Product Elements:
Sodium chloride sodium chloride sodium chloride chloride ion sodium cation water hydrochloric acid sodium hydroxide sodium chloride sodium chloride sodium chloride chloride ion sodium cation water hydrochloric acid sodium hydroxide
Indications and Usage:
Indications and usage this parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Dosage and Administration:
Dosage and administration the volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. this parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Adverse Reactions:
Adverse reactions reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
Overdosage:
Overdosage use only as a diluent or solvent. this parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. in the event these should occur, re-evaluate the patient and institute appropriate corrective measures. see precautions and adverse reactions .
Description:
Description this preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% sodium chloride injection, usp is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. each ml contains sodium chloride 9 mg. it contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mosmol/ml (calc.). 0.9% sodium chloride injection, usp contains no preservatives. the solution may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. ph 5.3 (4.5 to 7.0). sodium chloride, usp is chemically designated nacl, a white crystalline compound freely soluble in water. the glass container is a type i borosilicate glass and meets the requirements of the powdered glass test according to the usp standards. the semi-rigid vial is fabricated from a specially formulated polyolefin. it is a copolymer of ethylene and propylene. the safety of the plastic has been confirmed by tests in animals according to usp biological standards for plastic containers. the container requires no vapor barrier to maintain the proper drug concentration.
Clinical Pharmacology:
Clinical pharmacology sodium chloride in water dissociates to provide sodium (na + ) and chloride (clâ¾) ions. these ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. the distribution and excretion of sodium (na + ) and chloride (clâ¾) are largely under the control of the kidney which maintains a balance between intake and output. the small volume of fluid and amount of sodium chloride provided by 0.9% sodium chloride injection, usp when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). wat
Read more...er balance is maintained by various regulatory mechanisms. water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (na + ) plays a major role in maintaining physiologic equilibrium.
How Supplied:
How supplied 0.9% sodium chloride injection, usp is supplied in the following: unit of sale concentration ndc 0409-1918-32 tub of 50 carpujectâ¢, single-dose cartridge with luer lock for the carpuject syringe system 0.9% (2 ml) ndc 0409-1918-33 tub of 25 carpujectâ¢, single-dose cartridge with luer lock for the carpuject syringe system 0.9% (3 ml) ndc 0409-1918-35 tub of 25 carpujectâ¢, single-dose cartridge with luer lock for the carpuject syringe system 0.9% (5 ml) ndc 0409-4888-90 tray of 10 single-dose plastic fliptop vials 0.9% (10 ml) ndc 0409-4888-10 tray of 25 single-dose plastic fliptop vials 0.9% (10 ml) ndc 0409-4888-20 tray of 25 single-dose plastic fliptop vials 0.9% (20 ml) ndc 0409-4888-50 tray of 25 single-dose plastic fliptop vials 0.9% (50 ml) ndc 0409-4888-12 tray of 25 single-dose lifeshield ® plastic fliptop vials 0.9% (10 ml) store at 20 to 25°c (68 to 77°f) [see usp controlled room temperature.] instructions for use of the syringe systems ins
Read more...tructions for using the carpuject syringe are available with the reusable carpuject holder, list 2049-02. lifeshield ® is the trademark of icu medical, inc. and is used under license. distributed by hospira, inc., lake forest, il 60045 usa lab-1097-3.0 revised: 08/2021 hospira logo
Package Label Principal Display Panel:
Principal display panel - 10 ml vial label 10 ml single-dose rx only 0.9% sodium chloride injection, usp for use as a sterile diluent. hospira lot ##-###-aa exp dmmmyyyy principal display panel - 10 ml vial label
Principal display panel - 10 ml vial tray 10 ml single-dose ndc 0409-4888-10 contains 25 of ndc 0409-4888-02 rx only 0.9% sodium chloride injection, usp for use as a sterile diluent hospira principal display panel - 10 ml vial tray
Principal display panel - 20 ml vial label 20 ml single-dose rx only preservative-free 0.9% sodium chloride injection, usp for use as a sterile diluent. hospira lot ##-###-aa exp dmmmyyyy principal display panel - 20 ml vial label
