NDC 24571-113 Prismasol Bk0/0/1.2

Magnesium Chloride, Lactic Acid, Sodium Chloride And Sodium Bicarbonate

NDC Product Code 24571-113

NDC Code: 24571-113

Proprietary Name: Prismasol Bk0/0/1.2 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Magnesium Chloride, Lactic Acid, Sodium Chloride And Sodium Bicarbonate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 24571 - Baxter Healthcare Corporation

NDC 24571-113-06

Package Description: 2 BAG in 1 CASE > 5 L in 1 BAG

NDC Product Information

Prismasol Bk0/0/1.2 with NDC 24571-113 is a a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Prismasol Bk0/0/1.2 is magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate. The product's dosage form is injection and is administered via intravenous form.

Labeler Name: Baxter Healthcare Corporation

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Prismasol Bk0/0/1.2 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM CHLORIDE 2.44 g/L
  • LACTIC ACID, UNSPECIFIED FORM 5.4 g/L
  • SODIUM CHLORIDE 6.46 g/L
  • SODIUM BICARBONATE 3.09 g/L

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • CARBON DIOXIDE (UNII: 142M471B3J)
  • WATER (UNII: 059QF0KO0R)
  • CARBON DIOXIDE (UNII: 142M471B3J)
  • WATER (UNII: 059QF0KO0R)
  • CARBON DIOXIDE (UNII: 142M471B3J)
  • WATER (UNII: 059QF0KO0R)
  • CARBON DIOXIDE (UNII: 142M471B3J)
  • WATER (UNII: 059QF0KO0R)
  • CARBON DIOXIDE (UNII: 142M471B3J)
  • WATER (UNII: 059QF0KO0R)
  • CARBON DIOXIDE (UNII: 142M471B3J)
  • WATER (UNII: 059QF0KO0R)
  • CARBON DIOXIDE (UNII: 142M471B3J)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Baxter Healthcare Corporation
Labeler Code: 24571
FDA Application Number: NDA021703 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-25-2006 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Prismasol Bk0/0/1.2 Product Label Images

Prismasol Bk0/0/1.2 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

2.1 Administration Instructions

Visually inspect PRISMASOL and PHOXILLUM for particulate matter and discoloration prior to administration.Administration should only be under the direction of a physician competent in intensive care treatment including CRRT. Use only with extracorporeal dialysis equipment appropriate for CRRT.The prepared solution is for single patient use only.Aseptic technique should be used throughout administration to the patient.Discard any unused solution.

2.2 Dosing Considerations

  • PRISMASOL replacement solutions contain 4 different combinations of active ingredients (8 different products with varying ingredient amounts). PHOXILLUM replacement solutions contain 2 different combinations of active ingredients (2 different products with varying ingredient amounts). PRISMASOL and PHOXILLUM are supplied in a two-compartment bag that must be mixed immediately prior to use [see Dosage and Administration (2.3)]: • Small compartment A (250 mL) containing an electrolyte solution, and • Large compartment B (4750 mL) containing the buffer solution.See Table 1 for the concentrations of the active ingredients (after mixing) in these 10 different replacement solutions (total volume is 5 Liters).Table 1: Concentrations of Active Ingredients in the 8 PRISMASOL and 2 PHOXILLUM Replacement Solutions after MixingCa2+mEq/LHCO3-mEq/LK+mEq/LMg2+mEq/LNa+mEq/LHPO42-mmol/LCl-mEq/LLactatemEq/LDextrosemg/dLOsmolaritymOsm/LCa2+ = calcium, HCO3- = bicarbonate, K+ = potassium, Mg2+ = magnesium, Na+ = sodium, HPO42- = phosphate, Cl- = chloride; osmolarity is estimatedPRISMASOL Replacement SolutionsBGK0/2.52.53201.514001093100292BGK4/2.52.53241.514001133100300BGK4/3.53.532411400113.53100300BGK2/3.53.532211400111.53100296BGK2/00322114001083100291B22GK4/002241.51400120.53100296BGK4/0/1.203241.21400110.23100295BK0/0/1.203201.21400106.230282PHOXILLUM Replacement SolutionsBK4/2.52.53241.51401114.500294B22K4/002241.5140112200290The mode of therapy, solute formulation, flow rates, and length of PRISMASOL and PHOXILLUM replacement therapy in CRRT should be established by a physician based on the patient’s clinical condition, blood concentration of phosphate and other electrolytes, acid-base and glucose balance. Administer either PRISMASOL or PHOXILLUM into the extracorporeal circuit: •Before (pre-dilution) the hemofilter or hemodiafilter, •After (post-dilution) the hemofilter or hemodiafilter, or •Before and after the hemofilter or hemodiafilter.

