Consumer medicine information

Plasma-lyte 148 and 5% Glucose Replacement IV infusion

Sodium chloride; Sodium gluconate; Sodium acetate; Potassium chloride; Magnesium chloride hexahydrate; Glucose

BRAND INFORMATION

Brand name

Plasma-Lyte 148 and 5% Glucose IV Infusion

Active ingredient

Sodium chloride; Sodium gluconate; Sodium acetate; Potassium chloride; Magnesium chloride hexahydrate; Glucose

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Plasma-lyte 148 and 5% Glucose Replacement IV infusion.

What is in this leaflet

This leaflet answers some common questions about Plasma-Lyte 148 and 5% Glucose Replacement Infusion. It does not contain all of the available information. It does not take the place of talking to your doctor, nurse or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this product against the benefit they expect it will have for you.

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

What Plasma-Lyte 148 and 5% Glucose Replacement Infusion is used for

Plasma-Lyte 148 and 5% Glucose Replacement Infusion is a solution used as a source of water, electrolytes (salts) and calories.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

Before you start Plasma-Lyte 148 and 5% Glucose Replacement Infusion

When you must not be given it

Plasma-Lyte 148 Replacement and 5% Glucose Infusion must not be given to you if:

  • you have an allergy to any ingredient listed at the end of this leaflet;
  • you have had an allergic reaction to corn or corn products. Some of the symptoms of an allergic reaction may include skin rash, peeling of the skin and swelling of the face, lips or tongue, causing difficulty swallowing or shortness of breath;
  • the expiry date printed on the pack has passed.

You must tell your doctor if you have or have had any of the following medical conditions:

  • heart failure;
  • respiratory failure (lung disease);
  • severe kidney failure;
  • high blood pressure (hypertension);
  • build up of fluid under the skin, particularly around the ankles (peripheral oedema);
  • build up of fluid in the lungs (pulmonary oedema);
  • high blood pressure during pregnancy (pre-eclampsia or eclampsia)
  • aldosteronism (a disease that causes high levels of hormone called aldosterone);
  • any other condition associated with retaining sodium or fluid , such as treatment with steroids;
  • diabetes (your blood sugar levels will be monitored closely and your insulin treatment may need to be modified);
  • any condition that means you are more likely to have high blood levels of potassium (hyperkalaemia), such as kidney failure, adrenocortical insufficiency, severe dehydration (a loss of water from the body, eg. due to vomiting or diarrhoea) or extensive tissue damage (as can occur in severe burns) – your doctor will need to check your blood potassium levels;
  • myasthenia gravis (a disease that causes progressive muscle weakness);
  • recovery after an operation;
  • head injury within the past 24 hours;
  • a high pressure within the skull (intracranial hypertension);
  • a stroke;
  • are pregnant;
  • are breast-feeding.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Plasma-Lyte 148 and 5% Glucose Replacement Infusion. These include:

  • potassium-sparing diuretics (certain water tablets, eg. amiloride, spironolactone, triamterene);
  • angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure);
  • tacrolimus (used to prevent rejection of a transplant and to treat some skin diseases);
  • cyclosporin (used to prevent rejection of a transplant);

These medicines can increase the concentration of potassium in your blood. This can be life-threatening. A rise in your blood potassium levels is more likely to occur if you have kidney disease.

  • corticosteroids (anti-inflammatory medicines);
  • acidic medicines including: salicylates used to treat inflammation (aspirin), sleeping tablets (barbiturates) and lithium (used to treat psychiatric illnesses);
  • alkaline (basic) medicines including: sympathomimetics (medicines used in cough & cold preparations (eg. phenylephrine and pseudoephedrine), and for treating ADHD (eg. dexamphetamine).

How Plasma-Lyte 148 and 5% Glucose Replacement Infusion is given

How much it is given

Your doctor will decide how much Plasma-Lyte 148 and 5% Glucose Replacement Infusion will be given to you, which, depends on your need and condition.

You should not be given Plasma-Lyte 56 Maintenance and 5% Glucose Infusion if there are particles floating in the solution or if the pack is damaged in any way.

How it is given

The Plasma-Lyte 148 and 5% Glucose Replacement Infusion will be given at a slow rate of injection (drip) by your health professional. Usually, you will need to stay in a health institution (hospital, nursing home, etc.) but in some cases at home, as it requires a special medical equipment to deliver the medicine into your circulation. This delivery should be attended by a health professional. A cannula (administration needle) is placed in a vein by your doctor or nurse.

