Sodium chloride 30%wv concentrate for solution for. The product insert states that stoppers for both the 10ml and the 20ml vials do not contain natural rubber latex. Bacterial endotoxins 85 it contains not more than 0. Sodium, the major cation of the extracellular fluid, functions primarily in the control of water. Nsn 65050308924 sodium chloride injection, usp pricing and availability, cross reference parts, and webflis data.
Sodium chloride injection, usp solutions are sterile and nonpyrogenic. A sterile, concentrated solution of sodium chloride in water for injection. Each milliliter ml contains sodium chloride 9 mg and 0. Currently approved cber ndasandas by applicant as of 31. Sodium chloride injection fda prescribing information, side. Use in accord with any warnings or precautions appropriate to the medication being administered. Halite, rock salt, saline, salt, sea salt sodium chloride injection is a sterile solution of sodium chloride in water for injection.
In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Sodium chloride injections usp are sterile, nonpyrogenic, isotonic and contain no bacteriostatic or antimicrobial agents. Where sodium chloride must be subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled. Sodium chloride injection, usp 4 mmolml, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion.
The sodium chloride monograph will be incorporated into and become official with the second supplement to usp 39nf 34. Find patient medical information for sodium chloride 0. Click here for our full prescription policy and form please note that. The intravenous administration of sodium chloride injection, usp can cause fluid andor solute overloading. The sodium chloride monograph will be incorporated into and become official with the second supplement to usp 38nf 33. Chemicals and reagents used in this study were united states pharmacopeia uspnational formulary quality or american chemical society grade and were used as supplied. It is an inorganic chloride and an inorganic sodium salt. Freeflex bags 50ml aust r 144596 100ml aust r 144609 250ml aust r 144632. These products are intended for intravenous administration. Sodium chloride 30 % wv concentrate for solution for infusion should be diluted sufficiently to obtain an isotonic 0.
When administered intravenously, these solutions provide a source of water and electrolytes. Fresenius kabi usa is voluntarily recalling 163 lots of sodium chloride injection, usp, 0. Torrance, ca, asclemed usa inc is voluntarily recalling 20 lots of dyural40 and 61 lots of dyural80, to the user level. Medefil announces launch of 10% calcium chloride injection, usp 10 ml singledose prefilled syringe. An isotonic solution can be prepared by diluting 30 ml sodium chloride 30 % wv concentrate for solution for infusion to 1 litre with a nonelectrolyte solution or water for injections. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Anticoagulant sodium citrate solution approved date. Sodium chloride injection usp, single dose plastic vial, 0. Were eager to meet your needs and deliver solutions. Sodium chloride injection usp, single dose tear top vial, 0. May 23, 2018 therefore, it is not known whether 3% and 5% sodium chloride injection, usp can cause fetal harm when administered to a pregnant woman. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with sodium chloride injection, usp, 0.
These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. Withdraw 1 ml from a singledose vial of vyepti and inject into a 100 ml bag of 0. Bacteriostatic sodium chloride for injection usp is a sterile, multiple dose vial that repeated withdrawals may be made to dilute or dissolve drugs for medication. Sodium chloride 8 mg, sodium hydroxide andor hydrochloric acid may be added to adjust ph to 4. Bacteriostatic sodium chloride sodium chloride injection. Commercial grade usually contains some chlorides of calcium and magnesium which absorb moisture and cause caking. The new general chapters, will not be applicable until may 1, 2016.
See the tables below for a full list of the affected lots including lot numbers and expiration dates. Enovachem pharmaceuticals issues voluntary nationwide recall. Enovachem pharmaceuticals issues voluntary nationwide. Usp 40 annotated listxxxix performance tests cisplatin, 3444 dissolution identification impurities infrared absorption, test b and thinlayer ascorbic acid injection, 2866 chromatography, test c deleted identification assay test c impurities azathioprine sodium for injection, 2917 limit of trichloroammineplatinate and limit identification of. Sodium chloride injection, usp fresenius kabi canada. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte. Therefore, it is not known whether 3% and 5% sodium chloride injection, usp can cause fetal harm when administered to a pregnant woman. Sodium chloride appears as a white crystalline solid.
Sodium chloride injection fda prescribing information. The product is packaged as sodium chloride injection, usp 0. It is capable of inducing diuresis depending on the clinical condition of the patient. B braun medical sodium chloride injections s80045410. The products include recalled sodium chloride, usp, 0. Nsn 65050308924 sodium chloride injection,usp pricing and availability, cross reference parts, and webflis data. Maintenance electrolyte solutions usually contain sodium at a concentration of 33 to 40 meql, on the assumption the patient will receive two to three liters of fluid.
141 623 944 1160 940 1534 236 289 336 405 449 1420 140 377 156 489 1138 856 380 1476 559 282 1305 653 180 108 1247 424 723 540 72 1052 712 776 30 467 436 427 1488 7 1059 414 692 1272 238 743 420 440