Phoxillum（肾脏替代液）

批准日期：2015年1月13日

公司：巴克斯特国际公司

治疗：持续性肾脏替代治疗

Phoxillum（肾脏替代液）是用于连续性肾脏替代治疗（CRRT）的电解质管理的替代溶液。

福辛普利剂量

总称：氯化钙0.139g/L，氯化镁0.071g/L，氯化钠6.023g/L，氯化钾0.298g/L，磷酸钠0.146g/L，碳酸氢钠2.936g/L

剂型：肾替代液

管理说明

给药前目视检查Prismasol和Phoxilum有无颗粒物和变色。

只有在具备包括CRRT在内的重症监护治疗能力的医生的指导下才可以给药。只能与适合CRRT的体外透析设备一起使用。

所制备的溶液仅供一名患者使用。

整个给药过程中应使用无菌技术。

丢弃任何未使用的溶液。

加药注意事项

Prismasol替代溶液含有4种不同的活性成分组合（8种不同的产品，成分含量不同）。腓骨替代液含有2种不同的有效成分组合（2种不同的产品，成分含量不同）。Prismasol和Phoxilum装在一个双室袋中，使用前必须立即混合[见剂量和给药（2.3）]：

含有电解质溶液的小室A（250毫升），以及

含有缓冲溶液的大隔间B（4750毫升）。

在这10种不同的替代溶液中（总体积为5升），见表1的活性成分（混合后）的浓度。

根据患者的临床情况，以及液体、电解质、酸碱、葡萄糖的平衡，选择crrt的治疗方式、溶质配方、流速、primasol和phoxillium替代治疗的时间长短。在体外循环中给予普利马索或腓肠肌：

在（预稀释）血液滤过器或血液滤过器之前，

血液滤过器或血液滤过器（稀释后）后，或

血液滤过器或血液滤过器前后。

配制溶液

仅在没有损坏过卷、所有密封件都完好无损且溶液清澈的情况下使用。用力按压袋子，检查是否有泄漏。如果容器损坏或泄漏，请勿使用。

溶液可在覆盖层内加热至不超过40°C/104°F。加热后，确认溶液保持透明且不含颗粒物。

连接溶液袋时，请按照以下说明正确使用接入端口

在溶液中添加药物

混合后，可以在大室B中通过注射连接器（钉连接器）向袋中添加药物。一般而言，除磷酸盐以外的药物应通过不同的接入线进行管理。当引入添加剂时，使用无菌技术。

Prismasol解决方案：

磷酸盐：可向溶液中添加高达1.2 mmol/L的磷酸盐。如果添加磷酸钾，总钾浓度不应超过4meq/L。

phoxilum解决方案：

磷酸盐：可向溶液中添加高达0.2 mmol/L的磷酸盐。如果向袋子中添加磷酸盐，则使用磷酸钠。总磷酸盐浓度不应超过1.2 mmol/L。

Phoxillum (renal replacement solution)

Date of Approval: January 13, 2015
Company: Baxter International Inc.
Treatment for: Continuous Renal Replacement Therapy

Phoxillum (renal replacement solution) is a replacement solution used for electrolyte management in Continuous Renal Replacement Therapy (CRRT).

Phoxillum

Generic Name: renal replacement solution
Dosage Form: renal replacement solution

Medically reviewed by Drugs.com. Last updated on Feb 1, 2019.

Indications and Usage for Phoxillum

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.

Phoxillum 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).

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.

Follow the instructions below when connecting the solution bags for correct use of the access ports

Figure 1

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.

Phoxillum 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)

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

Phoxillum - 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

PRISMASOL and Phoxillum solutions are supplied in a two-compartment bag made of polyvinyl chloride (PVC). 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.

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)].

Not all formulations may be marketed.

Storage conditions

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15º-30ºC (59º-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 by:
Gambro Renal Products, Inc
1845 Mason Avenue
Daytona Beach, FL 32117, USA

PRINCIPAL DISPLAY PANEL - 5000 mL Bag Label - BK4/2.5

Phoxillum BK4/2.5
Replacement Solution for Continuous Renal Replacement Therapy

PRINCIPAL DISPLAY PANEL - 5000 mL Bag Label - B22K4/0

Phoxillum B22K4/0
Replacement Solution for Continuous Renal Replacement Therapy

Gambro Renal Products