Plasma-Lyte 148 Intravenous Infusion

MIMS Revision Date: 01 July 2025

1 Name of Medicine

Sodium chloride, sodium gluconate, sodium acetate trihydrate, potassium chloride and magnesium chloride hexahydrate.

2 Qualitative and Quantitative Composition

Plasma-Lyte 148 (approx. pH 7.4) intravenous (IV) infusion is a sterile, clear, nonpyrogenic isotonic solution in a single dose container for intravenous administration. It contains no antimicrobial agents. The approximate osmolality is 271 mOsm/kg. An injection with an osmolality within the range of 250 to 350 mOsm/kg is considered to be isotonic. Administration of substantially hypertonic solutions may cause vein damage.
Each 1000 mL of Plasma-Lyte 148 (approx. pH 7.4) IV infusion contains:
Active ingredient. Sodium chloride 5.26 g, sodium gluconate 5.02 g, sodium acetate trihydrate 3.68 g, potassium chloride 370 mg, magnesium chloride hexahydrate 300 mg.
Excipient. Sodium hydroxide (pH adjustment), water for injections q.s. to 1000 mL.
Solution properties. pH range 6.5 to 8.0, approximate osmolality 271 mOsm/kg, approximate kilojoules 66 kJ.
Plasma-Lyte 148 (approx. pH 7.4) IV infusion when administered intravenously is a source of water, electrolytes, and calories.
Each 1000 mL of Plasma-Lyte 148 (approx. pH 7.4) IV infusion has ionic concentration of: sodium 140 mmol, potassium 5 mmol, magnesium 1.5 mmol, chloride 98 mmol, acetate 27 mmol, gluconate 23 mmol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for intravenous infusion.

4 Clinical Particulars

4.1 Therapeutic Indications

Plasma-Lyte 148 (approx. pH 7.4) IV infusion is indicated as a source of water and electrolytes or as an alkalinising agent.

4.2 Dose and Method of Administration

Dosage. As directed by the physician. Dosage, rate, and duration of administration are to be individualised and depend upon the indication for use, the patient's age, weight, clinical condition, and concomitant treatment, and on the patient's clinical and laboratory response to treatment.
Each Viaflex container is for single patient use only.
Parenteral medicine products should be inspected visually for particulate matter and discolouration prior to the administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact.
All injections in Viaflex plastic containers are intended for intravenous administration using sterile equipment.
Directions for use of Viaflex plastic container. Warning. Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete (see Section 4.4 Special Warnings and Precautions for Use, Risk of air embolism).
To open. Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilisation process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. If supplemental medication is desired, follow the directions below.
Preparation for administration. Plasma-Lyte 148 (approx. pH 7.4) IV infusion is sterile preparation. Thus, aseptic technique must be applied throughout the administration.
(1) Suspend container from eyelet support.
(2) Remove plastic protector from outlet port at the bottom of container.
(3) Attach administration set.
To add medications. Warning. Additives may be incompatible. Additives known or determined to be incompatible must not be used. Consult with a pharmacist, if available. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Plasma-Lyte 148 (approx. pH 7.4) IV infusion is appropriate. After addition, check for possible colour change and/or the appearance of precipitates, insoluble complexes or crystals. The instructions for use of the medication to be added and other relevant literature must be consulted (see Section 6.2 Incompatibilities).
If, in the informed judgement of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
To add medication before solution administration. Prepare medication site. Using syringe with 0.63 to 0.80 mm needle, puncture resealable medication port and inject. Mix solution and medication thoroughly. For high-density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
To add medication during solution administration. Close clamp on the set. Prepare medication site. Using syringe with 0.63 to 0.80 mm needle, puncture resealable medication port and inject. Remove container from IV pole and/or turn to upright position. Evaluate both ports by squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in use position and continue administration.
After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers.

4.3 Contraindications

Plasma-Lyte 148 (approx. pH 7.4) IV infusion is contraindicated in patients with a known hypersensitivity to the product.

