Bupivacaine hydrochloride — 5 mg/mL, Solution for injection, 1 × 50 mL vial in 1 carton

Bupivacaine hydrochloride — 5 mg/mL, Solution for injection, 1 × 50 mL vial in 1 carton

Bupivacaine hydrochloride is a solution for injection for infiltration, 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. Supplied as 1 × 50 mL vial in 1 carton; NDC 70069-753-01; manufacturer Somerset Therapeutics, LLC. Rx only. 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). Protect from light. [See USP Controlled Room Temperature.

• Active ingredient or product type: BUPIVACAINE HYDROCHLORIDE
• Strength/concentration: 5 mg/mL
• Dosage form and route: Solution for injection, Infiltration, Perineural
• Exact package presentation: 1 × 50 mL vial in 1 carton
• NDC/item number: 70069-753-01
• Manufacturer/labeler: Somerset Therapeutics, LLC
• 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). Protect from light. [See USP Controlled Room Temperature.
• 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.