Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: DNE Pharma AS, Karihaugveien 22, 1086 Oslo, Norway
Ventizolve is intended for immediate administration as emergency therapy for known or suspected opioidoverdose as manifested by respiratory and/or central nervous system depression, in both non-medicaland healthcare settings.
Ventizolve is indicated in adults.
Ventizolve is not a substitute for emergency medical care.
The recommended dose is 1.26 mg administered into one nostril (one nasal spray).
If respiration is stabilized the patient should be monitored and placed in the recovery position until health care professionals (HCP) are on site.
Ventizolveis administered in opioid-dependent subjects, especially when expected to be at risk of severe opioid withdrawal. In some cases, further doses may be necessary. The appropriate maximum dose of Ventizolve issituationspecific. If the patient does not respond, the second dose should be administered after 2-3 minutes. Ifthe patient responds to the first administration but then relapses again into respiratory depression, thesecond dose should be administered immediately. Further doses (if available) should be administeredin alternate nostrils and the patient should be monitored whilst awaiting arrival of the emergencyservices.
The safety and efficacy of Ventizolve in children and adolescents has not been established. No data are available.
No adjustment of dose is required.
Nasal use.
Ventizolve should be administered as soon as possible to avoid damage to the central nervous system ordeath.
Detailed instructions on how to use Ventizolve are provided in the Package Leaflet and a Quick Start Guide is enclosed in the packaging. In addition, training is provided via a video and a Patient Information Card.
The device contains only one dose. Do not prime or test the device prior to administration. Do not reuse the device after administration.
Overdose is not expected considering the indication and the broad therapeutic index. Single doses of 10 mg naloxone administered intravenously has been tolerated without adverse reactions or changes in clinical laboratory values.
3 years.
Do not freeze.
Keep the single-dose containers in the plastic cover in order to protect from light.
The immediate container consists of a type I glass vial with a chlorobutyl rubber stopper enclosed in a spray device comprised of polypropylene actuator and spray pin and a stainless steel cannula.
One pack contains 2 single-dose containers of 0.1 ml nasal spray, solution packed in a plastic cover.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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