Remifentanil 2mg powder for concentrate for solution for injection/infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Remifentanil

Dostupné z:

Actavis Group PTC ehf

ATC kód:

N01AH; N01AH06

INN (Medzinárodný Name):

Remifentanil

Dávkovanie:

2 milligram(s)

Forma lieku:

Powder for concentrate for solution for injection/infusion

Typ predpisu:

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

Terapeutické oblasti:

Opioid anesthetics; remifentanil

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2011-04-01

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
REMIFENTANIL 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
REMIFENTANIL 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
REMIFENTANIL 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
remifentanil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINES
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Remifentanil is and what it is used for
2.
What you need to know before you use Remifentanil
3.
How to use Remifentanil
4.
Possible side effects
5.
How to store Remifentanil
6.
Contents of the pack and other information
1.
WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR
Remifentanil contains the active substance remifentanil. Remifentanil
belongs to a group called
opioids. It differs from other medicines in this group by its very
quick onset and very short duration of
action.
Remifentanil may be used to stop you feeling pain before or while you
are having an operation.
Remifentanil 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 NEED TO KNOW BEFORE YOU TAKE REMIFENTANIL
DO NOT USE REMIFENTANIL
-
if you are allergic to remifentanil or any of the other ingredients of
this medicine (listed in
section 6)
-
if you are allergic to any other fentanyl derivates (such as
alfentanil, fentanyl, sufentanil). An
allergic reaction may include rash, itching, difficulty of breathing
or swelling of the face, lips,
throat or tongue. You may know this from earlier experience
-
as injection into the spinal canal
-
as sole medicine to initiate anaesthesia
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using R

Súhrn charakteristických

Health Products Regulatory Authority
16 April 2019
CRN008JHZ
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Remifentanil 2mg powder for concentrate for solution for
injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Remifentanil 2 mg powder for concentrate for solution for
injection/infusion
1 vial contains 2 mg remifentanil (as remifentanil hydrochloride).
After reconstitution the solution contains 1 mg/ml remifentanil (as
hydrochloride), if prepared as recommended (see section
6.6)
Excipient with known effect: sodium 1.15 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for injection/infusion
Lyophilized white to slightly yellow cake or powdery mass.
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 of 18 years of age and
older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
General Anaesthesia
The administration of Remifentanil must be individualised based on the
patient's response.
_Adults_
_Administration by manually-controlled infusion (MCI)_
Dosing guidelines for adults
REMIFENTANIL
BOLUS INJECTION
(micrograms /kg)
REMIFENTANIL
CONTINUOUS
INFUSION
(micrograms/kg/min)
Starting Rate Range
1 (within at least 30 seconds)
0.5 to 1
_
Maintenance of anaesthesia in ventilated patients
• Nitrous oxide (66 %)
0.5 to 1
0.4
0.1 to 2
• Isoflurane (starting dose 0.5 MAC)
0.5 to 1
0.25
0.05 to 2
• Propofol (Starting dose 100 microtrams /kg/min)
0.5 to 1
0.25
0.05 to 2
Health Products Regulatory Authority
16 April 2019
CRN008JHZ
Page 2 of 19
When given by bolus injection at induction Remifentanil should be
administered over not less than 30 seconds.
At the doses recommended above, remifentanil significantly reduces the
amount of hypnotic agent required to maintain
anaesthesia. Therefore, iso