Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Piramal Critical Care Limited, Suite 4, Ground Floor, Heathrow Boulevard East Wing, 280 Bath Road, West Drayton, UB7 0DQ, United Kingdom
Sublimaze.
| Pharmaceutical Form |
|---|
|
Solution for injection. |
Each 1ml of solution contains 78.5 micrograms fentanyl citrate equivalent to 50 micrograms per ml fentanyl base.
Excipient(s) with known effect: Sodium 3.5 mg/ml.
For Sublimaze 2 and 5 ml ampoules: This medicine contains less than 1 mmol sodium (23 mg) per 2 and 5 ml ampoule, that is to say essentially ‘sodium-free’.
For Sublimaze 10 ml ampoule: This medicinal product contains 35.4 mg sodium per 10 ml ampoule, equivalent to 1.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
For a 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 |
|---|
|
Sodium chloride |
Colourless glass ampoules (PhEur, USP Type I).
Pack size: packs of 10 and 50* of 2 ml and 5 ml* ampoules; packs of 5 and 10* of 10 ml ampoules.
* not marketed
Piramal Critical Care Limited, Suite 4, Ground Floor, Heathrow Boulevard – East Wing, 280 Bath Road, West Drayton, UB7 0DQ, United Kingdom
PL 37071/0004
26 February 1980 / 25 March 2002
| Drug | Countries | |
|---|---|---|
| SUBLIMAZE | Ireland, New Zealand, United Kingdom, South Africa |
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