国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (Lidocaine - UNII:98PI200987)
Centurion Medical Products
AQUEOUS SOLUTIONS FOR INFILTRATION AND NERVE BLOCK Ampul Plastic Multiple-dose Fliptop Vial Glass Teartop Vial Rx only DESCRIPTION Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows: Concentration 0.5% 1% 1.5% 2% mg/mL lidocaine HCl (anhyd.) 5 10 15 20 mg/mL sodium chloride 8 7 6.5 6 Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82.
Exempt device
CARDIOVASCULAR PROCEDURE KIT- CENTURION MEDICAL PRODUCTS ---------- CARDIOVASCULAR PROCEDURE KIT DRUG DESCRIPTION AQUEOUS SOLUTIONS FOR INFILTRATION AND NERVE BLOCK AMPUL PLASTIC MULTIPLE-DOSE FLIPTOP VIAL GLASS TEARTOP VIAL Rx only DESCRIPTION Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows: Concentration 0.5% 1% 1.5% 2% mg/mL lidocaine HCl (anhyd.) 5 10 15 20 mg/mL sodium chloride 8 7 6.5 6 Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)- acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. CARDIOVASCULAR PROCEDURE KIT - PRIMARY LABEL MM1 CARDIOVASCULAR PROCEDURE KIT cardiovascular procedure kit kit PRODUCT INFORMATION PRODUCT T YPE MEDICAL DEVICE ITE M CODE (SOURCE ) NHRIC:248 40 -110 4 PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NHRIC:248 40 -110 4-2 10 in 1 CASE 1 NHRIC:248 40 -110 4-1 1 in 1 PACKAGE, COMBINATION QUANTITY OF PARTS PART # PACKAGE QUANTITY TOTAL PRODUCT QUANTITY PA RT 1 1 AMPULE 10 mL PART 1 OF 1 LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride anhydrous injection, solution PRODUCT INFORMATION ITE M CODE (SOURCE ) NDC:0 40 9 -428 2 ROUTE OF ADMINISTRATION INFILTRATION ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH LIDO CAINE HYDRO CHLO RIDE ANHYDRO US (UNII: EC2CNF7XFP) (Lido caine - UNII:9 8 PI20 0 9 8 7) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) 6 mg in 1 mL WA TER (UNII: 0 59 QF0 KO0 R) SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I) HYDRO CHLO RIC ACID 完全なドキュメントを読む