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 |
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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 |
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Sufentanil is a synthetic, potent opioid with highly selective binding to μ-opioid receptors. Sufentanil acts as a full agonist in μ-opioid receptors. Sufentanil does not induce histamine release. |
List of Excipients |
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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 | |
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SOFENTIL | Cyprus, Malta, Romania |
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