The infusion is for single use, and for one person only. Any unused portion must be discarded and not used later, either for you or anyone else.

Your doctor will decide when to stop giving you this infusion.

Ask your doctor or nurse if you want to know more about the use of PlasmaLyte 148 and 5% Glucose Replacement Infusion.

If you are given too much (overdose)

The doctor or nurse giving you the Plasma-Lyte 148 and 5% Glucose Replacement Infusion has had experience in the use of this sort of medicine, so it is unlikely that you will be given an overdose. However, in case of an overdose, the infusion will be discontinued and another treatment may be needed. You may experience some of the effects listed under “Side effects” below.

Side effects

Tell your doctor, pharmacist or nurse as soon as possible if you do not feel well while you are being given Plasma-Lyte 148 and 5% Glucose Replacement Infusion.

As with any medicine, some side effects may occur.

Tell your doctor immediately if you notice any of the following:

  • skin rash;
  • shortness of breath (dyspnoea);
  • wheezing;
  • difficulty breathing;
  • swelling of the skin of the face, lips and swelling of the throat;
  • redness of the skin (erythema).

These are very serious side effects. You may need urgent medical attention.

All of these side effects are very rare.

Other side effects are:

  • reactions due to the administration technique:
    - fever (febrile response);
    - infection at the site of infusion;
    - local pain or reaction (redness or swelling) at the site of infusion;
    - irritation or inflammation of the vein into which the solution is infused (phlebitis);
    - formation of a blood clot (venous thrombosis) at the site of infusion;
    - escape of the infusion solution into the tissues around the vein (extravasation);
    - an excess of fluid in the body (hypervolaemia);
    - high levels of blood potassium which can cause abnormal heart rhythm (hyperkalaemia);
    - hyperglycaemia.
  • low blood pressure (hypotension);
  • chest discomfort;
  • flushing
  • feeling of weakness;
  • cold sweat;
  • chills.

Tell your doctor, pharmacist or nurse if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some patients.

Discuss any concerns you have with your doctor.

After using Plasma-Lyte 148 and 5% Glucose Replacement Infusion

Storage

Plasma-Lyte 148 and 5% Glucose Replacement Infusion will be stored in the pharmacy or the hospital ward. It is recommended that the product be stored below 30°C. Do not freeze.

Product description

What it looks like

Plasma-Lyte 148 and 5% Glucose Replacement Infusion is a clear solution filled in plastic bags.

What is in Plasma-Lyte 148 and 5% Glucose Replacement Infusion

The active components are Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride and Glucose-anhydrous.

The other ingredients are water for injections and hydrochloric acid.

Manufacturer

Name and address of sponsor

Baxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie NSW 2146

AUST R number

AUST R 19438

Date of preparation:

July 2014

BRAND INFORMATION

Brand name

Plasma-Lyte 148 and 5% Glucose IV Infusion

Active ingredient

Sodium chloride; Sodium gluconate; Sodium acetate; Potassium chloride; Magnesium chloride hexahydrate; Glucose

Schedule

Unscheduled

 

1 Name of Medicine

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

6.7 Physicochemical Properties

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.

Glucose (D-(+)glucopyranose).

Molecular formula: C6H12O6.
Molecular Weight: 180.2.
Appearance: a white or almost white, crystalline powder.
Solubility: freely soluble in water, sparingly soluble in ethanol (96%).

Chemical structure.


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.

Glucose (D-(+)glucopyranose).

CAS No.: 50-99-7.

2 Qualitative and Quantitative Composition

Plasma-Lyte 148 and 5% Glucose Intravenous (IV) Infusion is a sterile, clear, non-pyrogenic hypertonic solution in a single dose container for intravenous administration. It contains no antimicrobial agents. The approximate osmolality is 584 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 (≥ 600 mOsm/kg) may cause vein damage.
Each 1000 mL of Plasma-Lyte 148 and 5% Glucose IV Infusion contains (see Table 1):
Each 1000 mL of Plasma-Lyte 148 and 5% Glucose 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; Glucose 278 mmol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for intravenous infusion.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Plasma-Lyte 148 and 5% Glucose IV Infusion is a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.
Plasma-Lyte 148 and 5% Glucose 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 and 5% Glucose IV Infusion have not been performed to evaluate mutagenic potential.

Carcinogenicity.

Studies with Plasma-Lyte 148 and 5% Glucose IV Infusion have not been performed to evaluate carcinogenic potential.

