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PROPOFOL-LIPURO 2 % (20 MG/ML) EMULSION FOR INJECTION OR INFUSION

Active substance(s): PROPOFOL

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599/12608212/0216

SUMMARY OF PRODUCT CHARACTERISTICS
B. Braun Melsungen AG · 34209 Melsungen, Germany

1

NAME OF THE MEDICINAL PRODUCT

Propofol-®Lipuro 2 % (20 mg/ml)
emulsion for injection or infusion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml emulsion for injection or infusion contains
Propofol
20 mg
One vial of 50 ml contains
1000 mg Propofol
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 2 % (20 mg/ml) is a short-acting intravenous general
anaesthetic for
• induction and maintenance of general anaesthesia in adults and children > 3 years
• 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 > 3 years.
4.2 Posology and method of administration
General instructions
Propofol-Lipuro 2 % (20 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
2 % (20 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 2 % (20 mg/ml).
Posology
Propofol-Lipuro 2 % (20 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 2 % (20 mg/ml) should be
titrated (20 – 40 mg 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 2 % (20 mg/ml) may be
reduced to 1 mg/kg body weight or less. In these patients lower rates of
administration should be applied (approximately 1 ml corresponding to
20 mg every 10 seconds).
Maintenance of anaesthesia:
Anaesthesia is maintained by administering Propofol-Lipuro 2 % (20 mg/
ml) 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 grade III and IV and in hypovolaemic patients the dosage may have
to be reduced further depending on the severity of the patient´s condition
and on the performed anaesthetic technique.
• General anaesthesia in children over 3 years of age
Induction of anaesthesia:
For induction of anaesthesia Propofol-Lipuro 2 % (20 mg/ml) should be
slowly titrated 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, the dose requirements
may be higher (2.5 – 4 mg/kg body weight).
Maintenance of general anaesthesia:
Anaesthesia can be maintained by administering Propofol-Lipuro 2 %
(20  mg/ml) by infusion 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-Lipuro 2 %
(20 mg/ml) 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 – 4.0 mg
of propofol per kg body weight per hour (see section 4.4).
Propofol is not indicated for sedation of patients of 16 years or younger
in intensive care (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 2 % (20 mg/ml) infusion to the desired level of
sedation. Most patients will require 1.5 – 4.5 mg/kg body weight/h.
In patients older than 55 years and in patients of ASA grade III and IV
lower doses of Propofol-Lipuro 2 % (20 mg/ml) may be required and the
rate of administration may need to be reduced.
According to required dose, alternatively Propofol 1 % (10 mg/ml) may
be used.
• Sedation for diagnostic and surgical procedures in children over
3 years 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 of propofol
infusion to the desired level of sedation. Most patients require 1.5 – 9 mg/
kg/h of propofol.
In ASA III and IV patients lower doses may be required.
Method and duration of administration
• Method of administration
Intravenous use
Propofol-Lipuro 2 % (20 mg/ml) is administered undiluted intravenously.
Containers should be shaken before use.
Before use, 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 2 % (20 mg/ml) contains no antimicrobial preservatives
and supports growth of microorganisms. Therefore, Propofol-Lipuro 2 %
(20 mg/ml) is to be drawn up aseptically into a sterile syringe or an infusion set immediately after breaking the vial seal. Administration must
commence without delay. Asepsis must be maintained for both PropofolLipuro 2 % (20 mg/ml) and the infusion equipment throughout the infusion period.
Any medicinal products or fluids added to a running Propofol-Lipuro
2 % (20 mg/ml) infusion must be administered close to the cannula site.
Propofol-Lipuro 2 % (20 mg/ml) must not be administered via infusion
sets with microbiological filters.
The contents of one vial of Propofol-Lipuro 2 % (20 mg/ml) and any syringe containing Propofol-Lipuro 2 % (20 mg/ml) are for single use in
one patient. Any portion of the contents remaining after use must be
discarded.