2.3 Preparing The Solution

Use only if the overwrap is not damaged, all seals are intact, frangible pin or peel seal is not broken, and the solution is clear.The solution may be warmed to 37°C/98.6°F inside of the overwrap to enhance patient comfort. However, only dry heat should be used. Solutions should not be heated in water or in a microwave oven. After heating, verify that the solution remains clear and contains no particulate matter.The solutions are supplied in two different two-compartment bags, one made of polyvinyl chloride with a frangible pin separating compartment A and B (see Figure 1) and one made of polyolefin with a peel seal separating compartment A and B (see Figure 6).Follow the instructions below when connecting the solution bags for correct use of the access ports.

Other

Instructions for preparing solutions supplied in a two-compartment, polyvinyl chloride (PVC) bag with a red frangible pin:Figure 1Figure 2Step 1 Immediately before use, remove the overwrap from the bag and mix the solutions in the two different compartments. After removing the overwrap, inspect the container for leakage by pressing firmly on the bag. Discard the bag if any leakage is detected since sterility cannot be assured. As soon as the overwrap is removed, the reconstitution of compartments A and B should be done and the mixed solution should be used immediately.After removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment.Open the seal by breaking the red frangible pin between the two compartments of the bag. The frangible pin will remain in the bag. (See Figure 2 beside)Figure 3 Step 2 Make sure all the fluid from the small compartment A is transferred into the large compartment B. (See Figure 3 beside)Step 3 Rinse the small compartment A twice by pressing the mixed solution back into the small compartment A and then back into the large compartment B. (See Figure 3 beside)Figure 4Step 4 When the small compartment A is empty, shake the large compartment B so that the contents mix completely. (See Figure 4 beside)The solution is now ready to use and the bag can be hung on the equipment.Figure 5aStep 5 The replacement line may be connected to the bag through either the luer connector or the injection connector (spike connector).Step 5a The luer connector is a needle-less and swabbable connector. Remove the cap with a twist and pull motion, and connect the male luer lock on the replacement line to the female luer receptor on the bag. (See Figure 5a beside)Ensure that the connection is fully seated and tighten. The connector is now open. Verify that the fluid is flowing freely during use.When the replacement line is disconnected from the luer connector, the connector will close and the flow of the solution will stop.Figure 5bStep 5b If the injection connector (spike connector) is used, first remove the snap-off cap. Then introduce the replacement line spike through the rubber septum of the bag connector. (See Figure 5b beside)Ensure that the spike is fully inserted and verify that the fluid is flowing freely during use.

Instructions for preparing solutions supplied in a two-compartment, polyolefin bag with a peel seal:Figure 6Figure 7Step 1 Immediately before use, remove the overwrap from the bag and mix the solutions in the two different compartments. After removing the overwrap, inspect the container for leakage by pressing firmly on the bag. Discard the bag if any leakage is detected since sterility cannot be assured. As soon as the overwrap is removed, the reconstitution of compartments A and B should be done and the mixed solution should be used immediately.After removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment.Hold the small compartment with both hands and squeeze it until an opening is created in the peel seal. (See Figure 7 beside)Figure 8Step 2 Squeeze with both hands on the large compartment until the peel seal between the two compartments is entirely open. Shake gently to mix. (See Figure 8 beside)The solution is now ready to use and the bag can be hung on the equipment.Figure 9aStep 3 The replacement line may be connected to the bag through either of the luer connector or the injection connector (spike connector).Step 3a The luer connector is a needle-less and swabbable connector. Remove the cap with a twist and pull motion, and connect the male luer lock on the replacement line to the female luer receptor on the bag. (See Figure 9a beside)Ensure that the connection is fully seated and tighten. The connector is now open. Verify that the fluid is flowing freely during use.When the replacement line is disconnected from the luer connector, the connector will close and the flow of the solution will stop.Figure 9bStep 3b If the injection connector (spike connector) is used, first remove the snap-off cap. Then introduce the replacement line spike through the rubber septum of the bag connector. (See Figure 9b beside)Ensure that the spike is fully inserted and verify that the fluid is flowing freely during use.