4 Clinical Particulars

4.1 Therapeutic Indications

Plasma-Lyte 148 and 5% Glucose IV Infusion is indicated as a source of water, electrolytes and calories or as an alkalinising agent.

4.3 Contraindications

Plasma-Lyte 148 and 5% Glucose IV Infusion is contraindicated in patients with a known hypersensitivity to the product. Solutions containing glucose may be contraindicated in patients with known allergy to corn or corn products.
Plasma-Lyte 148 and 5% Glucose IV Infusion must not be used in patients with clinically significant hyperglycemia.

4.4 Special Warnings and Precautions for Use

Plasma-Lyte 148 and 5% Glucose IV Infusion is not indicated for:
the treatment of hypochloremic hypokalaemic alkalosis;
the primary treatment of severe metabolic acidosis;
the treatment of hypomagnesaemia.
Although Plasma-Lyte 148 and 5% Glucose 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.
Plasma-Lyte 148 and 5% Glucose IV Infusion should not be administered simultaneously with blood through the same administration set because of the possibility of pseudo-agglutination or haemolysis.

Hypersensitivity reactions.

Hypersensitivity/infusion reactions, including anaphylactoid reactions, have been reported with Plasma-Lyte 148 and 5% Glucose 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.

Hypertonic solution.

Plasma-Lyte 148 and 5% Glucose IV Infusion is a hypertonic solution, having an osmolality of 584 mOsm/kg. Administration of hypertonic solutions may cause venous irritation including phlebitis. Hyperosmolar solution should be administered with caution, if at all, to patients with hyperosmolar states e.g. hypochloraemic hypokalaemic alkalosis due to prolonged vomiting, pyloric stenosis, prolonged nasogastric suctioning.

Fluid and/or solute overload and electrolyte disturbances.

Depending on the volume and rate of infusion, intravenous administration of Plasma-Lyte 148 and 5% Glucose IV Infusion can cause:
fluid and/or solute overload resulting in overhydration/hypervolaemia and for example congested states, including pulmonary congestion and oedema;
clinically relevant electrolyte disturbances and acid-base imbalance.
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 or the rate of administration warrants such evaluation.

Hyponatraemia.

Glucose intravenous infusions are usually isotonic solutions. Plasma-Lyte 148 and 5% Glucose IV Infusion has an osmolarity of 584 mOsm/kg. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolisation. Monitoring of serum sodium is particularly important for hypotonic fluids.
Depending on the tonicity of the solution, the volume and rate of infusion, and depending on a patient's underlying clinical condition and capability to metabolise glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatraemia.
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) characterized 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 and 5% Glucose IV Infusion should be used with particular caution, if at all, in patients with alkalosis or at risk for alkalosis. Excess administration 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.

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.
Plasma-Lyte 148 and 5% Glucose IV Infusion should be administered with particular caution, to hypervolaemia or overhydrated patients.
Plasma-Lyte 148 and 5% Glucose 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 and fluid overload, such as patients with primary hyperaldosteronism, secondary hyperaldosteronsim (associated with, for example, hypertension, congestive heart failure, renal artery stenosis or nephrosclerosis) or preeclampsia.

Use in patients with hypocalcaemia.

Plasma-Lyte 148 and 5% Glucose 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 and 5% Glucose 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 and 5% Glucose 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.

In patients with diminished renal function, administration of Plasma-Lyte 148 and 5% Glucose IV Infusion may result in sodium and/or potassium or magnesium retention.

Use in patients with or at risk of hyperglycaemia.

Plasma-Lyte 148 and 5% Glucose IV Infusion should be used with caution in patients with impaired glucose tolerance or diabetes mellitus.
Because Plasma-Lyte 148 and 5% Glucose IV Infusion contains glucose as well as gluconate (a portion of which may be metabolised into glucose), administration of Plasma-Lyte 148 and 5% Glucose IV Infusion that exceeds the metabolic capacity for glucose may lead to hyperglycaemia (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
In order to avoid hyperglycaemia, the infusion rate should not exceed the patient's ability to utilise glucose. Hyperglycaemia has been implicated in increasing cerebral ischemic brain damage and impairing recovery after acute ischemic strokes. Caution is recommended in using glucose-containing solutions in such patients.
Early hyperglycaemia has been associated with poor outcomes in patients with severe traumatic brain injury. Glucose-containing solutions should, therefore, be used with caution in patients with head injury, in particular during the first 24 hours following the trauma.
If hyperglycaemia occurs, the rate of glucose administration should be reduced and/or insulin administered, or the insulin dose adjusted.

