SODIUM CHLORIDE- sodium chloride injection, solution

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27-03-2017

Virkt innihaldsefni:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Fáanlegur frá:
B. Braun Medical Inc.
INN (Alþjóðlegt nafn):
SODIUM CHLORIDE
Samsetning:
SODIUM CHLORIDE 3 g in 100 mL
Stjórnsýsluleið:
INTRAVENOUS
Gerð lyfseðils:
PRESCRIPTION DRUG
Ábendingar:
These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration. 3% and 5% Sodium Chloride Injections USP are of particular value in severe salt depletion when rapid electrolyte restoration is of paramount importance. The low salt syndrome may occur in the presence of heart failure, renal impairment, during surgery, and postoperatively. In these conditions, chloride loss frequently exceeds sodium loss. These hypertonic sodium chloride solutions are also indicated for the following clinical conditions. -  Hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium-free fluids. -  Drastic dilution of extracellular body fluid following excessive water intake sometimes resulting from multiple enemas or perfusion of irrigating fluids into open venous sinuses during transurethral prostatic resections. -  Emergency treatment of severe salt depletion due to excess sweating, vomiting, diarrhea and other conditions. 3% and 5
Vörulýsing:
3% and 5% Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL® Containers packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.
Leyfisstaða:
New Drug Application
Leyfisnúmer:
0264-7805-10, 0264-7806-10

SODIUM CHLORIDE- sodium chloride injection, solution

B. Braun Medical Inc.

----------

3% and 5% Sodium Chloride

Injections USP, (Hypertonic)

These are concentrated sodium chloride solutions. Infuse slowly with constant observation of

patient to avoid pulmonary edema.

DESCRIPTION

Each 100 mL of 3% Sodium Chloride Injection USP contains:

Sodium Chloride USP 3 g; Water for Injection USP qs

pH: 5.8 (4.5–7.0) Calculated Osmolarity: 1030 mOsmol/liter

pH may be adjusted with Hydrochloric Acid NF

Concentration of Electrolytes (mEq/liter): Sodium 513 Chloride 513

Each 100 mL of 5% Sodium Chloride Injection USP contains:

Sodium Chloride USP 5 g; Water for Injection USP qs

pH: 5.8 (4.5–7.0) Calculated Osmolarity: 1710 mOsmol/liter

pH may be adjusted with Hydrochloric Acid NF

Concentration of Electrolytes (mEq/liter): Sodium 856 Chloride 856

3% and 5% Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or

antimicrobial agents.

The formula of the active ingredient is:

Ingredient

Molecular Formula Molecular Weight

Sodium Chloride USP

NaCl

58.44

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It

contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized

copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-

solution unit is a closed system and is not dependent upon entry of external air during administration.

The container is overwrapped to provide protection from the physical environment and to provide an

additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique.

The closure system has two ports; the one for the administration set has a tamper evident plastic

protector and the other is a medication addition site. Refer to the Directions for Use of the container.

CLINICAL PHARMACOLOGY

3% and 5% Sodium Chloride Injections USP provide electrolytes and are a source of water for

hydration. They are capable of inducing diuresis depending on the clinical condition of the patient.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water

distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with

chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the

acid-base balance of the body are reflected by changes in the chloride concentration.

INDICATIONS AND USAGE

These intravenous solutions are indicated for use in adults and pediatric patients as sources of

electrolytes and water for hydration.

3% and 5% Sodium Chloride Injections USP are of particular value in severe salt depletion when rapid

electrolyte restoration is of paramount importance. The low salt syndrome may occur in the presence of

heart failure, renal impairment, during surgery, and postoperatively. In these conditions, chloride loss

frequently exceeds sodium loss.

These hypertonic sodium chloride solutions are also indicated for the following clinical conditions.

Hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium-free

fluids.

Drastic dilution of extracellular body fluid following excessive water intake sometimes resulting

from multiple enemas or perfusion of irrigating fluids into open venous sinuses during transurethral

prostatic resections.

Emergency treatment of severe salt depletion due to excess sweating, vomiting, diarrhea and other

conditions.

