Consumer medicine information

Compound Sodium Lactate (Hartmann’s) Solution with Glucose Intravenous Infusion

Glucose anhydrous; Calcium chloride dihydrate; Sodium lactate; Sodium chloride; Potassium chloride

BRAND INFORMATION

Brand name

Compound Sodium Lactate (Hartmann's Solution) and 5% Glucose Solution for infusion

Active ingredient

Glucose anhydrous; Calcium chloride dihydrate; Sodium lactate; Sodium chloride; Potassium chloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Compound Sodium Lactate (Hartmann’s) Solution with Glucose Intravenous Infusion.

What is in this leaflet?

This leaflet answers some common questions about Compound Sodium Lactate (Hartmann’s) Solution with Glucose Intravenous (IV) Infusion.

It does not contain all of the available information. All medicines have risks and benefits. Your doctor has weighed the risks of you using Hartmann’s Solution with Glucose IV Infusion against the benefit they expect it will have for you.

It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

What Hartmann’s Solution with Glucose IV Infusion is used for

This medicine is used to replace and balance body fluid and mineral salts that may be lost for a variety of medical reasons and also as an energy source.

Before you are given Hartmann’s Solution with Glucose IV Infusion

The Hartmann’s Solution with Glucose IV Infusion should 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;
  • you have congestive heart failure (constant wheezing, shortness of breath);
  • you have severely reduced kidney function;
  • you have too much sodium and chloride in your blood that is not being corrected with medication
  • you have ischaemic stroke or head trauma in the last 24 hours
  • it is intended to be administered at the same time and through the same injection equipment as blood preparations (citrate anticoagulated /preserved blood) or ceftriaxone, an antibiotic (if a baby < 1 month of age is to be treated, administration at the same time as ceftriaxone must never occur)
  • the expiry date printed on the pack has passed.

You must tell your doctor if you:

  • have heart problems
  • have kidney problems including kidney stones
  • have diabetes
  • are taking any other medicine including those you can buy without a prescription, in particular digoxin (a medicine for heart problems), medicines for high blood pressure (diuretics, ACE inhibitors or ARAs), immunosuppressant medicines (tacrolimus or cyclosporine), corticosteroids, lithium or vitamin D
  • are pregnant
  • are breast feeding

How Hartmann’s Solution with Glucose IV Infusion is given

How much it is given:

Your doctor will decide how much Hartmann’s Solution with Glucose IV Infusion will be given to you, which depends on your need and condition. The medicine is given by a slow rate (drip) injection; therefore it should be given by using special equipment and attended by a health professional (doctor, trained nurse).

How it is given:

The Hartmann’s Solution with Glucose IV 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.

Overdosage

The doctor or nurse giving you the Hartmann’s Solution with Glucose IV 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.

While you are given Hartmann’s Solution with Glucose IV Infusion

Discuss with your doctor the progress you have experienced after the treatment, whether any complication has occurred, especially during the first few days of therapy. Frequent clinical evaluation and laboratory tests may be required. As Hartmann’s Solution and Glucose IV Infusion is normally given in a hospital, your nurse provider will take records of the progress and unexpected reactions.

Side effects

As with any medicines, some side effects may occur. Undesirable side effect such as nausea, vomiting, headache or dizziness may occur. Your body may also retain sodium and this may result in a build-up of fluid and swelling of the hands, ankles and feet. Additionally, as with other preparations similar to Hartmann’s Solution with Glucose IV Infusion, pain, irritation, inflammation, and swelling or abnormal clotting at the site of injection is also possible.

Always tell your doctor or nurse if you have any unexpected effects during or after receiving Hartmann’s Solution with Glucose IV Infusion and they worry you. In rare circumstances, more serious side effects may occur such as chest pain, fast or slow heartbeat, or fluid on the lungs or swelling of the face, lips or mouth causing breathing difficulties. If these occur, tell your health professional on duty immediately. These may be symptoms of a serious allergic reaction. Your health professional will take appropriate action promptly, such as stopping the infusion.

