Ultiva Pdr/Conc/Soln for Infus 1mg/vial

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

REMIFENTANIL HYDROCHLORIDE

Available from:

Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland

ATC code:

N01AH06

INN (International Name):

REMIFENTANIL HYDROCHLORIDE 1 mg

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

REMIFENTANIL HYDROCHLORIDE 1 mg

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Withdrawn

Authorization date:

2007-06-19

Patient Information leaflet

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 given

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
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
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 1 mg, 2mg or 5 mg of remifentanil (as remifentanil
hydrochloride).
Excipient(s) with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per vial, that
is to
say essentially ‘sodium-free’.
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 o