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Ringer’s Irrigation
Posted by admin on November 10th, 2009
Ringer’s Irrigation
FOR ALL GENERAL IRRIGATION,
Not For Injection By Usual Parenteral Routes
Semi-rigid Irrigation Container
Ringer’s Irrigation Description
Ringer’s Irrigation USP is a sterile, nonpyrogenic, solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes.
Each 100 mL contains:
Sodium Chloride USP 0.86 g; Potassium Chloride USP 0.03 g
pH: 5.8 (5.0–7.5). The solution is isotonic (310 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na
The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Ringer’s Irrigation USP may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle.
The formulas of the active ingredients are:
The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.
Ringer’s Irrigation – Clinical Pharmacology
Ringer’s Irrigation USP exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations.
Ringer’s Irrigation USP provides an isotonic irrigation with the same ionic constituents as Ringer’s Injection USP, a modification of Ringer’s solution (also called Ringer’s mixture) originally used only as a topical physiologic salt solution.
Ringer’s Irrigation USP is considered generally compatible with living tissues and organs.
Calcium Chloride in water dissociates to provide calcium (Ca
Potassium chloride in water dissociates to provide potassium (K
Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium free diet, potassium loss from the body continues resulting in potassium depletion.
Sodium chloride in water dissociates to provide sodium (Na
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na
Indications and Usage for Ringer’s Irrigation
Ringer’s Irrigation USP is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Contraindications
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.
An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Warnings
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus this irrigation must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Do not warm above 150°F (66°C).
After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservatives.
Precautions
General
Do not use for irrigation that may result in absorption into the blood.
Caution should be observed when the solution is used for continuous irrigation or allowed to “dwell” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.
Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.
When used as a “pour” irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the semi-rigid wide mouth container. When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.
Use only if solution is clear and container and seal are intact. Discard unused portion.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Ringer’s Irrigation USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with Ringer’s Irrigation USP. It is also not known whether Ringer’s Irrigation USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ringer’s Irrigation USP should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Caution should be exercised when Ringer’s Irrigation USP is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of Ringer’s Irrigation have not been performed to determine whether patients over 65 years respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug 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. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Adverse Reactions
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distention or disruption of tissues. Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Overdosage
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See
Ringer’s Irrigation Dosage and Administration
The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer’s recommendations should be followed.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits. See
How is Ringer’s Irrigation Supplied
Ringer’s Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 1000 mL containers are packaged 16 per case and the 2000 mL containers are packaged 8 per case.
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.
Do not warm above 150°F (66°C).
Rx only
Issued: June 2003
PIC is a trademark of B. Braun Medical Inc.
Made in USA
Directions For Use of PIC Containers
Not for injection.
Aseptic technique is required.
Use only if solution is clear and container and seal are intact.
Single dose container. Discard unused portion.
B. Braun Medical Inc.
©2003 B. Braun Medical Inc.
Y36-002-476
Plegisol
Posted by admin on November 10th, 2009
Plegisol
CARDIOPLEGIC SOLUTION FOR CARDIAC PERFUSION
NOT FOR INTRAVENOUS INJECTION
Flexible Plastic Container
Rx Only
Plegisol Description
Plegisol (Cardioplegic Solution) is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in water for injection. It is a “core solution” intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation. (See INSTRUCTIONS FOR USE.)
Each 100 mL of solution contains calcium chloride, dihydrate 17.6 mg, magnesium chloride, hexahydrate 325.3 mg, potassium chloride 119.3 mg and sodium chloride 643 mg in water for injection. May contain HCl or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca
It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours.
The buffered admixture contains the following electrolytes (per liter): Ca
The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded.
Plegisol with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia.
Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl
Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl
Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Water for Injection, USP is chemically designated H
The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. 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. 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.
Plegisol – Clinical Pharmacology
Plegisol with added sodium bicarbonate when cooled and instilled into the coronary artery vasculature, causes prompt arrest of cardiac electromechanical activity, combats intracellular ion losses and buffers ischemic acidosis. When used with hypothermia and ischemia, the action may be characterized as cold ischemic potassium-induced cardioplegia. This is conducive to providing the surgeon with a quiet, relaxed heart and bloodless field of operation.
Calcium (Ca
Magnesium (Mg
Potassium (K
The chloride (Cl‾) and sodium (Na
Added bicarbonate (HCO
Extemporaneous alternative buffering to the described formulation of this solution is not recommended.
Indications and Usage for Plegisol
Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.
