البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)
RX PHARMA-PACK, INC.
LIDOCAINE HYDROCHLORIDE ANHYDROUS
LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
PRESCRIPTION DRUG
Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Sodium Chloride Injection, USP, 0.9% preparations are indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing of intravenous catheters. Antiseptic Antiseptic skin preparation Antiseptic For preparation of the skin prior to injection.
Xylocaine® (lidocaine HCl Injection, USP) NDC 63323-484-57 Unit of 25 NDC 63323-485-27 Unit of 25 NDC 63323-485-57 Unit of 25 NDC 63323-486-17 Unit of 25 NDC 63323-486-27 Unit of 25 NDC 63323-486-57 Unit of 25 Xylocaine® -MPF (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000 Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Xylocaine® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 For single-dose vials and ampules: Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC. Fresenius Kabi Logo www.fresenius-kabi.com/us 4 5 1 1 7 5 F Revised: March 2019 Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: NDC 63323-186-04 2 mL fill, in a 3 mL Single-Dose Vial NDC 63323-186-01 10 mL Single-Dose vial NDC 63323-186-03 20 mL Single-Dose vial Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Fresenius Kabi Logo www.fresenius-kabi.com/us 45764E Revised: October 2018
New Drug Application
P-CARE X- LIDOCAINE HYDROCHLORIDE, SODIUM CHLORIDE, POVIDONE-IODINE, ISOPROPYL ALCOHOL RX PHARMA-PACK, INC. ---------- P-CARE X XYLOCAINE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION XYLOCAINE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTION XYLOCAINE - LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTION FRESENIUS KABI USA, LLC XYLOCAINE (LIDOCAINE HCL INJECTION, USP) XYLOCAINE (LIDOCAINE HCL AND EPINEPHRINE INJECTION, USP) For Infiltration and Nerve Block Rx only DESCRIPTION Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C H N • HCl) has the following structural formula: : XYLOCAINE STRUCTURAL FORMULA Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21. Epinephrine (C H NO ) has the following structural formula: EPINEPHRINE STRUCTURAL FORMULA ® ® 14 22 2O 9 13 3 Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Xylocaine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a s اقرأ الوثيقة كاملة