For administration of Propofol-Lipuro 2 % (20 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
2 % (20 mg/ml) from one infusion system must not exceed 12 hours. The
infusion line and the reservoir of Propofol-Lipuro 2 % (20 mg/ml) must
be discarded and replaced after 12 hours at the latest. Any portion of
Propofol-Lipuro 2 % (20 mg/ml) remaining after the end of infusion or
after replacement of the infusion system must be discarded.
This medicinal product must not be mixed with other medicinal products
except those mentioned in section 6.6.
In order to reduce pain on initial injection of Propofol-Lipuro 2 % (20 mg/
ml) for induction of general anaesthesia, lidocaine may be injected immediately prior to the injection of Propofol-Lipuro 2 % (20 mg/ml).
Before giving the muscle relaxants atracurium or mivacurium subsequent
to Propofol-Lipuro 2 % (20 mg/ml) through the same intravenous line, the
line should 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 2 % (20 mg/ml) can be administered for a maximum period of 7 days.
4.3 Contraindications
Propofol-Lipuro 2 % (20 mg/ml) is contraindicated in patients with a
known hypersensitivity to propofol or any of the excipients.
Propofol-Lipuro 2 % (20 mg/ml) contains soya-bean oil and should not be
used in patients who are hypersensitive to peanut or soya.
Propofol-Lipuro 2 % (20 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
resuscitative 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-Lipuro 2 % (20 mg/ml) is not recommended for use in children
< 3 years of age due to difficulty in titrating small volumes.
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-segment 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 intracranial 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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Propofol-®Lipuro 2 % (20 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.
2.
3.
4.
5.
6.

What Propofol-Lipuro 2 % (20 mg/ml) is and what it is used for
What you need to know before you use Propofol-Lipuro 2 % (20 mg/ml)
How to use Propofol-Lipuro 2 % (20 mg/ml)
Possible side effects
How to store Propofol-Lipuro 2 % (20 mg/ml)
Contents of the pack and other information

1. What Propofol-Lipuro 2 % (20 mg/ml) is and
what it is used for
Propofol-Lipuro 2 % (20 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 2 % (20 mg/ml) is used to:
• induce and maintain general anaesthesia in adults and children
> 3 years
• sedate patients > 16 years of age receiving artificial respiration in intensive care
• sedate adults and children > 3 years during diagnostic and surgical
procedures, alone or in combination with local or regional anaesthesia.

2. What you need to know before you use PropofolLipuro 2 % (20 mg/ml)
Do not use Propofol-Lipuro 2 % (20 mg/ml):
• if 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
• if you have serious head injuries,
• if you have a mitochondrial disease,
• if you have a disorder in which your body does not handle fat properly,
• if you have any other health problems which require much caution in the
use of fat emulsions,
• if your blood volume is too low (hypovolaemia),
• if you are very weak (debilitated) or have heart, kidney or liver problems,
• if you have high pressure within in the skull,
• if you have problems with your breathing,
• if you have epilepsy,
• if 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 children < 3 years of age.
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 ‘Do not use
Propofol-Lipuro 2% (20 mg/ml):’).

Other medicines and Propofol-Lipuro 2 % (20 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 2 % (20 mg/ml) and alcohol
Your doctor will advise you on the consumption of alcohol before and
after the use of Propofol-Lipuro 2 % (20 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 2 % (20 mg/ml) 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 2 %
(20 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 2 % (20 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 2 % (20 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 2 % (20 mg/ml) contains soya-bean oil. If you are allergic
to peanut or soya, do not use this medicine.

3. How to use Propofol-Lipuro 2 % (20 mg/ml)
Propofol-Lipuro 2 % (20 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 2 % (20 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. When used
as a sedative it will usually be given by infusion.
Propofol-Lipuro 2 % (20 mg/ml) will only be given for a maximum of
7 days.

Method of administration
You will receive Propofol-Lipuro 2 % (20 mg/ml) by intravenous injection
or infusion, that is, through a needle or small tube placed in one of your
veins.
Because Propofol-Lipuro 2 % (20 mg/ml) does not contain preservatives,
an infusion from one vial of Propofol-Lipuro 2 % (20 mg/ml) will not last
longer than 12 hours.

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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 normothermia, 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 2 % (20 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’.
4.5 Interaction with other medicinal products and other forms of interaction
Propofol has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular blocking
drugs, inhalational agents and analgesic agents; no pharmacological
incompatibility has been encountered. Lower doses of propofol may be
required where general anaesthesia or sedation is used as an adjunct to
regional anaesthetic techniques.
Profound hypotension has been reported following anaesthetic induction
with propofol in patients treated with rifampicin.
4.6 Pregnancy and lactation
Pregnancy
The safety of propofol during pregnancy has not been established. Propofol should not be given to pregnant women except when absolutely necessary. Propofol crosses the placenta and can cause neonatal depression.
Propofol can, however, be used during an induced abortion.
Breast-feeding
Studies of breast-feeding mothers showed that small quantities of propofol are excreted in human milk. Woman should therefore not breastfeed
for 24 hours after administration of propofol. Milk produced during this
period should be discarded.
4.7 Effects on the ability to drive and to use machines
Patients should be advised that performance at skilled tasks, such as driving and operating machinery, may be impaired for some time after use
of propofol.
Propofol induced impairment is not generally detectable beyond 12 hours
(please see section 4.4).
4.8 Undesirable effects
Induction and maintenance of anaesthesia or sedation with propofol is
generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side effects of
an anaesthetic/sedative agent, such as hypotension. The nature, severity
and incidence of adverse events observed in patients receiving propofol
may be related to the condition of the recipients and the operative or
therapeutic procedures being undertaken.
Table of Adverse Drug Reactions
System Organ Class
Immune system
disorders:

Frequency
Very rare
(<1/10 000)

Frequency not known (9)
Metabolism and
Nutritional disorder:
Psychiatric disorders: Frequency not known (9)

Nervous system
disorders:

Common
(>1/100, <1/10)
Rare
(>1/10 000, <1/1000)

Undesirable Effects
Anaphylaxis – may
include angioedema,
bronchospasm,
erythema and hypotension
Metabolic acidosis (5),
hyperkalaemia (5),
hyperlipidaemia (5)
Euphoric mood, drug
abuse and drug dependence (8)
Headache during
recovery phase
Epileptiform movements, including
convulsions and opisthotonus during induction, maintenance
and recovery
Postoperative
unconsciousness
Involuntary movements
Bradycardia (1)

Very rare
(<1/10 000)
Frequency not known (9)
Common
Cardiac disorders:
(>1/100, <1/10)
Very rare
Pulmonary oedema
(<1/10 000)
Frequency not known (9) Cardiac arrhythmia (5),
cardiac failure (5), (7)
Common
Hypotension (2)
Vascular disorders:
(>1/100, <1/10)
Uncommon
Injection site throm(>1/1000, <1/100)
bosis and phlebitis
Common
Transient apnoea durRespiratory, thoracic
(>1/100, <1/10)
ing induction
and mediastinal
disorders:
Frequency not known (9) Respiratory depression
(dose-dependent)
Common
Nausea and vomiting
Gastrointestinal
(>1/100, <1/10)
during recovery phase
disorders:
Very rare
Pancreatitis
(<1/10 000)
Frequency not known (9) Hepatomegaly (5)
Hepatobiliary disorders
Musculoskeletal and Frequency not known (9) Rhabdomyolysis (3), (5)
connective tissue
disorders:
Very rare
Discolouration of urine
Renal and urinary
(<1/10 000)
following prolonged
disorders
administration
Frequency not known (9) Renal failure (5)
Sexual disinhibition
Reproductive system Very rare
(<1/10 000)
and breast
Very common
Local pain on inducGeneral disorders
(>1/10)
tion (4)
and administration
site conditions:
Very rare
Tissue necrosis (10)
(<1/10 000)
following accidental
extravascular administration
Frequency not known (9) Local pain, swelling,
following accidental
extravascular administration
Frequency not known (9) Brugada type ECG (5), (6)
Investigations
Postoperative fever
Injury, poisoning and Very rare
procedural compli- (<1/10 000)
cations:
(1)

