598/12260486/0216

SUMMARY OF PRODUCT CHARACTERISTICS

B. Braun Melsungen AG ■ 34209 Melsungen, Germany 1 NAME OF THE MEDICINAL PRODUCT

Propofol-®Lipuro 1 % (10 mg/ml)

emulsion for injection or infusion

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Propofol-Lipuro 1 % (10 mg/ml) contains

per 1 ml per 20 ml ampoule or vial per 50 ml vial per 100 ml vial Propofol 10 mg    200 mg    500 mg    1000 mg

Excipients with known effect:

1 ml emulsion for injection or infusion contains

Soya-bean oil, refined 50 mg

Sodium    0.03 mg

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM Emulsion for injection or infusion White milky oil-in-water emulsion

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Propofol-Lipuro 1 % (10 mg/ml) is a short-acting intravenous general anaesthetic for

•    i nduction and maintenance of general anaesthesia in adults and children >

1 month

•    sedation of ventilated patients > 16 years of age in the intensive care unit

•    sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month.

4.2    Posology and method of administration General instructions

Propofol-Lipuro 1 % (10 mg/ml) must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care. Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse-oxymeter) and facilities for maintenance of patient airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times. For sedation during surgical or diagnostic procedures Propofol-Lipuro 1 % (10 mg/ml) should not be given by the same person that carries out the surgical or diagnostic procedure.

Supplementary analgesic medicinal products are generally required in addition to Propofol-Lipuro 1 % (10 mg/ml).

Posology

Propofol-Lipuro 1 % (10 mg/ml) is given intravenously. The dosage is adjusted individually according to the patient's response.

•    General anaesthesia in adults Induction of anaesthesia:

For induction of anaesthesia Propofol-Lipuro 1 % (10 mg/ml) should be titrated (20 - 40 mg of propofol every 10 seconds) against the patient's response until the clinical signs show the onset of anaesthesia. Most adult patients younger than 55 years are likely to require 1.5 to 2.5 mg/kg body weight.

In patients over this age and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of Propofol-Lipuro 1 % (10 mg/ml) may be reduced to a minimum of 1 mg/kg body weight. In these patients lower rates of administration should be applied (approximately 2 ml, corresponding to 20 mg every 10 seconds).

Maintenance of anaesthesia:

Anaesthesia can be maintained by administering Propofol-Lipuro 1 % (10 mg/ml) either by continuous infusion or by repeat bolus injections. If a technique involving repeat bolus injections is used, increments of 25 mg (2.5 ml Propofol-Lipuro 1 % (10 mg/ml)) to 50 mg (5.0 ml Propofol-Lipuro 1 % (10 mg/ml)) may be given according to clinical requirements. For maintenance of anaesthesia by continuous infusion the dosage requirements usually are in the range of 4 - 12 mg/kg body weight/h.

In elderly patients, in patients of poor general condition, in patients of ASA grades III and IV and in hypovolaemic patients the dosage may be reduced further depending on the severity of the patient's condition and on the performed anaesthetic technique.

•    General anaesthesia in children over 1 month of age Induction of anaesthesia:

For induction of anaesthesia Propofol-Lipuro 1 % (10 mg/ml) should be slowly titrated against the patient's response until the clinical signs show the onset of anaesthesia. The dosage should be adjusted according to age and/or body weight.

Most patients over 8 years of age require approximately 2.5 mg/kg body weight of propofol for induction of anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher (2.5 - 4 mg/kg body weight).

Maintenance of general anaesthesia:

Anaesthesia can be maintained by administering Propofol-Lipuro 1 % (10 mg/ml) by infusion or repeated bolus injection to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients but rates in the region of 9 - 15 mg/kg/h usually achieve satisfactory anaesthesia. In younger children, especially between the age of

1    month and 3 years, dose requirements may be higher.

For ASA III and IV patients lower doses are recommended (see also section 4.4)

•    Sedation of ventilated patients in the Intensive Care Unit

For sedation during intensive care it is advised that propofol should be administered by continuous infusion. The infusion rate should be determined by the desired depth of sedation. In most patients sufficient sedation can be obtained with a dosage of 0.3 - 4 mg/kg/h of propofol (see also section 4.4). Propofol is not indicated for sedation in intensive care of patients of 16 years of age or younger (see section 4.3).

Administration of propofol by Target Controlled Infusion (TCI) system is not advised for sedation in the intensive care unit.

