Product Elements:
Sodium chloride sodium chloride sodium chloride sodium cation chloride ion water
Drug Interactions:
Drug interactions other products that affect fluid and/or electrolyte balance administration of sodium chloride injection, usp to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. avoid use of sodium chloride injection, usp in patients receiving such products, such as corticosteroids or corticotropin. if use cannot be avoided, monitor serum electrolytes, fluid balance and acid base balance. lithium renal sodium and lithium clearance may be decreased during administration of sodium chloride injection, usp. monitor serum lithium concentration during concomitant use. renal sodium and lithium clearance may be increased during administration of 0.9% sodium chloride injection, usp. monitor serum lithium concentrations during concomitant use. other drugs that increase the risk of hyponatremia administration of sodium chloride injection, usp in patients treated concomitantly with medications associat
Read more...ed with hyponatremia may increase the risk of developing hyponatremia. avoid use of sodium chloride injection, usp in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. if use cannot be avoided, monitor serum sodium concentrations.
Indications and Usage:
Indications and usage sodium chloride injection, usp is indicated as a source of water and electrolytes. 0.9% sodium chloride injection, usp is also indicated for use as a priming solution in hemodialysis procedures.
Warnings:
Warnings hypersensitivity hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% sodium chloride injection, usp. stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. appropriate therapeutic countermeasures must be instituted as clinically indicated. electrolyte imbalances fluid overload depending on the volume and rate of infusion, and the patients underlying clinical condition, the intravenous administration of sodium chloride injection, usp can cause fluid disturbances such as overhydration/hypervolemia and congested states, including pulmonary congestion and edema. avoid 0.9% sodium chloride injection, usp in patients with or at risk for fluid and/or solute overloading. if use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially durin
Read more...g prolonged use. hyponatremia sodium chloride injection, usp may cause hyponatremia. hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. the risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including siadh) treated with high volume of sodium chloride injection, usp. the risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). see drug interactions. patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. avoid sodium chloride injection, usp in patients with or at risk for hyponatremia. if use cannot be avoided, monitor serum sodium concentrations. rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ods). to avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. hypernatremia hypernatremia may occur with sodium chloride injection, usp. conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see drug interactions . avoid sodium chloride injection, usp in patients with, or at risk for, hypernatremia. if use cannot be avoided, monitor serum sodium concentrations. rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ods) with risk of seizures and cerebral edema.
General Precautions:
Patients with severe renal impairment administration of sodium chloride injection, usp in patients with or at risk of severe renal impairment, may result in hypernatremia and/or fluid overload (see warnings ). avoid sodium chloride injection, usp in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. if use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.
Dosage and Administration:
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 dur
Read more...ation of administration is dependent upon the age, weight and clinical condition of the patent 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 discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. do not store solutions containing additives. discard any unused portion.
Contraindications:
Contraindications none known.
Adverse Reactions:
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 condition s: infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria hypersensitivity 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, evalua
Read more...te the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Drug Interactions:
Drug interactions other products that affect fluid and/or electrolyte balance administration of sodium chloride injection, usp to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. avoid use of sodium chloride injection, usp in patients receiving such products, such as corticosteroids or corticotropin. if use cannot be avoided, monitor serum electrolytes, fluid balance and acid base balance. lithium renal sodium and lithium clearance may be decreased during administration of sodium chloride injection, usp. monitor serum lithium concentration during concomitant use. renal sodium and lithium clearance may be increased during administration of 0.9% sodium chloride injection, usp. monitor serum lithium concentrations during concomitant use. other drugs that increase the risk of hyponatremia administration of sodium chloride injection, usp in patients treated concomitantly with medications associat
Read more...ed with hyponatremia may increase the risk of developing hyponatremia. avoid use of sodium chloride injection, usp in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. if use cannot be avoided, monitor serum sodium concentrations.
