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PrismaSol

Generic Name: electrolytes, bicarbonate and dextrose
Dosage Form: intravenous solution

Indications and Usage for PrismaSol

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.

PrismaSol Dosage and Administration

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.

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 Mixing
Ca2+
mEq/L
HCO3-
mEq/L
K+
mEq/L
Mg2+
mEq/L
Na+
mEq/L
HPO42-
mmol/L
Cl-
mEq/L
Lactate
mEq/L
Dextrose
mg/dL
Osmolarity
mOsm/L
Ca2+ = calcium, HCO3- = bicarbonate, K+ = potassium, Mg2+ = magnesium, Na+ = sodium, HPO42- = phosphate, Cl- = chloride; osmolarity is estimated

PrismaSol Replacement Solutions

BGK0/2.5

2.5

32

0

1.5

140

0

109

3

100

292

BGK4/2.5

2.5

32

4

1.5

140

0

113

3

100

300

BGK4/3.5

3.5

32

4

1

140

0

113.5

3

100

300

BGK2/3.5

3.5

32

2

1

140

0

111.5

3

100

296

BGK2/0

0

32

2

1

140

0

108

3

100

291

B22GK4/0

0

22

4

1.5

140

0

120.5

3

100

296

BGK4/0/1.2

0

32

4

1.2

140

0

110.2

3

100

295

BK0/0/1.2

0

32

0

1.2

140

0

106.2

3

0

282

PHOXILLUM Replacement Solutions

BK4/2.5

2.5

32

4

1.5

140

1

114.5

0

0

294

B22K4/0

0

22

4

1.5

140

1

122

0

0

290

Select the mode of therapy, solute formulation, flow rates, and length of PrismaSol and PHOXILLIUM replacement therapy in CRRT based on the patient's clinical condition, and fluid, electrolyte, acid-base, 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.

Preparing the Solution

Use only if the overwrap is not damaged, all seals are intact, and the solution is clear. Press bag firmly to test for any leakage. Do not use if container is damaged or leaking.

The solution may be heated to no more than 40°C/104°F inside of the overwrap. 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.

Instructions for preparing solutions supplied in a two-compartment, polyvinyl chloride (PVC) bag with a red frangible pin:

Figure 1

Figure 2

Step 1 Immediately before use, remove the overwrap from the bag and mix the solutions in the two different compartments. 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 4

Step 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 5a

Step 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 5b

Step 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 6

Figure 7

Step 1 Immediately before use, remove the overwrap from the bag and mix the solutions in the two different compartments. 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 8

Step 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 9a

Step 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 9b

Step 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.

 

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 additives, use aseptic techniques.

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.

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)].

Contraindications

None

Warnings and Precautions

Electrolyte and Volume Abnormalities

Monitor hemodynamic status and fluid, electrolyte and acid-base balance throughout the procedure. During hemofiltration or hemodiafiltration using PrismaSol or PHOXILLUM replacement solutions, abnormalities in the plasma concentration of potassium, calcium, magnesium, and phosphate may develop. These abnormalities may be corrected by changing the formulations of replacement solution or by supplementation [see Dosage and Administration (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.

Drug Interactions

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

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.

USE IN SPECIFIC POPULATION

Pregnancy

Pregnancy Category C

Animal 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.

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.

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.

Geriatric Use

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

PrismaSol 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 ∙ 2H2O Magnesium Chloride ∙ 6H2O Dextrose anhydrous (as monohydrate) Lactic Acid Sodium Chloride Sodium bicarbonate Potassium Chloride Sodium Phosphate ∙ 2H2O

PrismaSol SOLUTIONS

BGK 0/2.5

3.68

3.05

20 (22)

5.40

6.46

3.09

0

0

BGK 4/2.5

3.68

3.05

20 (22)

5.40

6.46

3.09

0.314

0

BGK 4/3.5

5.15

2.03

20 (22)

5.40

6.46

3.09

0.314

0

BGK 2/3.5

5.15

2.03

20 (22)

