Remifentanil Kabi 1mg powder for concentrate for solution for injection or infusion

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

REMIFENTANIL

Saadav alates:

Fresenius Kabi Limited Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire WA7 1NT, United Kingdom

ATC kood:

N01AH06

INN (Rahvusvaheline Nimetus):

REMIFENTANIL 1 mg

Ravimvorm:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION

Koostis:

REMIFENTANIL 1 mg

Retsepti tüüp:

POM

Terapeutiline ala:

ANESTHETICS

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2010-08-20

Infovoldik

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMIFENTANIL KABI 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
REMIFENTANIL KABI 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
REMIFENTANIL KABI 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
Remifentanil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Remifentanil Kabi is and what it is used for
2.
What you need to know before you use Remifentanil Kabi
3.
How to use Remifentanil Kabi
4.
Possible side effects
5.
How to store Remifentanil Kabi
6.
Contents of the pack and other information
1.
WHAT REMIFENTANIL KABI IS AND WHAT IT IS USED FOR
Remifentanil Kabi contains a medicine called remifentanil. This
belongs to a group of medicines
known as opioids which are used to reduce pain. It differs from other
medicines in this group by its
very quick onset and very short duration of action.
-
Remifentanil Kabi may be used to stop you feeling pain before or while
you are having an
operation.
-
Remifentanil Kabi may be used to relieve pain while you are under
controlled mechanical
ventilation in an Intensive Care Unit (for patients 18 years of age
and over).
2.
WHAT YOU SHOULD KNOW BEFORE YOU USE REMIFENTANIL KABI
DO NOT USE REMIFENTANIL KABI
-
if you are allergic to remifentanil, fentanyl derivates (such as
alfentanil, fentanyl sufentanil)
or any of the other ingredients of this medicine (listed in section
6).
-
as injection into the spinal canal
-
as sole medicine to initiate anaesthesia
➔
If you are not sure if any of the above apply to you, talk to your
doctor, pharmacist or nurse
before you are given Remifentanil Kabi.
WARNINGS AND PRECAUTIONS

Toote omadused

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
Remifentanil Kabi 1 mg, powder for concentrate for solution for
injection or infusion
Remifentanil Kabi 2 mg, powder for concentrate for solution for
injection or infusion
Remifentanil Kabi 5 mg, powder for concentrate for solution for
injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains remifentanil hydrochloride equivalent to 1 mg
remifentanil.
One vial contains remifentanil hydrochloride equivalent to 2 mg
remifentanil.
One vial contains remifentanil hydrochloride equivalent to 5 mg
remifentanil.
Each ml of Remifentanil Kabi 1 mg/ 2 mg/ 5 mg, powder for concentrate
for solution for
injection or infusion contains 1 mg remifentanil when reconstituted as
directed.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for injection or infusion.
White to off-white or yellowish, compact powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Remifentanil is indicated as an analgesic agent for use during
induction and/or maintenance of
general anaesthesia.
Remifentanil is indicated for provision of analgesia in mechanically
ventilated intensive care
patients 18 years of age and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
REMIFENTANIL SHOULD 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 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 remifentanil 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 to minimise the potential dead space (see
_ _
section 6.6 for
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