Consumer medicine information

Volulyte 6%

Hydroxyethyl starch; Sodium chloride; Sodium acetate trihydrate; Potassium chloride; Magnesium chloride hexahydrate

BRAND INFORMATION

Brand name

Volulyte Solution for infusion

Active ingredient

Hydroxyethyl starch; Sodium chloride; Sodium acetate trihydrate; Potassium chloride; Magnesium chloride hexahydrate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Volulyte 6%.

What is in this leaflet

This leaflet answers some common questions about Volulyte. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you given Volulyte against any benefits they expect it will have for you.

Please read this leaflet carefully. If you have any questions or are unsure about anything, please ask your doctor or pharmacist.

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

What is Volulyte used for

Volulyte is a plasma volume substitute that is used to restore the blood volume when you have lost blood when other products called crystalloids are not considered sufficient alone. It is not a substitute for blood or blood containing products.

Before you are given Volulyte

You must NOT use this product if you:

  • are critically ill to be admitted to intensive care unit.
  • have too much fluid in your body and you have been told that you have a condition known as hyperhydration
  • have been told that you have pulmonary oedema where too much fluid is in your lungs
  • have been told that you have a congestive heart failure (a condition in which your heart cannot pump enough blood to other organs of your body)
  • have kidney failure and you produce little or no urine and if this is not caused by low blood volumes (hypovolemia)
  • are receiving dialysis treatment (an artificial kidney treatment)
  • suffer from bleeding within or around the brain (intracranial bleeding)
  • are allergic (hypersensitive) to hydroxyethyl starch or any of the other ingredients.
  • have coagulation or bleeding disorder
  • have severe liver disease
  • have too high sodium, potassium or chloride levels in your blood
  • have a severe blood infection

Your doctor may need to take special precautions and will decide whether you can receive Volulyte if you suffer from:

  • problems with your heart or kidneys as there is an increased risk of fluid overload with the use of Volulyte
  • a severe lack of fluid (dehydration). In this case your doctor should administer a salt solution first

Before you use Volulyte, you must also tell your doctor if you have problems with your heart, liver or lung. Special care has to be taken while this product is given to you. Infusion of large quantities of plasma substitutes may cause too much dilution of blood components or blood clotting factors and blood samples may be taken to check this.

If you have impaired kidney function, your doctor will need to adjust the dosage since Volulyte is excreted by the kidneys

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

The safety of the product in pregnant and breast-feeding women has not been investigated.

How Volulyte is given

How much will be given

Your doctor will determine the amount of Volulyte that is appropriate for you.

How is it given

Volulyte should be administered by continuous drip into the vein using a sterile tubing and needle. It should only be administered to you by qualified medical staff. You will be kept under close observation by a health professional at the beginning of Volulyte infusion to ensure that you do not have an allergic reaction as all plasma substitutes carry a slight risk of allergic reactions that can be mild or severe.

If you are given too much (overdose)

This rarely happens as Volulyte is usually administered under the care of a trained health care professional in a hospital or clinic setting.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

Otherwise immediately telephone your doctor or contact the Poisons Information Centre in your country.
Australia: 13 11 26
New Zealand: 0800 764 766.

Side Effects

Like all medicines, Volulyte can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nursing staff immediately:

Rare (occurring in more than 1 in 10,000 patients, but less than 1 in 1,000 patients)

  • Medicinal products containing hydroxyethyl starch may lead to severe allergic reactions (reddening of the skin, swelling of the throat, and difficult breathing, mild influenza like symptoms, low or high heart rate, fluid in the lungs not caused by heart problems).
  • After administration of hydroxyethyl starch disturbances of blood clotting can occur depending on the dose.

Common (occurring in more than 1 in 100 patients, but less than 1 in 10 patients)

  • Itching is a known side effect of hydroxyethyl starches when used over long periods of time and at high doses.
  • Other effects are associated with the dilution of the blood and its components, which occurs at high dosages, such as prolonged blood clotting time.
  • The level of the enzyme serum amylase can rise during administration of hydroxyethyl starch and can interfere with the diagnosis of inflammation of the pancreas (pancreatitis); however, hydroxyethyl starch does not cause pancreatitis.

