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REMIFENTANIL 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): REMIFENTANIL HYDROCHLORIDE

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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

• Due to the rapid offset of action of remifentanil, patients
may emerge rapidly from anaesthesia and no residual
opioid activity will be present within 5-10 minutes after
the discontinuation of Remifentanil. For those patients
undergoing surgical procedures where post-operative
pain is anticipated, analgesics should be administered
prior to discontinuation of Remifentanil.
• At the doses recommended muscle rigidity may occur.
As with other opioids, the incidence of muscle rigidity
is related to the dose and rate of administration.
Therefore, bolus injections should be administered over
not less than 30 seconds.
Hypotension and bradycardia may be managed by
reducing the rate of infusion of Remifentanil or the dose
of concurrent anaesthetics or by using intravenous fluids,
vasopressor or anticholinergic agents.

Drug Abuse

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,
pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any of the side effects talk to your doctor,
pharmacist or nurse. This includes any 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 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 USE
REMIFENTANIL

Do not use Remifentanil
• if you are allergic (hypersensitive) to remifentanil, any
of the other ingredients of this medicine (see list of
ingredients in Section 6) or 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, pharmacist or nurse before you receive
Remifentanil, tell your doctor if you:
• ever had any adverse reactions during an operation
• ever had any allergic reactions or if you have been told
that you are allergic to:
• any medicines used during an operation
• opioid medicines (e.g., morphine, fentanyl,
pethidine, codeine), see also section above
“Do not use Remifentanil”
• suffer from impaired lung and/or liver function
(you may be more sensitive for breathing difficulties)
Elderly or weak patients (caused by decreased blood
volume and/or low blood pressure) are more sensitive to
suffer from cardiac or circulatory disturbances.
• As with other opioids remifentanil may produce
dependency.
• Following anaesthesia with Remifentanil, you should
leave home only accompanied and you should not drink
alcohol.
• 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 medicines
and the recognition and management of the expected
adverse effects of potent opioids, including respiratory
and cardiac resuscitation.
• In ventilated intensive care patients the use of
Remifentanil for more than 3 days is not recommended.

The following information is intended for medical or
healthcare professionals only:

Instructions on use/handling of Remifentanil
1, 2 and 5 mg powder for concentrate for
solution for injection/infusion
FOR INTRAVENOUS USE ONLY
Remifentanil should be prepared for intravenous use by
adding the appropriate volume (as stated in the table below)
of one of the below listed diluents to give a reconstituted
solution with a concentration of approximately 1 mg/ml.
Presentation

Volume of diluent
to be added

Concentration of
the reconstituted
solution

Remifentanil 1 mg

1 ml

1 mg/ml

Remifentanil 2 mg

2 ml

1 mg/ml

Remifentanil 5 mg

5 ml

1 mg/ml

As with other opioids remifentanil may produce dependency.

Children
Remifentanil is not recommended in neonates and
infants (children under the age of one year). There is
little experience of use of Remifentanil to treat children in
intensive care units.

Elderly
If used for an operation under general anaesthesia,
the initial dose of Remifentanil should be appropriately
reduced in elderly patients.

Other medicines and Remifentanil
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription.
This is especially important with the following medicines
as they may interact with your Remifentanil:
• medicines for blood pressure or heart problems
(known as beta-blockers or calcium channel
blockers). These medicines may increase the effect
of Remifentanil on your heart (lowering of your blood
pressure and your heart beat).
• other sedative medicines, such as benzodiazepines.
Your doctor or pharmacist will alter the dose of these
medicines when you are being given Remifentanil.
It may still be all right for you to receive Remifentanil and
your doctor will be able to decide what is suitable for you.
Remifentanil is not metabolized by plasmacholinesterase,
therefore, interactions with medicines metabolized by this
enzyme are not anticipated.

Remifentanil with food, drink and alcohol
After having received Remifentanil you should not drink
alcohol until fully recovered.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before this medicine is given to you.
Your doctor will discuss the possible risks and benefits
of being given Remifentanil if you are pregnant or
breast-feeding.
Remifentanil should not be given to pregnant
women unless medically justified. Remifentanil is not
recommended during labour or a Caesarian section.
It is recommended that you stop breast-feeding for
24 hours after Remifentanil has been given to you.