Principal display panel - 20 ml vial tray 20 ml single-dose ndc 0409-4888-20 contains 25 of ndc 0409-4888-03 rx only 0.9% sodium chloride injection, usp for use as a sterile diluent hospira principal display panel - 20 ml vial tray
Principal display panel - 50 ml vial label 50 ml single-dose rx only preservative-free 0.9% sodium chloride injection, usp for use as a sterile diluent. hospira lot ##-###-aa exp dmmmyyyy principal display panel - 50 ml vial label
Principal display panel - 50 ml vial tray 50 ml single-dose ndc 0409-4888-50 contains 25 of ndc 0409-4888-06 rx only 0.9% sodium chloride injection, usp for use as a sterile diluent hospira principal display panel - 50 ml vial tray
Principal display panel - 10 ml vial label - lifeshield 10 ml single-dose rx only preservative-free lifeshield ® vial 0.9% sodium chloride injection, usp for use as a sterile diluent. hospira principal display panel - 10 ml vial label - lifeshield
Principal display panel - 10 ml vial tray - lifeshield 10 ml single-dose lifeshield ® vial ndc 0409-4888-12 contains 25 of ndc 0409-4888-01 rx only 0.9% sodium chloride injection, usp for use as a sterile diluent hospira principal display panel - 10 ml vial tray - lifeshield
Principal display panel - 2 ml cartridge label 2 ml single-dose carpuject⢠sterile cartridge unit with luer lock preservative-free 0.9% sodium chloride injection, usp dist. by hospira, inc., lake forest, il 60045 usa rx only ndc 0409-1918-42 paa140972 hospira lot #####aa exp dmmmyyyy principal display panel - 2 ml cartridge label
Principal display panel - 2 ml cartridge container label 2 ml single-dose preservative-free 50 carpuject⢠sterile cartridge units with luer lock needle not included ndc 0409-1918-32 rx only 0.9% sodium chloride injection, usp carpuject cartridges are to be used only with carpuject holders. each carpuject sterile cartridge unit contains 2 ml of a sterile isotonic solution of sodium chloride injection, usp, 0.9%, and has a total osmolar concentration of 0.31 mosmol/ml. each ml contains 9 mg of sodium chloride. do not use if solution is discolored or contains a precipitate. sterile aqueous injection. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] do not freeze. paa116988 lot #####aa exp dmmmyyyy principal display panel - 2 ml cartridge container label
Principal display panel - 3 ml cartridge label 3 ml single-dose carpuject⢠sterile cartridge unit with luer lock preservative-free 0.9% sodium chloride injection, usp dist. by hospira, inc., lake forest, il 60045 usa ndc 0409-1918-43 rx only paa140974 hospira lot #####aa exp dmmmyyyy principal display panel - 3 ml cartridge label
Principal display panel - 3 ml cartridge container label 3 ml single-dose preservative-free ndc 0409-1918-33 rx only 25 carpuject⢠sterile cartridge units with luer lock needle not included 0.9% sodium chloride injection, usp carpuject cartridges are to be used only with carpuject holders. each carpuject sterile cartridge unit contains 3 ml of a sterile isotonic solution of sodium chloride injection, usp, 0.9%, and has a total osmolar concentration of 0.31 mosmol/ml. each ml contains 9 mg of sodium chloride. do not use if solution is discolored or contains a precipitate. sterile aqueous injection. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] do not freeze. paa116990 lot #####aa exp dmmmyyyy principal display panel - 3 ml cartridge container label
Principal display panel - 5 ml cartridge label 5 ml single-dose carpuject⢠sterile cartridge unit with luer lock preservative-free 0.9% sodium chloride injection, usp dist. by hospira, inc., lake forest, il 60045 usa ndc 0409-1918-45 rx only paa140975 hospira lot #####aa exp dmmmyyyy principal display panel - 5 ml cartridge label
Principal display panel - 5 ml cartridge container label 5 ml single-dose preservative-free 25 carpuject⢠sterile cartridge units with luer lock needle not included ndc 0409-1918-35 rx only 0.9% sodium chloride injection, usp carpuject cartridges are to be used only with carpuject holders. each carpuject sterile cartridge unit contains 5 ml of a sterile isotonic solution of sodium chloride injection, usp, 0.9%, and has a total osmolar concentration of 0.31 mosmol/ml. each ml contains 9 mg of sodium chloride. do not use if solution is discolored or contains a precipitate. sterile aqueous injection. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] do not freeze. paa116992 lot #####aa exp dmmmyyyy principal display panel - 5 ml cartridge container label