Sodium Chloride is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Sodium Chloride is 65219-228. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - 450 mg/100mL . The currest status of Sodium Chloride drug is Active.

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Drug interactions caution must be exercised in the administration of 0.45% sodium chloride injection to patients receiving corticosteroids or corticotropin.

Indications and usage: intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

Warnings: 0.45% sodium chloride injection 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 exists edema with sodium retention. the intravenous administration of 0.45% sodium chloride injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. in patients with diminished renal function, administration of 0.45% sodium chloride injection may result in sodium retention.

General do not use plastic containers in series connections. such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the 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.

Dosage and administration: the dose is dependent upon the age, weight and clinical condition of the patient. additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see precautions ).

Contraindications: none known.

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. 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. in addition to the above listed adverse reactions hyponatremia has been reported for 0.45% sodium chloride injection (see pediatric use ).

Drug interactions caution must be exercised in the administration of 0.45% sodium chloride injection to patients receiving corticosteroids or corticotropin.

Pregnancy teratogenic effects pregnancy category c animal reproduction studies have not been conducted with 0.45% sodium chloride injection. it is also not known whether 0.45% sodium chloride injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.45% sodium chloride injection should be given to a pregnant woman only if clearly needed.

Pediatric use the use of 0.45% sodium chloride injection in pediatric patients is based on clinical practice. plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. the infusion of hypotonic fluids (0.45% sodium chloride injection) together with the non-osmotic secretion of adh may result in hyponatremia in patients with acute volume depletion. hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency.

Geriatric use clinical studies of 0.45% sodium chloride injection 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 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. this drug 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. 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. do not administer unless solution is clear and container is undamaged. discard unused portion.

Overdosage: in the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (see warnings , precautions , and adverse reactions ).

Description: 0.45% sodium chloride injection, usp solution is a sterile and nonpyrogenic solution intended for intravenous administration. each 100 ml of 0.45% sodium chloride injection, usp contains 450 mg sodium chloride in water for injection. electrolytes per 1,000 ml: sodium 77 meq; chloride 77 meq. the osmolarity is 154 mosmol/l (calc.). the ph in the 100 ml and smaller containers is 6.0; for the 250 ml and larger containers, the ph is 5.6. the ph range is 4.5 to 7.0 for all containers. the solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. when smaller doses are required the unused portion should be discarded. 0.45% sodium chloride injection, usp is a parenteral fluid and electrolyte replenisher. sodium chloride, usp is chemically designated nacl, a white crystalline powder freely soluble in water. water for injection, usp is chemically designated h 2 o. the flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). the free flex ® + bag has a needle-free injection port and can accept standard luer lock syringes to add medication. the amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. the suitability of the container material has been confirmed by tests in animals according to usp biological tests for plastic containers.

Clinical pharmacology: when administered intravenously, these solutions provide a source of water and electrolytes. solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements. isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. a hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome. sodium chloride in water dissociates to provide sodium (na + ) and chloride (cl − ) ions. sodium (na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. chloride (cl − ) has an integral role in buffering action w Read more...

Carcinogenesis, mutagenesis, impairment of fertility studies have not been performed with 0.45% sodium chloride injection to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility.

How supplied: 0.45% sodium chloride injection, usp is supplied in single-dose flexible plastic containers as follows: product code unit of sale strength each 242250 ndc 65219-226-50 package of 60 free flex ® + bags 0.225 grams per 50 ml (4.5 mg per ml) ndc 65219-226-01 50 ml in a 100 ml free flex ® + bag 242200 ndc 65219-228-10 package of 50 free flex ® + bags 0.45 grams per 100 ml (4.5 mg per ml) ndc 65219-228-01 100 ml free flex ® + bag 242325 65219-230-25 package of 30 1.125 grams per 250 ml (4.5 mg per ml) 65219-230-01 250 ml in a 250 ml free flex ® bag 242350 65219-232-50 package of 20 2.25 grams per 500 ml (4.5 mg per ml) 65219-232-01 500 ml in a 500 ml free flex ® bag

Package label - principal display – 0.45% sodium chloride 50 ml bag label ndc 65219-226-01 50 ml 0.45% sodium chloride injection, usp 0.225 grams per 50 ml (4.5 mg per ml) for intravenous use. rx only package label - principal display – 0.45% sodium chloride 50 ml bag label

Package label - principal display – 0.45% sodium chloride 50 ml case label ndc 65219-226-50 242250 0.45% sodium chloride injection, usp 50 ml x 60 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from freezing. package label - principal display – 0.45% sodium chloride 50 ml case label

Package label - principal display – 0.45% sodium chloride 100 ml bag label ndc 65219-228-01 100 ml 0.45% sodium chloride injection, usp 0.45 grams per 100 ml (4.5 mg per ml) for intravenous use. rx only package label - principal display – 0.45% sodium chloride 100 ml bag label

Package label - principal display – 0.45% sodium chloride 100 ml case label ndc 65219-228-10 242200 0.45% sodium chloride injection, usp 100 ml x 50 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from freezing. package label - principal display – 0.45% sodium chloride 100 ml case label

Package label - principal display – 0.45% sodium chloride 250 ml bag label ndc 65219-230-01 250 ml 0.45% sodium chloride injection, usp 1.125 grams per 250 ml (4.5 mg per ml) for intravenous use. rx only package label - principal display – 0.45% sodium chloride 250 ml bag label

Package label - principal display – 0.45% sodium chloride 250 ml case label ndc 65219-230-25 242325 0.45% sodium chloride injection, usp 250 ml x 30 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from freezing. package label - principal display – 0.45% sodium chloride 250 ml case label

Package label - principal display – 0.45% sodium chloride 500 ml bag label ndc 65219-232-01 500 ml 0.45% sodium chloride injection, usp 2.25 grams per 500 ml (4.5 mg per ml) for intravenous use. rx only package label - principal display – 0.45% sodium chloride 500 ml bag label

Package label - principal display – 0.45% sodium chloride 500 ml case label ndc 65219-232-50 242350 0.45% sodium chloride injection, usp 500 ml x 20 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from freezing. package label - principal display – 0.45% sodium chloride 500 ml case label