Sodium Chloride (Page 2 of 2)

Geriatric Use

Geriatric patients are at increased risk of developing electrolyte imbalances. Sodium Chloride Injection, USP is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, 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. Consider monitoring renal function in elderly patients.

ADVERSE REACTIONS

Post-Marketing Adverse Reactions

The following adverse reactions have been identified during post approval use of Sodium Chloride Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported in the post-marketing experience during use of 0.9% Sodium Chloride Injection, USP and include the following:

General disorders and administration site conditions: Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria.

Hypersensitvity reactions: Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus.

Metabolism and nutrition disorders: Hypernatremia, hyponatremia, hyperchloremic metabolic acidosis.

Nervous System Disorders: Hyponatremic encephalopathy.

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

Excessive administration of 0.9% Sodium Chloride Injection, USP can cause hypernatremia. Hypernatremia can lead to CNS manifestations, including seizures, coma, cerebral edema and death.

Excessive administration of Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary and/or peripheral edema). See Warnings and Adverse Reactions.

When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment.

Interventions include discontinuation of Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

DOSAGE AND ADMINISTRATION

Important Administration Instructions

  • Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment.
  • Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
  • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
  • Use a dedicated line without any connections to avoid air embolism.
  • Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container.
  • Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged.

Dosing Information

The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.

Introduction of Additives

Additives may be incompatible.

Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available.

If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.

HOW SUPPLIED

The available sizes of 0.9% Sodium Chloride Injection, USP are shown below:

Size (mL) NDC
Fleboflex bags:
50 (115 units in one carton) 76297-001-11
100 (70 units in one carton) 76297-001-21
250 (28 units in one carton) 76297-001-31
500 (20 units in one carton) 76297-001-01
1000 (10 units in one carton) 76297-001-41
Fleboflex Luer bags:
50 (90 units in one carton) 76297-001-51
100 (50 units in one carton) 76297-001-61
250 (32 units in one carton) 76297-001-71
500 (24 units in one carton) 76297-001-81
1000 (10 units in one carton) 76297-001-91

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at 20° to 25°C (68° to 77°F); excursions are permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.]Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product.

DIRECTIONS FOR USE OF FLEBOFLEX AND FLEBOFLEX LUER PLASTIC CONTAINERS

For Information on Risk of Air Embolism – see Dosage and Administration.

To Open
Peel off the overwrap and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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
1. Suspend container from eyelet support.
2. Fleboflex bags: Remove plastic protector from outlet port at bottom of container.
Fleboflex Luer bags: Break the twist-off administration port by means of torsion.
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. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject.
3. Mix solution and medication thoroughly.

To add medication during solution administration
1. Close clamp on the set.
2. Prepare medication site.
3. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject.
4. Remove container from intravenous pole and/or turn to an upright position.
5. Mix solution and medication thoroughly.
6. Return container to in-use position and continue administration.

Laboratorios Grifols , S.A.
Murcia — SPAIN
Printed in SPAIN
Rev. 08/2020
GRIFOLS and FLEBOFLEX are trademarks of Grifols, S.A.
3054391
GRIFOLS
Laboratorios Grifols, S.A. Calle Marte nº4 – Polígono Industrial Los Llanos
30565 Las Torres de Cotillas- Murcia SPAIN

PACKAGE LABEL

NDC 76297-001-01

0.9% Sodium Chloride Injection, USP

500 mL

Fleboflex Container

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.] Avoid excessive heat.
Lot Exp
LABEL REFERENCE
20 x 500 mL

GRIFOLS
LABORATORIOS GRIFOLS, S.A. Murcia — SPAIN
Num.: IN HOUSE CONTROL NUMBER

Carton Label
(click image for full-size original)

NDC 76297-001-02

0.9% Sodium Chloride Injection, USP

500 mL

For intravenous use

Rx Only
Single dose container
Each 100 ml contains 900 mg Sodium Chloride USP; pH 4.5 to 7.0 Sodium 154 mEq/L Chloride 154 mEq/L; Osmolarity 308 mOsmol/L (calc)
Sterile Non pyrogenic. Dosage intravenously as directed by a physician. See directions. Cautions: Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found. Must not be used in series connections. Do not use unless solution is clear. Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique. Mix thoroughly. Do not store.
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.] Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Read package insert for full information.
Grifols and Fleboflex are trademarks of Grifols, S.A.
Laboratorios Grifols, S.A.
Murcia — SPAIN
DATA MATRIX
Fleboflex Container
(PVC-free and DEHP-free)
The container closure is not made with natural rubber latex.
GRIFOLS
LOT XXXXXX
EXP MM-YYYY
INTERNAL REFERENCE