Driving and using machines
This medicine is only used in hospitalized patients.
If you are discharged early, after you have been given
Remifentanil, you must not drive, operate machinery, or
work in dangerous situations. You should not go home
alone. Your doctor will advise you when it is safe to
resume these activities.
This medicine can affect your ability to drive. Do not
drive whilst taking this medicine until you know how
this medicine affects you. It may be an offence to drive
if your ability to drive safely is affected. There is further
information for patients who are intending to drive in
Great Britain - go to https://www.gov.uk/drug-driving-law.

Remifentanil contains:
This medicinal product contains less than 1 mmol sodium
(23 mg) per ml, i.e. essentially ‘sodium-free’.
3. HOW TO HAVE REMIFENTANIL

The way you are given the drug and the dose you receive
will depend on:
• your weight
• the operation you have
• how much pain you will be in
• how sleepy the medical staff want you to be in the
Intensive Care Unit. The dose varies from one patient
to another.

If you are given too much
The effects of Remifentanil are carefully monitored
throughout your operation and in intensive care, and
appropriate action will be taken promptly if you receive
too much.

After your operation
Tell your doctor or nurse if you are in pain. If you are in
pain after your procedure, they will be able to give you
other painkillers.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Remifentanil can cause side effects,
although not everybody gets them.
Very common (may affect more than 1 in 10 people)
• muscle stiffness
• feeling sick (nausea)
• being sick (vomiting)
• low blood pressure (hypotension)
Common (may affect up to 1 to 10 people)
• slow heart beat (bradycardia)
• shallow breathing (respiratory depression)
• breathing stops (apnoea)
• itching
• shivering after the operation
• high blood pressure (hypertension) after the operation

Rare (may affects up to 1 to 1000 people)
• slow heart beat followed by heart block in
patients receiving remifentanil with one or more
anaesthetic medicines
• sleepiness (during recovering from the operation)
• severe allergic reactions including shock, circulatory
failure and heart attack in patients receiving remifentanil
with one or more anaesthetic medicines
Not known (frequency cannot be estimated from the
available data)
• fits
• abnormal heart rhythm due to heart block
• remifentanil having less effect than normal
(drug tolerance)
As with other medicines of this class (opioids), long-term
use of Remifentanil can lead to dependence. Please ask
your doctor for advice.

Reporting of side effects
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE REMIFENTANIL
Keep out of the reach and sight of children.
Do not use Remifentanil after the expiry date which is
stated on the carton/vial after “EXP”. The expiry date
refers to the last day of that month.

Unopened medicinal product
1 mg: Do not store above 25°C.
2 mg: Do not store above 30°C.
5 mg: Do not store above 30°C.

You will never be expected to give yourself this medicine.
It will always be given to you by a person who is qualified
to do so.

1 mg: Keep the vial in the outer carton in order to protect
from light.

For manually-controlled infusion, Remifentanil should be
administered following further dilution to a concentration
of 20 to 250 micrograms/ml (50 micrograms/ml is the
recommended dilution for adults and 20 to 25 micrograms/ml
for paediatric patients aged 1 year and over).
For target controlled infusion (TCI), Remifentanil should be
administered following further dilution to a concentration of
20 to 50 micrograms/ml.
Dilution should be adjusted to the technical equipment of the
infusion system and the expected patient requirements.

Q710217

Request number:

AS5840

Country:

UK

OI template:
Amalia version:
Mulgrave version:

CLI001
5
N/A

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

320 x 560 mm
Vial
Elaiapharm
40 g/m2
70 x 40 mm
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

N/A
N/A
N/A

Colours
Black:

Requester
I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q77161
Signed:
Date:

Uncommon (may affect up to 1 to 100 people)
• constipation
• pain after the operation
• oxygen deficiency (hypoxia)

Do not refrigerate or freeze.