4.4 Special Warnings and Precautions for Use

Plasma-Lyte 148 (approx. pH 7.4) IV infusion is not indicated for:
the treatment of hypochloremic hypokalaemic alkalosis and should be used with caution, if at all, in patients with hypochloremic hypokalaemic alkalosis;
the primary treatment of severe metabolic acidosis;
the treatment of hypomagnesaemia.
Although Plasma-Lyte 148 (approx. pH 7.4) IV infusion has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency; therefore, it should not be used for correction of severe potassium deficiency.
Hypersensitivity reactions. Hypersensitivity/infusion reactions, including anaphylactoid reactions, have been reported with Plasma-Lyte 148 (approx. pH 7.4) IV infusion. The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Fluid and/or solute overload and electrolyte disturbances. Depending on the volume and rate of infusion, intravenous administration of Plasma-Lyte 148 (approx. pH 7.4) IV infusion can cause:
fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolaemia, congested states, including pulmonary congestion and oedema;
clinically relevant electrolyte disturbances and acid-base imbalance.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of the infusion. The risk of solute overload causing congested states with peripheral and pulmonary oedema is directly proportional to the electrolyte concentrations of the infusion.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
Hyponatraemia. Monitoring of serum sodium is important for all fluids. High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital acquired hyponatraemia.
Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterised by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening cerebral injury.
Use in patients with or at risk of hypermagnesaemia. Solutions containing magnesium should be used with caution, if at all, in patients with:
hypermagnesaemia or conditions predisposing to hypermagnesaemia including, but not limited to, severe renal impairment or magnesium therapy such as eclampsia; myasthenia gravis.
Use in patients with or at risk of alkalosis. Plasma-Lyte 148 (approx. pH 7.4) IV infusion should be used with particular caution, if at all, in patients with alkalosis or at risk for alkalosis. Excess administration of Plasma-Lyte 148 (approx. pH 7.4) IV infusion may result in metabolic alkalosis.
The administration of acetate or gluconate ions should be done with great care in those conditions in which there is an increased level or an impaired utilisation of these ions, such as severe hepatic insufficiency.
Use in patients with hypervolaemia or overhydration, or conditions that cause sodium retention and oedema. Plasma-Lyte 148 (approx. pH 7.4) IV infusion should be administered with particular caution, if at all, to hypervolaemia or overhydrated patients.
Plasma-Lyte 148 (approx. pH 7.4) IV infusion should be administered with particular caution, if at all, to patients with conditions that may cause sodium retention, fluid overload and oedema, such as patients with primary hyperaldosteronism, secondary hyperaldosteronism (associated with, for example, hypertension, congestive heart failure, renal artery stenosis, or nephrosclerosis), or preeclampsia.
Plasma-Lyte 148 (approx. pH 7.4) IV infusion should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists oedema with sodium retention.
Use in patients with hypocalcaemia. Plasma-Lyte 148 (approx. pH 7.4) IV infusion contains no calcium and an increase in plasma pH due to its alkalinising effect may lower the concentration of ionised (not protein-bound) calcium. Plasma-Lyte 148 (approx. pH 7.4) IV infusion should be administered with particular caution, if at all, to patients with hypocalcaemia.
Use in patients with or at risk of hyperkalaemia. Plasma-Lyte 148 (approx. pH 7.4) IV infusion should be used with caution, if at all, in patients with hyperkalaemia or conditions predisposing to hyperkalaemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration or extensive tissue injury or burns) and in patients with cardiac disease and in conditions where potassium retention is present.
Use in patients with severe renal impairment. Plasma-Lyte 148 (approx. pH 7.4) IV infusion should be administered with particular caution, if at all, to patients with severe renal impairment. In patients with diminished renal function, administration of Plasma-Lyte 148 (approx. pH 7.4) IV infusion may result in sodium and/or potassium or magnesium retention.
Risk of air embolism. Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
