0.9% Sodium Chloride Irrigation, USPBaxter Sterile Container System |

05:18 EDT 27th August 2014 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.


0.9% Sodium Chloride Irrigation, USP in the Baxter Sterile Container System is a sterile, nonpyrogenic, isotonic solution for the preparation of slushed solution. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1.

The Baxter Sterile Container System is designed to provide a slush container with a sterile exterior surface for use within the surgical field. Within the overwrap, the unit is packaged in a dispensing bag which maintains the sterility of this surface.

The flexible plastic slush container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by culture toxicity studies.

Table 1
Size (mL)Composition (g/L)Osmolarity (mOsmol/L) (calc)pHIonic Concentration
Sodium Chloride, USP (NaCl)SodiumChloride
0.9 % Sodium Chloride Irrigation, USP100093085.0 (4.5 to 7.0)154154


Slushed solution is used to induce regional hypothermia in conditions such as certain open heart and kidney surgical procedures by direct application of slushed solution. The objective of regional hypothermia is to reduce cellular metabolic activity so that body tissues can tolerate a period of total or relative ischemia thereby inhibiting the formation and buildup of destructive autolytic enzymes and anaerobic by-products usually produced and accumulated in ischemic tissues.


Slushed solution is used to create regional hypothermia in order to reduce and minimize manifestations of warm-temperature ischemia. Temperature probes may be used to determine requirements for replacement or addition of slushed solution.


None known


Not for injection. For use in slush preparation for regional hypothermia.


Avoid prolonged direct contact between ice crystals and body tissues.

Experience in use of slushed solutions in pediatrics is limited.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Studies performed with slushed 0.9% Sodium Chloride Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.


Teratogenic Effects

Animal reproduction studies have not been conducted with slushed 0.9% Sodium Chloride Irrigation, USP. It is also not known whether slushed 0.9% Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Slushed 0.9% Sodium Chloride Irrigation, USP should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when slushed 0.9% Sodium Chloride Irrigation, USP is administered to a nursing mother.

Pediatric Use

Safety and effectiveness of slushed 0.9% Sodium Chloride Irrigation, USP in pediatric patients have not been established by adequate and well controlled trials; however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

Do not administer unless seals of outer dispensing bag are intact.


No serious adverse reactions are known.


The volume of slushed solution required will vary with patient’s age, clinical condition, cooling effect desired and duration of cooling effect desired, according to physician’s instructions.


0.9% Sodium Chloride Irrigation, USP in the Baxter Sterile Container System is supplied as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Avoid freezing except during controlled slushing procedure. It is recommended that this product be stored at room temperature (25ºC); brief exposure up to 40ºC does not adversely affect this product.

CodeSize (mL)NDCDIN

The following instructions are intended only as guidelines for the preparation of slush using the Baxter Sterile Container System. The specific procedure necessary to achieve the desired slush consistency will depend on the type of freezer used, location of the product in the freezer, and the utilization of freezer capacity.

A. To prepare the unit outside of the surgical field

B. To transfer sterile slush container to the surgical field

Baxter Healthcare Corporation Deerfield, IL 60015 USA

Printed in USA

Distributed in Canada by Baxter Corporation Toronto, Ontario, Canada

©Copyright 1984, 1986, 1988, 1995, Baxter Healthcare Corporation. All rights reserved.

07-19-04-501Rev. October 2003

BAXTER and PL 146 are trademarks of Baxter International Inc.

*Bar Code Position Only


IMAGE sodium_chloride_Figure-1.JPGIMAGE sodium_chloride_Figure-2.JPGIMAGE sodium_chloride_Figure-3.JPGIMAGE sodium_chloride_Figure-4.JPGIMAGE sodium_chloride_Figure-5.JPG


Baxter Healthcare Corporation

Active Ingredients


Clinical Trials [163034 Results]

The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery

Arnica montana is a homeopathic drug that is made in accordance with the official methods of the Homeopathic Pharmacopoeia of the United States (HPUS) and is commonly used by cosmetic surg...

Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

Enlarged tonsils and malocclusion has relationship with sleep disturbance in children. The consequences of these features can include aggravation of craniofacial growth such that the devel...

The Biology of Chronic Preconditioning: Genomic and Physiologic Mechanisms of Response

The purpose of this study is to assess the effects of repeated RIPC and exercise, on exercise performance, skeletal muscle responses and circulating cellular and humoral biology in humans

Pilot Study of Raltegravir Lipodystrophy IISP

The substitution of raltegravir for the NRTIs will result in some reversal of the long term adverse effect of lipodystrophy (specifically peripheral lipoatrophy) that is associated with th...

Esophagoscopy in Evaluating Treatment in Patients With Stage I-IV Head and Neck Cancer Who Are Undergoing Radiation Therapy and/or Chemotherapy

Brief Summary: RATIONALE: Comparing results of diagnostic procedures, such as esophagoscopy, done before and after radiation therapy and/or chemotherapy may help doctors predict a patient...

PubMed Articles [1002839 Results]

Effects of proinsulin misfolding on β-cell dynamics, differentiation and function in diabetes.

ER stress due to proinsulin misfolding has an important role in the pathophysiology of rare forms of permanent neonatal diabetes (PNDM) and probably also of common type 1 (T1D) and type 2 diabetes (T2...

Regulation of islet glucagon secretion: Beyond calcium.

The islet of Langerhans plays a key role in glucose homeostasis through regulated secretion of the hormones insulin and glucagon. Islet research has focused on the insulin-secreting β-cells, even tho...

Biosynthesis, structure, and folding of the insulin precursor protein.

Insulin synthesis in pancreatic β-cells is initiated as preproinsulin. Prevailing glucose concentrations, which oscillate pre- and postprandially, exert major dynamic variation in preproinsulin biosy...

Role of ghrelin in pancreatic development and function.

Ghrelin is a gastric peptide with anabolic functions. It acutely stimulates growth hormone (GH) secretion from the anterior pituitary glands and modulates hypothalamic circuits that control food intak...

Lysosomes in nutrient signalling: A focus on pancreatic β-cells.

Regulated insulin secretion from pancreatic β-cells is a major process maintaining glucose homeostasis in mammals. Enhancing insulin release in response to chronic nutrient overload and obesity-relat...

Quick Search


Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Drugs and Medication Quicklinks

Searches Linking to this Drug Record