Contraindications
Plegisol must not be administered without the addition of 8.4% Sodium Bicarbonate Injection, USP, Hospira List 4900.
NOT FOR INTRAVENOUS INJECTION.
This solution is only for instillation into cardiac vasculature after buffering with sodium bicarbonate.
Warnings
This solution should be used only by those trained to perform open heart surgery. This solution is intended only for use during cardiopulmonary bypass when the coronary circulation is isolated from the systemic circulation. (See INDICATIONS AND USAGE.)
Do not instill the solution into the coronary vasculature unless sodium bicarbonate has been added. If large volumes of cardioplegic solution are infused and allowed to return to the heart lung machine without any venting from the right heart, then plasma magnesium and potassium levels may rise. Development of severe hypotension and metabolic acidosis while on bypass has been reported when large volumes (8 to 10 liters) of solution are instilled and allowed to enter the pump and then the systemic circulation. Right heart venting is therefore recommended. The buffered solution with added sodium bicarbonate should be cooled to 4°C prior to administration and used within 24 hours of mixing.
Precautions
Myocardial temperature should be monitored during surgery to maintain hypothermia.
Continuous electrocardiogram monitoring is essential to detect changes in myocardial activity during the procedure.
Appropriate equipment to defibrillate the heart following cardioplegia should be readily available.
Inotropic support drugs should be available during postoperative recovery.
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. (See INSTRUCTIONS FOR USE.)
Pregnancy Category C.
Animal reproduction studies have not been conducted with Plegisol. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plegisol should be given to a pregnant woman only if clearly needed.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Because of differences in structure, function, and metabolism, clinical myocardial protection strategies and Cardioplegia solutions that are effective in adult hearts may be less effective in the immature heart.
Geriatric Use
Clinical studies of Plegisol did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between older and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease.
This product is unique in that there is no hepatic or renal excretion and specific adjustments for dosing in the elderly are not known.
Adverse Reactions
Intraoperative and perioperative potential hazards of open heart surgery include myocardial infarction, electrocardiographic abnormalities, and arrhythmias, including ventricular fibrillation. Spontaneous recovery after cardioplegic cardiac arrest may be delayed or absent when circulation is restored. Defibrillation by electric shock may be required to restore normal cardiac function.
Overdosage
Overzealous instillation of the solution may result in unnecessary dilatation of the myocardial vasculature and leakage into the perivascular myocardium, possibly causing tissue edema. (SEE WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.)
Plegisol Dosage and Administration
The following information is suggested as a guide and is subject to variation according to the preference and experience of the surgeon.
It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be used within 24 hours. The solution should be cooled to 4°C prior to use.
Following institution of cardiopulmonary bypass at perfusate temperatures of 28° to 30°C, and after cross-clamping of the ascending aorta, the buffered solution is administered by rapid infusion into the aortic root. The initial rate of infusion may be 300 mL/m
Should myocardial electromechanical activity persist or recur, the solution may be reinfused at a rate of 300 mL/m
The volumes of solution instilled into the aortic root may vary depending on the duration or type of open heart surgical procedure.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)
INSTRUCTIONS FOR USE
To Open
Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To add 10 mL of 8.4% Sodium Bicarbonate Injection, USP, Hospira List 4900, and other supplemental medication, follow directions below before preparing for administration.
To Add Medication
Prepare additive port.
Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.
The additive port may be protected by covering with an additive cap.
Mix container contents thoroughly.
Preparation for Administration
(Use aseptic technique)
Close flow control clamp of administration set.
Remove cover from outlet port at bottom of container.
Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.
Suspend container from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber.
Attach aortic infusion device to set.
Open flow control clamp to expel air from set and aortic infusion device. Close clamp.
Position aortic infusion device to introduce solution into aortic root.
Regulate rate of administration with flow control clamp.
How is Plegisol Supplied
Plegisol
WARNING: Do not use flexible container in series connections.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
Revised: March, 2007
Printed in USA
EN-1479
Hospira, Inc., Lake Forest, IL 60045 USA
Physiosol
Posted by admin on November 10th, 2009
Physiosol
Balanced Electrolyte Solution for Irrigation
for all General and Arthroscopic Irrigation, Washing and Rinsing Purposes
Not for Injection
Flexible Irrigation Container
R
Physiosol Description
Physiosol® Irrigation pH 7.4 is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes.
Each 100 mL of Physiosol Irrigation pH 7.4 contains sodium chloride, 526 mg; sodium acetate, anhydrous 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate 30 mg. May contain HCl and/or NaOH for pH adjustment. pH 7.4 (6.5 to 7.6).
