Source: Web Search Revision Year: 2019 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011, Limassol, Cyprus
Sofentil 5 micrograms/ml solution for injection/infusion.
Sofentil 50 micrograms/ml solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. The solution is clear and colourless, free from visible particles, with pH 4.0-6.0 and osmolality 250–310 mOsmol/kg. |
Sofentil 5 micrograms/ml solution for injection/infusion: Each ml solution contains 5 micrograms sufentanil as sufentanil citrate.
Sofentil 50 micrograms/ml solution for injection/infusion: Each ml solution contains 50 micrograms sufentanil as sufentanil citrate.
Excipients with known effect: Sodium hydroxide and sodium chloride.
Each ml of solution for injections contains sodium 0.39 mmol (9 mg).
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 |
|---|
|
Sodium chloride |
Clear glass ampoules of 10 ml and 5 ml filling capacity respectively, Type I.
The ampoules are presented with an adhesive label and are secondarily packed in molded PVC trays (each tray contains 5 ampoules), sealed with PE foil.
The peel able membrane on PVC blisters is used only in the case of ampoules of 5 ml filling capacity.
Not all pack sizes may be marketed.
Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011, Limassol, Cyprus
MA032/12101 – Sofentil 5 micrograms/ml solution for injection/infusion
MA032/12102 – Sofentil 50 micrograms/ml solution for injection/infusion
10th May 2019
| Drug | Countries | |
|---|---|---|
| SOFENTIL | Cyprus, Malta, Romania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