CONTRAINDICATIONS

3% and 5% Sodium Chloride Injections USP are contraindicated in the presence of elevated, normal, or

only slightly decreased plasma electrolyte concentrations, or when additives of sodium and chloride

could be clinically detrimental.

WARNINGS

Caution: These are concentrated hypertonic sodium chloride solutions. Infuse very slowly with

constant observation of the patient to avoid pulmonary edema.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution

of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of

dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload

causing congested states with peripheral and pulmonary edema is directly proportional to the

electrolyte concentration.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive

heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with

edema. In patients with diminished renal function, administration of solutions containing sodium ions may

result in sodium retention.

PRECAUTIONS

General

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.

These solutions should be used with care in patients with hypervolemia, renal insufficiency, urinary

tract obstruction, or impending or frank cardiac decompensation.

Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting,

diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

Additional essential electrolytes, minerals and vitamins should be supplied as needed.

Sodium-containing solutions should be administered with caution to patients receiving corticosteroids

or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions

containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive

heart failure, particularly if they are postoperative or elderly.

Excessive infusion of hypertonic sodium chloride solutions may supply more sodium and chloride than

normally found in serum and can exceed normal tolerance, resulting in hypernatremia. Infusion of excess

chloride ions may cause a loss of bicarbonate, resulting in an acidifying effect.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives

that may be prescribed, the final infusate should be inspected for cloudiness or precipitation

immediately after mixing, prior to administration, and periodically during administration.

Do not use plastic containers in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action

before the container runs dry or air embolism may result. If administration is not controlled by a

pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the

container such as wringing or twisting. Such handling could result in breakage of the container.

These solutions are intended for intravenous administration using sterile equipment. It is recommended

that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with 3% and 5% Sodium Chloride Injections USP have not been performed to evaluate

carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with 3% and 5% Sodium Chloride Injections USP.

It is also not known whether 3% and 5% Sodium Chloride Injections USP can cause fetal harm when

administered to a pregnant woman or can affect reproduction capacity. 3% and 5% Sodium Chloride

Injections 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 3% and 5% Sodium Chloride Injections USP are administered to

a nursing woman.

Pediatric Use

Safety and effectiveness of sodium chloride injections 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.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response

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 other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions 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.

ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile

response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of

injection, extravasation and hypervolemia.

Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of

administration should be adjusted according to tolerance. Use of the largest peripheral vein and a well-

placed small bore needle is recommended. (See DOSAGE AND ADMINISTRATION.)

The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing

information for drug additives to be administered in this manner should be consulted.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution;

therefore, frequent monitoring of electrolyte levels is essential.

Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the

retention of water, resulting in an expanded extracellular fluid volume.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an

acidifying effect.

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.

OVERDOSAGE

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and

institute appropriate corrective treatment.

DOSAGE AND ADMINISTRATION

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the

patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are

essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte

balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a

small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully

avoid infiltration.

Maximum intravenous dosage should be 100 mL given over a period of one hour. Before additional

amounts are given, the serum electrolyte concentrations, including chloride and bicarbonate, should be

determined to evaluate the need for more sodium chloride.

Intravenous administration of these solutions should not exceed 100 mL/hour or 400 mL/24 hours.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for

each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic

techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit.

HOW SUPPLIED

3% and 5% Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL®

Containers packaged 24 per case.

NDC

REF

Size

3% Sodium Chloride Injection USP

0264-7805-10

L8051

500 mL

5% Sodium Chloride Injection USP

(Canada DIN 01928007)

0264-7806-10

L8061

500 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from

freezing. It is recommended that the product be stored at room temperature (25°C); however, brief

exposure up to 40°C does not adversely affect the product.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent

light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of

the red label. Rotate stock frequently.

Rx only

Revised: September 2016

EXCEL is a registered trademark of B. Braun Medical Inc.

Directions for Use of EXCEL® Container

Caution: Do not use plastic containers in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing

solution container firmly. If leaks are found, discard solution as sterility may be impaired. If

supplemental medication is desired, follow directions below before preparing for administration.

