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REMIFENTANIL 1 MG POWDER FOR CONCENTRATION FOR SOLUTION FOR INJECTION OR 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 or infusion
Remifentanil 2 mg powder for concentrate for solution for injection or infusion
Remifentanil 5 mg powder for concentrate for solution for injection or infusion
Remifentanil (as hydrochloride)
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Remifentanil is and what it is used for
Before you have Remifentanil
How to use Remifentanil
Possible side effects
How to store Remifentanil
Further information

1. WHAT REMIFENTANIL IS AND WHAT IT IS
USED FOR
Remifentanil belongs to a group of medicines 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. BEFORE YOU HAVE REMIFENTANIL
You should not be given Remifentanil
- if you are allergic (hypersensitive) to remifentanil,
any of the other ingredients (see list of ingredients
in Section6) 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
Take special care with Remifentanil
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:
o any medicines used during an operation
o opioid medicines (e.g., morphine, fentanyl,
pethidine, codeine), see also section above “You
should not be given 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.
Using other medicines
Please tell your doctor or pharmacist if you are taking,
or have recently taken, any other medicines, including
medicines you can get without a prescription. This
is especially important with the following medicines
as they may interact with your Remifentanil:
o 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).
o other sedative medicines, such as benzodiazepines.
Your doctor or pharmacist will alter the dose
of these medicines when you are being given
Remifentanil.

The following information is intended for
medical or healthcare professionals only:
PREPARATION GUIDE for
Remifentanil 1 mg powder for concentrate for
solution for injection or infusion
Remifentanil 2 mg powder for concentrate for
solution for injection or infusion
Remifentanil 5 mg powder for concentrate for
solution for injection or infusion
It is important that you read the entire contents of
this guide prior to the preparation of this medicinal
product.
Remifentanil should not be administered without
further dilution after reconstitution of the lyophilised
powder.
Reconstitution:
Remifentanil 1 mg / 2 mg / 5 mg 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 Concentration of the
be added
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

Shake until completely dissolved. The reconstituted
solution should be clear, colourless and free of
visible particles.

It may still be all right for you to receive Remifetanil
and your doctor will be able to decide what is
suitable for you.
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.
Taking Remifentanil with food and drink
After having received Remifentanil you should not
drink alcohol until fully recovered.
Pregnancy and 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.
Ask your doctor or pharmacist for advice before taking
any medicine. Your doctor will discuss the possible
risks and benefits of being given Remifentanil if you
are pregnant or breast-feeding.
Driving and using machines
This medicine is only used in hospitalised 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.
3. HOW TO USE REMIFENTANIL
Remifentanil must only be given under
carefully controlled conditions and emergency
equipment has to be available. Remifentanil
will be given by or under the supervision of
an experienced doctor who is familiar with
the use and action of the type of medicine.
You will never be expected to give yourself this
medication. It will always be given to you by a person
who is qualified to do so.
Remifentanil must be given only by injection or infusion
directly into a vein.
It should not be given over less than 30 seconds.
Remifentanil must not be injected into the spinal
canal (intrathecal or epidural).

Further Dilution:
After reconstitution, Remifentanil should not
be administered without further dilution to
concentrations of 20 to 250 μg/ml (50 μg/ml is the
recommended dilution for adults and 20 to 25 μg/
ml for paediatric patients aged 1 year and over) with
one of the following IV fluids llisted below.
For target controlled infusion (TCI) the recommended
dilution of Remifentanil is 20 to 50 µg/ml.
The dilution is dependent upon the technical capability
of the infusion device and the anticipated requirements
of the patient.
One of the following solutions should be used for dilution:
Water for Injections
Glucose 50 mg/ml (5%) solution for injection
Glucose 50 mg/ml (5%) solution for injection 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
The following intravenous fluids may also be used
when administered into a running IV catheter:
Lactated Ringer’s Injection
Lactated Ringer’s and glucose 50 mg/ml (5%) solution for
injection
Remifentanil is compatible with propofol when
administered into a running IV catheter.
No other diluents should be used.
The solution is to be inspected visually for particulate
matter prior to administration. The solution should