•    Sedation for diagnostic and surgical procedures in adults

To provide sedation during surgical and diagnostic procedures, doses and administration rates should be adjusted according to the clinical response. Most patients will require 0.5 - 1 mg/kg body weight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol-Lipuro 1 % (10 mg/ml) infusion to the desired level of sedation. Most patients will require 1.5 - 4.5 mg/kg body weight/h. The infusion may be supplemented by bolus administration of 10 - 20 mg (1 -

2    ml Propofol-Lipuro 1 % (10 mg/ml)) if a rapid increase of the depth of sedation is required.

In patients older than 55 years and in patients of ASA grades III and IV lower doses of Propofol-Lipuro 1 % (10 mg/ml) may be required and the rate of administration may need to be reduced.

•    Sedation for diagnostic and surgical procedures in children over1 month of age

Doses and administration rates should be adjusted according to the required depth of sedation and the clinical response. Most paediatric patients require 1 - 2 mg/kg body weight of propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol-Lipuro 1 % (10 mg/ml) as infusion to the desired level of sedation. Most patients require 1.5 - 9 mg/kg/h of propofol. The infusion may be supplemented by bolus administration of up to 1 mg/kg b.w. if a rapid increase of depth of sedation is required.

In ASA III and IV patients lower doses may be required.

Method and duration of administration

•    Method of administration Intravenous use

Propofol-Lipuro 1 % (10 mg/ml) is administered intravenously by injection or continuous infusion either undiluted or diluted with 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution as well as in a 0.18 % w/v sodium chloride and 4 % w/v glucose solution (see also section 6.6). Containers should be shaken before use.

Before use, the neck of the ampoule or the surface of the rubber stopper of the vial should be cleaned with medicinal alcohol (spray or swabs). After use, tapped containers must be discarded.

■ Propofol-Lipuro 1 % (10 mg/ml) contains no antimicrobial preservatives - and supports growth of microorganisms. Therefore, Propofol-Lipuro 1 % (10 mg/ml) is to be drawn up aseptically into a sterile syringe or an infusion set immediately after opening the ampoule or breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both Propofol-Lipuro 1 % (10 mg/ml) and the infusion equipment throughout the infusion period.

Any medicinal products or fluids added to a running Propofol-Lipuro 1 % (10 mg/ml) infusion must be administered close to the cannula site. Propofol-Lipuro 1 % (10 mg/ml) must not be administered via infusion sets with microbiological filters.

The contents of one ampoule or one vial of Propofol-Lipuro 1 % (10 mg/ml) and any syringe containing Propofol-Lipuro 1 % (10 mg/ml) are for single use in one patient.

Infusion of undiluted Propofol-Lipuro 1 % (10 mg/ml)

When administering Propofol-Lipuro 1 % (10 mg/ml) by continuous infusion, it is recommended that burettes, drop counters, syringe pumps or volumetric infusion pumps, should always be used to control the infusion rates. As established for the parenteral administration of all kinds of fat emulsions, the duration of continuous infusion of Propofol-Lipuro 1 % (10 mg/ ml) from one infusion system must not exceed 12 hours. The infusion line and the reservoir of Propofol-Lipuro 1 % (10 mg/ml) must be discarded and replaced after 12 hours at the latest. Any portion of Propofol-Lipuro 1 % (10 mg/ml) remaining after the end of infusion or after replacement of the infusion system must be discarded.

Infusion of diluted Propofol-Lipuro 1 % (10 mg/ml)

For administering infusion of diluted Propofol-Lipuro 1 % (10 mg/ml), burettes, drop counters, syringe pumps, or volumetric infusion pumps should always be used to control infusion rates and to avoid the risk of accidentally uncontrolled infusion of large volumes of diluted Propofol-Lipuro 1 % (10 mg/ml).

The maximum dilution must not exceed 1 part of Propofol-Lipuro 1 % (10 mg/ml) with 4 parts of 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution, or 0.18 % w/v sodium chloride and 4 % w/v glucose solution (minimum concentration 2 mg propofol/ml). The mixture should be prepared aseptically immediately prior to administration and must be used within 6 hours of preparation.

In order to reduce pain on initial injection, Propofol-Lipuro 1 % (10 mg/ml) may be mixed with preservative-free lidocaine injection 1 % (mix 20 parts of Propofol-Lipuro 1 % (10 mg/ml) with up to 1 part of lidocaine injection 1 %).

Before giving the muscle relaxants atracurium or mivacurium subsequent to Propofol-Lipuro 1 % (10 mg/ml) through the same intravenous line, it is recommended that the line be rinsed prior to administration.

Propofol may also be used by Target Controlled Infusion. Due to the different algorithms available on the market for dosage recommendations please refer to the instructions for use leaflet of the device manufacturer.

