Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)
Smiths Medical ASD, Inc.
EPINEPHRINE
EPINEPHRINE 1 mg in 1 mL
Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal conge
Lidocaine Hydrochloride and Epinephrine Injection, USP is supplied in single-dose and multiple-dose containers as shown below: NDC No. Container Size Drug Concentration Lidocaine HCl Epinephrine Single-dose 0409-3181-01 Fliptop Vial 30 mL 1.5% 1:200,000 0409-3183-01 Fliptop Vial 20 mL 2% 1:200,000 Epidural Test Dose (single-dose) 0409-1209-01 Ampul 5 mL 1.5% 1:200,000 0409-1209-05 Ampul 5 mL 1.5% 1:200,000 0409-1209-65 Ampul 5 mL 1.5% 1:200,000 Multiple-dose 0409-3177-01 Fliptop Vial 50 mL 0.5% 1:200,000 0409-3178-01 Fliptop Vial 20 mL 1% 1:100,000 0409-3178-02 Fliptop Vial 30 mL 1% 1:100,000 0409-3178-03 Fliptop Vial 50 mL 1% 1:100,000 0409-3182-01 Fliptop Vial 20 mL 2% 1:100,000 0409-3182-02 Fliptop Vial 30 mL 2% 1:100,000 0409-3182-03 Fliptop Vial 50 mL 2% 1:100,000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Revised: 9/2015 EN-4048 Hospira, Inc., Lake Forest, IL 60045 USA Unit of Sale Total Strength/ Total Volume (Concentration) Each NDC 0409-7241-61 Case of 800 1 mg/mL NDC 0409-7241-60 1 mL single dose Ampule Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Revised: 11/2015 EN-4114 Hospira, Inc., Lake Forest, IL 60045 USA Lidocaine Hydrochloride Injection, USP is supplied as follows: Unit of Sale Concentration Each Single-dose NDC 0409-4278-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4278-16 Glass Teartop Vial NDC 0409-4713-02 Carton of 25 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-12 Glass Ampul NDC 0409-4713-32 Carton of 50 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-42 Glass Ampul NDC 0409-4713-62 Case of 800 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-72 Glass Ampul NDC 0409-4713-65 Case of 800 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-75 Glass Ampul NDC 0409-4279-02 Carton of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4279-16 Glass Teartop Vial NDC 0409-4270-01 Case of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4270-11 Sterile Glass Teartop Vial NDC 0409-4776-01 Carton of 25 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4776-10 Glass Ampul NDC 0409-4056-01 Carton of 5 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4056-11 Sterile Glass Ampul NDC 0409-4282-01 Bundle of 25 2% 40 mg/2 mL (20mg/mL) NDC 0409-4282-11 Glass Ampul NDC 0409-4282-02 Carton of 25 2% 200 mg/10 mL (20 mg/mL) NDC 0409-4282-12 Glass Ampul Unit of Sale Concentration Each Multiple-dose: NDC 0409-4275-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4275-16 Plastic Fliptop Vial NDC 0409-4276-01 Tray of 25 1% 200 mg/20 mL (10 mg/mL) NDC 0409-4276-16 Plastic Fliptop Vial NDC 0409-4276-02 Tray of 25 1% 500 mg/50 mL (10 mg/mL) NDC 0409-4276-17 Plastic Fliptop Vial NDC 0409-4277-01 Tray of 25 2% 400 mg/20 mL (20 mg/mL) NDC 0409-4277-16 Plastic Fliptop bottle NDC 0409-4277-02 Tray of 25 2% 1000 mg/50 mL (20 mg/mL) NDC 0409-4277-17 Plastic Fliptop Vial Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: 1/2015 EN-3679 Hospira, Inc., Lake Forest, IL 60045 USA 5 mL ampuls packaged in box of 25 each (NDC-65282-1505-1) 10 mL ampuls packaged in box of 25 each (NDC-65282-1510-1)
Premarket Notification
8024-20 CONTINUOUS EPIDURAL 17G TUOHY- ANESTHESIA CONDUCTION KIT SMITHS MEDICAL ASD, INC. ---------- For Infiltration and Nerve Block. Ampul Fliptop Vial Multiple-dose Fliptop Vial Protect from light. Rx only Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows: Concentration Lidocaine HCl Epinephrine Lidocaine HCl (anhyd.) mg/mL Epinephrine mcg/mL Sodium Chloride mg/mL 0.5% 1:200,000 5 5 8 1% 1:200,000 10 5 7 1.5% 1:200,000 15 5 6.5 2% 1:200,000 20 5 6 1% 1:100,000 10 10 7 2% 1:100,000 20 10 6 Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2’,6’-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula: Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula: Mechanism of action: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Hemodynamics: Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to সম্পূর্ণ নথি পড়ুন