Consumer medicine information

Accusol 35

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

BRAND INFORMATION

Brand name

Accusol 35

Active ingredient

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

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Accusol 35.

What is in this leaflet

This leaflet answers some common questions about ACCUSOL 35 haemofiltration solution for injection. 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 ACCUSOL 35 haemofiltration solution for injection. It contains the active ingredients calcium chloride, glucose, magnesium chloride, potassium chloride, sodium chloride and sodium bicarbonate.

ACCUSOL 35 solutions are available in 3 different strengths of potassium, called potassium-free (K0), potassium 2 mmol (K2) and potassium 4 mmol (K4).

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 ACCUSOL 35 has been prescribed for you.

How it works

ACCUSOL 35 solutions purify your blood of waste products; they correct the chemistry and mineral levels in your blood.

As a replacement fluid, it can also be used to provide adequate hydration and mineral levels.

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 high level of potassium in your blood (for ACCUSOL 35 K4)
  • if you have a low level of potassium in your blood (for ACCUSOL 35 K0 or K2)
  • if you have a high level of bicarbonate in your blood
  • if the access to your veins and/or arteries is not good.
  • if you have an excessive risk of bleeding

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 ACCUSOL 35.

Before you are given it

Before starting the CRRT therapy, your doctor or nurse will ensure there is good access to your veins.

Your doctor or nurse will also ensure that you do not present a high risk of bleeding.

ACCUSOL 35 solutions are available in different potassium and glucose concentrations. Your potassium and glucose blood level will be closely checked to ensure that the most appropriate ACCUSOL 35 solution is used.

Prior to your CRRT therapy with ACCUSOL 35, your doctor should be told if you:

  • take any regular medications or other types of medicines from your pharmacy, supermarket or health food shop. This will help with your doctor's choice of ACCUSOL 35 solution and ongoing monitoring of your blood mineral and glucose levels.
  • are pregnant or breast-feeding. Your doctor will determine the benefits versus the risks of using ACCUSOL 35 solutions.
  • 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 the heart known as cardiac glycosides, your blood potassium levels may need to be modified.

How to take this medicine

ACCUSOL 35 solutions must only be prescribed by a doctor and used in an intensive care unit experienced in CRRT treatment.

ACCUSOL 35 solutions are normally administered by way of the tubing connected to specialised CRRT equipment. Your doctor and nurse are experienced in the treatment technique in their intensive care unit.

ACCUSOL 35 solutions are supplied in specialised medicinal plastic bags with two chambers. Prior to use, your doctor or nurse will thoroughly mix the contents of the two-chambers so that the ACCUSOL 35 solution is ready to administer.

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 strength of ACCUSOL 35 solution you need for your condition.

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

For acute kidney injury, CRRT therapy with ACCUSOL 35 solution is carried out for a limited period and stopped when your kidney function has improved.

Overdose

As ACCUSOL 35 solutions are 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 ACCUSOL 35 solutions (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 ACCUSOL 35, your nurse will replace the bag and tubing.

Side effects

If it appears your condition or symptoms are getting worse while you are receiving ACCUSOL 35 solutions, your doctor or nurse should be told immediately.

All medicines can have side effects. They may not be due to the solutions. As CRRT therapy with ACCUSOL 35 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 be told if you notice any of the following possible side effects to ACCUSOL 35 solutions or to CRRT therapy:

  • disturbances in various mineral blood levels (e.g. sodium, potassium, calcium)
  • low phosphate blood levels
  • changes in blood pressure
  • dizziness or light-headedness
  • nausea
  • vomiting
  • bleeding or clotting problems
  • infection
  • shortness of breath or irregular breathing (on the very rare event that particles have formed in the solution causing air bubbles to get into the blood stream)

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

Storage

ACCUSOL 35 solutions 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

ACCUSOL 35 are clear and colourless solutions supplied in a specialised plastic bag with two chambers. The two chambers are separated by an inter-chamber seal called the 'long-seal'.

The large chamber ‘A’ is at the top of the bag and the small chamber ‘B’ at the bottom is fitted with an access port which is used to connect the bag to suitable administration tubing. Your nurse will first open the long- seal to mix the ACCUSOL 35 solution and prepare it ready use. The shorter "SafetyMoon" seal at the bottom of chamber B will only be opened when your nurse is sure that the ACCUSOL 35 solution is fully mixed and ready for administration.

The two-chamber bag is provided in a protective transparent overpouch.

The volume of ACCUSOL 35 solution after mixing is 5000 mL (3750 mL from chamber A and 1250 mL from chamber B)

ACCUSOL 35 solutions are available as 2x5000 mL bags.

