Sodium Chloride is a human prescription drug labeled by 'B. Braun Medical Inc.'. National Drug Code (NDC) number for Sodium Chloride is 0264-2201. This drug is available in dosage form of Irrigant. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - .9 g/100mL . The currest status of Sodium Chloride drug is Active.

Sodium chloride sodium chloride sodium chloride sodium cation chloride ion water hydrochloric acid

Drug interactions some additives may be incompatible. consult with pharmacist. when introducing additives, use aseptic technique. mix thoroughly. do not store.

Indications and usage 0.9% sodium chloride irrigation usp is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Warnings for irrigation only. not for injection. irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. absorption of large amounts 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 concentrations of the administered parenteral solutions. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. do not warm above 150°f (66°c). after opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. discard unused portion of irrigating solution since it contains no preservatives.

General use aseptic technique when preparing and administering sterile irrigation solutions. use only if solution is clear and container and seal are intact. do not use for irrigation that may result in absorption of large amounts of fluid into the blood. caution should be observed when the solution is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of circulatory overload. when used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. for repeated irrigations of urethral catheters, a separate container should be used for each patient.

Dosage and administration as required for irrigation. when used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed. some additives may be incompatible. consult with pharmacist. when introducing additives, use aseptic techniques. mix thoroughly. do not store. solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

Contraindications 0.9% sodium chloride irrigation usp is not for injection by usual parenteral routes. an electrolyte solution should not be used for irrigation during electrosurgical procedures.

Adverse reactions possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. accidental contamination from careless technique may transmit infection. if an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Drug interactions some additives may be incompatible. consult with pharmacist. when introducing additives, use aseptic technique. mix thoroughly. do not store.

Pregnancy teratogenic effects - pregnancy category c animal reproduction studies have not been conducted with 0.9% sodium chloride irrigation usp. it is also not known whether 0.9% sodium chloride irrigation usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% sodium chloride irrigation usp should be given to a pregnant woman only if clearly needed.

Pediatric use the safety and effectiveness of 0.9% sodium chloride irrigation usp in pediatric patients have not been established. its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Geriatric use clinical studies of 0.9% sodium chloride irrigation usp did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. 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 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. frequent laboratory determinations and clinical evaluations are recommended to monitor changes in blood glucose, electrolyte concentrations, and renal function.

Overdosage in the event of overhydration or solute overload, reevaluate the patient's condition, and institute appropriate corrective treatment. intravasular volume overload may respond to hemodialysis. see warnings , precautions , and adverse reactions .

Description each 100 ml contains: sodium chloride usp 0.9 g; water for injection usp qs ph adjusted with hydrochloric acid nf ph: 5.0 (4.5–7.0) calculated osmolarity: 310 mosmol/liter concentration of electrolytes (meq/liter): sodium 154; chloride 154 0.9% sodium chloride irrigation usp is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. the formula of the active ingredient is: ingredient molecular formula molecular weight sodium chloride usp nacl 58.44 the plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. the copolymer contains no plasticizers and exhibits virtually no leachability. the plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. the safety of the plastic container has been confirmed by biological evaluation procedures. the material passes class vl testing as specified in the u.s. pharmacopeia for biological tests — plastic containers. these tests have shown that the container is nontoxic and biologically inert. the pic™ container is pvc-free and dehp-free.

Clinical pharmacology 0.9% sodium chloride irrigation usp is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. it also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations. 0.9% sodium chloride irrigation usp provides an isotonic saline irrigation identical in composition with 0.9% sodium chloride injection usp (normal saline). physiological irrigation solutions are considered generally compatible with living tissues and organs. 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 extracellu Read more...

Carcinogenesis, mutagenesis, impairment of fertility studies with 0.9% sodium chloride irrigation usp have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

How supplied 0.9% sodium chloride irrigation usp is supplied sterile and nonpyrogenic in pic™ (plastic irrigation container). the 1000 ml and 500 ml containers are packaged 16 per case, the 2000 ml containers are packaged 8 per case, and the 4000 ml containers are packaged 4 per case. ndc cat. no. size 0.9% sodium chloride irrigation usp 0264-2201-00 r5200-01 1000 ml 0264-2201-10 r5201-01 500 ml 0264-2201-50 r5205-01 2000 ml 0264-2201-70 r5207 4000 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. do not warm above 150°f (66°c).

