Plasma-Lyte® 148 pH 7.4

/ Teva

As directed by a physician. Dosage, rate and duration of administration are to be individualized and dependent upon the indication for use, the patient’s age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.
The solution is compatible with blood or blood components. It may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used
as a diluent in the transfusion of packed erythrocytes. The solution and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components.
All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

Indicated as a source of water and electrolytes or as an alkalinizing agent.

– Hyperkalaemia
– Renal failure
– Heart block
-Metabolic or respiratory alkalosis
– Hypochlorhydria
-Hypersensitivity to the active substances or to any of the excipients

Electrolyte balance
Not indicated for the treatment of hypochloraemic hypokalaemic alkalosis
not indicated for the primary treatment of severe metabolic acidosis neither for the treatment of hypomagnesaemia.
Use in Patients with or at Risk for and from Hypermagnaesemia
Parenteral magnesium salts should be used with caution in less severe degrees of renal impairment and in patients with myasthenia gravis. Patients should be monitored for clinical signs of excess magnesium, particularly when being treated for eclampsia
Use in patients with Hypocalcaemia
Contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not protein-bound) calcium. The solution should be administered with particular caution to patients with hypocalcaemia.
Use in Patients with or at Risk for Hyperkalaemia
Solutions containing potassium salts should be administered with caution to patients with cardiac disease or conditions predisposing to hyperkalaemia such as renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns. The plasma potassium level of the patient should be particularly closely monitored in patients at risk of hyperkalaemia.
The following combinations are not recommended; they increase the concentration of potassium in the plasma and may lead to potentially fatal hyperkalaemia notably in case of renal failure increasing the hyperkalaemic effects .
– Concomitant use with potassium-sparing diuretics (amiloride, potassium canreonate, spironolactone, triamterene)
– Angiotensin converting enzyme inhibitors (ACEi) and, by extrapolation, angiotensin II receptor antagonists: hyperkalaemia potentially lethal
– Tacrolimus, cyclosporin
Use in patients with potassium deficiency
Although the solution has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency and therefore it should not be used for this purpose.
Fluid balance/renal function
Risk of Fluid and/or Solute Overload and Electrolyte Disturbances
The patient’s clinical status and laboratory parameters (fluid balance, blood and urine electrolytes as well as acid-base balance) must be monitored during use of this solution. Depending on the volume and rate of infusion, intravenous administration of The solution can cause
− fluid and/or solute overload resulting in overhydration/hypervolaemia therefore high volume infusion must be used under specific monitoring in patients with cardiac, pulmonary or renal failure.
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 .
Hyponatraemia
Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress, infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids.
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 brain injury.
Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.
Use in Patients with Hypervolaemia or Overhydration, or Conditions that Cause Sodium Retention and Oedema
The solution should be administered with particular caution to hypervolaemic or overhydrated patients.
Solutions containing sodium chloride should be carefully administered to patients with hypertension, heart failure, peripheral or pulmonary edema, impaired renal function, pre-eclampsia, aldosteronism, or other conditions associated with sodium retention.
Use in Patients with Severe Renal Impairment
The solution should be administered with particular caution to patients with severe renal impairment. In such patients administration may result in sodium and/or potassium or magnesium retention.
Acid-base balance
Use in Patients with or at Risk for Alkalosis
The solution should be administered with particular caution to patients with alkalosis or at risk for alkalosis. Excess administration can result in metabolic alkalosis because of the presence of acetate and gluconate ions.
Hypersensitivity Reactions
Hypersensitivity/infusion reactions, including anaphylactoid reactions, have been reported.
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.
Administration
Administration in the postoperative period shortly after recovery from neuromuscular block should be used with caution since magnesium salts can lead to recurarisation effect.
When used concomitantly with parenteral nutrition, electrolyte supply should be taken into account and adjusted accordingly.