Following reconstitution, the product must be inspected
visually (as far as supported by the vial) for solids,
discoloration or damage to the vials. If such changes are
detected, the solution must be discarded. The finished
solution is for single use only. Unused solution must
be discarded.

Item number:

The following side effects have been reported:

How your injection is given

Remifentanil can be given:
• as a single injection into your vein
• as a continuous infusion into your vein. This is where
the drug is slowly given to you over a longer period
of time.

Component Specification

Reconstituted/diluted medicinal product
After reconstitution:
After reconstitution, chemical and physical in-use stability
has been demonstrated for 24 hours at 25°C.

For dilution, one of the following IV fluids listed below
should be used:
• Water for Injections
• Glucose 50 mg/ml (5%) solution for Injection
• Glucose 50 mg/ml (5%) and sodium chloride 9 mg/ml
(0.9%) solution for injection
• Sodium chloride 9 mg/ml (0.9%) solution for injection
• Sodium chloride 4.5 mg/ml (0.45%) solution for injection
Remifentanil has been shown to be compatible with
the following IV fluids when administered into a running
IV catheter:
• Lactated Ringer’s solution for injection
• Lactated Ringer’s and Glucose 50 mg/ml (5%) solution
for injection
Remifentanil has been shown to be compatible with propofol
when administered into a running IV catheter.
Any unused product or waste material should be disposed of
in accordance with local requirements.
For full prescribing information refer to the Summary of
Product Characteristics.
Q710217

Version 1
Technician: JE
Date: 18/Feb/16

Version 2
Technician: JH
Date: 19/Feb/16

Version 3
Technician: JH
Date: 22/Feb/16

Version 4
Technician: JW
Date: 04/Mar/16

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

From a microbiological point of view, unless the
method of reconstitution precludes the risk of microbial
contamination, the product should be use immediately.
If not used immediately, in-use storage times and condition
prior to use are the responsibility of the user.
After dilution:
Following dilution, the solution must be inspected visually
to ensure that it is clear, colourless and virtually free from
solids, and that there is no damage to the vials. If such
changes are detected, the solution must be discarded.

Finland

Remifentanil Hospira 1/ 2/ 5 mg
kuiva-aine välikonsentraatiksi
injektio-/infuusionestettä varten, liuos

France

Remifentanil Hospira 1/ 2/ 5 mg poudre
pour solution injectable /pour perfusion

Component Specification

Hungary

Remifentanil Hospira 1/ 2/ 5 mg por
oldatos injekcióhoz vagy infúzióhoz való
koncentrátumhoz

Item number:

Q710217

Request number:

AS5840

Country:

UK

OI template:
Amalia version:
Mulgrave version:

CLI001
5
N/A

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

320 x 560 mm
Vial
Elaiapharm
40 g/m2
70 x 40 mm
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

N/A
N/A
N/A

Iceland

Remifentanil Hospira 1/ 2/ 5 mg stofn
fyrir stungulyfs/innrennslisþykkni, lausn

Ireland

Remifentanil 1/ 2/ 5 mg powder
for concentrate for solution for
injection/infusion

Italy

Remifentanil Hospira Pharma 1/ 2/ 5 mg
polvere per concentrato per soluzione
iniettabile o per infusione

Latvia

Remifentanil Hospira 1/ 2/ 5 mg
pulveris injekciju vai infūziju šķīduma
koncentrāta pagatavošanai

Lithuania

Remifentanil Hospira 1/ 2/ 5 mg milteliai
injekcinio ar infuzinio tirpalo koncentratui

Luxembourg

Remifentanil Hospira 1/ 2/ 5 mg Pulver
für ein Konzentrat zur Herstellung einer
Injektions-/Infusionslösung

Malta

Remifentanil Hospira 1/ 2/ 5 mg powder
for concentrate for solution for injection
or infusion

1 vial contains 5 mg remifentanil (as remifentanil
hydrochloride).

Netherlands

After reconstitution the solution contains
1 mg/ml remifentanil (as hydrochloride), if prepared
as recommended.