Use in Pregnancy:
Pregnancy there are no adequate and well controlled studies with sodium chloride injection, usp in pregnant women and animal reproduction studies have not been conducted with this drug. therefore, it is not known whether sodium chloride injection, usp can cause fetal harm when administered to a pregnant woman. sodium chloride injection, usp should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric Use:
Pediatric use the use of sodium chloride injection, usp in pediatric patients is based on clinical practice. (see dosage and administration ). closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. in very low birth weight infants, excessive or rapid administration of sodium chloride injection, usp may result in increased serum osmolality and risk of intracerebral hemorrhage. children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.
Geriatric Use:
Geriatric use geriatric patents 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.
Overdosage:
Overdosage excessive administration of: 0.9% sodium chloride injection, usp may lead to hypernatremia. hypernatremia can lead to cns manifestations, including seizures, coma, cerebral edema and death. 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).
Description:
Description sodium chloride injection, usp is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. it contains no antimicrobial agents. the nominal ph is 5.0 (4.5 to 7.0). composition, osmolarity, and ionic concentration are shown below: 0.9% sodium chloride injection, usp contains 9 g/l sodium chloride, usp (nacl) with an osmolarity of 308 mosmol/l (calc). it contains 154 meq/l sodium and 154 meq/l chloride. viaflo is a flexible plastic container fabricated from a multilayer sheeting (pl-2442) composed of polypropylene (pp), polyamide (pa) and polyethylene (pe). the amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. two different administration connectors are available with viaflo containers. the viaflo dripless access container (dac) will not drip once the spike is removed. the non-dac viaflo will drip once the spike is removed from the administration port. viaflo is not made with natural rubber latex, dehp, or pvc.
Clinical Pharmacology:
Clinical pharmacology sodium chloride injection, usp has value as a source of water and electrolytes. it is capable of inducing diuresis depending on the clinical condition of the patient.
How Supplied:
How supplied the available sizes of each 0.9% sodium chloride injection, usp in viaflo dripless access containers (dac) and non-dac plastic containers are shown below. viaflo dac will not drip once the spike is removed. viaflo non-dac will drip once the spike is removed from the administration port: code size (ml) product ndc ue1322 250 non-dac 0338-9543-01 ue1322d 250 dac 0338-9543-02 ue1323 500 non-dac 0338-9543-03 ue1323d 500 dac 0338-9543-04 ue1324 1000 non-dac 0338-9543-05 ue1324d 1000 dac 0338-9543-06 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.
Package Label Principal Display Panel:
Package/label principal display panel container label baxter logo ndc 0338-9543-01 ue1322 viaflo logo 250 ml 0.9% sodium chloride injection usp ph 5.0 (4.5 7.0) osmolarity 308 mosm/l (calc) sterile non pyrogenic single dose container each 100 ml contains 900 mg sodium chloride usp meq/l sodium 154 chloride 154 additives may be incompatible consult with pharmacist if available when introducing additives use aseptic technique mix thoroughly do not store dosage intravenously as directed by a physician see directions cautions squeeze and inspect inner bags which maintains product sterility discard if leaks are found must not be used in series connections do not use unless solution is clear rx only store unit in moisture barrier overwrap at room temperature (25°c/77°f) until ready to use avoid excessive heat see insert viaflo is not made with natural rubber latex, dehp, or pvc baxter viaflo and pl-2442 are trademarks of baxter international inc for product information 1-800-933-0303 baxter healthcare corporation deerfield il 60015 usa made in spain bar code (01) 00303389543015 lot expiry un-35-03-047 50 100 150 200 carton label ue1324 10 x 1000 ml (? 11.5 kg) 0.9% sodium chloride injection, usp formula per 1000 ml sodium chloride 9 g water for injection osmolarity 308 mosm/l (calc) mmol per 1000 ml (approx.) sodium 154 chloride 154 ph 5.0 (4.5 7.0) iv administration. read package insert before use. keep out of the reach and sight of children. do not connect partially used drugs. baxter healthcare corporation deerfield il 60015 usa made in spain viaflo logo lot: xxxxx part # p222e644 barcode ue1322 10 x 1000 ml (? 11.5 kg) 0.9% sodium chloride injection, usp viaflo logo lot: xxxxx exp: xxxxx representative container label ndc 0338-9543-01 sodium chloride representative carton label