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 15 micrograms sublingual tablets.
| Pharmaceutical Form |
|---|
|
Sublingual tablet. Zalviso sublingual tablets of 3 mm diameter are orange-coloured flat-faced tablets with rounded edges. |
Each sublingual tablet contains 15 micrograms sufentanil (as citrate).
Excipient(s) with known effect:
Each sublingual tablet contains 0.074 mg sunset yellow FCF Aluminium Lake (E110).
Each sublingual tablet contains 0.013 mg sodium.
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) |
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.
FGK Representative Service GmbH, Heimeranstrasse 35, 80339 Munich, Germany
Tel. +49 89 89 3119 22
EU/1/15/1042/001
EU/1/15/1042/002
EU/1/15/1042/003
EU/1/15/1042/004
EU/1/15/1042/005
EU/1/15/1042/006
Date of first authorisation: 18 September 2015
Date of latest renewal: 24 September 2020
| Drug | Countries | |
|---|---|---|
| ZALVISO | Austria, Estonia, Ireland, Lithuania, Poland |
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