Ultiva 5 mg Powder for Concentrate for Solution for Infusion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Remifentanil hydrochloride

Tilgjengelig fra:

Aspen Pharma Trading Limited

ATC-kode:

N01AH; N01AH06

INN (International Name):

Remifentanil hydrochloride

Dosering :

5 milligram(s)

Legemiddelform:

Powder for concentrate for solution for infusion

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Opioid anesthetics; remifentanil

Autorisasjon status:

Marketed

Autorisasjon dato:

1999-05-27

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ULTIVA 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ULTIVA 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ULTIVA 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
remifentanil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor, pharmacist or
nurse.
−
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ultiva is and what it is used for
2.
What you need to know before you are given Ultiva
3.
How Ultiva is given
4.
Possible side effects
5.
How to store Ultiva
6.
Contents of the pack and other information
1.
WHAT ULTIVA IS AND WHAT IT IS USED FOR
Ultiva contains a medicine called remifentanil. This belongs to a
group of medicines
known as opioids.
It is used:
•
to help put you to sleep BEFORE an operation in combination with other
medicines
•
to keep you asleep and stop you feeling pain DURING an operation in
combination
with other medicines, while your breathing and heart are monitored and
supported
•
alone or in combination with other medicines, to make you feel sleepy
and stop you
feeling pain while you receive treatment in an Intensive Care Unit
(ICU).
•
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ULTIVA
DO NOT HAVE ULTIVA IF:
•
you are allergic (hypersensitive) to remifentanil or any of the other
ingredients of this
medicine (listed in Section 6)
•
you are allergic (hypersensitive) to fentanyl analogues (pain
relieving medicines
which are similar to fentanyl and which are related to the class of
medicines known
as opioids).
If you are not sure if any of the above apply to you, talk to your
doctor, pharmacist or
nurse before you are given Ultiva.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are

Preparatomtale

Health Products Regulatory Authority
29 November 2023
CRN00DKL1
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ultiva 5 mg Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 5 mg remifentanil (as remifentanil hydrochloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
A white to off-white, lyophilised powder.
4 CLINICAL PARTICULARS
4.1 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 provision of analgesia in mechanically
ventilated intensive care patients of 18 years of age and over.
Ultiva is not indicated for use for post-operative analgesia or for
use during spontaneous ventilation anaesthesia until further
information becomes available.
4.2 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 drugs and the recognition and
management of the expected adverse effects of potent opioids,
including respiratory and cardiac resuscitation. Such training
must include the establishment and maintenance of a patent airway and
assisted ventilation.
Continuous infusions of Ultiva must be administered by a calibrated
infusion device into a fast flowing IV line or via a dedicated
IV line. This infusion line should be connected at, or close to, the
venous cannula and primed, to minimise the potential dead
space (see section 6.6 for additional information, including tables
with examples of infusion rates by body weight to help titrate
Ultiva to the patient’s anaesthetic needs).
Care should be taken to avoid obstruction or disconnection of infusion
lines and to adequately clear the lines to rem