If you have any unexpected effects after receiving Volulyte, or you feel unwell during treatment, contact your doctor or pharmacist.

Storage

Volulyte should be stored below 25°C and not be frozen. As with any medicine, Volulyte should be stored out of the reach of children. Do not use injections that have been used, have expired or the container is damaged.

Product Description

What it looks like

Volulyte 6% is a clear to slightly opalescent, colourless to slightly yellow solution which comes in a plastic bag.

Ingredients

Volulyte contains the active ingredients Hydroxyethyl starch 130/0.4, Sodium chloride, Sodium acetate trihydrate, Potassium chloride and Magnesium chloride hexahydrate.

It also contains other inactive ingredients such as hydrochloric acid, sodium hydroxide and water for injections.

Volulyte does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Volulyte does not contain any preservative.

Volulyte comes in 2 different sizes of plastic (freeflex®) bag. They can be identified by the following AUST R numbers:

freeflex® bags 250 mL
AUST R 172173

freeflex® bags 500 mL
AUST R 187473

Further Information
More detailed information is available from your doctor or pharmacist. Therefore, if you have any concerns about the information or about Volulyte please ask your doctor or pharmacist.

BRAND INFORMATION

Brand name

Volulyte Solution for infusion

Active ingredient

Hydroxyethyl starch; Sodium chloride; Sodium acetate trihydrate; Potassium chloride; Magnesium chloride hexahydrate

Schedule

Unscheduled

 

1 Name of Medicine

Hydroxyethyl starch 130/0.4; magnesium chloride hexahydrate; potassium chloride; sodium acetate trihydrate; sodium chloride.

6.7 Physicochemical Properties

Hydroxyethyl starch (HES) is a derivative of amylopectin, which is a highly branched compound of starch. In humans and animals amylopectin is rapidly hydrolysed by amylase. In order to reduce the metabolic degradation, glucose residues of the amylopectin are reacted with ethylene oxide. The hydroxyethyl groups can be introduced at three positions (C2, C3, C6) of the glucose residues. The degree of substitution and the substitution pattern expressed by the C2/C6 ratio determines the enzymatic degradation of HES. Volulyte is characterised by its molar substitution, molecular weight and the C2/C6 ratio.
Molecular weight (Mw): the molecular weight indicates the weight average. The Mw of HES 130/0.4 lies between 110,000 and 150,000 Dalton, which corresponds approximately to 609 to 830 partially hydroxyethylated glucose units.
Molar substitution (MS): the ratio of hydroxyethyl groups to glucose units is called the molar substitution (MS). The MS for this substance is 0.4 (range 0.38 - 0.45) and determines the molar ratio of hydroxyethyl ether groups to glucose units.
C2/C6 ratio: this parameter gives information about the preferred position of hydroxyethylation and reflects the different intrinsic reactivity of the secondary and the primary alcohol functionality at the respective positions of the glucose ring. The value of the C2/C6 ratio should be higher than 8.
Hydroxyethyl starch 130/0.4 is a white to yellowish white, odourless and tasteless, amorphous powder, readily soluble in water at room temperature, soluble in DMSO, practically insoluble in most organic solvents.

Chemical structure.


Proper or common name: Hydroxyethyl starch (HES) 130/0.4.
Chemical name: Poly (O-2 hydroxyethyl) starch.
Molar substitution: 0.4 (0.38 - 0.45).
Weight average molecular weight: 130,000 ± 20,000 Dalton.

CAS number.

Active substance.

Hydroxyethyl starch 130/0.4 [9005-27-0].

2 Qualitative and Quantitative Composition

Active.

Hydroxyethyl starch 130/0.4: 60.0 g/L, (molar substitution: 0.38 - 0.45), (mean molecular weight: 130,000 Da); sodium chloride 6.02 g/L; sodium acetate trihydrate 4.63 g/L; potassium chloride 0.30 g/L; magnesium chloride hexahydrate 0.30 g/L.

Electrolytes.

Sodium (Na+) 137.0 mmol/L; potassium (K+) 4.0 mmol/L; magnesium (Mg2+) 1.5 mmol/L; chloride (Cl-) 110.0 mmol/L; acetate (CH3COO-) 34.0 mmol/L.

Titratable acidity.

