ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Post-Marketing Adverse Reactions. The following adverse reactions associated with the use of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish causal relationship to drug exposure.Hypersensitivity and Infusion Reactions: tachycardia, chest pain, chest discomfort, dyspnea, flushing, hyperemia, asthenia, pyrexia, hypotension, wheezing, urticaria, cold sweat, chills.General Disorders and Administration Site Conditions: infusion site pain, burning sensation.Metabolism and nutrition disorders: hyperkalemia, hyponatremia.Nervous System Disorders: hyponatremic encephalopathy.. Overdose. Excessive administration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause:ofluid overload with risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. hypernatremia and hyperkalemia, especially in patients with severe renal impairment. ohypermagnesemia. See WARNINGS and ADVERSE REACTIONS ometabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations. When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP), dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).. ofluid overload with risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. o hypernatremia and hyperkalemia, especially in patients with severe renal impairment. ohypermagnesemia. See WARNINGS and ADVERSE REACTIONS ometabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations.

DESCRIPTION SECTION.

DESCRIPTION. PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is sterile, nonpyrogenic isotonic solution in single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO2o3H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl2o6H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0).PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, mEq potassium, mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is 280 to 310 mOsmol/L. The caloric content is 21 kcal/L.The VIAFLEX plastic container is fabricated from 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 of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Important Administration Instructions oPLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is intended for intravenous administration using sterile equipment. oDo not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. oSet the vent to the closed position on vented intravenous administration set to prevent air embolism. oUse dedicated line without any connections to avoid air embolism. oDo not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. oPrior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged. oPLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) 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 priming solution), added to or infused concurrently with blood components, or used as diluent in the transfusion of packed erythrocytes. PLASMA-LYTE Injection and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components.Dosing InformationThe choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by physician experienced in intravenous fluid therapy.Introduction of Additives Additives may be incompatible. Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. 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. After addition, if there is discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.. oPLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is intended for intravenous administration using sterile equipment. oDo not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. oSet the vent to the closed position on vented intravenous administration set to prevent air embolism. oUse dedicated line without any connections to avoid air embolism. oDo not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. oPrior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged. oPLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) 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 priming solution), added to or infused concurrently with blood components, or used as diluent in the transfusion of packed erythrocytes. PLASMA-LYTE Injection and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components.

DRUG INTERACTIONS SECTION.

Drug Interactions. Other Products that Affect Fluid and/or Electrolyte BalanceAdministration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) to patients treated concomitantly with drugs associated with sodium and fluid retention, may increase the risk of hypernatremia and volume overload. Avoid use of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance. Other Drugs that Increase the Risk of Hyponatremia Administration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.Avoid use of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.LithiumRenal clearance of lithium may be increased during administration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). Monitor serum lithium concentrations during concomitant use. Other Products that Increase the Risk of HyperkalemiaBecause of its potassium content, avoid use of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. If use cannot be avoided, monitor serum potassium concentrations.Drugs with pH Dependent Renal Elimination Due to its alkalinizing effect (formation of bicarbonate), PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may interfere with the elimination of drugs with pH dependent renal elimination. Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased.

OVERDOSAGE SECTION.

Overdose. Excessive administration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause:ofluid overload with risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. hypernatremia and hyperkalemia, especially in patients with severe renal impairment. ohypermagnesemia. See WARNINGS and ADVERSE REACTIONS ometabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations. When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP), dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).. ofluid overload with risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. o hypernatremia and hyperkalemia, especially in patients with severe renal impairment. ohypermagnesemia. See WARNINGS and ADVERSE REACTIONS ometabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL. PLASMA-LYTE(R) Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) Carton Label PLASMA-LYTE(R) Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) Carton Label 2B2544X 14-1000 ML VIAFLEX(R) CONTAINER PLASMA-LYTE(R) INJ PH 7.4 (MULTIPLE ELECTROLYTES INJ, TYPE 1, USP) EXP XXXXX SECONDARY BAR CODE(17) YYMM00 (10) XXXXX LOT XXXXX PRIMARY BAR CODE(01) 50303380221047 NOTE: YY=Year, MM=Month and date will always be 00. Lot and Exp. Date added at time of printing. Secondary bar code human readable is variable and will be added at time of printing. The parenthesis are not encoded in actual bar code. Plasma-Lyte Injection pH 7.4 (Multiple Electrolytes Injection Type USP) 1000mL Container Label Plasma-Lyte Injection pH 7.4 (Multiple Electrolytes Injection Type USP) 1000mL Container Label 2B2544NDC 0338-0221-04Plasma-Lyte AInjection pH 7.4(Multiple Electrolytes InjectionType USP)1000 mLEach 100 mL contains 526 mg Sodium Chloride USP 502mg Sodium Gluconate USP 368 mg Sodium AcetateTrihydrate USP 37 mg Potassium Chloride USP 30 mgMagnesium Chloride USP pH adjusted with SodiumHydroxide ph 7.4 (6.5 to 8.0) mEq/L Sodium 140Potassium Magnesium Chloride 98 Acetate 27Gluconate 23 Osmolarity 294 mOsmol/L (calc) SterileNonpyrogenic Single dose container Additives may beincompatible Consult with pharmacist if available Whenintroducing additives use aseptic technique Mix thoroughlyDo not store Dosage Intravenously as directed by aphysician See directions Cautions Squeeze and inspectinner bag which maintains product sterility Discard if leaksare found Must not be used in series connections Do notuse unless solution is clear Rx Only Store unit inmoisture barrier overwrap at room temperature(25C/77F) until ready to use Avoid excessive heat SeeinsertVIAFLEX container PL 146 plasticBAXTER PLASMA-LYTE VIAFLEX and PL 146 aretrademarks of Baxter International IncFor product information 1-800-933-0303BaxterBaxter Healthcare CorporationDeerfield IL 60015 USAMade in USA. Carton Label. Container Label.