Ingredients

Active ingredients:

  • sodium chloride
  • sodium bicarbonate
  • calcium chloride dihydrate
  • magnesium chloride hexahydrate
  • glucose (Potassium 2 mmol/L & Potassium 4 mmol/L strengths only)
  • potassium chloride (Potassium 2 mmol/L & Potassium 4 mmol/L strengths only)

It also contains the following inactive ingredients:

  • dibasic sodium phosphate dihydrate
  • water for injections
  • hydrochloric acid (for pH adjustment)
  • sodium hydroxide (for pH adjustment)

Australian Registration Number

ACCUSOL 35 (K0) replacement fluid solution: AUST R 302424

ACCUSOL 35 Potassium 2 mmol/L (K2) replacement fluid solution: AUST R 302425

ACCUSOL 35 Potassium 4 mmol/L (K4) replacement fluid solution: AUST R 302426

Distributed in Australia by

Medline International Two Australia Pty Ltd
Sydney Australia
Telephone: 1800 110 511

This leaflet was prepared July 2020.

Published by MIMS September 2020

BRAND INFORMATION

Brand name

Accusol 35

Active ingredient

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

Schedule

Unscheduled

 

Notes

Distributed by Medline International Two Australia Pty Ltd

1 Name of Medicine

Calcium chloride dihydrate, glucose monohydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride and sodium bicarbonate.

2 Qualitative and Quantitative Composition

Before mixing.

Each 1000 mL Accusol 35 solution contains (see Table 1):

After mixing.

1000 mL of the ready-to-use Accusol 35 solution contains (see Table 2):
The mixed solution is equivalent to the following ionic composition, per 1000 mL (see Table 3):
The 5000 mL of final solution results from mixing 3750 mL of solution 'A' with 1250 mL of solution 'B'.
The pH of the final solution is between 7.0-7.5.
For a full list of excipients, see Section 6.1 List of Excipients.

Note.

The number "35" in the name specifies the buffer concentration of the solution (bicarbonate = 35 mmol/L).

3 Pharmaceutical Form

Injection, solution.
Accusol 35 potassium-free (K0), potassium 2 mmol/L (K2) and potassium 4 mmol/L (K4) are large volume solutions used undiluted as replacement fluids 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.
Accusol 35 solutions are supplied in a flexible, two-chamber bag which ensures physical separation of the electrolyte and bicarbonate solutions in their chambers, preventing possible formulation instability with precipitation of calcium carbonate during storage and transport. The Accusol 35 bag design also enables easy and complete mixing of the bicarbonate-buffered replacement fluid immediately prior to use.
Accusol 35 is a sterile, non-pyrogenic, clear and colourless replacement fluid solution for injection, free of antimicrobial preservatives. The mixed, ready-for-use, bicarbonate-buffered solution has a close to physiological pH.

4 Clinical Particulars

4.1 Therapeutic Indications

A continuous renal replacement therapy (CRRT) replacement fluid used in intensive care units for the treatment of acute kidney injury.

4.2 Dose and Method of Administration

Accusol 35 solutions should only be prescribed by physicians experienced in CRRT. Use of Accusol 35 solutions is only recommended in clinical units with appropriate equipment and trained personnel.
As CRRT replacement fluids, Accusol 35 solutions are infused intravenously 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 Accusol 35 solution as required. The specific volume and strength of mixed, ready-to-use Accusol 35 K0, K2 or K4 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.
There is no clinical experience on the use and dosing of this product in children.
In acute kidney injury, CRRT treatment is carried out for a limited period and is discontinued when renal function is fully restored.
72 hours is the maximum intended period of use for a single CRRT line.

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:

1) Removal of overpouch.

Only remove the overwrap immediately before administration. Do not store the contents for a subsequent infusion.
Do not carry Accusol 35 by overpouch.
Do not lift the bag using the bag connector.

2) Careful inspection of the bag.

Carefully inspect the bag before connection, particularly around the welded ports, seals 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 one of the seals (see Section 6.5 Nature and Contents of Container) is opened prematurely, 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.
Check that Accusol 35 is clear and free from particles and that the wings of the bag connector are in open position.
Check for leaks by squeezing the bag.

3) Add concomitant medication (if needed).

If concomitant medication is required, add this through the medication port (located in the larger electrolyte chamber, see Section 6.5 Nature and Contents of Container).
Remove blue pull ring and disinfect medication port.
Inject additives before opening the long seal.
As with all parenteral solutions, compatibility of any additive medications must be checked before any admixture occurs (see Section 6.2 Incompatibilities).

4) Mixing of the buffer and electrolyte solution.