Product description

What Hartmann’s Solution with Glucose IV Infusion looks like

It is a clear, colourless solution filled in plastic bags.

What is in Hartmann’s Solution with Glucose IV Infusion?

The active components are Sodium Lactate, Potassium Chloride, Sodium Chloride, Calcium Chloride and Glucose, formulated and dissolved in water for injection. The bag pack sizes are included below:

AHB2073

Potassium Chloride (0.04%),
Sodium Chloride (0.6%),
Sodium lactate (0.322%),
Calcium Chloride (0.027%),
Glucose (5%), AUST R 19422,
500mL

AHB2074

Potassium Chloride (0.04%),
Sodium Chloride (0.6%),
Sodium lactate (0.322%),
Calcium Chloride (0.027%),
Glucose (5%), AUST R 48490,
1000mL

Storage

Hartmann’s Solution with glucose IV Infusion will be stored in the pharmacy or the hospital ward. It is recommended that the product be stored below 30°C.

Where can you get more information?

You can get more information from your doctor or pharmacist.

Name and address of the sponsor

Baxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie NSW 2146

Date of preparation:

March 2014

BRAND INFORMATION

Brand name

Compound Sodium Lactate (Hartmann's Solution) and 5% Glucose Solution for infusion

Active ingredient

Glucose anhydrous; Calcium chloride dihydrate; Sodium lactate; Sodium chloride; Potassium chloride

Schedule

Unscheduled

 

1 Name of Medicine

Sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate and 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 lactate.

Molecular formula: C3H5O3Na. Molecular Weight: 112.06. Appearance: clear, colourless, slightly syrupy liquid. Solubility: miscible with water.

Potassium chloride.

Molecular formula: KCl. Molecular Weight: 74.55. Appearance: colourless or white crystal. Solubility: freely soluble in water.

Calcium chloride dihydrate.

Molecular formula: CaCl2,2H2O. Molecular Weight: 147.01. Appearance: a white crystalline powder. Solubility: hygroscopic, freely 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 lactate CAS No.: 867-56-1.
Potassium chloride CAS No.: 7447-40-7.
Calcium chloride dihydrate CAS No.: 10035-04-8.
Glucose (D-(+)glucopyranose) CAS No.: 50-99-7.

2 Qualitative and Quantitative Composition

Baxter Compound Sodium Lactate (Hartmann's) and 5% Glucose Intravenous (IV) Infusion comprises sodium chloride (6 g/L), sodium lactate (3.22 g/L), potassium chloride (0.4 g/L), calcium chloride dihydrate (0.27 g/L) and glucose (50 g/L) in Water for Injections.
Hartmann's and 5% Glucose IV Infusions are sterile, non-pyrogenic solutions. There is no antimicrobial agent or buffer added. They are hypertonic intravenous solutions (osmolality of 563 mOsm/kg) with pH of 4.0 - 6.5.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Clear liquid solution for Intravenous Infusion.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

A multiple electrolyte intravenous and glucose solution is intended for restoring the electrolyte balance as well as providing energy and water for hydration. A combination of multiple electrolyte and sodium lactate alkalinising agent, will provide electrolyte balance and normalise the pH of the acid/ base balance of the physiological system.
Sodium is the major cation of extracellular fluid and functions principally in the control of water distribution, fluid and electrolyte balance and osmotic pressure of body fluids. Chloride, the major extracellular anion, closely follows the physiological disposition of sodium cation in maintenance of acid/ base balance, isotonicity and electrodynamic characteristic of the cells.
In contrast to sodium ion, potassium is a major cation of the intracellular fluid (160 mEq/liter of intracellular water) and functions principally in the control of body fluid composition and electrolyte balance. Potassium participates in carbohydrate utilisation, protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.
Calcium is essential for maintenance of the functional integrity of nervous, muscular, and skeletal system and cell membrane and capillary permeability. Calcium is the major component of the body skeleton. The calcium content in bone is continuously undergoing a process of resorption and formation. The normal concentration of calcium in plasma is between 2.2 to 2.6 mmol per litre.
Sodium lactate is an alkalising agent. Lactate is slowly metabolised to bicarbonate and water. This reaction depends on the cellular oxidative activity. Under normal physiological condition conversion of sodium lactate to bicarbonate requires about 1-2 hours. The bicarbonate metabolite then has similar actions to those of sodium bicarbonate preparations. That is, bicarbonate metabolites react with acid to produce carbon dioxide and water.
Glucose is readily metabolised into carbon dioxide and water, with a release of energy. As such, an administration of a glucose solution either by oral or parenteral route provides water for body hydration as well as calories. In addition, it may reduce catabolic loss of nitrogen from the body and aids in prevention of depletion of liver glycogen. That is, in the absence of glucose, amino acids undergo deamination. It is followed by oxidation, with a release of energy.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

As Hartmann's solution and 5% glucose IV infusion is directly administered to the systemic circulation, the bioavailability (absorption) of the active components is complete (100%). Excess of calcium is predominantly excreted by renal system, as in the case of potassium and sodium excretion.

5.3 Preclinical Safety Data

The active ingredients potassium chloride, sodium chloride, calcium chloride, sodium lactate and glucose are not mutagenic.

Carcinogenicity.

The active ingredients potassium chloride, sodium chloride, calcium chloride, sodium lactate and glucose are not carcinogenic.

4 Clinical Particulars

4.1 Therapeutic Indications

Hartmann's solution and 5% glucose IV infusion is indicated as a source of water and electrolytes. It is also used in patients as a source of bicarbonate in the treatment of mild to moderate metabolic acidosis associated with dehydration or associated with potassium deficiency. These solutions are indicated as methods of intravenous drug delivery, if the drugs are compatible with the solutions.

4.3 Contraindications

Hartmann's solution and 5% glucose IV infusion is contraindicated in patients with:
known hypersensitivity to sodium lactate, or corn/ corn products (because cornstarch is used as raw material for glucose production);
congestive heart failure or severe impairment of renal function;
clinical states in which the administration of sodium and chloride is detrimental.
As for other calcium containing infusion solutions, concomitant administration of ceftriaxone and Hartmann's and 5% glucose IV infusion is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (due to risk of fatal ceftriaxone-calcium salt precipitation in the neonate's bloodstream).
In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium containing solutions, including Hartmann's and 5% glucose IV infusion, through the same infusion line (e.g. via Y connector).

4.4 Special Warnings and Precautions for Use

Hartmann's and 5% Glucose IV Infusion is not for use in the treatment of lactic acidosis, severe metabolic acidosis or treatment of severe potassium deficiency. Although the solutions have potassium concentrations similar to that of plasma, it is insufficient to produce a useful effect in severe potassium deficiency.
The safety of the Viaflex plastic container used in Hartmann's Solution and 5% Glucose Intravenous Infusion has been confirmed in tests in animals according to the USP biological tests for plastic container, as well as by tissue culture toxicity studies. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. Nevertheless, care should be exercised regarding possible incompatibility outcomes resulted either from the interaction between the plastic container or active ingredients and the added therapeutic substances (see Section 4.2 Dose and Method of Administration).
In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, through the same infusion line.
If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid.
Due to the risk of coagulation precipitated by its calcium content Hartmann's Solution and 5% Glucose Intravenous Infusion must not be added to or administered simultaneously through the same tubing with citrate anticoagulated/preserved blood (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Hypersensitivity reactions.

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.

Osmolality.

Hartmann's and 5% Glucose IV Infusion is a hypertonic solution (563 mOsm/kg). It is important to bear in mind that an administration of substantially hypertonic solution may cause venous irritation, including phlebitis, and may lead to a wide variety of complications, such as crenation (shrinkage) of red blood cells and general cellular dehydration. Hyperosmolar solutions should be administered with caution, if at all, to patients with hyperosmolar states.

Use in patients with renal impairment.

In patients with diminished renal function, administration of Hartmann's and 5% Glucose IV Infusion may result in sodium, calcium and/or potassium retention. If a patient receives prolonged therapy, or the rate of administration warrants review, clinical evaluation and laboratory monitoring for changes in fluid balance, electrolyte concentration and acid-base balance should be conducted.

Use in patients with or at risk of hyperkalaemia.

Hartmann's and 5% Glucose IV Infusion should be administered with particular caution, if at all, to patients with hyperkalaemia or conditions predisposing to hyperkalaemia (e.g. potassium excretion impairment, adrenocortical insufficiency, acute dehydration, severe renal impairment or extensive tissue injury or burns) and in patients with cardiac disease, as administration of IV potassium can rapidly result in severe hyperkalaemia without symptoms, which may lead to fatal adverse reactions.

Use in patients with hypervolaemia or overhydration, or conditions that cause sodium retention and oedema.

Hartmann's and 5% Glucose IV Infusion should be administered with particular caution, if at all, to patients with conditions that may cause sodium retention, fluid overload and oedema. Consideration should be given to withholding Hartmann's and 5% Glucose IV Infusion altogether in hypervolaemic or overhydrated patients, including those with severe renal impairment, primary or secondary hyperaldosteronism or preeclampsia, due to the risk of potassium and/or sodium retention, fluid overload and oedema.
Hartmann's and 5% Glucose IV Infusion should be used with caution in patients receiving corticosteroids or corticotropin, i.e. potential sodium retention.

Fluid/ solute overload and electrolyte disturbances.

Depending on the volume and rate of infusion, intravenous administration of Hartmann's and 5% Glucose IV Infusion can cause:
Fluid and/or solute overloading resulting in dilution of the serum electrolyte concentrations, over-hydration, congested states, including pulmonary congestion and oedema.
Clinically relevant electrolyte disturbance and acid-base imbalance. The risk of dilution states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary oedema is directly proportional to the electrolyte concentrations of the injections.
Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

Use in patients with or at risk of alkalosis.

Hartmann's and 5% Glucose IV Infusion should be administered with particular caution, if at all, to patients with alkalosis or at risk of alkalosis, because lactate is metabolised to bicarbonate and administration may result in, or worsen, metabolic alkalosis. The effect of sodium lactate component in Hartmann's and 5% Glucose IV Infusion on patients with metabolic or respiratory alkalosis should be monitored closely.

Use in patients with or at risk for increased lactate levels or with impaired lactate utilisation.

Hartmann's and 5% Glucose IV Infusion should be administered with extreme caution, if at all, in patients with conditions associated with increased lactate levels, impaired lactate utilisation such as cardiac disease, shock and severe hepatic insufficiency or otherwise at risk of alkalosis. Hyperlactataemia (i.e. high lactate levels) can develop in patients with severe hepatic insufficiency, since lactate metabolism may be impaired. In addition, Hartmann's and 5% Glucose IV Infusion may not produce its alkalinising action in patients with severe hepatic insufficiency, since lactate metabolism may be impaired. Seizure may be precipitated by the alkalosis induced by lactate but this is uncommon.
Lactate-containing solutions should be administered with particular caution to neonates and infants less than 6 months of age (see Paediatric use).

Use in patients with or at risk of hyponatraemia.

Glucose intravenous infusions are usually isotonic solutions. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolism. Monitoring of serum sodium is particularly important for hypotonic fluids. Hartmann's and 5% Glucose IV Infusion has an osmolality of 563 mOsm/kg (see Section 6.5 Nature and Contents of Container, Table 1).
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 (brain oedema) characterised by headache, nausea, seizures, lethargy and vomiting. Patients with brain oedema are at particular risk of severe, irreversible and life-threatening brain injury.

Use in patients with or at risk of hyperglycaemia.

Solutions containing glucose should be used with caution in patients with impaired glucose tolerance or diabetes mellitus. Lactate is a substrate for gluconeogenesis so caution should be used with Hartmann's and 5% Glucose IV Infusion in Type 2 diabetics. As Hartmann's and 5% Glucose IV Infusion contains glucose and lactate (which is metabolised to glucose), administration that exceeds the metabolic capacity for glucose may lead to hyperglycaemia.
Hyperglycaemia has been implicated in increasing cerebral ischaemic brain damage and impairing recovery after acute ischaemic strokes. Caution is recommended in using glucose containing solutions in such patients. Early hyperglycaemia has also 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.
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 (see Paediatric use below).

Use in patients with or at risk of hypercalcaemia.

Solutions containing calcium salts (including Hartmann's and 5% Glucose IV Infusion) should be used with caution in patients with:
hypercalcaemia or conditions predisposing to hypercalcaemia, such as patients with severe renal impairment and granulomatous diseases associated with increased calcitriol synthesis such as sarcoidosis;
calcium renal calculi or a history of such calculi.

Use in the elderly.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

Paediatric use.

Safety and effectiveness of Hartmann's and 5% Glucose IV Infusion in paediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the paediatric population is referenced in the medical literature. Plasma electrolyte concentrations should be closely monitored in the paediatric population.
Lactate-containing solutions should be administered with particular caution to neonates and infants < 6 months of age.
The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy, and should be determined by the consulting physician experienced in paediatric intravenous fluid therapy.
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.

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

4.5 Interactions with Other Medicines and Other Forms of Interactions

Hartmann's and 5% glucose IV infusion should not be administered simultaneously with blood preparations (e.g. citrate anticoagulated/preserved blood) through the same administration set, because of a possibility of the likelihood of coagulation.
Use of intravenous infusions containing glucose may necessitate review of a patient's oral hypoglycaemic or insulin requirements. Close monitoring of serum glucose may be required.
Concomitant administration with ceftriaxone is not recommended through the same infusion line (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use) due to the risk of fatal ceftriaxone-calcium salt precipitation.
Administration of calcium may increase the effects of digitalis and lead to serious or fatal cardiac arrhythmias. Therefore larger volumes or faster infusion rates should be used with caution in patients treated with digitalis glycosides.
Caution is advised when administering Hartmann's and 5% glucose IV infusion to patients treated with:
thiazide diuretics or vitamin D as these can increase the risk of hypercalcaemia;
medicines that may increase the risk of sodium and fluid retention such as carbenoxolone and corticosteroids;
medicines for which renal elimination is pH dependent. Due to the alkalinising action of lactate (formation of bicarbonate), Hartmann's 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 medicines such as sympathomimetics (e.g. pseudoephedrine), dexamphetamine sulphate and fenfluramine hydrochloride may be decreased.
Hartmann's solution and 5% glucose intravenous infusion should not be administered concomitantly with drugs that can cause hyperkalaemia or increase the risk of hyperkalaemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARAs) or the immunosuppressants tacrolimus and cyclosporin, or potassium supplement preparations. Simultaneous administration of these medicines can result in severe and potentially fatal hyperkalaemia, particularly in patients with severe renal insufficiency.
Caution is advised when administering Hartmann's 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 intravenous 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-Nmethamphetamine, ifosfamide, antipsychotics, opioids.
Drugs potentiating vasopressin action such as chlorpropamide, non-steroidal antiinflammatories (NSAIDS), cyclophosphamide.
Vasopressin analogues such as desmopressin, oxytocin, vasopressin, terlipressin.
Caution is advised when administering Hartmann's 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.

No data available.
(Category C)
There are no adequate data from the use Hartman's and 5% Glucose IV Infusion in pregnant women. The potential risks and benefits for each specific patient should be carefully considered before using Hartmann's and 5% Glucose IV Infusion in pregnant women.
There are no adequate data from the use of Hartmann's and 5% Glucose IV Infusion in lactating women. The potential risks and benefits for each specific patient should be carefully considered before using Hartmann's and 5% Glucose IV Infusion in lactating women.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions have been reported in the postmarketing experience.

Immune system disorders.

Hypersensitivity/ infusion reactions, including anaphylactic/ anaphylactoid reactions, and the following manifestations: angioedema, chest pain, chest discomfort, bronchospasm, dyspnoea, cough, urticaria, rash, pruritus, erythema, nausea, pyrexia.