5.40

6.46

3.09

0.157

0

BGK 2/0

0

2.03

20 (22)

5.40

6.46

3.09

0.157

0

B22GK 4/0

0

3.05

20 (22)

5.40

7.07

2.21

0.314

0

BK 0/0/1.2

0

2.44

0 (0)

5.40

6.46

3.09

0

0

BGK 4/0/1.2

0

2.44

20 (22)

5.40

6.46

3.09

0.314

0

PHOXILLUM SOLUTIONS

BK 4/2.5

3.68

3.05

0 (0)

0

6.34

3.09

0.314

0.187

B22K 4/0

0

3.05

0 (0)

0

6.95

2.21

0.314

0.187

The pH of the final solution is in the range of 7.0 to 8.5.

PrismaSol - Clinical Pharmacology

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.

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.

How Supplied/Storage and Handling

PHOXILLUM solutions are supplied in a two-compartment bag made of polyvinyl chloride (PVC). PrismaSol 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)].

Container Fill Volume NDC Bag Type

PrismaSol Solutions

PrismaSol BGK0/2.5

5000 mL

24571-108-05

PVC

PrismaSol BGK4/2.5

5000 mL

24571-105-05

 

PrismaSol BGK4/3.5

5000 mL

24571-104-05

 

PrismaSol BGK2/3.5

5000 mL

24571-103-05

 

PrismaSol BGK2/0

5000 mL

24571-102-05

 

PrismaSol B22GK4/0

5000 mL

24571-111-05

 

PrismaSol BK0/0/1.2

5000 mL

24571-113-05

 

PrismaSol BGK4/0/1.2

5000 mL

24571-114-05

 

PrismaSol BGK0/2.5

5000 mL

24571-108-06

Polyolefin

PrismaSol BGK4/2.5

5000 mL

24571-105-06

 

PrismaSol BGK2/3.5

5000 mL

24571-103-06

 

PrismaSol BGK2/0

5000 mL

24571-102-06

 

PrismaSol B22GK4/0

5000 mL

24571-111-06

 

PrismaSol BK0/0/1.2

5000 mL

24571-113-06

 

PrismaSol BGK4/0/1.2

5000 mL

24571-114-06

 

PHOXILLUM Solutions

PHOXILLUM BK4/2.5

5000 mL

24571-116-05

PVC

PHOXILLUM B22K4/0

5000 mL

24571-117-05

 

Not all formulations may be marketed.

Storage conditions

Store 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 have been damaged.

Manufactured for:
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, Illinois 60015

Gambro, Phoxillum and PrismaSol are trademarks of Baxter International Inc., or its subsidiaries

Package/Label Display Panel

! Symbol
BREAK red pin and MIX
Compartment A Symbol
D07900004 Rev. 2012-08/1

Break red pin and mix.

OK+
mEq/L

2.5 Ca2+
mEq/L

PrismaSol® BGK0/2.5
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H2O

3.68

Magnesium chloride • 6H2O

3.05

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Lactate
C3H5O3-

Bicarbonate
HCO3-

Potassium
K+

Dextrose

mmol/L

1.25

0.75

140

109.0

3.0

32

0

5.5

mEq/L

2.5

1.5

140

109.0

3.0

32

0

(100 mg/dL)

Theoretical osmolarity: 292 mOsm/L pH: 7.0 – 8.5

Mix 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 UNUSED
SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled
Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconsti-
tution of compartments A and B should be done and the reconstituted solution 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 latex free.

5000 mL
EAN-14: 07332414108649
Product # 113921

Batch No. and expiry date are printed on the
back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200015 Rev 2012-11

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

PrismaSol BGK0/2.5

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 113921
NDC 24571-108-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)37332414108640(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1473 D18000290 Ver. 1.0

! Symbol
BREAK red pin and MIX
Compartment A Symbol
D07900004 Rev. 2012-08/1

Break red pin and mix.

