Each 100 mL of Isolyte® P (Multi-Electrolyte Injection) in 5% Dextrose contains:

Hydrous Dextrose USP 5 g; Sodium Acetate Trihydrate USP 0.32 g

Potassium Chloride USP 0.13 g; Magnesium Chloride Hexahydrate USP 0.031 g

Dibasic Potassium Phosphate USP 0.026 g; Water for Injection USP qs

pH adjusted with Hydrochloric Acid NF

pH: 5.0 (4.0–6.0)   Calories per liter: 170

Calculated Osmolarity: 340 mOsmol/liter

Concentration of Electrolytes (mEq/liter): Sodium 23; Chloride 29

Acetate (CH3COO-) 23; Potassium 20; Magnesium 3; 1Phosphate (HPO) 3

Isolyte® P in 5% Dextrose is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents or added buffers. This product is intended for intravenous administration.

The formulas of the active ingredients are:

Ingredients	Molecular Formula	Molecular Weight
Sodium Acetate Trihydrate USP	CH3COONa•3H2O	136.08
Potassium Chloride USP	KCl	74.55
Magnesium Chloride Hexahydrate USP	MgCl2•6H2O	203.30
Dibasic Potassium Phosphate USP	K2HPO4	174.18
Hydrous Dextrose USP		198.17

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. The solution contact layer is a rubberized copolymer of ethylene and propylene. Solutions in contact with the plastic container may 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. 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. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

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 site. Refer to the Directions for Use of the container.

1

1.5 mmole P/liter

Isolyte® P in 5% Dextrose provides electrolytes and calories, and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Magnesium, a principal cation of soft tissue, is primarily involved in enzyme activity associated with the metabolism of carbohydrates and protein. Magnesium is also involved in neuromuscular irritability.

Phosphate is a major intracellular anion which participates in providing energy for metabolism of substrates and contributes to significant metabolic and enzymatic reactions in almost all organs and tissues. It exerts a modifying influence on calcium levels, a buffering effect on acid-base equilibrium and has a primary role in the renal excretion of hydrogen ions.

Acetate is an organic ion which is a hydrogen ion acceptor and contributes bicarbonate during its metabolism to carbon dioxide and water, and in sufficient quantities may serve as an alkalinizing agent.

Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

This solution is indicated for use in adults as a source of electrolytes, calories and water for hydration, and as an alkalinizing agent.

Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

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.

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.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Infuse solutions containing phosphate slowly to avoid phosphate intoxication. Infusing high concentrations of phosphate may cause hypocalcemia and tetany. Serum phosphorus and calcium levels should be monitored frequently.

Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate should be done with great care in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.

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.

Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended. (See DOSAGE AND ADMINISTRATION.)

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.

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.

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.

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.

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment.

In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels.

Treatment of hyperkalemia includes the following:

• Dextrose Injection USP, 10% or 25% containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour.
• Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema.
• Hemodialysis and peritoneal dialysis. The use of potassium-containing foods or medications must be eliminated. However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

Over-aggressive phosphate replacement may precipitate hypocalcemic tetany. To prevent hypocalcemia, calcium supplementation should always accompany phosphate 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.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

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.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

Before use, perform the following checks:

•  Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
•  Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.
•  Use only if solution is clear and container and seals are intact.

Preparation for Administration

1. Remove plastic protector from sterile set port at bottom of container.
2. Attach administration set. Refer to complete directions accompanying set.

To Add Medication Before Solution Administration

1. Prepare medication site.
2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration

1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
4. Remove container from IV pole and/or turn to an upright position.
5. Evacuate both ports by tapping and 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.

Isolyte® P (Multi-Electrolyte Injection) in 5% Dextrose is supplied sterile and nonpyrogenic in EXCEL® containers. The 500 mL containers are packaged 24 per case.

Rx only

Revised: June 2018

EXCEL and Isolyte are registered trademarks of B. Braun Medical Inc.

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

1-800-227-2862

Y36-002-950  LD-499-2

Isolyte® P in 5% Dextrose

(Multi-Electrolyte Injection)

REF L7301

NDC 0264-7730-10

HK 22411

500 mL

EXCEL® CONTAINER

Electrolytes (mEq/liter):

Na+ 23

K+ 20

Mg++ 3

Cl– 29

Acetate 23

Phosphate

(HPO) 3

(1.5 mmole P/L)

Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Acetate•3H2O USP

0.32 g; Potassium Chloride USP 0.13 g; Magnesium Chloride•6H2O USP 0.031 g;

Dibasic Potassium Phosphate USP 0.026 g; Water for Injection USP qs

pH adjusted with HCl NF

pH: 5.0 (4.0-6.0)     Calc Osmolarity: 340 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

Y94-003-244

LD-145-4

EXP

LOT