The solution is isotonic (294 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na
It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.
Physiosol Irrigation pH 7.4 may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle.
Magnesium Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl
Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Sodium Acetate, USP is chemically designated sodium acetate (C
Sodium gluconate is chemically designated C
Water for Injection, USP is chemically designated H
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
Physiosol – Clinical Pharmacology
Physiosol Irrigation pH 7.4 exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations.
Physiosol Irrigation pH 7.4 is useful as an irrigant of body joints because the pH and electrolyte composition of the solution approximates that of synovial fluid. Additionally, it provides a transparent fluid medium with optical properties suitable for good visualization of the interior joint surface during endoscopic examination. During arthroscopic surgical procedures, the solution acts as a lavage for removing blood, tissue fragments and bone fragments.
Physiosol Irrigation pH 7.4 provides an isotonic calcium-free balanced electrolyte irrigation with the same ionic composition as Normosol®-R, pH 7.4, a multiple electrolyte solution for I.V. replacement of acute extracellular fluid losses.
Physiosol Irrigation pH 7.4 is considered generally compatible with living tissues and organs.
Magnesium chloride in water dissociates to provide magnesium (Mg
Potassium chloride in water dissociates to provide potassium (K
Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium free diet, potassium loss from the body continues resulting in potassium depletion.
Sodium Chloride in water dissociates to provide sodium (Na
Sodium acetate provides sodium (Na
Sodium gluconate provides sodium (Na
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na
Indications and Usage for Physiosol
Physiosol Irrigation pH 7.4 is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Physiosol Irrigation pH 7.4 is also indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distention and irrigation of the knee, shoulder, elbow or other bone joints. This solution is not indicated for use with electrosurgical instruments.
Contraindications
NOT FOR INJECTION.
An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Warnings
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes, thus, those irrigations must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Do not heat container over 66°C (150°F).
Precautions
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Caution should be observed when a solution is used for continuous irrigation or allowed to“dwell” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.
Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.
When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
Pregnancy Category C.
Animal reproduction studies have not been conducted with this solution. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
Pediatric Use.
The safety and effectiveness of Physiosol Irrigation pH 7.4 have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
Geriatric Use.
Clinical studies of Physiosol Irrigation have not been performed to determine whether patients over 65 years respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug 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. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Adverse Reactions
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.
Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Overdosage
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.
Physiosol Dosage and Administration
The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer’s recommendations should be followed.
Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.
How is Physiosol Supplied
Physiosol Irrigation pH 7.4 is supplied in a single-dose 1000 mL flexible irrigation container (List No. 7012).
Exposure of pharmaceutical products to heat should be minimized. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Revised: January, 2005
©Hospira 2005 EN-0820 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
Physiolyte
Posted by admin on November 10th, 2009
Physiolyte
Balanced Electrolyte Solution for Irrigation.
Physiolyte Description
Physiolyte is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing, and rinsing purposes.
Each 100 mL contains:
pH: 6.8 (6.3–7.3)
Concentration of Electrolytes (mEq/liter): Sodium 140
It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.
Physiolyte may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle.
The formulas of the active ingredients are:
The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
Physiolyte – Clinical Pharmacology
Physiolyte exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations.
Physiolyte provides an isotonic calcium-free balanced electrolyte irrigation with the same ionic composition as Isolyte
Physiological irrigation solutions are considered generally compatible with living tissues and organs.
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 and cardiac conduction and irritability.
Gluconate and acetate are organic ions which are hydrogen ion acceptors and contribute bicarbonate during their metabolism to carbon dioxide and water, and serve as alkalinizing agents.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na
Indications and Usage for Physiolyte
Physiolyte
Contraindications
Physiolyte is not for injection by usual parenteral routes.
An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Warnings
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts 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 concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations.
Do not warm above 150°F (66°C).
After opening container, it’s contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservatives.
Precautions
General
Use aseptic technique when preparing and administering sterile irrigation solutions for irrigating body cavities, wounds and urethral catheters or for wetting dressings that come in contact with the body tissues.
Use only if solution is clear and container and seal are intact.
Do not use for irrigation that may result in absorption of large amounts into the blood.
Caution should be observed when the solution is used for continuous irrigation or allowed to “dwell” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.
