Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: FGK Representative Service GmbH, Heimeranstrasse 35, 80339 Munich, Germany Tel. +49 89 89 3119 22
Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Zalviso is to be administered in a hospital setting only. Zalviso should only be prescribed by physicians who are experienced in the management of opioid therapy, particularly opioid adverse reactions such as respiratory depression (see section 4.4).
Zalviso sublingual tablets are to be self-administered by the patient in response to pain using the Zalviso administration device. The Zalviso administration device is designed to deliver a single sufentanil 15 micrograms sublingual tablet, on a patient-controlled as needed basis, with a minimum of 20 minutes (lockout interval) between doses, over a period of up to 72 hours, which is the maximum recommended treatment duration. See section “Method of administration”.
No special population studies were performed using sufentanil sublingual tablets in elderly patients. In clinical trials approximately 30% of enrolled patients were 65 to 75 years of age. The safety and efficacy in elderly patients was similar to that observed in younger adults (see section 5.2).
No special population studies were performed using sufentanil sublingual tablets in hepatic and renal impaired patients. Only limited data are available for the use of sufentanil in such patients. Zalviso should be administered with caution to patients with moderate to severe hepatic or severe renal impairment (see section 4.4).
The safety and efficacy of Zalviso in children aged below 18 years have not been established. No data are available.
For sublingual use only.
The Zalviso sublingual tablets are to be self-administered using the Zalviso administration device which should only be actuated by the patient in response to pain (see section 6.6).
The dispensed sublingual tablet should dissolve under the tongue and should not be crushed, chewed, or swallowed. Patients should not eat or drink and minimize talking for 10 minutes after each dose of Zalviso.
The maximum amount of sublingual sufentanil that can be delivered via the Zalviso administration device over an hour is 45 micrograms (3 doses).
In the event of repeated maximal usage by the patient, one cartridge will last for a period of 13 hours 20 minutes. Additional Zalviso cartridges may be utilized if needed.
For instructions on the setup and handling of the Zalviso administration device before administration, see section 6.6.
Sufentanil overdose is manifested by an exaggeration of its pharmacological effects. Depending on individual sensitivity, the clinical picture is determined by the degree of respiratory depression. This may range from hypoventilation to respiratory arrest. Other symptoms that may occur are loss of consciousness, coma, cardiovascular shock and muscle rigidity.
Management of overdose should be focused on treating symptoms of µ-opioid receptor agonism including administration of oxygen. Primary attention should be given to obstruction of airways and the necessity of assisted or controlled ventilation. An opiate antagonist (e.g. naloxone) should be administered in the event of respiratory depression. This does not rule out more direct countermeasures. The shorter duration of activity of the opiate antagonist compared to sufentanil should be taken into account. In that case, the opioid antagonist can be administered repeatedly or by infusion.
3 years.
Store in the original package in order to protect from light.
Zalviso is provided in a polycarbonate cartridge, each of which contains 40 sublingual tablets and is packed in a polyester film/LDPE/aluminium foil/LDPE sachet with an oxygen absorber. Zalviso is available in pack sizes of 1 and 10, 20 cartridges and multipacks containing 40 (2 packs of 20), 60 (3 packs of 20) and 100 (5 packs of 20) cartridges, equivalent to 40, 400, 800, 1,600, 2,400 and 4,000 sublingual tablets, respectively.
Not all pack sizes may be marketed.
The cartridge should be used only with the Zalviso administration device, consisting of a controller and a dispenser to ensure the proper use of this system. After removing from the sachet, the cartridge should be placed into the Zalviso administration device immediately.
The device should be used as recommended in the information provided by the device manufacturer. The instructions for setting up the Zalviso administration device by a healthcare professional must be followed carefully. The Zalviso administration device should not be used if any component is visibly damaged.
The fully charged Zalviso administration device will operate without recharging for up to 72 hours.
After treatment discontinuation the health-care professional has to remove the cartridge from the device and any unused and/or not completely empty cartridges have to be disposed by the health-care professional in accordance with local laws and requirements for controlled substances. Any other waste material must be discarded in accordance to the institutional policies and local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