< 2.5 mmol NaOH/L.
For the full list of excipients, see Section 6.1 List of Excipients.
Hydroxyethyl starch is characterised by its molar substitution, molecular weight and the C2/C6 ratio. See Section 5.2 Pharmacokinetic Properties; Section 6.7 Physicochemical Properties.

3 Pharmaceutical Form

Injection, intravenous infusion.
Volulyte (HES 130/0.4 in a balanced electrolyte solution) is a clear to slightly opalescent solution, colourless to slightly yellow.
Osmolality: approx. 260 - 310 mOsm/kg water.
Theoretical osmolarity: 286.5 mOsm/L.
pH: 5.7 - 6.5.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Volulyte is an artificial colloid for volume replacement whose effect in intravascular volume expansion and haemodilution depends on the molar substitution by hydroxyethyl groups (0.4), the mean molecular weight (130,000 Da), the concentration (6%), as well as the dosage and infusion rate. HES 130/0.4 contained in Volulyte is derived from waxy maize starch and has a substitution pattern (C2/C6 ratio) of approximately 9:1.
Infusion of 500 mL of a similar product containing HES 130/0.4 (6%) in 0.9% sodium chloride solution in 30 minutes in volunteers results in a plateau-like nonexpansive volume increase of approximately 100% of the infused volume which lasts for approximately 4 to 6 hours.
Isovolaemic exchange of blood with HES 130/0.4 in 0.9% sodium chloride solution maintains blood volume for at least 6 hours.
Volulyte contains the electrolytes sodium (Na+), potassium (K+), magnesium (Mg++), chloride (Cl-) and acetate (CH3COO-) in an isotonic composition. Acetate is a metabolisable anion which is oxidised in different organs and has an alkalising effect.
Volulyte contains a reduced amount of chloride compared to normal saline based solutions and therefore counteracts the development of hyperchloraemic metabolic acidosis, especially when large dose infusions are required or in patients at risk for the development of metabolic acidosis.
In cardiac surgery, chloride levels were statistically significantly lower and base excess levels were seen to be less negative for Volulyte in comparison to HES 130/0.4 (6%) in 0.9% sodium chloride solution. Please also see Clinical trials.

Clinical trials.

A prospective, randomized, double blinded, multicentre, parallel group, phase III trial compared the clinical efficacy and safety of two different HES formulations: Volulyte (balanced group) versus a similar product containing 6% HES 130/0.4 in 0.9% sodium chloride solution (saline group) for intra- and post-operative volume therapy in patients undergoing cardiac surgery. Forty three patients were randomized to Volulyte, 38 were randomized to 6% HES 130/0.4 in 0.9% sodium chloride solution.
The primary objective of the study was to demonstrate therapeutic equivalence between Volulyte and 6% HES 130/0.4 in 0.9% sodium chloride solution regarding the volume of study drug needed for adequate therapy. Consecutive objectives for confirmatory analysis were to show that Volulyte results in lower chloride levels and higher arterial pH than 6% HES 130/0.4 in 0.9% sodium chloride solution.
The volume usage was equivalent in both treatment groups. Volulyte showed statistically significant advantages in terms of lower chloride levels over 6% HES 130/0.4 in 0.9% sodium chloride solution. Concerning the acid/base balance, there are explicit signs that treatment with Volulyte results in higher arterial pH, indicated by less negative base excess values.
The results for the efficacy variables are shown in Table 1.
Figure 6 demonstrates the course of the base excess during cardiac surgery.
Table 2 shows the treatment contrast of base excess between Volulyte and HES 130/0.4 in 0.9% sodium chloride for different time points.
Groups were comparable with regard to overall safety.
There is no evidence that the addition of Mg2+, K+, and acetate- in the solvent of Volulyte in comparison to saline solutions influences coagulation parameters or bleeding events, as both the measured and calculated red blood cell loss showed no differences between treatment groups in this study.
Please also see Clinical trials of the Voluven 6% product information. Voluven 6% is a similar product containing HES 130/0.4 in 0.9% sodium chloride solution.

