinine should be monitored regularly to detect any potential imbalance.
Blood glucose levels should also be monitored, especially in diabetic patients.

Use in the elderly.

No studies have been conducted to assess the effects of Haemofiltration Replacement Fluid on elderly patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or drug therapy.

Paediatric use.

No clinical data available to support paediatric use.

Effects on laboratory tests.

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

4.5 Interactions with Other Medicines and Other Forms of Interactions

When prescribing Haemofiltration Replacement Fluid for an individual patient, consideration should be given to potential interactions with other concomitant therapies and related pre-existing conditions. The correct dosing of replacement fluids and strict monitoring of clinical chemistry parameters and vital signs will limit interactions with other drugs. Diabetics require careful monitoring of insulin requirements during and after treatment with glucose-containing solutions.
The following interactions could occur with CRRT and replacement fluids:
1. Electrolyte replacement fluids, 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 replacement fluids.
2. CRRT replacement fluids may reduce the blood concentration of drugs, especially those with a low protein-binding capacity, a small distribution volume, a molecular weight below the haemofilter cut-off and drugs likely to adsorb to the haemofilter. Revision of the dose of such drugs may be required.
3. Plasma levels of potassium in patients using cardiac glycosides must be carefully monitored due to an increased risk of hypokalaemia-associated arrhythmias.
4. Vitamin D, vitamin D analogues and medicines containing calcium can increase the risk of hypercalcaemia.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies have been conducted to assess the effects of Haemofiltration Replacement Fluid on fertility.
The safety of replacement fluids in pregnant women has not been established. These solutions should only be used after assessment of the potential risks and benefits for the specific mother and child by a physician.
The safety of replacement fluids in lactating women has not been established. These solutions should only be used after assessment of the potential risks and benefits for the specific mother and child by a physician.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The undesirable effects listed in Table 3 reflect the type of undesirable effects that may be commonly reported with the use of replacement fluids and CRRT.

Reporting suspected adverse effects.

Ongoing reporting of suspected adverse reactions is important as it allows continued monitoring of the benefit-risk balance of the Haemofiltration Replacement Fluid. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

The electrolytes Na⁺, K⁺, Mg²⁺, Ca²⁺, Cl^-, and lactate are essential for the maintenance and correction of fluids and electrolyte homeostasis (blood volume, osmotic equilibrium, acid-base balance). Acute and severe renal injury leads to endogenous buffer systems being exhausted, causing metabolic acidosis. While Haemofiltration Replacement Fluid is pharmacologically inactive, CRRT with this solution aims to remove uraemic toxins and correct fluid balance, electrolytes and acid-base balance. The CRRT technique replaces ultrafiltrate with Haemofiltration Replacement Fluid's balanced electrolyte and buffer composition.
Lactate-buffered replacement fluids result in an indirect increase of the buffer capacity in blood via the endogenous conversion of lactate to bicarbonate by the liver.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Replacement fluids must only be administered intravenously.

Distribution.

The distribution of replacement fluids depends on the osmotic gradient between extra- and intra-cellular space, whereas the distribution of dissolved electrolytes and lactate is regulated according to their intra- and extra-cellular concentration gradients. Glucose freely distributes in the extracellular space and subsequently enters the cells under the assistance of insulin.

Metabolism.

The active substances in Haemofiltration Replacement Fluid are not metabolized except for glucose and lactate. Lactate is a biological precursor of bicarbonate.

Excretion.

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).

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

6.1 List of Excipients

Sodium hydroxide (for pH adjustment), Water for injections.

6.2 Incompatibilities

In the absence of compatibility studies, Haemofiltration Replacement Solution must not be mixed with other medicines.
It is the responsibility of the physician to judge the incompatibility of an additive medication with the Haemofiltration Replacement Fluid AHB7864.
See Section 4.2 Dose and Method of Administration.
Never add bicarbonate to the solution as precipitation of calcium and magnesium carbonate will occur.
Bicarbonate solutions, if required, must be infused separately.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australia Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.
Product is for single-use in one patient only. Discard any residue.
From a microbiological perspective, once connected to the CRRT circuit, the product should be used immediately or no later than 24 hours. Other in-use storage times and conditions are the responsibility of the user.

6.5 Nature and Contents of Container

The solution is packaged in flexible plasticised PVC bags of 5000 mL size, containing 5000 mL of solution.
Each bag is sealed inside a protective, transparent overpouch.
Haemofiltration Replacement Fluid is supplied as 2 x 5000 mL packs.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

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Consumer medicine information

Haemofiltration Replacement Fluid (AHB7864)

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

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BRAND INFORMATION