•    Duration of administration

Propofol-Lipuro 1 % (10 mg/ml) can be administered for a maximum period of 7 days.

4.3    Contraindications

Propofol-Lipuro 1 % (10 mg/ml) is contraindicated in patients with a known hypersensitivity to propofol or to any of the excipients.

Propofol-Lipuro 1 % (10 mg/ml) contains soya-bean oil and should not be used in patients who are hypersensitive to peanut or soya.

Propofol-Lipuro 1 % (10 mg/ml) must not be used in patients of 16 years of age or younger for sedation for intensive care.

Safety and efficacy for these age groups have not been demonstrated (see section 4.4).

4.4    Special warnings and precautions for use

Propofol should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care).

Patients should be constantly monitored and facilities for maintenance of a patient airway, artificial ventilation, oxygen enrichment and other resus-citative facilities should be readily available at all times. Propofol should not be administered by the person conducting the diagnostic or surgical procedure.

The abuse of and dependence on propofol, predominantly by health care professionals, have been reported. As with other general anaesthetics, the administration of propofol without airway care may result in fatal respiratory complications.

When propofol is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation.

As with other sedative agents, when propofol is used for sedation during operative procedures, involuntary patient movements may occur. During procedures requiring immobility these movements may be hazardous to the operative site.

An adequate period is needed prior to discharge of the patient to ensure full recovery after use of propofol. Very rarely the use of propofol may be associated with the development of a period of post-operative unconsciousness, which may be accompanied by an increase in muscle tone. This may or may not be preceded by a period of wakefulness. Although recovery is spontaneous, appropriate care of an unconscious patient should be administered. Propofol induced impairment is not generally detectable beyond 12 hours. The effects of propofol, the procedure, concomitant medications, the age and the condition of the patient should be considered when advising patients on:

•    The advisability of being accompanied on leaving the place of administration

•    The timing of recommencement of skilled or hazardous tasks such as driving

•    The use of other agents that may sedate (e.g. benzodiazepines, opiates, alcohol.)

As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients.

Propofol clearance is blood flow dependent, therefore, concomitant medication that reduces cardiac output will also reduce propofol clearance. Propofol lacks vagolytic activity and has been associated with reports of bradycardia (occasionally profound) and also asystole. The intravenous administration of an anticholinergic agent before induction or during maintenance of anaesthesia should be considered, especially in situations where vagal tone is likely to predominate or when propofol is used in conjunction with other agents likely to cause bradycardia.

When propofol is administered to an epileptic patient, there may be a risk of convulsion.

Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.

Paediatric population

The use of propofol is not recommended in newborn infants as this patient population has not been fully investigated. Pharmacokinetic data (see section 5.2) indicate that clearance is considerably reduced in neonates and has a very high inter-individual variability. Relative overdose could occur on administering doses recommended for older children and result in severe cardiovascular depression.

Propofol must not be used in patients of 16 years of age or younger for sedation for intensive care as the safety and efficacy of propofol for sedation in this age group have not been demonstrated (see section 4.3).

Advisory statements concerning Intensive Care Unit management

Use of propofol for ICU sedation has been associated with a constellation of metabolic disturbances and organ system failures that may result in death. Reports have been received of combinations of the following: Metabolic acidosis, Rhabdomyolysis, Hyperkalaemia, Hepatomegaly, Renal failure, Hyperlipidaemia, Cardiac arrhythmia, Brugada-type ECG (elevated ST-seg-ment and coved T-wave) and rapidly progressive Cardiac failure usually unresponsive to inotropic supportive treatment. Combinations of these events have been referred to as the Propofol infusion syndrome.

These events were mostly seen in patients with serious head injuries and children with respiratory tract infections who received dosages in excess of those advised in adults for sedation in the intensive care unit.

The following appear to be the major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents - vasoconstrictors, steroids, inotropes and/or propofol (usually at dose rates greater than 4 mg/kg/h for more than 48 hours). Prescribers should be alert to these events in patients with the above risk factors and promptly consider decreasing or stopping the propofol dosage when the above signs develop. All sedative and therapeutic agents used in the intensive care unit (ICU), should be titrated to maintain optimal oxygen delivery and haemodynamic parameters. Patients with raised intra-cranial pressure (ICP) should be given appropriate treatment to support the cerebral perfusion pressure during these treatment modifications. Treating physicians are reminded if possible not to exceed the dosage of 4 mg/kg/h. Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously. It is recommended that blood lipid levels should be monitored if propofol is administered to patients thought to be at particular risk of fat overload. Administration of propofol should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. If the patient is receiving other intravenous lipid concurrently, a reduction in quantity should be made in order to take account of the amount of lipid infused as part of the propofol formulation; 1.0 ml of Propofol-Lipuro contains approximately 0.1 g of fat.