Directions for use of pic™ (plastic irrigation container) not for injection. aseptic technique is required. caution – before use, perform the following checks: (a) read the label. ensure solution is the one ordered and is within the expiration date. (b) invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the container for leakage or damage. any container which is suspect should not be used. use only if solution is clear and container and seal are intact single unit container. discard unused portion. outer closure removal – grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off. connect the administration set through the sterile set port according to set instructions or remove screw cap and pour. do Read more...

Principal display panel - 1000 ml container 0.9% sodium chloride irrigation usp isotonic solution for irrigation ref r5200-01 ndc 0264-2201-00 1000 ml pic™ container lot exp. y37-002-348 each 100 ml contains: sodium chloride usp 0.9 g water for injection usp qs ph adjusted with hydrochloric acid nf ph: 5.0 (4.5-7.0) calc. osmolarity: 310 mosmol/liter electrolytes (meq/liter): sodium 154 chloride 154 sterile, nonpyrogenic. single unit container. discard unused portion. not for injection. use only if solution is clear and container and seal are intact. warning: do not warm above 150°f (66°c). recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free b. braun medical inc. irvine, ca 92614-5895 usa made in usa pic is a trademark of b. braun medical inc. 1000 ml container label r5200-01

Principal display panel - 500 ml container 0.9% sodium chloride irrigation usp isotonic solution for irrigation ref r5201-01 ndc 0264-2201-10 500 ml pic™ container lot exp. y37-002-347 each 100 ml contains: sodium chloride usp 0.9 g water for injection usp qs ph adjusted with hydrochloric acid nf ph: 5.0 (4.5-7.0) calc. osmolarity: 310 mosmol/liter electrolytes (meq/liter): sodium 154 chloride 154 sterile, nonpyrogenic. single unit container. discard unused portion. not for injection. use only if solution is clear and container and seal are intact. warning: do not warm above 150°f (66°c). recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free b. braun medical inc. irvine, ca 92614-5895 usa made in usa pic is a trademark of b. braun medical inc. 500 ml container label r5201-01

Principal display panel - 2000 ml container 0.9% sodium chloride irrigation usp isotonic solution for irrigation ref r5205-01 ndc 0264-2201-50 2000 ml pic™ container lot exp. y37-002-349 each 100 ml contains: sodium chloride usp 0.9 g water for injection usp qs ph adjusted with hydrochloric acid nf ph: 5.0 (4.5-7.0) calc. osmolarity: 310 mosmol/liter electrolytes (meq/liter): sodium 154 chloride 154 sterile, nonpyrogenic. single unit container. discard unused portion. not for injection. use only if solution is clear and container and seal are intact. warning: do not warm above 150°f (66°c). recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free b. braun medical inc. irvine, ca 92614-5895 usa made in usa pic is a trademark of b. braun medical inc. 2000 ml container label r5205-01

Principal display panel - 4000 ml container 0.9% sodium chloride irrigation usp isotonic solution for irrigation ref r5207 ndc 0264-2201-70 4000 ml pic™ container lot exp. y37-002-350 each 100 ml contains: sodium chloride usp 0.9 g water for injection usp qs ph adjusted with hydrochloric acid nf ph: 5.0 (4.5-7.0) calc. osmolarity: 310 mosmol/liter electrolytes (meq/liter): sodium 154 chloride 154 sterile, nonpyrogenic. single unit container. discard unused portion. not for injection. use only if solution is clear and container and seal are intact. warning: do not warm above 150°f (66°c). recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free b. braun medical inc. irvine, ca 92614-5895 usa made in usa pic is a trademark of b. braun medical inc. 4000 ml container label r5207