4K+
mEq/L

2.5 Ca2+
mEq/L

PrismaSol® BGK4/2.5
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H2O

3.68

Magnesium chloride • 6H2O

3.05

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Lactate
C3H5O3-

Bicarbonate
HCO3-

Potassium
K+

Dextrose

mmol/L

1.25

0.75

140

113.0

3.0

32

4.0

5.5

mEq/L

2.5

1.5

140

113.0

3.0

32

4.0

(100 mg/dL)

Theoretical osmolarity: 300 mOsm/L pH: 7.0 – 8.5

Mix 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 UNUSED
SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled
Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconsti-
tution of compartments A and B should be done and the reconstituted solution 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 latex free.

5000 mL
EAN-14: 07332414108663
Product # 113923

Batch No. and expiry date are printed on the
back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200013 Rev 2012-11

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

PrismaSol BGK4/2.5

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 113923
NDC 24571-105-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)37332414108664(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1466 D18000290 Ver. 1.0

! Symbol
BREAK red pin and MIX
Compartment A Symbol
D07900004 Rev. 2012-08/1

Break red pin and mix.

4K+
mEq/L

3.5 Ca2+
mEq/L

PrismaSol® BGK4/3.5
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H2O

5.15

Magnesium chloride • 6H2O

2.03

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Lactate
C3H5O3-

Bicarbonate
HCO3-

Potassium
K+

Dextrose

mmol/L

1.75

0.5

140

113.5

3.0

32

4.0

5.5

mEq/L

3.5

1.0

140

113.5

3.0

32

4.0

(100 mg/dL)

Theoretical osmolarity: 300 mOsm/L pH: 7.0 – 8.5

Mix 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 UNUSED
SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled
Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconsti-
tution of compartments A and B should be done and the reconstituted solution 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 latex free.

5000 mL
EAN-14: 07332414120160
Product # 115633

Batch No. and expiry date are printed on the
back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200052 Rev 2013-11

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

PrismaSol BGK4/3.5

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 115633
NDC 24571-104-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)37332414120161(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1496 D18000290 Ver. 1.0

! Symbol
BREAK red pin and MIX
Compartment A Symbol
D07900004 Rev. 2012-08/1

Break red pin and mix.

2K+
mEq/L

3.5 Ca2+
mEq/L

PrismaSol® BGK2/3.5
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H2O

5.15

Magnesium chloride • 6H2O

2.03

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.157

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Lactate
C3H5O3-

Bicarbonate
HCO3-

Potassium
K+

Dextrose

mmol/L

1.75

0.5

140

111.5

3.0

32

2.0

5.5

mEq/L

3.5

1.0

140

111.5

3.0

32

2.0

(100 mg/dL)

Theoretical osmolarity: 296 mOsm/L pH: 7.0 – 8.5

Mix 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 UNUSED
SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled
Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconsti-
tution of compartments A and B should be done and the reconstituted solution 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 latex free.

5000 mL
EAN-14: 07332414108670
Product # 113924

Batch No. and expiry date are printed on the
back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200012 Rev 2012-11

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

PrismaSol BGK2/3.5

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 113924
NDC 24571-103-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)37332414108671(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1463 D18000290 Ver. 1.0

! Symbol
BREAK red pin and MIX
Compartment A Symbol
D07900004 Rev. 2012-08/1

Break red pin and mix.

2K+
mEq/L

0Ca2+
mEq/L

PrismaSol® BGK2/0
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H2O

2.03

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.157

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Lactate
C3H5O3-

Bicarbonate
HCO3-

Potassium
K+

Dextrose

mmol/L

0

0.5

140

108.0

3.0

32

2.0

5.5

mEq/L

0

1.0

140

108.0

3.0

32

2.0

(100 mg/dL)

Theoretical osmolarity: 291 mOsm/L pH: 7.0 – 8.5

Mix 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 UNUSED
SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled
Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconsti-
tution of compartments A and B should be done and the reconstituted solution 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 latex free.

