SOFENTIL Solution for injection / infusion Ref.[50941] Active ingredients: Sufentanil

Source: Web Search  Revision Year: 2019  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011, Limassol, Cyprus

Product name and form

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.

Qualitative and quantitative composition

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
Sodium hydroxide 'for pH adjustment'
Hydrochloric acid 'for pH adjustment'
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011, Limassol, Cyprus

Marketing authorization dates and numbers

MA032/12101 – Sofentil 5 micrograms/ml solution for injection/infusion
MA032/12102 – Sofentil 50 micrograms/ml solution for injection/infusion

10th May 2019

Drugs

Drug Countries
SOFENTIL Cyprus, Malta, Romania

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