Pressurising intravenous solutions contained in flexible plastic containers to increase flow rates can results in air embolism if the residual air in the container is not fully evacuated prior to administration.
Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.
Other. The Viaflex plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain chemical components from the plastic in very small amounts, however, biological testing was supportive of the safety of the plastic container materials.
Use in the elderly. Clinical studies of Plasma-Lyte 148 (approx. pH 7.4) IV infusion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger 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 medicine therapy.
When selecting the type of infusion solution and the volume/rate of infusion for an elderly patient, consider that elderly patients are generally more likely to have cardiac, renal, hepatic and other diseases and/or concomitant drug therapy.
Paediatric use. Safety and effectiveness of Plasma-Lyte 148 (approx. pH 7.4) IV infusion in paediatric patients have not been established by adequate or well controlled trials, however, the use of electrolyte solutions in the paediatric population is referenced in the medical literature. The precautions and adverse reactions identified in this document should be observed in the paediatric population.
Effects on laboratory tests. There have been reports of false-positive test results using the Bio Rad Laboratories Platelia Aspergillus EIA test in patients receiving Baxter gluconate containing Plasma-Lyte solutions. These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving Baxter gluconate containing Plasma-Lyte solutions should be interpreted cautiously and confirmed by other diagnostic methods.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Caution must be exercised in the administration of Plasma-Lyte 148 (approx. pH 7.4) IV infusion to patients treated with drugs that may increase the risk of sodium and fluid retention such as corticosteroids or corticotropin.
Caution is advised when administering Plasma-Lyte 148 (approx. pH 7.4) IV infusion to patients treated with drugs for which renal elimination is pH dependent. Due to its alkalinising effect (formation of bicarbonate), Plasma-Lyte 148 (approx. pH 7.4) IV infusion may interfere with the elimination of such drugs:
renal clearance of acidic drugs such as salicylates, barbiturates and lithium may be increased;
renal clearance of alkaline drugs such as sympathomimetics (e.g. ephedrine, pseudoephedrine), quinidine or dextroamphetamine (dexamphetamine) sulfate may be decreased.
Because of its potassium content, Plasma-Lyte 148 (approx. pH 7.4) IV infusion should be administered with caution in patients treated with agents or products that can cause hyperkalaemia or increase the risk of hyperkalaemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene) with ACE inhibitors, angiotensin II receptor antagonists or the immunosuppressants tacrolimus and cyclosporin.
Caution is advised when administering Plasma-Lyte 148 (approx. pH 7.4) IV infusion to patients treated with drugs leading to an increased vasopressin effect. The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and may increase the risk of hyponatraemia following treatment with IV fluids (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Events (Undesirable Events)):
drugs stimulating vasopressin release such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors (SSRIs), 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, opioids;
drugs potentiating vasopressin action such as chlorpropamide, non-steroidal anti-inflammatories (NSAIDS), cyclophosphamide;
vasopressin analogues such as desmopressin, oxytocin, vasopressin, terlipressin.
Caution is advised when administering Plasma-Lyte 148 (approx. pH 7.4) IV infusion to patients treated with drugs that may increase the risk of hyponatraemia, such as diuretics and antiepileptics (e.g. oxcarbazepine).
See Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. Studies with Plasma-Lyte 148 (approx. pH 7.4) IV infusion have not been performed to evaluate effect on fertility.
Use in pregnancy. (No Category)
There are no adequate data from the use of Plasma-Lyte 148 (approx. pH 7.4) IV infusion in pregnant women. The potential risks and benefits for each specific patient should be carefully considered before using Plasma-Lyte 148 (approx. pH 7.4) IV infusion in pregnant women.
Use in lactation. There are no adequate data from the use of Plasma-Lyte 148 (approx. pH 7.4) IV infusion in lactating women. The potential risks and benefits for each specific patient should be carefully considered before using Plasma-Lyte 148 (approx. pH 7.4) IV infusion in lactating women.