5000 mL
EAN-14: 07332414108687
Product # 113925

Batch No. and expiry date are printed on the
back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200011 Rev 2012-11

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

PrismaSol BGK2/0

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 113925
NDC 24571-102-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)37332414108688(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1460 D18000290 Ver. 1.0

! Symbol
BREAK red pin and MIX
Compartment A Symbol
D07900004 Rev. 2012-08/1

Break red pin and mix.

4K+
mEq/L

Bicarbonate 22

0Ca2+
mEq/L

PrismaSol® B22GK4/0
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H2O

3.05

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

7.07

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

2.21

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Lactate
C3H5O3-

Bicarbonate
HCO3-

Potassium
K+

Dextrose

mmol/L

0

0.75

140

120.5

3.0

22

4.0

5.5

mEq/L

0

1.5

140

120.5

3.0

22

4.0

(100 mg/dL)

Theoretical osmolarity: 296 mOsm/L pH: 7.0 – 8.5

Mix 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 UNUSED
SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled
Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconsti-
tution of compartments A and B should be done and the reconstituted solution 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 latex free.

5000 mL
EAN-14: 07332414106034
Product # 113286

Batch No. and expiry date are printed on the
back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200032 Rev 2012-11

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

PrismaSol B22GK4/0

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 113286
NDC 24571-111-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)37332414106035(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1499 D18000290 Ver. 1.0

! Symbol
BREAK red pin and MIX
Compartment A Symbol
D07900004 Rev. 2012-08/1

Break red pin and mix.

0K+
mEq/L

0Ca2+
mEq/L

PrismaSol® BK0/0/1.2
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H2O

2.44

Sodium chloride

6.46

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Lactate
C3H5O3-

Bicarbonate
HCO3-

Potassium
K+

Dextrose

mmol/L

0

0.6

140

106.2

3.0

32

0

0

mEq/L

0

1.2

140

106.2

3.0

32

0

(100 mg/dL)

Theoretical osmolarity: 282 mOsm/L pH: 7.0 – 8.5

Mix 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 UNUSED
SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled
Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconsti-
tution of compartments A and B should be done and the reconstituted solution 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 latex free.

5000 mL
EAN-14: 07332414108632
Product # 113920

Batch No. and expiry date are printed on the
back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200031 Rev 2012-11

REPLACEMENT

PrismaSol BK0/0/1.2

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 113920
NDC 24571-113-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)37332414108533(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1476 D18000290 Ver. 1.0

! Symbol
BREAK red pin and MIX
Compartment A Symbol
D07900004 Rev. 2012-08/1

Break red pin and mix.

4K+
mEq/L

0Ca2+
mEq/L

PrismaSol® BGK4/0/1.2
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H2O

2.44

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Lactate
C3H5O3-

Bicarbonate
HCO3-

Potassium
K+

Dextrose

mmol/L

0

0.6

140

110.2

3.0

32

4.0

5.5

mEq/L

0

1.2

140

110.2

3.0

32

4.0

(100 mg/dL)

Theoretical osmolarity: 295 mOsm/L pH: 7.0 – 8.5

Mix 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 UNUSED
SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled
Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconsti-
tution of compartments A and B should be done and the reconstituted solution 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 latex free.

5000 mL
EAN-14: 07332414108656
Product # 113922

Batch No. and expiry date are printed on the
back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200034 Rev 2012-11

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

PrismaSol BGK4/0/1.2

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 113922
NDC 24571-114-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)37332414108657(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1469 D18000290 Ver. 1.0

! Symbol
BREAK red pin and MIX
compartment A with compartment B
Compartment A Symbol
D14000286 Ver. 1.0

Break red pin and mix.
Compartment B Symbol

4K+
mEq/L

1 Phosphate
mmol/L

2.5 Ca2+
mEq/L

Phoxillum BK4/2.5
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution, each 1000 mL contains (g):

A

B

Calcium chloride • 2H2O

3.68

Magnesium chloride • 6H2O

3.05

Sodium chloride

6.34

Potassium chloride

0.314

Sodium bicarbonate

3.09

Dibasic sodium phosphate • 2H2O

0.187

Water for injections q.s

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Bicarbonate
HCO3-

Potassium
K+

Phosphate
HPO42-

Dextrose

mmol/L

1.25

0.75

140

114.5

32

4.0

1

0

mEq/L

2.5

1.5

140

114.5

32

4.0

(1 mmol/L)