5.2 Pharmacokinetic Properties

The pharmacokinetics of hydroxyethyl starch is complex and depends on the molecular weight and mainly on the molar substitution degree and the substitution pattern (C2/C6 ratio). When applied intravenously, molecules smaller than the renal threshold (60,000-70,000 Da) are readily excreted in the urine, while larger ones are metabolised by plasma α-amylase before the degradation products are renally excreted.
The mean in vivo molecular weight of HES 130/0.4 in plasma is 70,000-80,000 Da immediately after infusion and remains above the renal threshold throughout the treatment period.
The volume of distribution is about 5.9 litres. Within 30 minutes of infusion the plasma level of HES 130/0.4 (6%) is still 75% of the maximum concentration. After 6 hours the plasma level has decreased to 14%. Following a single dose of 500 mL hydroxyethyl starch plasma levels almost return to baseline levels 24 hours.
Plasma clearance was 31.4 mL/min when 500 mL of HES 130/0.4 (6%) was administered with an AUC of 14.3 mg/mL x h. Plasma half-lives were t1/2α = 1.4 h and t1/2β = 12.1 h when 500 mL were administered on a single occasion.
Using the same dose (500 mL) in subjects with stable mild to severe renal impairment, the AUC moderately increased by a factor of 1.7 (95% confidence limits 1.44 and 2.07) in subjects with ClCr < 50 mL/min compared to > 50 mL/min. Terminal half-life and peak HES concentration were not affected by renal impairment. At ClCr ≥ 30 mL/min, 59% of the drug could be retrieved in the urine, vs 51% at ClCr 15 to 30 mL/min. Plasma levels of HES 130/0.4 returned to baseline levels 24 hours following infusion.
The pharmacokinetics of HES 130/0.4 is very similar following single and multiple dose administration. No significant plasma accumulation occurred even after a daily administration of 500 mL of a 10% solution containing HES 130/0.4 to volunteers over a period of 10 days. Elimination rates in the urine were approximately 70% within 72 hours.
In an experimental model in rats using repetitive doses of 0.7 g/kg BW per day of HES 130/0.4 over 18 days, 52 days after the last administration tissue storage was 0.6% of the total administered dose.
Pharmacokinetic data in patients with hepatic insufficiency or in pediatric or geriatric patients are not available. Effects of gender on the pharmacokinetics of Volulyte 6% have not been studied.

5.3 Preclinical Safety Data

Genotoxicity.

In vitro genotoxicity studies revealed no evidence for mutagenicity or clastogenicity for the type of hydroxyethyl starch present in Volulyte. An in vivo chromosomal aberration study in rats was also negative at the tested dose of 5 g/kg/day IV of HES 130/0.4.

Carcinogenicity.

The carcinogenic potential of Volulyte has not been investigated in animals.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. The use of Volulyte is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.

4.3 Contraindications

Volulyte should not be used, if any one or more of the following clinical conditions apply:
Critically ill patients (typically admitted to intensive care unit), including those with sepsis.
Fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure.
Patients with pre-existing coagulation or bleeding disorders.
Renal failure with oliguria or anuria not related to hypovolaemia.
Patients receiving dialysis treatment.
Intracranial bleeding.
Known hypersensitivity to hydroxyethyl starches.
Patients with severe liver disease.
Patients with severe hyperkalaemia, severe hypernatraemia or severe hyperchloraemia.

4.4 Special Warnings and Precautions for Use

Volulyte is not a substitute for red blood cells or coagulation in plasma.

Fluid overload.

Administration of Volulyte may cause fluid overload, resulting in cardiac and pulmonary failure. Administration should be carefully titrated to relevant physiological endpoints. Particular care must be taken in patients with cardiac insufficiency or severe renal dysfunction.

Dehydration.

Intravenous fluid resuscitation in cases of severe dehydration should be through the use of crystalloid solutions.

Electrolyte disturbances.

Particular care must be taken in patients with severe electrolyte abnormalities like hypermagnesaemia.
In metabolic alkalosis and clinical situations where alkalisation should be avoided, saline based solutions like a similar product containing HES 130/0.4 in 0.9% sodium chloride solution should be preferred over alkalising solutions like Volulyte.
Serum electrolytes should be monitored.

Bleeding risk.

Volulyte administration may cause coagulopathy, either through a direct effect; or indirectly through the dilution effect. This will increase the risk of bleeding. Administration should be ceased if a coagulopathy develops or excessive bleeding occurs.

