Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) is supplied sterile and nonpyrogenic in EXCEL ® Containers. The 1000 mL containers are packaged 12 per case and the 500 mL containers are packaged 24 per case. NDC REF Size Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) (Canada DIN 01931679) 0264-7707-00 L7070 1000 mL 0264-7707-10 L7071 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.; PRINCIPAL DISPLAY PANEL - 1000 mL Container Label Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) REF L7070 NDC 0264-7707-00 DIN 01931679 HK 22410 1000 mL EXCEL ® CONTAINER Electrolytes (mEq/liter): Na + 141 K + 5 Mg ++ 3 Cl – 98 Acetate 27 Phosphate (HPO ) 1 (0.5 mmole P/L) Gluconate 23 Each 100 mL contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g; Sodium Acetate•3H 2 O USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride•6H 2 O USP 0.03 g; Dibasic Sodium Phosphate•7H 2 O USP 0.012 g; Monobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qs pH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NF pH: 7.4 (7.0-7.8); Calc. Osmolarity: 295 mOsmol/liter Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL and Isolyte are registered trademarks of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-323 LD-149-4 EXP LOT Figure Recycle symbol 1000 mL container label L7070; PRINCIPAL DISPLAY PANEL - 500 mL Container Label Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) REF L7071 NDC 0264-7707-10 DIN 01931679 HK 22410 500 mL EXCEL ® CONTAINER Electrolytes (mEq/liter): Na + 141 K + 5 Mg ++ 3 Cl – 98 Acetate 27 Phosphate (HPO ) 1 (0.5 mmole P/L) Gluconate 23 Each 100 mL contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g; Sodium Acetate•3H 2 O USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride•6H 2 O USP 0.03 g; Dibasic Sodium Phosphate•7H 2 O USP 0.012 g; Monobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qs pH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NF p H: 7.4 (7.0–7.8); Calc. Osmolarity: 295 mOsmol/liter Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL and Isolyte are registered trademarks of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-324 LD-148-4 EXP LOT Figure Recycle symbol 500 mL Container label L7071
- HOW SUPPLIED Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) is supplied sterile and nonpyrogenic in EXCEL ® Containers. The 1000 mL containers are packaged 12 per case and the 500 mL containers are packaged 24 per case. NDC REF Size Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) (Canada DIN 01931679) 0264-7707-00 L7070 1000 mL 0264-7707-10 L7071 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
- PRINCIPAL DISPLAY PANEL - 1000 mL Container Label Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) REF L7070 NDC 0264-7707-00 DIN 01931679 HK 22410 1000 mL EXCEL ® CONTAINER Electrolytes (mEq/liter): Na + 141 K + 5 Mg ++ 3 Cl – 98 Acetate 27 Phosphate (HPO ) 1 (0.5 mmole P/L) Gluconate 23 Each 100 mL contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g; Sodium Acetate•3H 2 O USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride•6H 2 O USP 0.03 g; Dibasic Sodium Phosphate•7H 2 O USP 0.012 g; Monobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qs pH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NF pH: 7.4 (7.0-7.8); Calc. Osmolarity: 295 mOsmol/liter Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL and Isolyte are registered trademarks of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-323 LD-149-4 EXP LOT Figure Recycle symbol 1000 mL container label L7070
- PRINCIPAL DISPLAY PANEL - 500 mL Container Label Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) REF L7071 NDC 0264-7707-10 DIN 01931679 HK 22410 500 mL EXCEL ® CONTAINER Electrolytes (mEq/liter): Na + 141 K + 5 Mg ++ 3 Cl – 98 Acetate 27 Phosphate (HPO ) 1 (0.5 mmole P/L) Gluconate 23 Each 100 mL contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g; Sodium Acetate•3H 2 O USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride•6H 2 O USP 0.03 g; Dibasic Sodium Phosphate•7H 2 O USP 0.012 g; Monobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qs pH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NF p H: 7.4 (7.0–7.8); Calc. Osmolarity: 295 mOsmol/liter Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL and Isolyte are registered trademarks of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-324 LD-148-4 EXP LOT Figure Recycle symbol 500 mL Container label L7071
Overview
Each 100 mL of Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 g Magnesium Chloride Hexahydrate USP 0.03 g Dibasic Sodium Phosphate Heptahydrate USP 0.012 g Monobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qs pH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NF pH: 7.4 (7.0–7.8) Calculated Osmolarity: 295 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5 Magnesium 3; Chloride 98; 0.5 mmole P/liter Phosphate (HPO ) 1; Acetate (CH 3 COO – ) 27 Gluconate (HOCH 2 (CHOH) 4 COO – ) 23 Isolyte ® S pH 7.4 is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 Sodium Acetate Trihydrate USP CH 3 COONa•3H 2 O 136.08 Potassium Chloride USP KCl 74.55 Magnesium Chloride Hexahydrate USP MgCl 2 •6H 2 O 203.30 Dibasic Sodium Phosphate Heptahydrate USP Na 2 HPO 4 •7H 2 O 268.07 Monobasic Potassium Phosphate NF KH 2 PO 4 136.09 Sodium Gluconate USP 218.14 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container. symbol Structural formula
Indications & Usage
This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.
Dosage & Administration
This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of magnesium and phosphate ions in this solution should be considered when phosphate is present in the additive solution, in order to avoid precipitation. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
WARNINGS The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Solutions containing sodium ions 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 is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present. Solutions containing gluconate or acetate should be used with great care in patients with metabolic or respiratory alkalosis and in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.
Contraindications
Contraindications: None known. Accurate clinical and laboratory estimation of fluid and electrolyte balance in order to access benefit/risk ratio are essential prior to administration of this solution (see WARNINGS and PRECAUTIONS ).
Adverse Reactions
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability. Abnormally high plasma levels of magnesium can result in flushing, sweating, hypotension, circulatory collapse, and depression of cardiac and central nervous system function. Respiratory depression is the most immediate threat to life. Magnesium deficits can result in tachycardia, hypertension, hyperirritability and psychotic behavior. The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted. 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.
Drug Interactions
Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Administration of barbiturates, narcotics, hypnotics or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect. Parenteral magnesium should be administered with extreme caution to patients receiving digitalis preparations.
Storage & Handling
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
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