Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM CHLORIDE (SALT)
BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.
SODIUM CHLORIDE (SALT)
50ml mL; 100ml mL; 250ml mL; 500 ml mL; 1000 ml mL
BAXTER HEALTHCARE PTY LTD
Description 0.9% Sodium Chloride Injection 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 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 is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection is also indicated for use as a priming solution in hemodialysis procedures. Contraindications None known. Warnings 0.9% Sodium Chloride Injection 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. In patients with diminished renal function, administration of Sodium Chloride Injection may result in sodium retention. _Hypersensitivity reactions_ • Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus, have been reported with Sodium Chloride Injection. • Stop the infusion immediately if signs or symptoms of hypersensitivity/infusion reactions develop. Appropriate therapeutic countermeasu Đọc toàn bộ tài liệu