NOTE: Before use, perform the following checks:

Inspect each container. Read the label. Ensure solution is the one ordered and is within the

expiration date.

Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate

matter. Any container which is suspect should not be used.

Use only if solution is clear and container and seals are intact.

Preparation for Administration

1. Remove plastic protector from sterile set port at bottom of container.

2. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Some additives may be incompatible.

To Add Medication Before Solution Administration

1. Prepare medication site.

2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.

3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration

1. Close clamp on the set.

2. Prepare medication site.

3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable

medication port and inner diaphragm and inject.

4. Remove container from IV pole and/or turn to an upright position.

5. Evacuate both ports by tapping and 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.

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

1-800-227-2862

In Canada, distributed by:

B. Braun of Canada, Ltd.

Scarborough, Ontario M1H 2W4

Y36-002-928 LD-237-3

PRINCIPAL DISPLAY PANEL - 500 mL

3% Sodium Chloride

Injection USP

REF L8051

NDC 0264-7805-10

500 mL

EXCEL® CONTAINER

Hypertonic

Y94-003-261 LD-259-2

Each 100 mL contains: Sodium Chloride USP 3 g; Water for Injection USP qs

pH may be adjusted with HCI NF

pH: 5.8 (4.5-7.0); Calc. Osmolarity: 1030 mOsmol/liter

Electrolytes (mEq/liter): Na 513; CI 513

Sterile, nonpyrogenic. Single dose container.

CAUTION: This is a concentrated sodium chloride solution. Infuse slowly with

constant observation of patient to avoid pulmonary edema.

+

Do not use in series connection. For intravenous use only. Use only if solution is clear

and container and seals are intact.

WARNINGS: Some additives may be incompatible. Consult with pharmacist. When

introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from

freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by

squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

1-800-227-2862

Y94-003-260

LD-133-3

PRINCIPAL DISPLAY PANEL - 500 mL

5% Sodium Chloride

Injection USP

REF L8061

NDC 0264-7806-10

DIN 01928007

HK 22618

500 mL

EXCEL® CONTAINER

Hypertonic

Y94-003-269 LD-501-1

Each 100 mL contains: Sodium Chloride USP 5 g; Water for Injection USP qs

pH may be adjusted with HCI NF

pH: 5.8 (4.5-7.0) ; Calc. Osmolarity: 1710 mOsmol/liter

Electrolytes (mEq/liter): Na 856; CI 856

Sterile, nonpyrogenic. Single dose container.

CAUTION: This is a concentrated sodium chloride solution. Infuse slowly with

constant observation of patient to avoid pulmonary edema.

Do not use in series connection. For intravenous use only. Use only if solution is clear

and container and seals are intact.

WARNINGS: Some additives may be incompatible. Consult with pharmacist. When

introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from

freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by

squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

1-800-227-2862

In Canada, distributed by:

B. Braun of Canada, Ltd.

Scarborough, Ontario M1H 2W4

Y94-003-262

LD-132-3

+

SODIUM CHLORIDE

sodium chloride injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 26 4-78 0 5

Product T ype

Ite m Code (Source )

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE ION -

UNII:Q32ZN48 6 9 8 )

SODIUM

CHLORIDE

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 26 4-78 0 5-

24 in 1 CASE

0 3/19 /19 8 8

1

50 0 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 19 6 35

0 3/19 /19 8 8

SODIUM CHLORIDE

sodium chloride injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 26 4-78 0 6

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE ION -

UNII:Q32ZN48 6 9 8 )

SODIUM

CHLORIDE

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

B. Braun Medical Inc.

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 26 4-78 0 6 -

24 in 1 CASE

0 3/0 9 /19 8 8

1

50 0 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 19 6 35

0 3/0 9 /19 8 8

Labeler -

B. Braun Medical Inc. (002397347)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

B. Braun Medical Inc.

0 3742530 8

MANUFACTURE(0 26 4-78 0 5, 0 26 4-78 0 6 )

Revised: 3/2017

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