(0 mg/dL)

Theoretical osmolarity: 294 mOsm/L pH: 7.0 – 8.5

Mix 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
UNUSED SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º - 30ºC (59º - 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
solution 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 mL
EAN-14: 07332414113377
Product # 114483

Batch No. and expiry date are printed on the
back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200050 Ver. 1.0

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

Phoxillum BK4/2.5

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 114483
NDC 24571-116-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)3733241413378(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1499 D18000291 Ver. 1.0

! Symbol
BREAK red pin and MIX
compartment A with compartment B
Compartment A Symbol
D14000286 Ver. 1.0

Break red pin and mix.
Compartment B Symbol

4K+
mEq/L

0 Ca2+
mEq/L

22 Bicarbonate
mEq/L

1 Phosphate
mmol/L

Phoxillum B22K4/0
Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution, each 1000 mL contains (g):

A

B

Magnesium chloride • 6H2O

3.05

Sodium chloride

6.95

Potassium chloride

0.314

Sodium bicarbonate

2.21

Dibasic sodium phosphate • 2H2O

0.187

Water for injections q.s

Rx only
A
250 mL

B
4750 mL

After reconstitution, A + B

Calcium
Ca2+

Magnesium
Mg2+

Sodium
Na+

Chloride
Cl-

Bicarbonate
HCO3-

Potassium
K+

Phosphate
HPO42-

Dextrose

mmol/L

0

0.75

140

122.0

22

4.0

1

0

mEq/L

0

1.5

140

122.0

22

4.0

(1 mmol/L)

(0 mg/dL)

Theoretical osmolarity: 290 mOsm/L pH: 7.0 – 8.5

Mix 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
UNUSED SOLUTION. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15º - 30ºC (59º - 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
solution 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 mL
EAN-14: 07332414113384
Product # 114484

Batch No. and expiry date are printed
on the back of the bag.

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200051 Ver. 1.0

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

Phoxillum B22K4/0

Replacement Solution for Continuous Renal Replacement Therapy

REF Cat. # 114484
NDC 24571-117-05

LOT # 1234567890

Expiry 2016-12-31

Bar Code
(01)3733241413385(17)161231(10)1234567890(30)02

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
[See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

