Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
Sodium Chloride
BAXTER HEALTHCARE (ASIA) PTE LTD
B05XA03
INFUSION, SOLUTION
Sodium Chloride 900mg per 100mL
INTRAVENOUS
General Sale List
Baxter Healthcare Philppines, Inc.
ACTIVE
2022-09-14
PHRMLXXX 0.9% RX SODIUM CHLORIDE INJECTION, USP IN VIAFLEX PLASTIC CONTAINER DESCRIPTION 0.9% 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. Composition, osmolarity, pH and ionic concentration are shown in Table 1, The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 ® Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. CLINICAL PHARMACOLOGY 0.9% 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. INDICATIONS AND USAGE 0.9% 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. CONTRAINDICATIONS None known. WARNINGS 0.9% Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention. Hypersensitivity reactions • Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus, have been reported with Sodium Chloride Injection, USP. • Stop the infusion immediately if signs or symptoms of hypersensitivity/infusion reactions develop. Appropriate therapeutic countermeasures must be ins Прочитать полный документ