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801+802+803/46611/32/14

PACKAGE LEAFLET: INFORMATION FOR THE USER

B. Braun Melsungen AG ■ 34209 Melsungen, Germany

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

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_

You should not be given Remifentanil

-    if you are allergic to remifentanil, any of the other ingredients of this medicine (listed in Section 6) or fentanyl derivates (such as al-fentanil, 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

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 „You should not be given Remifentanil"

-    suffer from impaired lung and/or liver function (you may be more sensitive for breathing difficulties)

Elderly

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

Elderly or weak patients (caused by decreased blood volume and/or low blood pressure) are more sensitive to suffer from cardiac or circulatory disturbances.

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 of this age in intensive care units.

Other medicines and Remifentanil

Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines. 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 with alcohol

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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 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 breastfeeding.

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.

3.    How to use Remifentanil_

This medicine must only be given under carefully controlled conditions and emergency equipment has to be available. This medicine 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.

This medicine must be given only by injection or infusion directly into a vein. It should not be given over less than 30 seconds. This medicine must not be injected into the spinal canal (intrathecal or epidural).

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.

This medicine 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 this medicine, 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 medicine, ask your doctor or pharmacist.

4.    Possible side effects_

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

The following side effects may be serious and demand immediate treatment:

Common (may affect up to 1 in 10 people)

-    breathing stops (apnoea)

Rare (may affect up to 1 in 1,000 people)

-    severe allergic reactions including shock, circulatory failure and heart attack in patients receiving remifentanil with one or more anaesthetic medicines

-    slow heart beat followed by heart block in patients receiving remifentanil with one or more anaesthetic medicines

Not known (frequency cannot be estimated from the available data)

-    seizures

-    heart block

Other side effects

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 in 10 people)

-    slow heart beat (bradycardia)

-    shallow breathing (respiratory depression)

-    itching

-    shivering after the operation

-    high blood pressure (hypertension) after the operation

Uncommon (may affect up to 1 in 100 people)

-    constipation

-    pain after the operation

-    oxygen deficiency (hypoxia)

Rare (may affect up to 1 in 1,000 people)

-    sleepiness (during recovering from the operation)

Not known (frequency cannot be estimated from the available data)

-    drug tolerance Discontinuation of treatment

Symptoms following withdrawal of remifentanil including fast heart rate, high blood pressure and extreme arousal have been reported infrequently upon abrupt cessation, particularly after prolonged administration of more than 3 days.

As with other medicines of this class (opioids), long-term use of Remifentanil can lead to dependence. Please ask your doctor for advise.

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 the 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 this medicine out of the sight and reach of children.

Do not use this medicine 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.

Do not store above 25°C.

Do not refrigerate or freeze.

Do not use this medicine if you notice the solution is not clear and free of particles or if the container is damaged.

BBRAUN

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other 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.

Other ingredients are glycine and hydrochloric acid.

What Remifentanil looks like and contents of the pack

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: 5 vials per pack Remifentanil 2 mg powder for concentrate for solution for injection or infusion: 5 vials per pack Remifentanil 5 mg powder for concentrate for solution for injection or infusion: 5 vials per pack Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder B. Braun Melsungen AG Carl-Braun-StraBe 1    Postal address:

34212 Melsungen,    34209 Melsungen,

Germany    Germany

Phone: +49/5661/71-0 Fax: +49/5661/71-4567

Manufacturer IDT Biologika GmbH Am Pharmapark

06861 Dessau-RoBlau, Germany Hameln pharmaceuticals GmbH Langes Feld 13 31789 Hameln, Germany

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

FI, SE    Remifentanil B.    Braun    1    mg/ 2    mg/    5 mg

CZ, SK    Remifentanil B.    Braun    1    mg/ 2    mg

DE, LU    Remifentanil B.    Braun    1    mg/ 2    mg/    5 mg

Pulver zur Herstellung    eines Konzentrats

zur Herstellung einer Injektions-/Infu-sionslosung

DK, PL Remifentanil B. Braun FR Remifentanil B. Braun 1 mg/ 2 mg/ 5 mg, poudre pour solution a diluer pour solution injectable/ pour perfusion NL Remifentanil B. Braun 1 mg/ 2 mg/ 5 mg, poeder voor concentraat voor oplossing voor injectie of infusie PT Remifentanilo B. Braun UK Remifentanil 1 mg/ 2 mg/ 5 mg, powder for concentrate for solution for injection or infusion

This leaflet was last revised in 07/2014.

The following information is intended for 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 lyophilized 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.

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

Further Dilution

After reconstitution, Remifentanil may be further diluted (see below for storage conditions of the reconstituted/diluted product and for the recommended diluents).

For manually-controlled infusion this medicinal product can be diluted to concentrations of 20 to 250 |ug/ml (50 |ug/ml is the recommended dilution for adults and 20 to 25 |ug/ml for paediatric patients aged 1 year and over).

For target controlled infusion (TCI) the recommended dilution of Remifentanil is 20 to 50 |ug/ 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 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.

B. Braun Melsungen AG

34209 Melsungen Germany

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