PRISMASOL Solutions:Phosphate: Phosphate up to 1.2 mmol/L may be added to the solution. If potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/L.

PHOXILLUM Solutions:Phosphate: Phosphate up to 0.2 mmol/L may be added to the solution. Use sodium phosphate if adding phosphate to bag. The total phosphate concentration should not exceed 1.2 mmol/L.

Pregnancy Category CAnimal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm, or affect reproductive capacity. Maintenance of normal acid-base balance is important for fetal well-being.

2.4 Adding Drugs To The Solutions

After mixing, additional drugs may be added to the bag via injection connector (spike connector) in large compartment B. In general, drugs other than phosphate should be administered through a different access line. When introducing drugs, use aseptic techniques and mix thoroughly. Do not use if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals after addition of medication.

3 Dosage Forms And Strengths

See Table 1 for the concentrations of the active ingredients (after mixing) in these 10 different replacement solutions [see Dosage and Administration (2.2)].

4 Contraindications

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.

5.1 Electrolyte And Volume Abnormalities

PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately [see Dosage and Administration (2)].PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.

5.2 Hyperglycemia With Dextrose Containing Solutions

The use of PRISMASOL replacement solutions containing dextrose may increase the risk for hyperglycemia in patients with impaired glucose tolerance. Patients may require initiation of or modification of antidiabetic therapy during treatment with PRISMASOL solutions containing dextrose. Monitor blood glucose.

6 Adverse Reactions

  • The following adverse reactions have been identified with other similar products and therefore, may occur with use of these products: •Metabolic acidosis •Hypotension •Acid-base disorders •Electrolyte imbalance •Hyperphosphatemia (for phosphate containing solutions) •Fluid imbalance

7 Drug Interactions

As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment.

7.1 Citrate

When used as an anticoagulant, citrate contributes to the overall buffer load and can reduce plasma calcium levels. Select the PRISMASOL/PHOXILLUM formulation(s) accordingly.

8.3 Nursing Mothers

The components of PRISMASOL and PHOXILLUM solutions are excreted in human milk. Appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm a nursing infant.

8.4 Pediatric Use

Safety and effectiveness have been established based on published clinical data of CRRT replacement solutions with compositions similar to PRISMASOL and PHOXILLUM used in adults and two hemofiltration studies in pediatric patients, including a study of newborns to 17 years old.

8.5 Geriatric Use

The experience with PRISMASOL and PHOXILLUM solutions in geriatric patients has not identified novel concerns.

11 Description

PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain:Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 • 2H2O).Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 • 6H2O).Sodium chloride, USP, is chemically designated NaCl.Potassium chloride, USP, is chemically designated KCl.Sodium bicarbonate, USP, is chemically designated NaHCO3.Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 • H2O).Lactic acid, USP, is chemically designated CH3CH(OH)COOH.Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 • 2H2O)Table 2 – Compartment Composition (Before Mixing)Compartment A (g/L)Compartment B (g/L)Calcium Chloride ∙ 2H2OMagnesium Chloride ∙ 6H2ODextrose anhydrous (as monohydrate)Lactic AcidSodium ChlorideSodium bicarbonatePotassium ChlorideSodium Phosphate ∙ 2H2OPRISMASOL SOLUTIONSBGK 0/2.53.683.0520 (22)5.406.463.0900BGK 4/2.53.683.0520 (22)5.406.463.090.3140BGK 4/3.55.152.0320 (22)5.406.463.090.3140BGK 2/3.55.152.0320 (22)5.406.463.090.1570BGK 2/002.0320 (22)5.406.463.090.1570B22GK 4/003.0520 (22)5.407.072.210.3140BK 0/0/1.202.440 (0)5.406.463.0900BGK 4/0/1.202.4420 (22)5.406.463.090.3140PHOXILLUM SOLUTIONSBK 4/2.53.683.050 (0)06.343.090.3140.187B22K 4/003.050 (0)06.952.210.3140.187The pH of the final solution is in the range of 7.0 to 8.5.

12.1 Mechanism Of Action

PRISMASOL and PHOXILLUM solutions are pharmacologically inactive. The electrolyte concentrations in the solutions are chosen to restore plasma levels to clinically desired concentrations or maintain plasma levels at the desired concentrations.PRISMASOL and PHOXILLUM solutions are used as replacement solution to replace water and electrolytes removed during hemofiltration and hemodiafiltration. Bicarbonate (or precursor lactate) in the solution is used as an alkalinizing buffer to restore acid-base balance to a clinically desirable level.

