Label: SENSORCAINE MPF- bupivacaine hydrochloride injection, solution

  • NDC Code(s): 63323-464-08, 63323-464-38, 63323-466-08, 63323-466-38
  • Packager: Fresenius Kabi USA, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 18, 2024

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION:
    Sensorcaine - ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and ...
  • CLINICAL PHARMACOLOGY:
    Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve ...
  • INDICATIONS AND USAGE:
    Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures ...
  • CONTRAINDICATIONS:
    Sensorcaine (bupivacaine HCl) is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. Sensorcaine is ...
  • WARNINGS:
    THE 0.75% CONCENTRATION OF SENSORCAINE INJECTION IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA. THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION OR DEATH DURING USE OF ...
  • PRECAUTIONS:
    General - The safety and effectiveness of local anesthetics depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Resuscitative equipment, oxygen, and ...
  • ADVERSE REACTIONS:
    To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Reactions to Sensorcaine (bupivacaine HCl) are ...
  • OVERDOSAGE:
    Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local ...
  • DOSAGE AND ADMINISTRATION:
    The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the ...
  • HOW SUPPLIED:
    These solutions are not for spinal anesthesia. Sensorcaine-MPF (methylparaben free) is available in the following forms: With Epinephrine: Product CodeUnit of ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Fresenius Kabi - Lake Zurich, IL 60047 - www.fresenius-kabi.com/us - 451745 - Issued: May 2022
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine-MPF 10 mL Single Dose Vial Label
    NDC 63323-464-08        PRX460417 - Sensorcaine® -MPF - (Bupivacaine HCl Injection, USP) 0.25% 25 mg per 10 mL (2.5 mg per mL) For Infiltration, Nerve Block, Caudal and Epidural ...
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine-MPF 10 mL Single Dose Vial Tray Label
    NDC 63323-464-38        PRX460417 - Sensorcaine® -MPF - (Bupivacaine HCl Injection, USP) 0.25% 25 mg per 10 mL (2.5 mg per mL) For Infiltration, Nerve Block, Caudal and Epidural ...
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine-MPF 10 mL Single Dose Vial Label
    NDC 63323-466-08        PRX460617 - Sensorcaine® -MPF - (Bupivacaine HCl Injection, USP) 0.5% 50 mg per 10 mL (5 mg per mL) For Nerve Block, Caudal and Epidural Anesthesia. Not for Spinal ...
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine-MPF 10 mL Single Dose Vial Tray Label
    NDC 63323-466-38        PRX460617 - Sensorcaine® -MPF - (Bupivacaine HCl Injection, USP) 0.5% 50 mg per 10 mL (5 mg per mL) For Nerve Block, Caudal and Epidural Anesthesia. Not for Spinal ...
  • INGREDIENTS AND APPEARANCE
    Product Information