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 result 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. Solution 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 material.

Use in the elderly.

Clinical studies of Plasma-Lyte 148 and 5% Glucose 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 drug therapy.
When selecting the type of infusion solution and the volume/rate of infusion for an elder patient, consider that elderly patients are generally more likely to have cardiac, renal, hepatic and other diseases or concomitant drug therapy.

Paediatric use.

Safety and effectiveness of Plasma-Lyte 148 and 5% Glucose 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.
The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in paediatric intravenous fluid therapy.
In very low birth weight infants, excessive or rapid administration of glucose infusion may result in increased serum osmolarity and possible haemorrhage.
Newborns - especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycaemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycaemic control in order to avoid potential long term adverse effects. Hypoglycaemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycaemia has been associated with intraventricular haemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotising enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

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 by other diagnostic methods.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Plasma-Lyte 148 and 5% Glucose IV Infusion should not be administered simultaneously with blood through the same administration set because of the possibility of pseudo-agglutination or haemolysis (see Section 4.4 Special Warnings and Precautions for Use).
Caution must be exercised in the administration of Plasma-Lyte 148 and 5% Glucose 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 and 5% Glucose 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 and 5% Glucose 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 and 5% Glucose 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 and 5% Glucose 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 Effects (Undesirable Effects)):
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 and 5% Glucose 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 and 5% Glucose IV Infusion have not been performed to evaluate effect on fertility.
(No category)
Intrapartum maternal intravenous infusion of glucose containing solutions may result in foetal insulin production, with an associated risk of foetal hyperglycaemia and metabolic acidosis as well as rebound hypoglycaemia in the neonate. Physicians should carefully consider the potential risks and benefits for each specific patient before administering Plasma-Lyte 148 and 5% Glucose IV Infusion.
There are no adequate data from the use of Plasma-Lyte 148 and 5% Glucose IV Infusion in lactating women. The potential risks and benefits for each specific patient should be carefully considered before using Plasma-Lyte 148 and 5% Glucose IV Infusion in lactating women.

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 post-marketing experience with unspecified Plasma-Lyte products (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 manifestation: hypotension, chest discomfort, dyspnoea, wheezing, flushing, hyperaemia, asthenia, urticaria, cold sweat, pyrexia and chills.

Metabolism and nutrition disorders.

Hyperkalaemia and hyperglycaemia.

General disorders and administration site conditions.

Infusion site reaction (e.g. burning sensation).
Other adverse reactions reported with Plasma-Lyte or other similar products are other manifestations of hypersensitivity/ infusion reactions including tachycardia, palpitations, chest pain, respiratory rate increased, feeling abnormal, piloerection, oedema peripheral and infusion site pain.

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

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. All injections in Viaflex plastic containers are intended for intravenous administration using sterile equipment.
As reported in the literature, the dosage, volume and infusion rate of intravenous glucose must be selected with caution in paediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycaemia/hypoglycaemia (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).

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 completed (see Section 4.4 Special Warnings and Precautions for Use, Risk of air embolism).
Parenteral drug products should be inspected visually for particular matter and discolouration prior to the administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact.

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 and 5% Glucose IV Infusion is a 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. Those additives known to be incompatible should 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 and 5% Glucose 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.

4.7 Effects on Ability to Drive and Use Machines

There is no information of the effects of Plasma-Lyte 148 and 5% Glucose IV Infusion on the ability to operate an automobile or other heavy machinery.

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 and 5% Glucose 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 (see Section 4.4 Special Warnings and Precautions for Use).
An excessive volume of Plasma-Lyte 148 and 5% Glucose 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 (see Section 4.4 Special Warnings and Precautions for Use).
Excessive administration of potassium may lead to the development of hyperkalaemia, especially in patients with severe renal impairment (see Section 4.4 Special Warnings and Precautions for Use).
Excessive administration of magnesium many lead to hypermagnesaemia (see Section 4.4 Special Warnings and Precautions for Use).
Excessive administration of glucose-containing solution may lead to hyperglycaemia, hyperosmolarity, osmotic diuresis and dehydration.
When assessing an overdose, any additives in the solution must 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).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections; hydrochloric acid (for pH adjustment).

6.2 Incompatibilities

Additives may be incompatible. Those additives known to be incompatible should not be used. Consult with 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 and 5% Glucose IV Infusion in Viaflex plastic containers is available as shown in Table 2.
Package size: 1000 mL.

6.6 Special Precautions for Disposal

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

Summary Table of Changes