Cardiopulmonary bypass.

Coagulation status must be closely monitored during cardiopulmonary bypass in patients receiving Volulyte because of the bleeding risk.

Surgery and trauma.

There is a lack of robust, long-term safety data in patients undergoing surgical procedures and in patients with trauma. The expected benefit of treatment should be carefully weighed against uncertainty with regard to this long term safety. Other available treatment options should be considered.

Use in renal impairment.

Avoid use in patients with pre-existing renal dysfunction.
Discontinue use of HES at the first sign of renal injury. A need for renal replacement therapy has been reported up to 90 days after HES administration. Continue to monitor renal function for at least 90 days in any case of deterioration of renal function.

Use in hepatic impairment.

Monitor liver function in patients receiving HES products, including Volulyte.

Anaphylactic/anaphylactoid reactions.

Regarding the occurrence of anaphylactic/anaphylactoid reactions please see Section 4.8 Adverse Effects (Undesirable Effects).

Laboratory assessments.

Clinical evaluation and periodic laboratory determinations are necessary to monitor fluid balance, serum electrolyte concentrations, kidney function, acid-base balance, and coagulation parameters during prolonged parenteral therapy or whenever the patient's condition warrants such evaluation.

Use in the elderly.

Clinical experience with 6% HES 130/0.4 (including published trials) has included elderly populations, some exclusively with patients of 70 years and above. Dose reduction was not required and safety has been comparable to control treatments (gelatin or albumin) in elderly patients.

Paediatric use.

There is a lack of robust, long-term safety data in children undergoing surgical procedures. The expected benefit of treatment should be carefully weighed against uncertainty with regard to this long-term safety and informed consent obtained from the patient/parent where possible. Other available treatment options should be considered.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interactions of Volulyte with other drugs or nutritional products are known to date.
Consideration should be given to the concomitant administration of medicinal products that can cause potassium or sodium retention.
Please see Section 4.8 Adverse Effects (Undesirable Effects) concerning the concentration of serum amylase which can rise during administration of hydroxyethyl starch and can interfere with the diagnosis of pancreatitis.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

HES 130/0.4 10% solution in 0.9% sodium chloride did not impair fertility in male rats at IV doses up to 5 g/kg/day. In female rats, no adverse effects on fertility were observed at doses up to 2.5 g/kg/day. Slight inhibition of ovulation, evident as a decrease in corpora lutea and resulting in a reduced number of fetuses, was observed at a maternotoxic dose of 5 g/kg/day IV.
(Category B3)
No clinical data are currently available on the use of Volulyte during pregnancy.
Studies in pregnant rats and rabbits showed that the type of hydroxyethyl starch present in Volulyte was associated with embryofetal toxicity following IV administration at 5 g/kg/day. The embryofetal toxicity included resorptions, stillbirths, reduced fetal weight and delayed fetal development, but was only observed in conjunction with maternotoxicity.
Volulyte should not be used during pregnancy, unless the expected therapeutic benefit clearly outweighs the potential risk to the fetus.
It is not known whether hydroxyethyl starch is excreted in human breast milk. The excretion of hydroxyethyl starch in milk has not been studied in animals.
A study in lactating rats showed that the type of hydroxyethyl starch present in Volulyte was associated with decreased postnatal growth and development following IV administration at 5 g/kg/day, a maternotoxic dose.
A decision on whether to continue/discontinue breastfeeding or to discontinue/continue therapy with Volulyte should be made taking into account the benefit of breastfeeding to the child and the benefit of Volulyte therapy to the nursing mother.
There are currently no clinical data available on the use of Volulyte 6% in lactating women.

4.8 Adverse Effects (Undesirable Effects)

The undesirable effects are divided into: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 10,000), not known (cannot be estimated from the available data).

Blood and lymphatic system disorders.

Rare (in high dose).

With the administration of hydroxyethyl starch disturbances of blood coagulation beyond dilution effects can occur depending on the dosage.

Immune system disorders.

Rare.

Medicinal products containing hydroxyethyl starch may rarely lead to anaphylactic/anaphylactoid reactions (hypersensitivity, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, noncardiac pulmonary oedema). In the event of an intolerance reaction occurring, the infusion should be discontinued immediately and the appropriate emergency medical treatment initiated.