PRECAUTIONS SECTION.

PRECAUTIONS. Patients with Renal Impairment In patients with renal impairment, administration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may result in sodium and/or potassium or magnesium retention (see WARNINGS). PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention or magnesium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.. Drug Interactions. Other Products that Affect Fluid and/or Electrolyte BalanceAdministration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) to patients treated concomitantly with drugs associated with sodium and fluid retention, may increase the risk of hypernatremia and volume overload. Avoid use of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance. Other Drugs that Increase the Risk of Hyponatremia Administration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.Avoid use of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.LithiumRenal clearance of lithium may be increased during administration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). Monitor serum lithium concentrations during concomitant use. Other Products that Increase the Risk of HyperkalemiaBecause of its potassium content, avoid use of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. If use cannot be avoided, monitor serum potassium concentrations.Drugs with pH Dependent Renal Elimination Due to its alkalinizing effect (formation of bicarbonate), PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may interfere with the elimination of drugs with pH dependent renal elimination. Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased.. Drug/Laboratory Test Interactions. There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions. These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions should be interpreted cautiously and confirmed by other diagnostic methods.. Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies with PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.. Pregnancy. Teratogenic Effects. Animal reproduction studies have not been conducted with PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). It is also not known whether PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) should be given to pregnant woman only if clearly needed.. Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is administered to nursing mother.. Pediatric Use. The use of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in pediatric patients is based on clinical practice.. Geriatric Use. Geriatric patients are at increased risk of developing electrolyte imbalances. PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, 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 other drug therapy. Consider monitoring renal function in elderly patients.

WARNINGS SECTION.

WARNINGS. Hypersensitivity Reactions Hypersensitivity and infusion reactions have been reported with PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). See ADVERSE REACTIONS.Stop the infusion immediately if signs or symptoms of hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Electrolyte Imbalances Fluid OverloadDepending on the volume and rate of infusion, the intravenous administration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause electrolyte disturbances such as overhydration, and congested states, including pulmonary congestion and edema. Avoid PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. HyponatremiaPLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of hypotonic PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP).Avoid PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in hypervolemic or overhydrated patients. If use cannot be avoided, monitor serum sodium concentrations.HypernatremiaHypernatremia may occur with PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP)). Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia.Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see PRECAUTIONS.Avoid PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.HypermagnesemiaAvoid solutions containing magnesium including PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with or predisposed to hypermagnesemia, including patients with severe renal impairment and those patients receiving magnesium therapy (e.g., treatment of eclampsia and myasthenia gravis). PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is not indicated for the treatment of hypomagnesemia. AcidosisPLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is not for use for the treatment of lactic acidosis or severe metabolic acidosis in patients with severe liver and/or renal impairment.AlkalosisExcess administration of PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can result in metabolic alkalosis. Avoid PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with alkalosis or at risk for alkalosis. PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is not indicated for the treatment of hypochloremic hypokalemic alkalosis. Avoid use in patients with hypochloremic hypokalemic alkalosis.HypocalcemiaPLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not protein-bound) calcium. Avoid PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with hypocalcemia. HyperkalemiaPotassium-containing solutions, including PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may increase the risk of hyperkalemia. Patients at increased risk of developing hyperkalemia include those:oWith conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury or burns, certain cardiac disorders such as congestive heart failure.oTreated concurrently or recently with agents or products that cause or increase the risk of hyperkalemia (see PRECAUTIONS).Avoid PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with, or at risk for hyperkalemia. If use cannot be avoided, monitor serum potassium concentrations.Although PLASMA-LYTE Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) has potassium concentration in plasma, it is insufficient to produce useful effect in case of severe potassium deficiency; therefore, it is not indicated for correction of severe potassium deficiency.. oWith conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury or burns, certain cardiac disorders such as congestive heart failure.. oTreated concurrently or recently with agents or products that cause or increase the risk of hyperkalemia (see PRECAUTIONS).