ULTIVA Powder for concentrate for solution for infusion Ref.[8163] Active ingredients: Remifentanil

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Ultiva 1 mg Powder for Concentrate for Solution for Infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

A white to off-white, lyophilised powder.

Qualitative and quantitative composition

1 vial contains 1 mg remifentanil (as remifentanil hydrochloride).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Remifentanil

Remifentanil is a selective mu-opioid agonist with a rapid onset and very short duration of action. The mu-opioid activity, of remifentanil, is antagonised by narcotic antagonists, such as naloxone.

List of Excipients

Glycine
Hydrochloric Acid (for pH adjustment)
Sodium Hydroxide (for pH adjustment if needed)

Pack sizes and marketing

Ultiva injection for intravenous use is available as a glass vial with rubber stopper and aluminium overseal:

1 mg Remifentanil lyophilised powder in 3 ml vials in cartons of 5.

Not all pack sizes may be marketed.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA1691/032/001

Date of first authorisation: 27 May 1999
Date of last renewal: 27 May 2009

Drugs

Drug Countries
ULTIVA Austria, Brazil, Cyprus, Ecuador, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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