CYPSEDO Injectable emulsion Ref.[116740] Active ingredients: Cipepofol

2.1 Important Preparation and Administration Instructions

CYPSEDO should be administered only by health care providers trained in the administration of induction of general anesthesia who are not involved in the conduct of the surgical procedure.

Prepare CYPSEDO just prior to initiation of the surgery in the following way [see Warnings and Precautions (5.2)]:

• Visually inspect CYPSEDO for particulate matter and discoloration (only use if the emulsion is uniform and the container is undamaged and unopened).
• Shake well before use.
• Disinfect the vial rubber stopper using 70% isopropyl alcohol or an alcohol swab.
• Withdraw CYPSEDO from the vial, using a sterile vent spike, into a sterile syringe immediately after the vial is opened or pierced.
• Label the syringe with the date and time the vial is opened/pierced.
• After the vial has been opened/pierced, immediately administer undiluted CYPSEDO intravenously.
• Do not use vials that have been opened/pierced for more than 12 hours.
• After use, flush the intravenous line to remove residual CYPSEDO.
• Discard any unused CYPSEDO, reservoirs, and/or dedicated administration tubing at the end of the surgery or at 12 hours, whichever occurs sooner.

Do not co-administer CYPSEDO with blood/serum/plasma because of the risk of aggregation. Administration of CYPSEDO with an in-line filter during anesthesia is not recommended.

2.2 Recommended Dose(s) and Administration

Table 1 includes the recommended weight-based CYPSEDO intravenous dose(s) by age group (adults less than 65 years of age or adults greater than or equal to 65 years of age), by body mass index (BMI) group (BMI less than or equal to 40 kg/m² or BMI greater than 40 kg/m²), and by American Society of Anesthesiologists Physical Status classification (ASA-PS) (I or II OR III). The recommended dosage of CYPSEDO for induction of general anesthesia in adults undergoing surgery with ASA-PS IV or higher has not been established.

Administer an initial induction dose of CYPSEDO intravenously. If the induction is unsuccessful with the initial induction dose, an additional CYPSEDO dose intravenously over 10 seconds (approximately 1 minute after the end of the induction dose) may be administered.

After induction of general anesthesia with CYPSDEO, use other drug(s) for maintenance of general anesthesia.

Table 1. Recommended CYPSEDO Intravenous Doses:

ASA-PS = American Society of Anesthesiologists – physical status; BMI = body mass index

Overdose of CYPSEDO may cause cardiovascular and respiratory depression. Respiratory depression can be treated with mechanical ventilation, while cardiovascular depression may require other measures to increase cardiac output, (e.g., administering volume expansion, vasopressor drugs).

Store CYPSEDO vials at 2°C to 25°C (35.6°F to 77°F). Do not freeze. Shake well before use.