国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)
Medefil, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. Safety and effectiveness are based on similar clinical conditions in children and adults. An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. None known.
10% Cacliumn Chloride Injection, USP is supplied omn single-dose containers as follows: NDC 64253-900-91 10 mL Single-dose prefilled syringes, individually pouched, in a carton of 10s 1000 mg/10 mL (100 mg/mL) NDC 64253-900-30 10 mL fill in 12 mL Syringe Single-dose prefilled syringes, individually pouched NDC 64253-900-36 10 mL Single-dose prefilled syringes, individually pouched, in a carton of 60s 1000 mg/10 mL (100 mg/mL) NDC 64253-900-30 10 mL fill in 12 mL Syringe Single-dose prefilled syringes, individually pouched Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]. Do not freeze.
Abbreviated New Drug Application
CALCIUM CHLORIDE- CALCIUM CHLORIDE INJECTION INJECTION, SOLUTION MEDEFIL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE 10% CALCIUM CHLORIDE INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR 10% CALCIUM CHLORIDE INJECTION, USP. 10% CALCIUM CHLORIDE INJECTION, USP FOR INTRAVENOUS INJECTION INITIAL U.S. APPROVAL: 2019 INDICATIONS AND USAGE (3) 10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. (3) CONTRAINDICATIONS Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity. (4) Calcium chloride is not recommended in the treatment of asystole and electromechanical dissociation. (4) ADVERSE REACTIONS Rapid injection may cause the patient to complain of tingling sensations, a calcium taste, a sense of oppression or "heat wave". Injections of calcium chloride are accompanied by peripheral vasodilatation as well as a local "burning" sensation and there may be a moderate fall in blood pressure. Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once. Local infiltration of the affected area with 1% procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful. To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc., at 1-630-682-4600 or www.medefilinc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DOSAGE AND ADMINISTRATION 10% Calcium Chloride Injection, USP is administered only by slow intravenous injection (not to exceed 1 mL/min), preferably in a central or deep vein. (14) The usual precautions for intravenous therapy should be observed. If time permits, the solution should be warmed to body temperature. The injection should 阅读完整的文件