12.3 Pharmacokinetics

The distribution of electrolytes, bicarbonate, and dextrose is determined by the patient's clinical condition, metabolic status, and residual renal function.The elimination and replacement of water, electrolytes and buffer depend on the patient's electrolyte and acid-base balance, metabolic status, residual renal function and ongoing physiologic losses through intestinal, respiratory and cutaneous routes.

16 How Supplied/Storage And Handling

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of either polyvinyl chloride (PVC) or polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a red frangible pin in the PVC bag and by a peel seal in the polyolefin bag.The bag is overwrapped with a transparent overwrap. See Table 2 for the concentrations of the active ingredients in each compartment for each product [see Description (11)].ContainerFill VolumeNDCBag TypePRISMASOL SolutionsPRISMASOL BGK0/2.55000 mL24571-108-05PVCPRISMASOL BGK4/2.55000 mL24571-105-05PRISMASOL BGK4/3.55000 mL24571-104-05PRISMASOL BGK2/3.55000 mL24571-103-05PRISMASOL BGK2/05000 mL24571-102-05PRISMASOL B22GK4/05000 mL24571-111-05PRISMASOL BK0/0/1.25000 mL24571-113-05PRISMASOL BGK4/0/1.25000 mL24571-114-05PRISMASOL BGK0/2.55000 mL24571-108-06PolyolefinPRISMASOL BGK4/2.55000 mL24571-105-06PRISMASOL BGK2/3.55000 mL24571-103-06PRISMASOL BGK2/05000 mL24571-102-06PRISMASOL B22GK4/05000 mL24571-111-06PRISMASOL BK0/0/1.25000 mL24571-113-06PRISMASOL BGK4/0/1.25000 mL24571-114-06PHOXILLUM SolutionsPHOXILLUM BK4/2.55000 mL24571-116-05PVCPHOXILLUM B22K4/05000 mL24571-117-05PHOXILLUM BK4/2.55000 mL24571-116-06PolyolefinPHOXILLUM B22K4/05000 mL24571-117-06Not all formulations may be marketed.

Storage And Handling

Storage conditionsStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature]Do not freeze or expose to excessive heat. Do not use if precipitate has formed or if container seals havebeen damaged.Manufactured for:Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015Baxter, Gambro, Phoxillum and PrismaSol are trademarks of Baxter International Inc., or its subsidiaries

