DYURAL 40 KIT- methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, sodium chloride,

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

METHYLPREDNISOLONE ACETATE (UNII: 43502P7F0P) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

Доступна с:

Asclemed USA, Inc.

ИНН (Международная Имя):

Methylprednisolone Acetate

состав:

Methylprednisolone Acetate 40 mg in 1 mL

Администрация маршрут:

INTRAMUSCULAR

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)] . Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is contraindicated

Обзор продуктов:

Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). [See USP Controlled Room Temperature.] Bupivacaine Hydrochloride Injection, USP ─ Solutions of bupivacaine hydrochloride that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121 °C (250 °F) for 15 minutes. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. For single-dose vials: Discard unused portion. Methylprednisolone Acetate Injectable Suspension, USP is supplied as a white to off-white homogenous suspension in single-dose vial available in the following strengths and package sizes: 40 mg/mL (1 mL) Single vial in a carton: NDC 70121-1573-1 25 vials in a carton: NDC 70121-1573-5 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. This product’s label may have been updated. For current full prescribing information, please visit www.amneal.com. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 07-2021-05 Lidocaine Hydrochloride Injection, USP is supplied as follows: Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL) 5 mL Single Dose Vials in a Carton of 10 NDC 55150-162-05 Sterile, Nonpyrogenic Discard unused portion Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] The vial stopper is not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India Revised: February 2020 0.9% Sodium Chloride Injection, USP is supplied in the following: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] LIFESHIELD ® is the trademark of ICU Medical, Inc. and is used under license. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA  LAB-1097-2.0 10/2018 Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-1.0 Revised: 05/2018

Статус Авторизация:

unapproved drug other

Характеристики продукта

DYURAL 40 KIT- METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE,
BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL
ALCOHOL
ASCLEMED USA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPIVACAINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BUPIVACAINE HYDROCHLORIDE INJECTION.BUPIVACAINE HYDROCHLORIDE
INJECTION, FOR
INFILTRATION, PERINEURAL, CAUDAL, EPIDURAL, OR RETROBULBAR USE
INITIAL U.S. APPROVAL: 1972
WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE
INJECTION IN OBSTETRICAL ANESTHESIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION
OR DEATH DURING
USE OF BUPIVACAINE HYDROCHLORIDE INJECTION FOR EPIDURAL ANESTHESIA IN
OBSTETRICAL
PATIENTS. IN MOST CASES, THIS HAS FOLLOWED USE OF THE 0.75% (7.5
MG/ML) CONCENTRATION.
RESUSCITATION HAS BEEN DIFFICULT OR IMPOSSIBLE DESPITE APPARENTLY
ADEQUATE
PREPARATION AND APPROPRIATE MANAGEMENT. CARDIAC ARREST HAS OCCURRED
AFTER
CONVULSIONS RESULTING FROM SYSTEMIC TOXICITY, PRESUMABLY FOLLOWING
UNINTENTIONAL
INTRAVASCULAR INJECTION. THE 0.75% (7.5 MG/ML) CONCENTRATION OF
BUPIVACAINE
HYDROCHLORIDE INJECTION IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA
AND SHOULD BE
RESERVED FOR SURGICAL PROCEDURES WHERE A HIGH DEGREE OF MUSCLE
RELAXATION AND
PROLONGED EFFECT ARE NECESSARY ( 5.1).
INDICATIONS AND USAGE
Bupivacaine Hydrochloride Injection contains bupivacaine, an amide
local anesthetic. Bupivacaine
Hydrochloride Injection is indicated in adults for the production of
local or regional anesthesia or analgesia
for surgery, dental and oral surgery procedures, diagnostic and
therapeutic procedures, and for obstetrical
procedures. For each type of block indicated