국가: 싱가포르
언어: 영어
출처: HSA (Health Sciences Authority)
Calcium Chloride Dihydrate; Potassium Chloride; Sodium Chloride; Sodium Lactate Solution
BAXTER HEALTHCARE (ASIA) PTE LTD
B05BB01
INFUSION, SOLUTION
Calcium Chloride Dihydrate 20mg per 100mL; Potassium Chloride 30mg per 100mL; Sodium Chloride 600mg per 100mL; Sodium Lactate Solution 310mg per 100mL
INTRAVENOUS
General Sale List
Baxter Healthcare Philippines, Inc
ACTIVE
2022-09-14
PHRML00107 Lactated Ringer's Solution Lactated Ringer's Injection, USP in Viaflex ® Plastic Container 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 Lactated Ringer’s 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. Lactated Ringer’s Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations. INDICATIONS AND USAGE Lactated Ringer’s Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing agent. CONTRAINDICATIONS Lactated Ringer’s Injection, USP is contraindicated in: • Newborns ( ≤ 28 days of age) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream. • Patients older than 28 days, including adults, administered ceftriaxone simultaneously through the same infusion line (e.g., via a Y-connector). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid. • Patients with known hypersensitivity to sodium lactate (see WARNINGS). WARNINGS Potassium Content The potassium concentration in Lactated Ringer’s Injection, USP is similar to 전체 문서 읽기