4.7 Effects on Ability to Drive and Use Machines

There is no information of the effects of Plasma-Lyte 148 (approx. pH 7.4) IV infusion on the ability to operate an automobile or other heavy machinery.

4.8 Adverse Effects (Undesirable Effects)

Reactions that may occur because of the solution or the technique of administration include febrile response or infection at the site of infusion. Other reactions that may occur include circulatory effects: extravasation, hypervolaemia, venous thrombosis, phlebitis extending from the site of injection.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
The following adverse reactions have been reported in the postmarketing experience with unspecified Plasma-Lyte 148 (approx. pH 7.4) IV infusion and Plasma-Lyte products without glucose, listed by MedDRA system organ class (SOC), then by preferred term in order of severity, where feasible:
Immune system disorders. Hypersensitivity/ infusion reactions including anaphylactoid reaction and the following manifestations: tachycardia, palpitations, chest pain, chest discomfort, dyspnoea, respiratory rate increased, flushing, hyperaemia, asthenia, feeling abnormal, piloerection, oedema peripheral and pyrexia.
General disorders and administration site conditions. Infusion site reactions e.g. infusion site pain and burning sensation.
Other adverse reactions reported with other similar products are:
other manifestations of hypersensitivity/ infusion reactions including hypotension, wheezing, urticaria, cold sweat and chills; hyperkalaemia; hyponatraemia; hyponatraemic encephalopathy.
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

If overdosage is suspected (through the monitoring of electrolytes, especially sodium and potassium), administration of the medicine should be discontinued and the patient observed closely.
Excessive administration of Plasma-Lyte 148 (approx. pH 7.4) IV infusion may lead to metabolic alkalosis. Metabolic alkalosis may be accompanied by hypokalaemia as well as a decrease in ionised serum calcium and magnesium.
An excessive volume of Plasma-Lyte 148 (approx. pH 7.4) IV infusion may lead to fluid and sodium overload with a risk of oedema (peripheral and/or pulmonary) particularly when renal sodium excretion is impaired.
Excessive administration of potassium may lead to the development of hyperkalaemia, especially in patients with severe renal impairment.
Excessive administration of magnesium may lead to hypermagnesaemia.
Also see Section 4.4 Special Warnings and Precautions for Use.
When assessing an overdose, any additives in the solution must be also be considered. The effect of overdose may require immediate medical attention and treatment.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Plasma-Lyte 148 (approx. pH 7.4) IV infusion is a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
Plasma-Lyte 148 (approx. pH 7.4) IV infusion produces a metabolic alkalinising effect. Acetate and gluconate ions are metabolised ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity. Studies with Plasma-Lyte 148 (approx. pH 7.4) IV infusion have not been performed to evaluate mutagenic potential.
Carcinogenicity. Studies with Plasma-Lyte 148 (approx. pH 7.4) IV infusion have not been performed to evaluate carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

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

6.2 Incompatibilities

Additives may be incompatible with Plasma-Lyte 148 (approx. pH 7.4) IV infusion. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition. Consult a pharmacist if available.

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. Do not freeze.

6.5 Nature and Contents of Container

Plasma-Lyte 148 (approx. pH 7.4) IV infusion plastic containers is available as shown in Table 1:

Package size. 500 mL, 1000 mL.

6.6 Special Precautions for Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure. Sodium chloride. Molecular formula: NaCl.
Molecular weight: 58.44.
Appearance: colourless or white crystal.
Solubility: freely soluble in water.
Sodium gluconate (sodium D-gluconate).

Molecular formula: C₆H₁₁NaO₇.
Molecular weight: 218.14.
Appearance: white to off white crystalline powder.
Solubility: very soluble in water; sparingly soluble in alcohol; insoluble in ether.
Sodium acetate trihydrate. Molecular formula: C₂H₃NaO₂,3H₂O.
Molecular weight: 136.1.
Appearance: white crystalline solid.
Solubility: hygroscopic, very soluble in water; moderately soluble in ethanol.
Potassium chloride. Molecular formula: KCl.
Molecular weight: 74.55.
Appearance: colourless or white crystal.
Solubility: freely soluble in water.
Magnesium chloride hexahydrate. Molecular formula: MgCl₂.6H₂O.
Molecular weight: 203.31.
Appearance: white or colourless crystalline solid.
Solubility: very soluble in water.
CAS number. Sodium chloride. CAS No.: 7647-14-5.
Sodium gluconate (sodium D-gluconate). CAS No.: 527-07-1.
Sodium acetate trihydrate. CAS No.: 6131-90-4.
Potassium chloride. CAS No.: 7447-40-7.
Magnesium chloride hexahydrate. CAS No.: 7791-18-6.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Date of First Approval

11 December 2014

Date of Revision

30 May 2019

Summary Table of Changes