Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, UK
Abstral 100 microgram, 200 microgram, 300 microgram, 400 microgram, 600 microgram, 800 microgram sublingual tablets.
| Pharmaceutical Form |
|---|
|
Sublingual tablet. 100 microgram sublingual tablet is a white round tablet. 200 microgram sublingual tablet is a white oval-shaped tablet. 300 microgram sublingual tablet is a white triangle-shaped tablet. 400 microgram sublingual tablet is a white diamond-shaped tablet. 600 microgram sublingual tablet is a white “D”-shaped tablet. 800 microgram sublingual tablet is a white capsule-shaped tablet. |
Each sublingual tablet contains:
100 micrograms fentanyl (as citrate).
200 micrograms fentanyl (as citrate).
300 micrograms fentanyl (as citrate).
400 micrograms fentanyl (as citrate).
600 micrograms fentanyl (as citrate).
800 micrograms fentanyl (as citrate).
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 |
|---|
|
Mannitol (E421) |
Abstral sublingual tablets are packaged in child resistant blisters of OPA/Aluminium/PVC pockets with paper/polyester/Aluminium lidding contained in a cardboard outer carton. The packaging is colour-coded for each Abstral sublingual tablet strength.
Pack size: Packs of 10 or 30 sublingual tablets. Not all pack sizes may be marketed.
Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, UK
Abstral 100 microgram sublingual tablets: PL 16508/0030
Abstral 200 microgram sublingual tablets: PL 16508/0031
Abstral 300 microgram sublingual tablets: PL 16508/0032
Abstral 400 microgram sublingual tablets: PL 16508/0033
Abstral 600 microgram sublingual tablets: PL 16508/0034
Abstral 800 microgram sublingual tablets: PL 16508/0035
Date of first authorisation: 2008-02-29
Date of latest renewal: 2013-02-28
| Drug | Countries | |
|---|---|---|
| ABSTRAL | Australia, Cyprus, Spain, Finland, France, Ireland, Israel, Japan, Netherlands, Singapore, Turkey, United Kingdom, United States |
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