Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)
Zydus Lifesciences Limited
INTRAMUSCULAR
PRESCRIPTION DRUG
Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. It is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see WARNINGS ). The risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. The risk is dependent on the extent and location of the injury. The precise time of onset and the duration of the risk period are not known.
Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentrations and packages: Multiple-dose vials of 10 mL, box of 25 vials (NDC 70771-1352-7). Refrigeration of the undiluted agent will assure full potency until expiration date. All units carry a date of expiration. Store in refrigerator 2° to 8°C (36° to 46°F). The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency. Manufactured by: Cadila Healthcare Limited Ahmedabad, India Revised: 08/18
Abbreviated New Drug Application
SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION ZYDUS LIFESCIENCES LIMITED ---------- SUCCINYLCHOLINE CHLORIDE INJECTION, USP SPL UNCLASSIFIED PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Vial Label NDC 70771-1352-1 Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL) For Intravenous or Intramuscular use. 10 mL Multiple-dose Vial Rx only Zydus Pharmaceuticals PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton Label NDC 70771-1352-7 Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL) For Intravenous or Intramuscular use. Store in refrigerator 2º to 8ºC (36º to 46ºF). 25 (25 x 1) 10 mL Multiple-dose Vial Rx only Zydus Pharmaceuticals SUCCINYLCHOLINE CHLORIDE succinylcholine chloride injection, solution PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1352 ROUTE OF ADMINISTRATION INTRAMUSCULAR, INTRAVENOUS ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF) SUCCINYLCHOLINE CHLORIDE 20 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH HYDROCHLORIC ACID (UNII: QTT17582CB) METHYLPARABEN (UNII: A2I8C7HI9T) 1.8 mg in 1 mL Zydus Lifesciences Limited PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.2 mg in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1352-7 25 in 1 TRAY 05/10/2018 1 NDC:70771- 1352-1 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA209467 05/10/2018 LABELER - Zydus Lifesciences Limited (918596198) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1352) , MANUFACTURE(70771-1352) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1352) , ANALYSIS(70771-1352) Revis Прочетете целия документ