Only open the long peel seal (inter-chamber seal, see Section 6.5 Nature and Contents of Container) to mix the buffer and electrolyte solutions just prior to use, and after any concomitant medication is thoroughly mixed within the electrolyte solution.
Position Accusol 35 with the bag connector facing away from you.
Grasp the two sides of the large chamber and squeeze the sides inwards while rolling your wrists under the bag to open the long peel seal.
Press down on the upper and lower chambers to open the long peel seal and mix the solutions.
Check that the long peel seal has been completely opened and the two solutions are completely mixed.
The mixed, ready-to-use solution must be visually inspected for clarity and colour, and the container checked again for any leaks by squeezing the bag. Only bags without leaks, containing final solutions that are free of precipitates, insoluble complexes or crystals, and without any evidence of colour change, should be used.

5) To begin Accusol 35 administration.

Open the short safety-moon seal by lifting the large chamber, grabbing the bag firmly in both hands and rolling it towards the connector.
Apply pressure by leaning over the bag and pushing the solution towards the short seal to open it.
Remove the tip protector from the port, hang the bag onto either a drip stand or weighing scales (if using automated equipment), connect the bag to the patient line and activate the access port.
Hold the bag connector halfway down the wings.
Squeeze with one hand until the wings securely clip onto the main body of the connector (you will hear some clicks).

Important.

Solutions including any concomitant medications should be used immediately. Replacement fluids containing no additives should be used shortly after mixing, and within a maximum of 24 hours.
Solution should be warmed to 36.5°C-38.0°C immediately before infusion (see Section 4.4 Special Warnings and Precautions for Use). The exact temperature will depend on clinical requirements and administration equipment used.
Accusol 35 solutions are for single-use in one patient only. Do not reconnect any partially-used containers; discard any unused residue and/or damaged containers.

4.3 Contraindications

Contraindications are dependent on the CRRT technique and specific Accusol 35 solution strength used.

Accusol 35 K0- and K2-dependent contraindications.

Hypokalaemia, if no simultaneous adapted potassium supplementation.
Metabolic alkalosis.

Accusol 35 K4-dependent contraindications.

Hyperkalaemia, if no simultaneous adapted potassium supplementation.
Metabolic alkalosis.

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

General.

Use of Accusol 35 solutions is only recommended 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.
Do not use before mixing both chamber solutions (see Section 4.2 Dose and Method of Administration above). In case the long peel seal (interchamber seal) is not opened (i.e. only short SafetyMoon seal near access port opens) and the solution of the small chamber "B" is given, alkalosis may arise. The most common clinical signs and symptoms of alkalosis are nausea, lethargy, headache, arrhythmia and respiratory depression. The short SafetyMoon seal above the connector protects against this mis-use and avoid the mis-infusion to patient.
Prior to infusion of the mixed replacement fluid, the solution bag must be carefully inspected as described in detail in Dose and Method of Administration, Instructions for use and method of administration. Aseptic technique should be observed throughout preparation and delivery procedures.

Monitoring.

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.
Similarly, electrolyte balance (chloraemia, phosphataemia, calcaemia, magnesaemia and natraemia) as well as acid-base balance should be monitored regularly to detect any potential imbalances.
Rarely, precipitation of calcium carbonate may occur several hours after the start of therapy. If precipitate or particles are observed in the solution or in the CRRT tubing, Accusol 35 replacement fluid and CRRT tubing lines must be replaced immediately and the patient carefully monitored.
Accusol K0 solution does not contain glucose. In clinical study, an episode of hypoglycaemia was noted in a patient treated with Accusol K0 solution. Blood glucose levels should also be monitored, especially in diabetic patients.
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 potassium supplementation and/or preferential use of higher strength Accusol 35 K2 or K4 solutions may be required. If hyperkalaemia occurs, usual measures of intensive care management including use of increased filtration rate and/or use lower strength Accusol 35 K2 or K0 solutions may be required.

Use in the elderly.

No studies have been conducted to assess the effects of Accusol 35 on elderly patients.

Paediatric use.

There are no specific warnings or precautions when using this medicine in children.

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

Interactions.

When prescribing Accusol 35 solutions, consideration should be given to the 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.
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, with 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.
5. Additional sodium bicarbonate (from additional buffer fluids or from the replacement fluid itself) can increase the risk of metabolic alkalosis.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies have been conducted to assess the effects of Accusol 35 on fertility. However, as the active components are present at concentrations similar to physiological plasma levels, no adverse effects on fertility are anticipated.
There are no animal or clinical data on the use of Accusol 35 during pregnancy. The bicarbonate-buffered replacement fluid must only be used after assessment of the potential risks and benefits for the specific mother and child.
 There are no animal or clinical data on the use of Accusol 35 during lactation. The bicarbonate-buffered replacement fluid must only be used after assessment of the potential risks and benefits for the specific mother and child.

4.7 Effects on Ability to Drive and Use Machines

Not relevant.