Rx Only
2 x 5000 mL

1496 D18000291 Ver. 1.0

PrismaSol  BGK0/2.5
calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-108
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 0.139 g  in 1 L
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.071 g  in 1 L
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) ANHYDROUS DEXTROSE 1 g  in 1 L
LACTIC ACID (LACTIC ACID) LACTIC ACID 0.270 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.137 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.936 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
Packaging
# Item Code Package Description
1 NDC:24571-108-05 2 BAG in 1 CASE
1 5 L in 1 BAG
2 NDC:24571-108-06 2 BAG in 1 CASE
2 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021703 10/25/2006
PrismaSol  BGK4/2.5
calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride sodium bicarbonate, and potassium chloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-105
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 0.139 g  in 1 L
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.071 g  in 1 L
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) ANHYDROUS DEXTROSE 1 g  in 1 L
LACTIC ACID (LACTIC ACID) LACTIC ACID 0.270 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.137 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.936 g  in 1 L
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.298 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
Packaging
# Item Code Package Description
1 NDC:24571-105-05 2 BAG in 1 CASE
1 5 L in 1 BAG
2 NDC:24571-105-06 2 BAG in 1 CASE
2 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021703 10/25/2006
PrismaSol  BGK4/3.5
calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-104
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 0.194 g  in 1 L
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.048 g  in 1 L
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) ANHYDROUS DEXTROSE 1 g  in 1 L
LACTIC ACID (LACTIC ACID) LACTIC ACID 0.270 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.137 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.936 g  in 1 L
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.298 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
Packaging
# Item Code Package Description
1 NDC:24571-104-05 2 BAG in 1 CASE
1 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021703 10/25/2006
PrismaSol  BGK2/3.5
calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-103
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 0.194 g  in 1 L
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.048 g  in 1 L
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) ANHYDROUS DEXTROSE 1 g  in 1 L
LACTIC ACID (LACTIC ACID) LACTIC ACID 0.270 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.137 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.936 g  in 1 L
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.149 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
Packaging
# Item Code Package Description
1 NDC:24571-103-05 2 BAG in 1 CASE
1 5 L in 1 BAG
2 NDC:24571-103-06 2 BAG in 1 CASE
2 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021703 10/25/2006
PrismaSol  BGK2/0
magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-102
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.048 g  in 1 L
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) ANHYDROUS DEXTROSE 1 g  in 1 L
LACTIC ACID (LACTIC ACID) LACTIC ACID 0.270 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.137 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.936 g  in 1 L
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.149 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
Packaging
# Item Code Package Description
1 NDC:24571-102-05 2 BAG in 1 CASE
1 5 L in 1 BAG
2 NDC:24571-102-06 2 BAG in 1 CASE
2 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021703 10/25/2006
PrismaSol  B22GK4/0
magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-111
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.071 g  in 1 L
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) ANHYDROUS DEXTROSE 1 g  in 1 L
LACTIC ACID (LACTIC ACID) LACTIC ACID 0.270 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.717 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.100 g  in 1 L
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.298 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
Packaging
# Item Code Package Description
1 NDC:24571-111-05 2 BAG in 1 CASE
1 5 L in 1 BAG
2 NDC:24571-111-06 2 BAG in 1 CASE
2 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021703 10/10/2008
PrismaSol  BK0/0/1.2
magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-113
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.057 g  in 1 L
LACTIC ACID (LACTIC ACID) LACTIC ACID 0.270 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.137 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.936 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
Packaging
# Item Code Package Description
1 NDC:24571-113-05 2 BAG in 1 CASE
1 5 L in 1 BAG
2 NDC:24571-113-06 2 BAG in 1 CASE
2 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021703 10/10/2008
PrismaSol  BGK4/0/1.2
magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-114
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.057 g  in 1 L
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) ANHYDROUS DEXTROSE 1 g  in 1 L
LACTIC ACID (LACTIC ACID) LACTIC ACID 0.270 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.137 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.936 g  in 1 L
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.298 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
Packaging
# Item Code Package Description
1 NDC:24571-114-05 2 BAG in 1 CASE
1 5 L in 1 BAG
2 NDC:24571-114-06 2 BAG in 1 CASE
2 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021703 10/10/2008
PHOXILLUM  BK4/2.5
calcium chloride, magnesium chloride, sodium chloride, potassium chloride, dibasic sodium phosphate dihydrate, and sodium bicarbonate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-116
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 0.139 g  in 1 L
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.071 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.023 g  in 1 L
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.298 g  in 1 L
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (SODIUM CATION and PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.146 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.936 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:24571-116-05 2 BAG in 1 CASE
1 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207026 01/13/2015
PHOXILLUM  B22K4/0
magnesium chloride, sodium chloride, potassium chloride, dibasic sodium phosphate dihydrate and sodium bicarbonate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24571-117
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.071 g  in 1 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 6.603 g  in 1 L
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.298 g  in 1 L
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (SODIUM CATION and PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.146 g  in 1 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 2.1 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBON DIOXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:24571-117-05 2 BAG in 1 CASE
1 5 L in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207026 01/13/2015
Labeler - Gambro Renal Products Inc. (040047519)
Registrant - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Gambro Renal Products Inc. 040047519 ANALYSIS(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117), MANUFACTURE(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117), LABEL(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117), PACK(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117), STERILIZE(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117)
Establishment
Name Address ID/FEI Operations
Chemtrade Solutions, LLC 167166230 API MANUFACTURE(24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-114, 24571-116, 24571-117)
Revised: 12/2015
 
Gambro Renal Products Inc.



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