Additional precautions

Caution should be taken when treating patients with mitochondrial disease. These patients may be susceptible to exacerbations of their disorder when undergoing anaesthesia, surgery and ICU care. Maintenance of normother-mia, provision of carbohydrates and good hydration are recommended for such patients. The early presentations of mitochondrial disease exacerbation and of the 'propofol infusion syndrome' may be similar.

Propofol-Lipuro 1 % (10 mg/ml) contains no antimicrobial preservatives and supports growth of micro-organisms.

When propofol is to be aspirated, it must be drawn aseptically into a sterile syringe or giving set immediately after opening the ampoule or breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both propofol and infusion equipment throughout the infusion period. Any infusion fluids added to the propofol line must be administered close to the cannula site. If infusion sets with filters are to be used, these must be lipid-permeable.

Propofol and any syringe containing propofol are for single use in an individual patient. In accordance with established guidelines for other lipid emulsions, a single infusion of propofol must not exceed 12 hours. At the end of the procedure or at 12 hours, whichever is the sooner, both the reservoir of propofol and the infusion line must be discarded and replaced as appropriate.

This medicinal product contains less than 1 mmol (23 mg) sodium in 100 ml, i.e. essentially 'sodium free'.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Propofol-®Lipuro 1 % (10 mg/ml)

emulsion for injection or infusion

Propofol

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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Propofol-Lipuro 1 % (10 mg/ml) is and what it is used for

2.    What you need to know before you use Propofol-Lipuro 1 % (10 mg/ml)

3.    How to use Propofol-Lipuro 1 % (10 mg/ml)

4.    Possible side effects

5.    How to store Propofol-Lipuro 1 % (10 mg/ml)

6.    Contents of the pack and other information

1.    What Propofol-Lipuro 1 % (10 mg/ml) is and what

it is used for_

Propofol-Lipuro 1 % (10 mg/ml) belongs to a group of medicines called general anaesthetics. General anaesthetics are used to cause unconsciousness (sleep) so that surgical operations or other procedures can be performed. They can also be used to sedate you (so that you are sleepy but not completely asleep).

Propofol-Lipuro 1 % (10 mg/ml) is used to:

•    i nduce and maintain general anaesthesia in adults and children > 1 month

•    sedate patients > 16 years of age receiving artificial respiration in intensive care

•    sedate adults and children > 1 month during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia.

2.    What you need to know before you use Propofol-

Lipuro 1 % (10 mg/ml)_

Do not use Propofol-Lipuro 1 % (10 mg/ml):

•    i f you are allergic (hypersensitive) to propofol, soya, peanut or any of the other ingredients of this medicine (listed in section 6).

It must not be used in patients of 16 years of age or younger for sedation during intensive care.

Safety and efficacy for these age groups have not been demonstrated.

Warnings and precautions

Special care has to be taken

•    i f you have serious head injuries,

•    i f you have a mitochondrial disease,

•    i f you have a disorder in which your body does not handle fat properly,

•    i f you have any other health problems which require much caution in the use of fat emulsions,

•    i f your blood volume is too low (hypovolaemia),

•    i f you are very weak (debilitated) or have heart, kidney or liver problems,

•    i f you have high pressure within in the skull,

•    i f you have problems with your breathing,

•    i f you have epilepsy,

•    i f you are undergoing some procedures where spontaneous movements are particularly undesirable.

Please tell your doctor if you have one of these diseases or conditions.

If you are receiving other lipids by a drip into your vein at the same time your doctor will pay attention to your total daily fat intake.

Propofol will be administered to you by a physician trained in anaesthesia or intensive care. You will be constantly monitored during anaesthesia and waking-up time.

If you experience signs of the so called 'propofol infusion syndrome' (for a detailed list of the symptoms see section 4 'Possible side effects', a doctor must be called if the following happen') your doctor will decrease or stop the dosage of propofol.

Please see also section 'Driving and using machines' for precautions to be taken after the use of propfol.

Children and adolescents

The use of Propofol-Lipuro is not recommended in newborn infants.

This medicine must not be used in patients of 16 years of age or younger for sedation for intensive care (see section 'Do not use Propofol-Lipuro 10 mg/ ml:').

Other medicines and Propofol-Lipuro 1 % (10 mg/ml)

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

Propofol has effectively been used with different regional anaesthesia techniques that only numb a part of your body (epidural and spinal anaesthesia).

