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1.14.1.3 Draft Labeling Text | Sodium Chloride [Spectra Medical Devices, Inc.] | BioPortfolio

13:22 EST 27th January 2019 | BioPortfolio

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0.9% Sodium Chloride Injection, USP

Rx only

This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.

0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. The glass ampules made up of Type I glass are used as a primary container for the drug product.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.

Sodium chloride in water dissociates to provide sodium (Na ) and chloride (Cl ) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance.

The distribution and excretion of sodium (Na ) and chloride (Cl ) are largely under the control of the kidney which maintains a balance between intake and output.

The small volume of fluid and amount of sodium chloride provided by 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.

Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.

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

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.

Use aseptic technique for single or multiple entry and withdrawal from all containers.

When diluting or dissolving drugs, mix thoroughly and use promptly.

Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers, discard unused portion.

Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS .

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

0.9% Sodium Chloride Injection, USP is supplied in the following:

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured for: Spectra Medical Devices, Inc. 260-F Fordham Road Wilmington, MA 01887

By: Kwang Myung Pharm Co., Ltd

957, Wangam-dong

Jechon

Chungbuk 27159

Republic of Korea

XX#### Rev. # MM/YY

Size Container NDC
5 mL Glass ampules packaged in carton of 25 each 65282-1505-1
10 mL Glass ampules packaged in carton of 25 each 65282-1510-1

Rx only

25 Single-dose ampules

Each single-dose ampule contains 5 mL NDC 65282-1505-1

0.9% Sodium Chloride Injection, USP

Each mL contains sodium chloride, 9 mg in water for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. 0.308 mOsmol/mL (calc).

FOR USE AS A STERILE DILUENT

For additional information, see package insert.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature],

PRESERVATIVE-FREE

To open ampules, using gauze, place thumb and forefinger on color line, break at constriction.

Product Code: XXXX-Y

MANUFACTURED FOR: SPECTRA MEDICAL DEVICES, INC. WILMINGTON, MA. 01887 BY: K.M. PHARM. CO., LTD. Jecheon, Korea 27159

NDC 65282-1505-1

5mL Ampule

0.9% Sodium Chloride Injection, USP

0.308 mOsmol/mL (calc)

Rx only Single-dose

FOR USE AS A STERILE DILUENT

PRESERVATIVE-FREE

Each mL contains sodium chloride, 9 mg. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment.

The pH range is 4.5 to 7.0.

MANUFACTURED FOR:

Spectra Medical Devices, Inc.

Wilmington, MA 01887 By:

K.M. Pharm. co., Ltd.

Jecheon, Korea 27159

To open ampules, using gauze, place thumb and forefinger on color line, break at constriction.

Product Code: XXXX-Y

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

LOT No.: KXXXXXXX

EXP.: MM/YYYY

Rx only

25 Single-dose ampules

Each single-dose ampule contains 10 mL NDC 65282-1510-1

0.9% Sodium Chloride Injection, USP

Each mL contains sodium chloride, 9 mg in water for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. 0.308 mOsmol/mL (calc).

FOR USE AS A STERILE DILUENT

For additional information, see package insert.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

PRESERVATIVE-FREE

To open ampules, using gauze, place thumb and forefinger on color line, break at constriction.

Product Code: XXXX-Y

MANUFACTURED FOR: SPECTRA MEDICAL DEVICES, INC. WILMINGTON, MA. 01887

BY : K.M. PHARM. CO., LTD. Jecheon, Korea 27159

NDC 65282-1510-1

10 mL Ampule

0.9% Sodium Chloride Injection, USP

0.308 mOsmol/mL (calc)

Rx only Single-dose

FOR USE AS A STERILE DILUENT

PRESERVATIVE-FREE

Each mL contains sodium chloride, 9 mg.

The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment.

The pH range is 4.5 to 7.0.

MANUFACTURED FOR:

Spectra Medical Devices, Inc.

Wilmington, MA 01887 By:

K.M. Pharm. co., Ltd.

Jecheon, Korea 27159

To open ampules, using gauze, place thumb and forefinger on color line, break at constriction.

Product Code: XXXX-Y

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

LOT No.: KXXXXXXX

EXP.: MM/YYYY

Manufacturer

Spectra Medical Devices, Inc.

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