Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands
PecFent 100 micrograms/spray nasal spray, solution.
PecFent 400 micrograms/spray nasal spray, solution.
| Pharmaceutical Form |
|---|
|
Nasal spray, solution (nasal spray). A clear to practically clear colourless aqueous solution. |
PecFent 100 micrograms/spray nasal spray, solution: Each ml of solution contains 1,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate).
Bottles contain: 0.95 ml (950 micrograms fentanyl) - 2 spray bottle or 1.55 ml (1,550 micrograms fentanyl) - 8 spray bottle.
PecFent 400 micrograms/spray nasal spray, solution: Each ml of solution contains 4,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 400 micrograms fentanyl (as citrate).
Each bottle contains 1.55 ml (6,200 micrograms fentanyl).
Excipients with known effect: Each spray contains 0.02 mg propylparahydroxybenzoate (E216).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fentanyl |
Fentanyl is a potent µ-opioid analgesic with rapid onset of analgesia and short duration of action. Its primary therapeutic actions are analgesia and sedation and is approximately 100-fold more potent than morphine as an analgesic. Secondary effects of fentanyl on central nervous system (CNS), respiratory and gastro-intestinal function are typical of opioid analgesics and are considered to be class effects. |
| List of Excipients |
|---|
|
Pectin (E440) |
Bottle (clear Type I glass) with an attached metering pump incorporating an audible dose counter and a protective cap (solid white cap for the 2 spray and translucent cap for the 8 spray). In each case the product is packed in a clam-shell-like child resistant container.
Bottles contain:
Bottles in their child resistant containers are supplied in cartons containing:
Not all presentations or pack sizes may be marketed.
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands
EU/1/10/644/007
EU/1/10/644/001
EU/1/10/644/002
EU/1/10/644/005
EU/1/10/644/003
EU/1/10/644/004
EU/1/10/644/006
Date of first authorisation: 31 August 2010
Date of latest renewal: 17 July 2015
| Drug | Countries | |
|---|---|---|
| PECFENT | Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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