Additionally, safe use has been demonstrated in combination with

•    drugs you receive before surgery

•    other medicines like muscle relaxing drugs

•    anaesthetic drugs that can be inhaled

•    pain killers.

However your physician may give you lower doses of propofol if general anaesthesia or sedation is needed as a supplement to regional anaesthesia techniques.

Special care will also be taken if you receive in parallel an antibiotic containing rifampicin - you may develop profound low blood pressure.

Propofol-Lipuro 1 % (10 mg/ml) and alcohol

Your doctor will advise you on the consumption of alcohol before and after the use of Propofol-Lipuro 1 % (10 mg/ml).

Pregnancy and breast-feeding

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 taking this medicine.

Propofol-Lipuro should not be used during pregnancy unless it is definitely needed. It crosses the placenta and may depress the vital functions of the newborn.

However, propofol may be used during an induced abortion.

If you are breast-feeding your child you should stop nursing and discard breast milk for 24 hours after you have received Propofol-Lipuro 1 % (10 mg/ml). Studies in breast-feeding women showed that propofol is excreted in small amounts into the milk.

Driving and using machines

You should not drive or operate machinery for a while after you have had an injection or infusion of Propofol-Lipuro 1 % (10 mg/ml)

Your doctor will advise you

•    if you should be accompanied when you are leaving.

•    when you can drive and use machinery again.

•    on the use of other tranquillizing drugs (e.g. tranquillizers, strong pain killers, alcohol).

Propofol-Lipuro 1 % (10 mg/ml) contains sodium and soya-bean oil

This medicinal product contains less than 1 mmol (23 mg) sodium in 100 ml, that is, it is essentially 'sodium free'.

Propofol-Lipuro contains soya-bean oil. If you are allergic to peanut or soya, do not use this medicine.

3. How to use Propofol-Lipuro 1 % (10 mg/ml)

Propofol-Lipuro 1 % (10 mg/ml) will only be given by anaesthetists or by specially trained doctors in an intensive care unit.

Dosage

The dose you are given will vary depending on your age, body weight and physical condition. The doctor will give the correct dose to start and to sustain anaesthesia or to achieve the required level of sedation, by carefully watching your responses and vital signs (pulse, blood pressure, breathing, etc).

The doctor will also observe limits of the time of application, if necessary.

Propofol-Lipuro 1 % (10 mg/ml) will usually be given by injection when used to induce general anaesthesia and by continuous infusion (a slower, longer injection) when used to maintain general anaesthesia. It may given as an infusion either diluted or undiluted. When used as a sedative it will usually be given by infusion.

Propofol-Lipuro 1 % (10 mg/ml) will only be given for a maximum of 7 days. Method of administration

You will receive Propofol-Lipuro 1 % (10 mg/ml) by intravenous injection or infusion, that is, through a needle or small tube placed in one of your veins. Because Propofol-Lipuro 1 % (10 mg/ml) does not contain preservatives, an infusion from one vial of Propofol-Lipuro 1 % (10 mg/ml) will not last longer than 12 hours. An infusion from one container of diluted Propofol-Lipuro 1 % (10 mg/ml) will not last longer than 6 hours.

Your circulation and breathing will be constantly monitored while you are being given the injection or infusion.

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Table of Adverse Drug Reactions

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

•    Involuntary movements

•    Abnormally good mood

•    Drug abuse and drug dependence

•    Failure of the heart

•    Shallow breathing

•    Pain and/or swelling at the injection site after the medicine was accidentally injected outside of a vein

•    Breakdown of muscle tissue has been reported very rarely in cases where propofol has been given at greater doses than recommanded for sedation in intensive care units

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie

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

Propofol-Lipuro 1 % (10 mg/ml):

Propofol B. Braun 1 % (10 mg/ml): Propofol "B. Braun" 10 mg/ml: Propofol-Lipuro 10 mg/ml:

Propofol-Lipuro 1 %:

Czech Republic, Ireland, Malta, Poland, Portugal, Slovakia,

United Kingdom Italy

Denmark

Austria, Estonia, Finland, France, Germany, Hungary, Latvia, Lithuania, Luxembourg, Netherlands, Slovenia, Spain, Sweden, Norway Cyprus, Greece

This leaflet was last revised in 02/2016.

The following information is intended for healthcare professionals only:

The containers are for single use in one patient only.

Any unused emulsion must be thrown away at the end of administration. The containers must be shaken before use.

For complete information on this medicinal product please refer to the summary of product characteristics.

BIBRAUN