When used as a “pour” irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the plastic irrigation container. When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Physiolyte
Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with Physiolyte (A Physiological Irrigating Solution). It is also not known whether Physiolyte (A Physiological Irrigating Solution) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Physiolyte (A Physiological Irrigating Solution) should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Caution should be exercised when Physiolyte is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of Physiolyte in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
Geriatric Use
Clinical studies of Physiolyte (A Physiological Irrigating Solution) have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug 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. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Use in Patients with Renal Insufficiency/Failure
Clinical studies of Physiolyte (a Physiological Irrigation Solution) have not been performed to determine whether patients with renal failure respond differently from those with normal renal function. Given the potential for systemic absorption, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Increased caution should be exercised when administering Physiolyte to patients with impaired fluid and electrolyte homeostasis.
Adverse Reactions
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.
If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Overdosage
In the event of overhydration or solute overload, reevaluate the patient’s condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See
Physiolyte Dosage and Administration
As required for irrigation.
The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the directions of the additive’s manufacturer should be followed.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
How is Physiolyte Supplied
Physiolyte
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.
Do not warm above 150°F (66°C).
Rx only
Issued: July 2003
Directions For Use of PIC Containers
Not for injection.
Aseptic technique is required.
Use only if solution is clear and container and seal are intact.
Single unit container. Discard unused portion.
B. Braun Medical Inc.
©2003 B. Braun Medical Inc.
Y36-002-478
Lactated Ringer’s Irrigation
Posted by admin on November 10th, 2009
Lactated Ringer’s Irrigation
FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES
Not For Injection By Usual Parenteral Routes
Semi-rigid Irrigation Container
Isotonic Solution for Irrigation.
For Irrigation Only. Not for Injection.
Lactated Ringer’s Irrigation Description
Lactated Ringer’s Irrigation is a sterile, nonpyrogenic, solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. The composition is based on a modification of the injectable formula originally known as Hartmann’s Solution.
Each 100 mL contains:
pH adjusted with Hydrochloric Acid NF
Concentration of Electrolytes (mEq/liter): Sodium 130, Potassium 4, Calcium 3, Chloride 110,
The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required, the unused portions should be discarded. Lactated Ringer’s Irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle.
The formulas of the active ingredients are:
The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.
Lactated Ringer’s Irrigation – Clinical Pharmacology
Lactated Ringer’s Irrigation exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations.
Lactated Ringer’s Irrigation provides an isotonic irrigation with the same ionic constituents as Lactated Ringer’s Injection, USP, a modification of Hartmann’s Solution.
Lactated Ringer’s Irrigation is considered generally compatible with living tissues and organs.
Calcium chloride in water dissociates to provide calcium (Ca
Potassium chloride in water dissociates to provide potassium (K
Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion.
Sodium chloride in water dissociates to provide sodium (Na
Sodium lactate in water dissociates to provide sodium (Na
The lactate anion acts as a source (alternate) of bicarbonate when normal production and utilization of lactic acid is not impaired as a result of disordered lactate metabolism. Since metabolic conversion is dependent on the integrity of cellular oxidative processes, lactate may be inadequate or ineffective as a source of bicarbonate in patients suffering from acidosis associated with shock or other disorders involving reduced perfusion of body tissues. When oxidative activity is intact, one to two hours time is required for metabolism of lactate.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na
Indications and Usage for Lactated Ringer’s Irrigation
Lactated Ringer’s Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Contraindications
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.
An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Warnings
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus this irrigation must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Do not warm container over 150°F (66°C).
Precautions
General
Do not use for irrigation that may result in absorption into the blood.
Caution should be observed when the solution is used for continuous irrigation or allowed to “dwell” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.
Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.
When used as a “pour” irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the plastic irrigation container. When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.
Use only if solution is clear and container and seal are intact.
Pregnancy
Animal reproduction studies have not been conducted with Lactated Ringer’s Irrigation. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
Pediatric Use
The safety and effectiveness of Lactated Ringer’s Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
Adverse Reactions
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.
Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Overdosage
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See
Lactated Ringer’s Irrigation Dosage and Administration
The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer’s recommendations should be followed.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See
How is Lactated Ringer’s Irrigation Supplied
Lactated Ringer’s Irrigation is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL containers are packaged 16 per case, the 2000 mL containers are packaged 8 per case, and the 4000 mL containers are packaged 4 per case.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C-25°C (68°-77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C does not adversely affect the product.
Do not warm above 150°F (66°C).
Rx only
Issued: June 2007
Directions for Use of PIC™ (Plastic Irrigation Container)
Not for injection.
Use only if solution is clear and container and seal are intact.
B. Braun Medical Inc.
In Canada, distributed by:
Y36-002-477
Cardioplegic
Posted by admin on November 10th, 2009