País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
HF Acquisition Co LLC, DBA HealthFirst
INTRAVENOUS
PRESCRIPTION DRUG
Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. None known. To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Add Medication 1. Prepare additive port. 2. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. 3. The additive port may be protected by covering with an additive cap. 4. Mix container contents thoroughly. Preparation for Administration (Use aseptic technique) 1. Close flow control clamp of admin
0.9% SODIUM CHLORIDE INJECTION, USP is supplied in the following dosage forms: NDC 51662-1522-1 0.9% SODIUM CHLORIDE INJECTION, USP, 500mL BAG HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table. * Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA † Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA ICU Medical is transitioning NDC codes from "0409" to "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: 1/2018 EN-4686
New Drug Application
SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION HF ACQUISITION CO LLC, DBA HEALTHFIRST ---------- 0.9% SODIUM CHLORIDE INJECTION, USP 500ML BAG SPL UNCLASSIFIED Flexible Plastic Container Rx only DESCRIPTION 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 when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water 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. INDICATIONS AND USAGE Intravenous solutions containing sodium chloride are indicated for parenteral repleni Leia o documento completo