Interference with laboratory tests for gluconate containing solutions
There have been reports of false-positive test results using the Bio-Rad Laboratories Platelia
Aspergillus EIA test in patients receiving Baxter gluconate containing Plasmalyte 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 Plasmalyte
solutions should be interpreted cautiously and confirmed by other diagnostic methods.
Administration
Adding other medications or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.
See prescribing information for full details.

Undesirable effects  with unknown frequency: Hypersensitivity/infusion reaction, (including Anaphylactoid reaction, and the, following manifestations:, tachycardia, palpitations, chest pain, chest discomfort, dyspnea, respiratory rate increased, flushing, hyperaemia, asthenia, feeling abnormal, piloerection, oedema peripheral, pyrexia, urticaria, hypervolaemia, hospital acquired hyponatraemia, seizures, acute hyponatraemic encephalopathy, thrombophlebitis venous thrombosis, urticaria, infusion site reactions (e.g., burning sensation fever, injection site pain injection site reaction injection site phlebitis injection site irritation injection site infection extravasation), infusion site reactions (e.g., burning sensation fever, injection site pain injection site reaction injection site phlebitis injection site irritation injection site infection extravasation).

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 hospital acquired hyponatraemia following inappropriately balanced treatment with i.v. fluids.
• Drugs stimulating vasopressin release include: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
• Drugs potentiating vasopressin action include: Chlorpropamide, NSAIDs, cyclophosphamide
• Vasopressin analogues include: Desmopressin, oxytocin, terlipressin

Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as oxcarbazepine.
Interaction related to the presence of sodium:
– Corticoids/Steroids and carbenoxolone, which are associated with the retention of
sodium and water (with oedema and hypertension).
Interaction related to the presence of potassium:
The following combinations increase the concentration of potassium in the plasma and may lead to potentially fatal hyperkalaemia notably in case of renal failure increasing the hyperkalaemic effects:
– Potassium-sparing diuretics (amiloride, potassium canreonate, spironolactone, triamterene, alone or in combination) , – Angiotensin converting enzyme inhibitors (ACEi) and, by extrapolation, angiotensin II receptor antagonists: hyperkalaemia potentially lethal , Tacrolimus, cyclosporin
Administration of potassium in patients treated with such medications can produce severe and potentially fatal hyperkalaemia, particularly in patients with severe renal insufficiency.
Interaction related to the presence of magnesium:
Neuromuscular blockers such as tubocurarine, suxamethonium, and vecuronium whose effects are enhanced by the presence of magnesium.
Acetylcholine whose release and effects are reduced by magnesium salts what may contribute to neuromuscular blockade.
Aminoglycoside antibacterials and nifedipine that have additive effects with parenteral magnesium and enhanced the neuromuscular blocking.
Interaction related to the presence of acetate and gluconate (which are metabolised into bicarbonate):
Caution is advised when administering the solution  to patients treated with drugs for which renal elimination is pH dependent. Due to its alkalinizing effect (formation of bicarbonate), may interfere with the elimination of such
drugs. Renal clearance of acidic drugs such as salicylates, barbiturates and lithium may be increased because of the alkalinisation of urine by the bicarbonate resulting from acetate and gluconate metabolism.
Renal clearance of alkaline drugs such as sympathomimetics (e.g. ephedrine, pseudoephedrine) and stimulants (e.g. dexamphetamine sulphate, phenfluramine hydrochloride) may be decreased.
See prescribing information for full details.

Pregnancy and lactation
There are no adequate data from the use of the solution for infusion in pregnant or lactating women. The potential risks and benefits for each specific patient should be carefully considered before using the solution for infusion in pregnancy or lactating woman.
The  solution should be administrated with special caution for pregnant women during labour particularly as to serum-sodium if administered in combination with.
Fertility
There is no information on the effects of the solution for infusion on fertility.

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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not administer unless the solution is clear and seal is intact.
Additives may be incompatible with the solution. 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 the solution is appropriate. After addition, check for a possible color 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. Additives known or determined to be incompatible must not be used. When introducing additives to the solution, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.
See prescribing information for full details.