Remifentanil Hospira 1/ 2/ 5 mg poeder
voor concentraat voor oplossing voor
infusie/injectie

Norway

Remifentanil Hospira 1/ 2/ 5 mg
pulver til konsentrat til
injeksjons-/ infusionsvæske, oppløsning

The diluted product should be used immediately.
The diluted solution is for single use only.
Any unused solution must be discarded.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. CONTENT OF THE PACK AND OTHER INFORMATION

What Remifentanil contains
The active substance is:
remifentanil (as hydrochloride)
1 vial contains 1 mg remifentanil (as remifentanil
hydrochloride).
1 vial contains 2 mg remifentanil (as remifentanil
hydrochloride).

The other ingredients are:
Glycine; hydrochloric acid (for pH adjustment); sodium
hydroxide (for pH adjustment)

Poland

Remifentanil Hospira

Portugal

Remifentanil Hospira

What Remifentanil looks like and contents of the pack

Romania

Remifentanil Hospira 1/ 2/ 5 mg pulbere
pentru concentrat pentru soluţie
injectabilă/perfuzabilă

Remifentanil 1/ 2/ 5 mg is a lyophilized white to slightly
yellow cake or powdery mass for concentrate for solution
for injection/infusion.
Each carton of Remifentanil 1 mg contains 5 vials of 3.5 ml.

Slovak
Republic

Remifentanil Hospira 1/ 2/ 5 mg prášok
na injekčný/infúzny koncentrát

Each carton of Remifentanil 2 mg contains 5 vials of 3.5 ml.

Spain

Remifentanilo Hospira 1/ 2/ 5 mg
polvo para concentrado para solución
inyectable o para perfusion EFG

Sweden

Remifentanil Hospira 1/ 2/ 5 mg
pulver till koncentrat till
injections-/ infusionsvätska, lösning

Slovenia

Remifentanil Hospira 1/ 2/ 5 mg
prašek za koncentrat za raztopino za
injiciranje/infundiranje

United
Kingdom

Remifentanil 1/ 2/ 5 mg powder
for concentrate for solution for
injection/infusion

Each carton of Remifentanil 5 mg contains 5 vials of 8 ml.

Marketing Authorisation Holder and Manufacturer
Hospira UK Limited, Queensway, Royal Leamington Spa,
Warwickshire, CV31 3RW, UK

Manufacturer
Elaiapharm, 2881 route des Crêtes, Z.I. Les Bouillides,
Sophia Antipolis, 06560 Valbonne, France

This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany

Remifentanil Hospira 1/ 2/ 5 mg Pulver
für ein Konzentrat zur Herstellung einer
Injektions-/Infusionslösung

Austria

Remifentanil Hospira 1/ 2/ 5 mg Pulver
für ein Konzentrat zur Herstellung einer
Injektions- oder Infusionslösung

Belgium

Remifentanil Hospira 1/ 2/ 5 mg poeder
voor concentraat voor oplossing voor
injectie of infusie

Bulgaria

Remifentanil Hospira 1/ 2/ 5 mg
прах за концентрат за
инжекционен/инфузионен разтвор

Czech
Republic

Remifentanil Hospira 1/ 2/ 5 mg

Cyprus

Remifentanil Hospira 1/ 2/ 5 mg
powder for concentrate for solution for
injection/infusion

Denmark

Remifentanil Hospira 1/ 2/ 5 mg
pulver til koncentrat til injektions- og
infusionsvæske, opløsning

Estonia

Remifentanil Hospira 1/ 2/ 5 mg
süste- või infusioonilahuse
kontsentraadi pulber

Greece

Remifentanil Hospira 1/ 2/ 5 mg κόνις
για παρασκευή πυκνoύ διαλύματος
για παρασκευή ενέσιμου διάλυματος ή
διαλύματος προς έγχυση

Colours
Black:

Requester
I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q77161
Signed:
Date:

This leaflet was last revised in 07/2015.

Q710217

Version 1
Technician: JE
Date: 18/Feb/16

Version 2
Technician: JH
Date: 19/Feb/16

Version 3
Technician: JH
Date: 22/Feb/16

Version 4
Technician: JW
Date: 04/Mar/16

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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