Container Label
(click image for full-size original)

NDC 76297-001-81

0.9% Sodium Chloride Injection, USP

500 mL

Fleboflex Luer Container

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.] Avoid excessive heat.
Lot Exp 1001332
24 x 500 mL

GRIFOLS
LABORATORIOS GRIFOLS, S.A. — SPAIN
Num.: IN HOUSE CONTROL NUMBER

Carton Fleboflex Luer
(click image for full-size original)

LOT XXXXXX
EXP MM-YYYY
INTERNAL REFERENCE
NDC 76297-001-82

0.9% Sodium Chloride Injection, USP

500 mL

For intravenous use

Rx Only
Single dose container
Each 100 ml contains 900 mg Sodium Chloride USP; pH 4.5 to 7.0 Sodium 154 mEq/L Chloride 154 mEq/L; Osmolarity 308 mOsmol/L (calc)
Sterile Non pyrogenic. Dosage intravenously as directed by a physician. See directions. Cautions: Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found. Must not be used in series connections. Do not use unless solution is clear. Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique. Mix thoroughly. Do not store.
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.] Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat.
Read package insert for full information.
Grifols and Fleboflex are trademarks of Grifols, S.A.
Laboratorios Grifols, S.A. SPAIN
4000598
DATA MATRIX
Fleboflex Luer Container
(PVC-free and DEHP-free)
The container closure is not made with natural rubber latex.
GRIFOLS

Container Fleboflex Luer
(click image for full-size original)
SODIUM CHLORIDE sodium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76297-001
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Chloride (Chloride Ion and Sodium Cation) Sodium Chloride 9 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76297-001-11 115 BAG in 1 CARTON contains a BAG (76297-001-12)
1 NDC:76297-001-12 50 mL in 1 BAG This package is contained within the CARTON (76297-001-11)
2 NDC:76297-001-21 70 BAG in 1 CARTON contains a BAG (76297-001-22)
2 NDC:76297-001-22 100 mL in 1 BAG This package is contained within the CARTON (76297-001-21)
3 NDC:76297-001-31 28 BAG in 1 CARTON contains a BAG (76297-001-32)
3 NDC:76297-001-32 250 mL in 1 BAG This package is contained within the CARTON (76297-001-31)
4 NDC:76297-001-01 20 BAG in 1 CARTON contains a BAG (76297-001-02)
4 NDC:76297-001-02 500 mL in 1 BAG This package is contained within the CARTON (76297-001-01)
5 NDC:76297-001-41 10 BAG in 1 CARTON contains a BAG (76297-001-42)
5 NDC:76297-001-42 1000 mL in 1 BAG This package is contained within the CARTON (76297-001-41)
6 NDC:76297-001-51 90 BAG in 1 CARTON contains a BAG (76297-001-52)
6 NDC:76297-001-52 50 mL in 1 BAG This package is contained within the CARTON (76297-001-51)
7 NDC:76297-001-61 50 BAG in 1 CARTON contains a BAG (76297-001-62)
7 NDC:76297-001-62 100 mL in 1 BAG This package is contained within the CARTON (76297-001-61)
8 NDC:76297-001-71 32 BAG in 1 CARTON contains a BAG (76297-001-72)
8 NDC:76297-001-72 250 mL in 1 BAG This package is contained within the CARTON (76297-001-71)
9 NDC:76297-001-81 24 BAG in 1 CARTON contains a BAG (76297-001-82)
9 NDC:76297-001-82 500 mL in 1 BAG This package is contained within the CARTON (76297-001-81)
10 NDC:76297-001-91 10 BAG in 1 CARTON contains a BAG (76297-001-92)
10 NDC:76297-001-92 1000 mL in 1 BAG This package is contained within the CARTON (76297-001-91)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207956 05/25/2017
Labeler — LABORATORIOS GRIFOLS SA (461842294)
Registrant — LABORATORIOS GRIFOLS SA (461842294)
Establishment
Name Address ID/FEI Operations
LABORATORIOS GRIFOLS SA 461842294 analysis (76297-001)
Establishment
Name Address ID/FEI Operations
LABORATORIOS GRIFOLS SA 463720681 manufacture (76297-001), pack (76297-001), label (76297-001)
Establishment
Name Address ID/FEI Operations
LABORATORIOS GRIFOLS, S.A. 463719725 manufacture (76297-001), pack (76297-001), label (76297-001)

Revised: 10/2023 LABORATORIOS GRIFOLS SA

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