Normal Saline

DESCRIPTION

Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP is a sterile, nonpyrogenic solution for fluid andelectrolytereplenishment in single dose containers for intravenous administration. It contains noantimicrobialagents. The nominal pH is 5.5 (4.5 to 7.0). Composition,osmolarity, and ionic concentration are shown below:

0.45% Sodium Chloride Injection, USPcontains 4.5 g/L Sodium Chloride (sodium chloride (sodium chloride injection) injection) , USP (NaCl) with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride.

0.9% Sodium Chloride Injection, USPcontains 9 g/L Sodium Chloride (sodium chloride (sodium chloride injection) injection) , USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.

The flexible container is made with non-latex plastic materials specially designed for a wide range ofparenteraldrugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The solution contact materials do not containPVC,DEHP, or other plasticizers.

The suitability of the container materials has been established through biological evaluations, which have shown the container passes Class VI U.S.药典(USP) testing for plastic containers. These tests confirm the biological safety of the container system. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration.

The container has two ports: one is the administrationoutletport for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication (SeeDirections for Use). The primary function of the overwrap is to protect the container from the physicalenvironment.

INDICATIONS

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

0.9% Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP is also indicated for use as a priming solution inhemodialysisprocedures.

DOSAGE AND ADMINISTRATION

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact.

All injections in AVIVA plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used.

Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, useaseptictechnique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

HOW SUPPLIED

The available sizes of each injection in AVIVA plastic containers are shown below:

Code	Size (mL)	NDC	Product Name
6E1313	500	0338-6333-03	0.45% Sodium Chloride Injection, USP
6E1314	1000	0338-6333-04
6E1356	250	0338-6333-02
6E1322	250	0338-6304-02	0.9% Sodium Chloride Injection, USP
6E1323	500	0338-6304-03
6E1324	1000	0338-6304-04

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C (104°F) does not adversely affect the product.

Directions For Use Of Aviva Plastic Container

To Open

Tear overwrap down side at slit and remove solution container. Moisture and some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for Administration

Caution:Do not use plastic containers in series connections.

Caution:Use only with a non-vented set or a vented set with the vent closed.

1. Suspend container from eyelet support.
2. Remove protector from outlet port at bottom of container.
3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Additives may be incompatible.

To add medication before solution administration

1. Prepare medication site.
2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
3. Mix solution and medication thoroughly. For high density medication such aspotassiumchloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
4. Remove container from IV pole and/or turn to an upright position.
5. Evacuate both ports by squeezing them while container is in the upright position.
6. Mix solution and medication thoroughly.
7. Return container to in-use position and continue administration.

Baxter HealthcareCorporation Deerfield, IL 60015 USA 07-19-51-541. Baxter and AVIVA are trademarks of Baxter International Inc. For Product Information 1-800-933-0303

SIDE EFFECTS

Reactions which may occur because of the solution or the technique of administration includefebrileresponse, infection at the site of injection, venousthrombosisorphlebitisextending from the site of injection, extravasation, andhypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

DRUG INTERACTIONS

Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP.

警告

Sodium Chloride Injection, USP should be used with great care, if at all, in patients withcongestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

In patients with diminished renal function, administration of Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP may result in sodium retention.

PRECAUTIONS

General

Do not connect flexible plastic containers of intravenous solutions in series connections. Such use could result in airembolismdue toresidualair being drawn from one container before administration of the fluid from a secondary container is completed. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Laboratory Tests

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Studies with Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP have not been performed to evaluatecarcinogenicpotential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP should be given to a pregnant woman only if clearly needed.

Labor and Delivery

Studies have not been conducted to evaluate the effects of Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery.

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 Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of sodium chloride (sodium chloride (sodium chloride injection) injection) 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.

Geriatric Use

Clinical studies of Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in the responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or drug therapy.

这种药物是大幅排泄the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

OVERDOSE

No information provided.

CONTRAINDICATIONS

None known.

CLINICAL PHARMACOLOGY

Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducingdiuresisdepending on the clinical condition of the patient.

PATIENT INFORMATION

No information provided. Please refer to the警告andPRECAUTIONSsections.