Skin and subcutaneous tissue disorders.

Common (dose dependent).

Prolonged administration of high dosages of hydroxyethyl starch may cause pruritus (itching) which is a known undesirable effect of hydroxyethyl starches. The itching may not appear until weeks after the last infusion and may persist for months.

Investigations.

Common (dose dependent).

The concentration of serum amylase can rise during administration of hydroxyethyl starch and can interfere with the diagnosis of pancreatitis. The elevated amylase is due to the formation of an enzyme/substrate complex of amylase and hydroxyethyl starch subject to slow elimination and must not be considered diagnostic of pancreatitis.

Common (dose dependent).

At high dosages the dilution effects may result in a corresponding dilution of blood components such as coagulation factors and other plasma proteins and in a decrease of haematocrit.

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.

4.2 Dose and Method of Administration

For intravenous infusion.
Use of Volulyte should be restricted to the initial phase of volume resuscitation with a maximum duration of use of 24 hours.
Administration of Volulyte may cause anaphylactic reactions that may manifest as acute hypotension. In all patients, the initial 10-20 mL of Volulyte should be infused slowly, keeping the patient under close observation for anaphylactic/anaphylactoid reactions manifesting as unexpected hypotension, or the development of wheeze or rash. (Please also see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
The daily dose and rate of infusion depend on the patient's blood loss, on the maintenance or restoration of haemodynamics and on the haemodilution (dilution effect).
In clinical trials, infusions up to 33 mL/kg/day were most commonly used. There is limited experience with infusions between 33 mL/kg/day and 50 mL/kg/day.
Hepatic and renal monitoring is necessary at higher doses. (Please also see Section 4.4 Special Warnings and Precautions for Use).
The majority of clinical trial data stem from maximal dose of up to 33 mL/kg/day.

Treatment of children.

Data are limited in children. It is therefore recommended not to use HES products in paediatric patients. (Please also see Section 4.4 Special Warnings and Precautions for Use).

Instructions for use/handling.

Each container should be used in one patient and on one occasion only. It should be used immediately after the bottle or bag is opened and any unused solution must be discarded. The solution contains no antimicrobial preservatives. Do not use if the solution is not clear or if the container is damaged.

Appendix: special handling instructions.

Before administering the product in plastic bags to patient, review the directions in Figures 1 to 5.

Warnings.

1. Do not remove the Freeflex IV container from its overwrap until immediately before use.
2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
3. Do not administer unless the solution is clear, free from particles and the Freeflex IV container is undamaged.
4. Volulyte should be used immediately after insertion of the administration set.
5. Use the blue port only to administer solution. Never use the white port.
6. Do not vent.
7. If administered by pressure infusion, air should be withdrawn or expelled from the bag through the medication/administration port prior to infusion.
8. Discontinue the infusion if an adverse reaction occurs.
9. It is recommended that administration sets are changed at least once every 24 hours.
10. For single use only. Discard unused portion.

4.7 Effects on Ability to Drive and Use Machines

Volulyte has no influence on the ability to drive and use machines.

4.9 Overdose

Excessive or rapid administration of volume expanders such as Volulyte may result in fluid overload with resulting cardiac and pulmonary failure. If this occurs, volume replacement should be ceased and supportive care provided. Use of diuretics may be required.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) or 0800 764 766 (New Zealand).

7 Medicine Schedule (Poisons Standard)

Australia: Not Scheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Excipient: sodium hydroxide (for pH adjustment) q.s.; hydrochloric acid (for pH adjustment) q.s.; water for injections q.s..

6.2 Incompatibilities

In the absence of compatibility studies, Volulyte must not be mixed with other medicinal products.

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 25°C. Do not freeze.

6.5 Nature and Contents of Container

Polyolefin bag (Freeflex) with overwrap.
All packaging components for the Freeflex bag are latex and PVC free.

Pack sizes.

Australia and New Zealand:
AUST R 172173 Freeflex bags with overwrap 250 mL (cartons of 20/30/35/40 bags);
AUST R 187473 Freeflex bags with overwrap 500 mL (cartons of 15/20 bags).
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

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

Summary Table of Changes