4.8 Adverse Effects (Undesirable Effects)

Potential adverse effects reported with the use of Accusol 35 may be associated with CRRT treatment or with the medicine itself. The tolerability of bicarbonate-buffered replacement fluid solution is generally good; however, the following adverse effects have been reported in literature with CRRT procedures (see Table 4):
The following adverse effects have been reported in literature with the use of replacement fluids (see Table 5):

Clinical trials.

The following adverse reaction was identified from a clinical trial with 16 patients requiring high-volume CRRT for severe acute renal injury in intensive care (see Table 6):

Post-marketing experience.

No additional adverse reactions have been reported with Accusol 35 to date.
No administration error; mis-infusion or product quality issues such as overdose, off-label use, inter-chamber seal malfunction, or precipitate formation have been reported with Accusol 35 to date.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdose with Accusol 35 should not occur if CRRT procedures and monitoring are carried out correctly by experienced personnel, thus no reports of emergency situations have been reported. 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, e.g. an overdose of bicarbonate may occur if the bag is erroneously connected and administered prior to adequate mixing of the chambers (see Section 4.4 Special Warnings and Precautions for Use) 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 information on the management of overdose, contact the Poison Information Centre on 13 1126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

The mixed, ready-to-use Accusol 35 solution is a bicarbonate-buffered replacement fluid for intravenous administration for the treatment of acute kidney injury, of any origin, by CRRT.

Mechanism of action.

The electrolytes Na+, K+, Mg2+, Ca2+, Cl-, and HCO3- 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. CRRT aims to remove uraemic toxins and correct fluid balance, electrolytes, bicarbonate levels and acid-base balance. The CRRT technique replaces ultrafiltrate with Accusol 35's balanced electrolyte and buffer composition.
Bicarbonate-buffered replacement fluids result in a direct increase of the buffer capacity in blood.

Clinical trials.

The use of replacement fluids such as Accusol 35 in CRRT have been well established in clinical practice, as documented in Kidney Health Australia's Caring for Australasians with Renal Impairment (KHI-CARI) Dialysis Interventions for the Treatment of Acute Kidney Injury Guidelines1.
1 http://www.cari.org.au/CKD/CKD%20aki/Section_5_2_Dialysis_interventions_AKI%20_Final.pdf.

5.2 Pharmacokinetic Properties

The ready-to-use Accusol 35 solutions must only be administered intravenously.
No pharmacokinetic interactions between the individual ingredients of Accusol 35 are known.

Absorption.

Bioavailability of intravenously administered replacement fluids is 100%.

Distribution.

The distribution of replacement fluids depends on the osmotic gradient between extra- and intra-cellular space, whereas the distribution of dissolved electrolytes and bicarbonate 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 of Accusol 35 are not metabolized except for glucose.

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).

Special populations.

No studies have been conducted on special target patient groups.

5.3 Preclinical Safety Data

All ingredients are physiological components in human plasma.

Genotoxicity.

No specific studies on genotoxicity have been performed with Accusol 35. Given the nature of its components, Accusol 35 is not considered to pose a genotoxic hazard.

Carcinogenicity.

No carcinogenicity studies have been performed with Accusol 35. Given the nature of its components, Accusol 35 is not considered to pose a carcinogenic hazard.

6 Pharmaceutical Particulars

6.1 List of Excipients

Dibasic sodium phosphate dihydrate, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).

6.2 Incompatibilities

Additives should always be made via the larger electrolyte solution medication port (see Section 4.2 Dose and Method of Administration, Instructions for use and method of administration).
As with all parenteral solutions, compatibility of any additive medications must be checked before any admixture with Accusol 35 occurs. Those additives known to be incompatible should not be used. If available, consult with the pharmacist for confirmation.
In the absence of compatibility studies, Accusol 35 must not be mixed with other medicines.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian 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, and as bicarbonate is present, the product should be used immediately or no later than 24 hours after mixing. Other in-use storage times and conditions are the responsibility of the user.

6.5 Nature and Contents of Container

Accusol 35 solutions are provided in two-chamber bags - the container material being a non-PVC, coextruded film of 3 layers (polypropylene; polyamide; and compound polypropylene + styrene-ethylene butylene-styrene + polyethylene). A long, peel seal (inter-chamber seal) separates the two chambers in the bag.
The large chamber 'A' is fitted with a medication port (also known as the 'injection site' port) and the small chamber 'B' is fitted with an access port for connection to a suitable administration set. A short SafetyMoon seal, located near the access port, needs to be opened to allow administration of the mixed ready-to-use replacement fluid.
The two-chamber bag is sealed in a protective, transparent over-pouch.
The volume of the bag after mixing is 5000 mL (3750 mL in the large chamber A and 1250 mL in the small chamber B).
Accusol 35 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.

6.7 Physicochemical Properties

See Table 7.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes