Product information

Product Information
Plasma-Lyte 148 (approx. pH 7.4) IV Infusion

Name of the medicine

Plasma-Lyte 148 (approx. pH 7.4) IV Infusion
Description

Plasma-Lyte 148 (approx. pH 7.4) IV Infusion is a sterile, clear, nonpyrogenic isotonic solution
in a single dose container for intravenous administration.
Each 1000mL of Plasma-Lyte 148 (approx. pH 7.4) IV Infusion contains:
Sodium Gluconate Potassium Chloride Magnesium Chloride Sodium Hydroxide Water for Injections Approximate Osmolality Approximate Kilojoules Plasma-Lyte 148 (approx. pH 7.4) IV Infusion when administered intravenously is a source of water, electrolytes, and calories. It contains no antimicrobial agents. The 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 1000mL of Plasma-Lyte 148 (approx. pH 7.4) IV Infusion has an ionic concentration of: Plasma-Lyte 148 (approx. pH 7.4) IVI ccsi41920130326 Pharmacology

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.

Indications

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

Contraindications

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

Precautions
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, in patients with hypochloremic hypokalaemic alkalosis.  the primary treatment of severe metabolic acidosis.
 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. 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. Plasma-Lyte 148 (approx. pH 7.4) IV Infusion should be administrated with particular caution, if at all to patients with conditions that may cause sodium retention, fluid overload and oedema. 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. Plasma-Lyte 148 (approx. pH 7.4) IVI ccsi41920130326
Plasma-Lyte 148 (approx. pH 7.4) IV Infusion should be used with great care in patients with
metabolic or respiratory 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.
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 /hypervolemia, congested states, including
pulmonary congestion and oedema, and 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.

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.
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.
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 may result in metabolic
alkalosis.
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.
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. Plasma-Lyte 148 (approx. pH 7.4) IV Infusion should be administered with particular caution, if at all, to hypervolemia 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 edema, 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 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. Plasma-Lyte 148 (approx. pH 7.4) IVI ccsi41920130326
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.
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.
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.

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 elder patient,
consider that elderly patients are generally more likely to have cardiac, renal, hepatic and other
diseases or concomitant drug therapy.
Carcinogenicity
Studies with Plasma-Lyte 148 (approx. pH 7.4) IV Infusion have not been performed to evaluate
carcinogenic potential.
Genotoxicity
Studies with Plasma-Lyte 148 (approx. pH 7.4) IV Infusion have not been performed to evaluate
mutagenic potential.

Effects on fertility
Studies with Plasma-Lyte 148 (approx. pH 7.4) IV Infusion have not been performed to evaluate
effect on fertility.
Plasma-Lyte 148 (approx. pH 7.4) IVI ccsi41920130326
Effect 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.
General
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.

Interactions with other medicines

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 cyclosporine.
Adverse 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
Hypervolemia Venous thrombosis Phlebitis extending from the site of injection Plasma-Lyte 148 (approx. pH 7.4) IVI ccsi41920130326 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 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 Plasma-Lyte products with Glucose are:
 other manifestations of hypersensitivity/infusion reactions including hypotension, wheezing, urticaria, cold sweat and chills  hyperkalaemia
Dosage and administration
Dosage
As directed by the physician. Dosage is dependent on age, weight and clinical condition of the
patient as well as laboratory determinations. 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.
All injections in Viaflex plastic containers are intended for intravenous administration using
sterile equipment.
Additives may be incompatible. Complete information is not 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.
Plasma-Lyte 148 (approx. pH 7.4) IVI ccsi41920130326
Those additives known to be incompatible should not be used. Consult with a pharmacist, if
available. 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.

Directions for use

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.
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
1. Suspend container from eyelet support. 2. Remove plastic protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set.
To Add Medication
Warning: Additives may be incompatible

To add medication before solution administration
1. Prepare medication site. 2. Using a syringe with a 0.63 to 0.80 mm needle, puncture resealable medication port and 3. 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
1. Close clamp on the set. 2. Prepare medication site. 3. Using a syringe with a 0.63 to 0.80 mm needle, puncture resealable medication port and 4. Remove container from IV pole and turn to an upright position. 5. Evacuate both ports by squeezing them while container is in the upright position. 6. Mix solution and medication thoroughly. 7. Return container to in use position and continue administration. Plasma-Lyte 148 (approx. pH 7.4) IVI ccsi41920130326 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.
Overdosage

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. See PRECAUTIONS.
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. See PRECAUTIONS.
Excessive administration of potassium may lead to the development of hyperkalaemia,
especially in patients with severe renal impairment. See PRECAUTIONS.
Excessive administration of magnesium many lead to hypermagnesaemia. See PRECAUTIONS.
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.

Presentation and storage conditions

Plasma-Lyte 148 (approx. pH 7.4) IV Infusion in Viaflex plastic containers is available as
shown below:

Storage condition

Store product below 30C.
Do not freeze.
Name and address of the sponsor

Baxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie, NSW 2146.
Plasma-Lyte 148 (approx. pH 7.4) IVI ccsi41920130326
Poison schedule of the medicine

Unscheduled
Date of first inclusion in the Australian Register of Therapeutic Goods
(the ARTG)

11 December 2014
Viaflex and Plasma-Lyte are trademarks of Baxter International Inc
Plasma-Lyte 148 (approx. pH 7.4) IVI ccsi41920130326

Source: http://www.baxterhealthcare.com.au/downloads/healthcare_professionals/cmi_pi/plasma-Lyte148(approx%20pH%207.4)_pi.pdf