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ULTIVA Powder for concentrate for solution for infusion (2023)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ultiva 1 mg Powder for Concentrate for Solution for Infusion.

Qualitative and quantitative composition

1 vial contains 1 mg remifentanil (as remifentanil hydrochloride). For a full list of excipients, see section 6.1.

Pharmaceutical form

Powder for concentrate for solution for infusion. A white to off-white, lyophilised powder.

Therapeutic indications

Ultiva is indicated as an opioid analgesic adjunct for use with other agents during induction and/or maintenance of general anaesthesia in conjunction with controlled ventilation. Ultiva is indicated for ...

Posology and method of administration

Ultiva shall be administered in hospitals only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function, and by persons specifically trained in the use of anaesthetic ...

Contraindications

As glycine is present in the formulation, Ultiva is contraindicated for epidural and intrathecal use (see Preclinical safety data). Hypersensitivity to the active substance, other fentanyl analogues, or ...

Special warnings and precautions for use

<b>Ultiva shall be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function, and by persons specifically trained in the use of anaesthetic ...

Interaction with other medicinal products and other forms of interaction

Ultiva is not metabolised by plasmacholinesterase, therefore, interactions with drugs metabolised by this enzyme are not anticipated. As with other opioids, Ultiva decreases the doses of inhaled and IV ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate and well-controlled studies in pregnant women. Ultiva should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Labour and ...

Effects on ability to drive and use machines

After anaesthesia with Ultiva the patient should not drive or operate machinery. The physician should decide when these activities may be resumed. It is advisable that the patient is accompanied when returning ...

Undesirable effects

Summary of the safety profile The most common undesirable effects associated with Ultiva are direct extensions of mu-opioid agonist pharmacology. These adverse events resolve within minutes of discontinuing ...

Overdose

Symptoms As with all potent opioid analgesics, overdose would be manifested by an extension of the pharmacologically predictable actions of remifentanil. Due to the very short duration of action of Ultiva, ...

Pharmacodynamic properties

<b>ATC code:</b> N01AH06 Remifentanil is a selective mu-opioid agonist with a rapid onset and very short duration of action. The mu-opioid activity of remifentanil is antagonized by narcotic antagonists, ...

Pharmacokinetic properties

Following administration of the recommended doses of remifentanil, the effective half-life is 3-10 minutes. The average clearance of remifentanil in young healthy adults is 40ml/min/kg, the central volume ...

Preclinical safety data

Acute toxicity Expected signs of mu-opioid intoxication were observed in non-ventilated mice, rats, and dogs after large single bolus intravenous doses of remifentanil. In these studies, the most sensitive ...

List of excipients

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

Incompatibilities

Ultiva should only be reconstituted and diluted with those infusion solutions recommended (see section 6.6). It should not be reconstituted, diluted or mixed with Lactated Ringers Injection or Lactated ...

Shelf life

<u>Unopened:</u> 18 months. <u>Following reconstitution/dilution:</u> Chemical and physical in-use stability of the reconstituted solution of Ultiva has been demonstrated for 24 hours at room temperature ...

Special precautions for storage

Do not store above 25°C. For storage instructions of the reconstituted medicinal product, see section 6.3.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

Ultiva should be prepared for intravenous use by adding, as appropriate 1, 2 or 5ml of diluent to give a reconstituted solution with a concentration of approximately 1 mg/ml remifentanil. The reconstituted ...

Marketing authorization holder

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

Marketing authorization number(s)

PA1691/032/001

Date of first authorization / renewal of the authorization

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

Date of revision of the text

November 2023

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