SUFENTA Solution for injection / infusion Ref.[50458] Active ingredients: Sufentanil

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Piramal Critical Care (Pty) Ltd, Office 2, Ground Floor, Kiepersol House, Stonemill Office Park, 300 Acacia Road, Darrenwood 2194

Product name and form

SUFENTA 2 mL solution for injection or infusion.

SUFENTA 10 mL solution for injection or infusion.

Pharmaceutical Form

Solution for injection or infusion. (For IV or epidural use.)

A clear colourless solution. Free from visible foreign material.

Qualitative and quantitative composition

Each mL contains 0,005 mg (5 ยตg) sufentanil as sufentanil citrate.

Sugar free.

For a 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

Hydrochloric acid solution (for pH adjustment)
Sodium hydroxide solution (for pH adjustment)
Sodium chloride
Water for injection

Pack sizes and marketing

Cartons containing: 5 × 2 mL and 5 × 10 mL ampoules.

Marketing authorization holder

Piramal Critical Care (Pty) Ltd, Office 2, Ground Floor, Kiepersol House, Stonemill Office Park, 300 Acacia Road, Darrenwood 2194

Marketing authorization dates and numbers

SUFENTA 2 mL: T/2.9/240
SUFENTA 10 mL: T/2.9/241

22 February 1988

Drugs

Drug Countries
SUFENTA Brazil, Finland, France, Tunisia, South Africa

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