Package/Label Display Panel

  • Container Label! Symbol MIX Compartments ! SymbolD14000292 Ver. 1.0Mixing steps:1 SQUEEZE TOP corners to break seal2 Squeeze BAG SIDES to fully open sealBar CodeNDC# 24571-108-060K+mEq/L2.5 Ca2+mEq/LRx onlyPrismaSol® BGK0/2.5Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution each 1000 mL contains (g)ABCalcium chloride • 2H2O3.68Magnesium chloride • 6H2O3.05Dextrose anhydrous20.0(as dextrose monohydrate)22.0Sodium chloride6.46Lactic acid5.40Sodium bicarbonate3.09Water for injections q.s, Carbon dioxide for pH adjustmentA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-LactateC3H5O3-BicarbonateHCO3-PotassiumK+Dextrosemmol/L1.250.75140109.03.03205.5mEq/L2.51.5140109.03.0320(100 mg/dL) Theoretical osmolarity: 292 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information andfurther instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UNUSED SOLUTION. Store at +20ºC to +25ºC (68ºF to 77ºF); ex-cursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature].Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the recon-stitution of compartments A and B should be done and the reconstituted solution should be used im-mediately. After removal of the overwrap, the solu-tion is stable for 24 hours including the duration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.5000 mLGambro LogoGAMBRO®EAN-14: 07332414091613 Product No: 110240Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000293 2015-10Carton LabelPrismaSol BGK0/2.5Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 110240 SNDC# 24571-108-06 LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000293 Rev. 2016-04Container Label! Symbol MIX Compartments ! SymbolD14000292 Ver. 1.0Mixing steps:1 SQUEEZE TOP corners to break seal2 Squeeze BAG SIDES to fully open sealBar CodeNDC# 24571-105-064K+mEq/L2.5 Ca2+mEq/LRx onlyPrismaSol® BGK4/2.5Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution each 1000 mL contains (g)ABCalcium chloride • 2H2O3.68Magnesium chloride • 6H2O3.05Dextrose anhydrous20.0(as dextrose monohydrate)22.0Sodium chloride6.46Potassium chloride0.314Lactic acid5.40Sodium bicarbonate3.09Water for injections q.s, Carbon dioxide for pH adjustmentA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-LactateC3H5O3-BicarbonateHCO3-PotassiumK+Dextrosemmol/L1.250.75140113.03.0324.05.5mEq/L2.51.5140113.03.0324.0(100 mg/dL) Theoretical osmolarity: 300 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information andfurther instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UNUSED SOLUTION. Store at +20ºC to +25ºC (68ºF to 77ºF); ex-cursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature].Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the recon-stitution of compartments A and B should be done and the reconstituted solution should be used im-mediately. After removal of the overwrap, the solu-tion is stable for 24 hours including the duration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.5000 mLGambro LogoGAMBRO®EAN-14: 07332414091637 Product No: 110242Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000295 2015-10Carton LabelPrismaSol BGK4/2.5Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 110242 SNDC# 24571-105-06 LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000295 Rev. 2016-04Container Label! Symbol BREAK red pin and MIXcompartment A with compartment B Compartment A SymbolD14000299 Rev. 2015-09Break red pin and mix. ↑ Symbol Compartment B Symbol4K+mEq/L3.5 Ca2+mEq/LPrismaSol® BGK4/3.5Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution each 1000 mL contains (g)ABCalcium chloride • 2H2O5.15Magnesium chloride • 6H2O2.03Dextrose anhydrous20.0(as dextrose monohydrate)22.0Sodium chloride6.46Potassium chloride0.314Lactic acid5.40Sodium bicarbonate3.09Water for injections q.s, Carbon dioxide for pH adjustmentRx onlyA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-LactateC3H5O3-BicarbonateHCO3-PotassiumK+Dextrosemmol/L1.750.5140113.53.0324.05.5mEq/L3.51.0140113.53.0324.0(100 mg/dL) Theoretical osmolarity: 300 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information and further instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UNUSEDSOLUTION. Store at +20ºC to +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted solutionshould be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the du-ration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.5000 mLGambro LogoGAMBRO®EAN-14: 07332414120160 Product# 115633Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000306 Rev. 2015-09Carton LabelPrismaSol BGK4/3.5Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 1105633NDC# 24571-104-05 LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000306 Rev. 2015-09Container Label! Symbol MIX Compartments ! SymbolD14000292 Ver. 1.0Mixing steps:1 SQUEEZE TOP corners to break seal2 Squeeze BAG SIDES to fully open sealBar CodeNDC# 24571-103-062K+mEq/L3.5 Ca2+mEq/LRx onlyPrismaSol® BGK2/3.5Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution each 1000 mL contains (g)ABCalcium chloride • 2H2O5.15Magnesium chloride • 6H2O2.03Dextrose anhydrous20.0(as dextrose monohydrate)22.0Sodium chloride6.46Potassium chloride0.157Lactic acid5.40Sodium bicarbonate3.09Water for injections q.s, Carbon dioxide for pH adjustmentA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-LactateC3H5O3-BicarbonateHCO3-PotassiumK+Dextrosemmol/L1.750.5140111.53.0322.05.5mEq/L3.51.0140111.53.0322.0(100 mg/dL) Theoretical osmolarity: 296 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information andfurther instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UNUSED SOLUTION. Store at +20ºC to +25ºC (68ºF to 77ºF); ex-cursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature].Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the recon-stitution of compartments A and B should be done and the reconstituted solution should be used im-mediately. After removal of the overwrap, the solu-tion is stable for 24 hours including the duration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.5000 mLGambro LogoGAMBRO®EAN-14: 07332414091644 Product No: 110243Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000296 2015-10Carton LabelPrismaSol BGK2/3.5Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 110243 SNDC# 24571-103-06 LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000296 Rev. 2016-04Container Label! Symbol MIX Compartments ! SymbolD14000292 Ver. 1.0Mixing steps:1 SQUEEZE TOP corners to break seal2 Squeeze BAG SIDES to fully open sealBar CodeNDC# 24571-102-062K+mEq/L0Ca2+mEq/LRx onlyPrismaSol® BGK4/3.5Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution each 1000 mL contains (g)ABMagnesium chloride • 6H2O2.03Dextrose anhydrous20.0(as dextrose monohydrate)22.0Sodium chloride6.46Potassium chloride0.157Lactic acid5.40Sodium bicarbonate3.09Water for injections q.s, Carbon dioxide for pH adjustmentRx onlyA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-LactateC3H5O3-BicarbonateHCO3-PotassiumK+Dextrosemmol/L00.5140108.03.0322.05.5mEq/L01.0140108.03.0322.0(100 mg/dL) Theoretical osmolarity: 291 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information andfurther instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UNUSED SOLUTION. Store at +20ºC to +25ºC (68ºF to 77ºF); ex-cursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature].Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the recon-stitution of compartments A and B should be done and the reconstituted solution should be used im-mediately. After removal of the overwrap, the solu-tion is stable for 24 hours including the duration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.5000 mLGambro LogoGAMBRO®EAN-14: 07332414091651 Product No: 110244Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000297 2015-10Carton LabelPrismaSol BGK2/0Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 110244 SNDC# 24571-102-06 LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000297 Rev. 2016-04Container Label! Symbol MIX Compartments ! SymbolD14000292 Ver. 1.0Mixing steps:1 SQUEEZE TOP corners to break seal2 Squeeze BAG SIDES to fully open sealBar CodeNDC# 24571-111-064K+mEq/LBicarbonate 220Ca2+mEq/LRx onlyPrismaSol®B22GK4/0Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution each 1000 mL contains (g)ABMagnesium chloride • 6H2O3.05Dextrose anhydrous20.0(as dextrose monohydrate)22.0Sodium chloride7.07Potassium chloride0.314Lactic acid5.40Sodium bicarbonate2.21Water for injections q.s, Carbon dioxide for pH adjustmentA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-LactateC3H5O3-BicarbonateHCO3-PotassiumK+Dextrosemmol/L00.75140120.53.0224.05.5mEq/L01.5140120.53.0224.0(100 mg/dL) Theoretical osmolarity: 296 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information andfurther instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UNUSED SOLUTION. Store at +20ºC to +25ºC (68ºF to 77ºF); ex-cursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature].Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the recon-stitution of compartments A and B should be done and the reconstituted solution should be used im-mediately. After removal of the overwrap, the solu-tion is stable for 24 hours including the duration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.5000 mLGambro LogoGAMBRO®EAN-14: 07332414116781 Product No: 115001Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000298 2015-10Carton LabelPrismaSol B22GK4/0Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 115001 SNDC# 24571-111-06 LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000298 Rev. 2016-04Container Label! Symbol MIX Compartments ! SymbolD14000292 Ver. 1.0Mixing steps:1 SQUEEZE TOP corners to break seal2 Squeeze BAG SIDES to fully open sealBar CodeNDC# 24571-113-060K+mEq/L0Ca2+mEq/LRx onlyPrismaSol® BK0/0/1.2Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution each 1000 mL contains (g)ABMagnesium chloride • 6H2O2.44Sodium chloride6.46Lactic acid5.40Sodium bicarbonate3.09Water for injections q.s, Carbon dioxide for pH adjustmentA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-LactateC3H5O3-BicarbonateHCO3-PotassiumK+Dextrosemmol/L00.6140106.23.03200mEq/L01.2140106.23.0320(0 mg/dL) Theoretical osmolarity: 282 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information andfurther instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UNUSED SOLUTION. Store at +20ºC to +25ºC (68ºF to 77ºF); ex-cursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature].Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the recon-stitution of compartments A and B should be done and the reconstituted solution should be used im-mediately. After removal of the overwrap, the solu-tion is stable for 24 hours including the duration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.5000 mLGambro LogoGAMBRO®EAN-14: 07332414091309 Product No: 110239Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000292 2015-09Carton LabelPrismaSol BK0/0/1.2Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 110239 SNDC# 24571-113-06 LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000292 Rev. 2016-04Container Label! Symbol MIX Compartments ! SymbolD14000292 Ver. 1.0Mixing steps:1 SQUEEZE TOP corners to break seal2 Squeeze BAG SIDES to fully open sealBar CodeNDC# 24571-114-064K+mEq/L0Ca2+mEq/LRx onlyPrismaSol® BGK4/0/1.2Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution each 1000 mL contains (g)ABMagnesium chloride • 6H2O2.44Dextrose anhydrous20.0(as dextrose monohydrate)22.0Sodium chloride6.46Potassium chloride0.314Lactic acid5.40Sodium bicarbonate3.09Water for injections q.s, Carbon dioxide for pH adjustmentA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-LactateC3H5O3-BicarbonateHCO3-PotassiumK+Dextrosemmol/L00.6140110.23.0324.05.5mEq/L01.2140110.23.0324.0(100 mg/dL) Theoretical osmolarity: 295 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information andfurther instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UNUSED SOLUTION. Store at +20ºC to +25ºC (68ºF to 77ºF); ex-cursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature].Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the recon-stitution of compartments A and B should be done and the reconstituted solution should be used im-mediately. After removal of the overwrap, the solu-tion is stable for 24 hours including the duration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.5000 mLGambro LogoGAMBRO®EAN-14: 07332414091620 Product No: 110241Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000294 2015-10Carton LabelPrismaSol BK4/0/1.2Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 110241 SNDC# 24571-114-06 LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000294 Rev. 2016-04Container Label! Symbol MIX compartment A with compartment B Compartment A SymbolD14000349 Ver. 1.0Mixing steps1 SQUEEZE TOP corners to break seal2 Squeeze BAG SIDES to fully open sealCompartment B SymbolBar CodeNDC# 24571-116-064 K+mEq/L1 Phosphate mmol/L2.5 Ca2+mEq/LPhoxillum BK4/2.5Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution, each 1000 mL contains (g):ABCalcium chloride • 2H2O3.68Magnesium chloride • 6H2O3.05Sodium chloride6.34Potassium chloride0.314Sodium bicarbonate3.09Dibasic sodium phosphate • 2H2O0.187Water for injections q.s Rx onlyA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-BicarbonateHCO3-PotassiumK+Phosphate HPO42−Dextrosemmol/L1.250.75140114.5324.010mEq/L2.51.5140114.5324.0(1 mmol/L)(0 mg/dL) Theoretical osmolarity: 294 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information and further instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UN-USED SOLUTION. Store at +20ºC to +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted solu-tion should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.Carbon dioxide and diluted hydrochloric acid added for pH adjustment.5000 mLGambro LogoGAMBRO®EAN-14: 07332414116040 Product# 114905Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000349 Ver. 1.0Carton LabelPhoxillum BK4/2.5Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 114905NDC 24571-116-06LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000349 Ver. 1.0Container Label! Symbol MIXcompartment A with compartment B Compartment A SymbolD14000349 Ver. 1.0Mixing steps1 SQUEEZE TOP corners to break seal2 Squeeze BAG SIDES to fully open sealCompartment B SymbolBar CodeNDC# 24571-117-064 K+mEq/L0 Ca2+mEq/L 22 Bicarbonate mEq/L1 Phosphate mmol/LPhoxillum B22K4/0Replacement Solution for Continuous Renal Replacement TherapyBefore reconstitution, each 1000 mL contains (g):ABMagnesium chloride • 6H2O3.05Sodium chloride6.95Potassium chloride0.314Sodium bicarbonate2.21Dibasic sodium phosphate • 2H2O0.187Water for injections q.s Rx onlyA250 mLB4750 mLAfter reconstitution, A + BCalciumCa2+MagnesiumMg2+SodiumNa+ChlorideCl-BicarbonateHCO3-PotassiumK+PhosphateHPO42-Dextrosemmol/L00.75140122.0224.010mEq/L01.5140122.0224.0(1 mmol/L)(0 mg/dL) Theoretical osmolarity: 290 mOsm/LpH: 7.0 – 8.5Mix both compartments before use.See package insert for dosage information and further instructions. Sterile and free from bacterial endotoxins.Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UN-USED SOLUTION. Store at +20ºC to +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted solu-tion should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.Carbon dioxide and diluted hydrochloric acid added for pH adjustment.5000 mLGambro LogoGAMBRO®EAN-14: 07332414116057 Product# 114906Batch No. and expiry date are printed on the back of the bag.Manufactured for:Baxter Healthcare CorporationDeerfield IL 60015 USAMade in ItalyR E P L A C E M E N TSolution for Continuous Renal Replacement TherapyD11000350 Ver. 1.0Carton LabelPhoxillum B22K4/0Replacement Solution for Continuous Renal Replacement TherapyREF Cat. # 114906NDC 24571-117-06LOT # Expiry Rx Only2 x 5000 mLStore at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF). [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.D12000350 Ver. 1.0

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