MLK KIT F2- marcaine, lidocaine, kenalog, povidone iodine kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO)

Available from:

Asclemed USA, Inc.

INN (International Name):

Bupivacaine Hydrochloride

Composition:

Bupivacaine Hydrochloride Anhydrous 5 mg in 1 mL

Administration route:

EPIDURAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, 5.5, 5.7, 5.9)] . Bupivacaine Hydrochloride Injection is contraindicated in: - obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. - intravenous regional anesthesia (Bier Block) [see W

Product summary:

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 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. Unit of Sale Concentration NDC 0409-1162-01 Tray of 25 single-dose teartop vials 0.5% 50 mg/10 mL (5 mg/mL) NDC 0409-1162-02 Tray of 25 single-dose teartop vials 0.5% 150 mg/30 mL (5 mg/mL) For single-dose vials: Discard unused portion. Lidocaine Hydrochloride Injection, USP is supplied as follows: Lidocaine Hydrochloride Injection USP, 2% (20 mg/mL)   5 mL Single-Dose Vials in a Carton of 10                                   NDC 55150-165-05 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: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: October 2021 Triamcinolone Acetonide Injectable Suspension, USP is supplied in vials providing 40 mg triamcinolone acetonide per mL. 40 mg/mL, 1 mL 1 mL single-dose vial: NDC 70121-1049-1 25 single-dose vials in 1 carton: NDC 70121-1049-5 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from temperatures below 20°C (68°F). Store vial in carton to protect from light. Store vial upright. Discard unused portions of single-dose vials. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2020-05

Authorization status:

unapproved drug other

Summary of Product characteristics

MLK KIT F2- MARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINE
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 to produce local or
regional anesthesia or analgesia, specific
concentrations and prese