General disorders and administration site conditions.

Infusion site reactions, including infusion site pruritus, infusion site erythema and infusion site anaesthesia (numbness).

Other reactions.

Other adverse reactions reported with lactated ringer's injection (without glucose) and sodium lactate injection are:

Other manifestations of hypersensitivity/ infusion reactions.

Decreased heart rate, tachycardia, blood pressure decreased, respiratory distress, flushing, throat irritation, paresthesias, hypoesthesia oral, dysgeusia, anxiety and headache.

Hyperkalaemia.


Other infusion site reactions.

Phlebitis, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pain, infusion site burning.
Other adverse reactions reported with other similar products are: hyponatraemia; hyponatraemic encephalopathy.
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.

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

To be used as directed by the physician. The dosage, rate and duration of administration of Hartmann's and 5% Glucose IV Infusion is to be individualised and depend upon the indication for use, the patient's age, weight, concomitant treatments and clinical condition, as well as laboratory determinations and response.
The infusion rate should not exceed the patient's ability to utilise glucose in order to avoid hyperglycaemia. The infusion rate of intravenous solutions containing glucose should be selected with caution in children (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. Sterile and nonpyrogenic equipment must be used for intravenous administration. Do not administer unless the solution is clear and the seal is intact.
The introduction of additives to any solution, regardless of type of container, requires special attention to assure that no incompatibilities results. While some incompatibilities are readily observed, one must be aware that subtle physical, chemical and pharmacological incompatibilities can occur.
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 Hartmann's and 5% glucose IV infusion is appropriate. After addition, check for a possible colour change and/or the appearance of precipitates, insoluble complexes or crystals.
Complete information is not available. Those additives known to be incompatible should not be used. The medical literature, the package insert and other available sources of information should be reviewed for thorough understanding of possible incompatibilities. Consult with pharmacist, if available. If in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Refer to instructions below. Solutions containing additives should be used immediately, and not stored. Do not reconnect any partially used containers.
The product should be used for one patient on one occasion only. Any unused portion should be discarded.

Direction for use of Viaflex plastic container.

Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the product.
Do not use plastic containers in series connections. Such use could result in embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Pressurising intravenous solutions contained in flexible plastic containers to increase flow rate can also result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of vented intravenous administration sets 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.

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 inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for administration.

Hartmann's and 5% Glucose 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 medication.

Warning: Additives may be incompatible.

To add medication before solution administration.

Prepare medication site. Using syringe with 19 to 22 gauge 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 19 to 22 gauge 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.

4.7 Effects on Ability to Drive and Use Machines

There is no information on the effects of Hartmann's and 5% Glucose IV Infusion on the ability to operate an automobile or other heavy machinery.

4.9 Overdose

There is no overdose experience with Hartmann's solution and 5% glucose IV infusion. No specific antidotes to this preparation are known. Should overdose occur, immediate medical attention may be required to treat the symptoms and to institute appropriate supportive measures. The effects of an overdose may require immediate medical attention and treatment.
An excessive volume or too high a rate of administration 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 lactate may lead to metabolic alkalosis, which may be accompanied by hypokalaemia. Excessive administration of potassium may lead to the development of hyperkalaemia, especially in patients with severe renal impairment. Excessive administration of calcium salts may lead to hypercalcaemia. Excessive administration of glucose may lead to hyperglycaemia, hyperosmolarity, osmotic diuresis, and dehydration.
When assessing an overdose, any additives in the solution must also be considered.
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.

6.2 Incompatibilities

Additives may be incompatible. Those additives known to be incompatible should not be used (see Section 4.2 Dose and Method of Administration; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Ceftriaxone must not be mixed with calcium-containing solutions including Hartmann's and 5% Glucose IV Infusion (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).

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.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

6.5 Nature and Contents of Container

Hartmann's and 5% Glucose IV Infusion is supplied in Viaflex plastic containers as a single unit dose (see Table 1).
Package size: 500 mL x 1, 1000 mL x 1.

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