Dosage
The dosing and the duration of your infusion will be
worked out by the doctor and can vary according
to factors such as your body weight, age, physical
fitness, other medicines you are given and the type
of operation you have.
Dosage in adults:
Most patients respond to infusion rates between 0.1
and 2 microgram per kg body weight per minute.
Dosage can be reduced or enhanced by your doctor
according to your condition and/or response.
Dosage in elderly
If used for an operation under general anaesthesia,
the initial dose of Remifentanil should be appropriately
reduced in elderly patients.
Dosage in children (1 to 12 years of age):
For most children, infusion rates between 0.05 and
1.3 microgram per kg body weight per minute are
sufficient to maintain sleep during an operation. The
doses can be altered by the doctor and may be as high
as 3 microgram per kg body weight per minute.
There is little experience of use of Remifentanil to
treat children in intensive care units.
Remifentanil is not recommended in neonates and
infants (children under the age of one year).
Dosage in special patient groups
In obese or critically ill patients the initial dose will be
appropriately reduced and enhanced due to the response.
In patients with impaired liver or kidney function
and in patients undergoing neurosurgery a dose
reduction will not be necessary.
If you receive more Remifentanil than you
should or if you miss a dose of Remifentanil
Since Remifentanil will usually be given to you by a
doctor or nurse under carefully controlled conditions,
it is unlikely that you will be given too much or that
you will miss a dose.
If you have received too much of Remifentanil, or
if it is suspected, that you may have received too
much, appropriate action will be taken promptly by
your healthcare specialist team.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Rare (affects 1 to 10 users in 10 000)
- slow heart beat followed by heart block in patients
receiving remifentanil with one or more anaesthetic
medicines
- sleepiness (during recovering from the operation)
As with other medicines of this class (opioids),
longterm use of Remifentanil can lead to
dependence. Please ask your doctor for advise.
If any of the side effects become serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE REMIFENTANIL
Keep out of the sight and reach of children.
Remifentanil should not be used after the expiry date
which is stated on the carton and label after “EXP.”.
The expiry date refers to the last day of that month.
Unopened vials: Do not store above 25°C. Do not
refrigerate or freeze.
Reconstituted/diluted solution: the product should be
used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility
of the user and would normally not be longer than 24
hours at 2 to 8°C, unless reconstitution has taken place
in controlled and validated aseptic conditions.
Do not use Remifentanil if you notice the solution is not
clear and free of particles or if the container is damaged.
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. FURTHER INFORMATION
What Remifentanil contains
The active substance is remifentanil.
Each vial contains either 1 mg, 2 mg or 5 mg of
remifentanil (as hydrochloride). After reconstitution
as directed each ml contains 1 mg remifentanil.

4. POSSIBLE SIDE EFFECTS

Other ingredients are glycine and hydrochloric acid.

Like all medicines, Remifentanil can cause side
effects, although not everybody gets them.

What Remifentanil looks like and contents of the pack

Tell your doctor immediately if you notice any
of the following severe allergic reactions;
- pale, sweaty, raised heart beat or confusion
caused by shock or circulatory failure.
- chest pain or shortness of breath caused by a
heart attack.
The following side effects have been reported:
Very common (affects more than 1 user in 10)
- muscle stiffness
- feeling sick (nausea)
- being sick (vomiting)
- low blood pressure (hypotension)
Common (affects 1 to 10 users in 100)
- slow heart beat (bradycardia)
- shallow breathing (respiratory depression)
- breathing stops (apnoea)
- itching
- shivering after the operation
- high blood pressure (hypertension) after the operation
Uncommon (affects 1 to 10 users in 1 000)
- constipation
- pain after the operation
- oxygen deficiency (hypoxia)

Remifentanil is a white to off white or yellowish
powder for concentrate for solution for injection or
infusion. It is supplied in colourless glass vials.
Package size:
Remifentanil 1 mg powder for concentrate for solution
for injection or infusion: 1 or 5 vials per pack
Remifentanil 2 mg powder for concentrate for solution
for injection or infusion: 1 or 5 vials per pack
Remifentanil 5 mg powder for concentrate for solution
for injection or infusion: 1 or 5 vials per pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Ltd
Cestrian Court, Eastgate Way, Manor Park
Runcorn, Cheshire, WA7 1NT United Kingdom
Manufacturer
IDT Biologika GmbH
Am Pharmapark, 06861 Dessau-Roßlau,Germany
Important note: In the event of the need to
return product, please forward any samples to the
following address:
Fresenius Kabi Ltd, Cestrian Court, Eastgate Way,
Manor Park, Runcorn, Cheshire, WA7 1NT, UK.
This leaflet was last approved in 10/2011.

only be used if the solution is clear and free from
particles.
Ideally, intravenous infusions of Remifentanil should be
prepared at the time of administration.
Chemical and physical in-use stability has been
demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product
should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are
the responsibility of the user and would normally
not be longer than 24 hours at 2 to 8°C, unless
reconstitution has taken place in controlled and
validated aseptic conditions.
The content of the vial is for single use only. Any
unused product or waste material should be
disposed of in accordance with local requirements.
Special precautions for storage
Do not store above 25°C.
Do not refrigerate or freeze.
For storage condition of the reconstituted/diluted
medicinal product, see section above under Further
dilution.

V001 4-5531001/00 GB/IE

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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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