Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Laboratoire Aguettant, 1, rue Alexander Fleming, 69007 Lyon, France
Dzuveo 30 micrograms sublingual tablet.
| Pharmaceutical Form |
|---|
|
Sublingual tablet. Blue-coloured flat-faced tablet with round edges and a diameter of 3 mm. |
Each sublingual tablet contains 30 micrograms of sufentanil (as citrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sufentanil |
Sufentanil is a synthetic opioid analgesic drug approximately 5 to 10 times as potent as its parent drug, fentanyl, and 500 times as potent as morphine. Structurally, sufentanil differs from fentanyl through the addition of a methoxymethyl group on the piperidine ring (which is believed to reduce duration of action), and the replacement of the phenyl ring by thiophene. The main use of this medication is in operating suites and critical care where pain relief is required for a short period of time. It also offers properties of sedation and this makes it a good analgesic component of anesthetic regimen during an operation |
| List of Excipients |
|---|
|
Mannitol E421 |
Dzuveo is packaged in a polypropylene single-dose applicator, which is packaged in a polyester film/LDPE/aluminium foil/LDPE sachet with an oxygen absorber.
Dzuveo will be available in cartons of 5 and 10. Not all pack sizes may be marketed.
Laboratoire Aguettant, 1, rue Alexander Fleming, 69007 Lyon, France
EU/1/18/1284/001
EU/1/18/1284/002
Date of first utilization: 25 June 2018
| Drug | Countries | |
|---|---|---|
| DZUVEO | Austria, Estonia, Croatia, Ireland, Lithuania, Poland |
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