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Bupivacaine Hydrochloride — 50MG, Solution for injection, carton of 10 × 10 mL vials

NDC/Item Number: 00143933110
Manufacturer:
HIKMA PHARMACEUTICALS USA INC
Form
VIAL
Unit size
10X10ML
Strength
50MG

Details

Details

Bupivacaine Hydrochloride — 50MG, Solution for injection, carton of 10 × 10 mL vials

Bupivacaine Hydrochloride is a solution for injection for epidural; intracaudal; perineural use. 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) ].

  • Active ingredient or product type: BUPIVACAINE HYDROCHLORIDE
  • Strength/concentration: 50MG
  • Dosage form and route: Solution for injection, Epidural; Intracaudal; Perineural
  • Exact package presentation: carton of 10 × 10 mL vials
  • NDC/item number: 0143-9331-10
  • Manufacturer: HIKMA PHARMACEUTICALS USA INC
  • Storage/handling: 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 injection, USP may be autoclaved. Protect from light. Discard unused portion.
  • Status: Rx only

Important safety information: Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after injection of Bupivacaine Hydrochloride injection. ( 5.2 ) Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.