Serious bradycardias are rare. There have been isolated reports of progression to asystole.
(2) Occasionally, hypotension may require use of intravenous fluids and
reduction of the administration rate of propofol.
(3) Very rare reports of rhabdomyolysis have been received where propofol
has been given at doses greater than 4 mg/kg/hr for ICU sedation.
(4) May be minimised by using the larger veins of the forearm and antecubital fossa. With Propofol-Lipuro 2 % (20 mg/ml) local pain can also
be minimised by the co-administration of lidocaine.
(5) Combinations of these events, reported as “Propofol infusion syndrome”, may be seen in seriously ill patients who often have multiple
risk factors for the development of the events, see section 4.4.
(6) Brugada-type ECG - elevated ST-segment and coved T-wave in ECG.
(7) Rapidly progressive cardiac failure (in some cases with fatal outcome)
in adults. The cardiac failure in such cases was usually unresponsive to
inotropic supportive treatment.
(8) Abuse of and drug dependence on propofol, predominantly by health
care professionals.
(9) Not known as it cannot be estimated from the available clinical trial data.
(10) Necrosis has been reported where tissue viability has been impaired.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/
risk balance of the medicinal product. Healthcare professionals are asked
to report any suspected adverse reactions via the following:
United Kingdom
- Yellow card scheme:
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
4.9 Overdose
Accidental overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen.
Cardiovascular depression may require lowering the patient’s head and, if
severe, use of plasma expanders and pressor agents.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmaco therapeutic group: other general anaesthetics, ATC-code
N01AX10.
Mechanism of action, pharmacodynamic effect
After intravenous injection of Propofol-Lipuro 2 % (20 mg/ml), onset of
the hypnotic effect is rapid. Depending on the rate of injection, the time
to induction of anaesthesia is between 30 and 40 seconds. The duration
of action after a single bolus administration is short due to the rapid
metabolism and excretion (4 – 6 minutes).
With the recommended dosage schedule, clinically relevant accumulation
of propofol after repeated bolus injection or after infusion has not been
observed.
Patients recover consciousness rapidly.
Bradycardia and hypotension occasionally occur during induction of anaesthesia probably due to the lack of vagolytic activity. The cardio-circulatory situation usually normalises during maintenance of anaesthesia.
Paediatric population
Limited studies on the duration of propofol based anaesthesia in children
indicate safety and efficacy is unchanged up to duration of 4 hours. Literature evidence of use in children documents use for prolonged procedures
without changes in safety or efficacy.
5.2 Pharmacokinetic properties
Distribution
After intravenous administration about 98 % of propofol is bound to
plasma protein.
After intravenous bolus administration the initial blood level of propofol declines rapidly due to rapid distribution into different compartments
(α-phase). The distribution half-life has is 2 – 4 minutes.
During elimination the decline of blood levels is slower. The elimination
half-life during the β-phase is in the range of 30 to 60 minutes. Subsequently a third deep compartment becomes apparent, representing the
re-distribution of propofol from weakly perfused tissue.
The central volume of distribution is in the range of 0.2 – 0.79 l/kg body
weight, the steady-state volume of distribution in the range of 1.8 – 5.3 l/
kg body weight.
Biotransformation
Propofol is mainly metabolized in the liver to form glucuronides of propofol and glucuronides and sulphate conjugates of its corresponding quinol.
All metabolites are inactive.
Elimination
Propofol is rapidly cleared from the body (total clearance approx. 2 l/min).
Clearance occurs by metabolism, mainly in the liver, where it is blood flow
dependent. Clearance is higher in children compared with adults. About
88 % of an administered dose is excreted in the form of metabolites in
urine. Only 0.3 % is excreted unchanged in the urine.
Paediatric population
After a single dose of 3 mg/kg intravenously, propofol clearance/kg body
weight increased with age as follows: Median clearance was considerably
lower in neonates < 1 month old (n = 25) (20 ml/kg/min) compared to
older children (n = 36, age range 4 months – 7 years). Additionally interindividual variability was considerable in neonates (range 3.7 – 78 ml/kg/
min). Due to this limited trial data that indicates a large variability, no
dose recommendations can be given for this age group.
Median propofol clearance in older aged children after a single 3 mg/kg
bolus was 37.5 ml/min/kg (4 – 24 months) (n = 8), 38.7 mL/min/kg (11 –
43 months) (n = 6), 48 ml/min/kg (1 – 3 years) (n = 12), 28.2 ml/min/kg
(4 – 7 years) (n = 10) as compared with 23.6 ml/min/kg in adults (n = 6).
5.3 Preclinical safety data
Preclinical data reveal no specific hazard for humans based on conventional studies on repeated dose toxicity or genotoxicity. Carcinogenicity
studies have not been conducted.
Reproductive toxicity studies have shown effects related to pharmacodynamic properties of propofol only at high doses. Teratogenic effects have
not been observed.
In local tolerance studies, intramuscular injection resulted in tissue damage around the injection site.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients:
Soya-bean oil, refined,
Medium-chain triglycerides,
Glycerol,
Egg lecithin,
Sodium oleate,
Water for injections.
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products
except those mentioned in section 6.6.
6.3 Shelf life
2 years.
After first opening: to be used immediately.
6.4 Special precautions for storage
Do not store above 25 °C.
Do not freeze.
6.5 Nature and contents of container
The product is supplied in
• vials of colourless glass (type II Ph. Eur.) sealed with bromobutyl rubber
closure and aluminium caps, containing 50 ml of emulsion. It is available in packs of 1 x 50 ml, 10 x 50 ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handlings
Any unused product or waste material should be disposed of in accordance with local requirements.
Containers should be shaken before use.
For single use only. Any portion of contents remaining after use must be
discarded, see section 4.2 and 4.4.
If two layers can be seen after shaking the medicinal product should no
be used.
Propofol-Lipuro 20 mg/ml must not be mixed with other solutions for injection or infusion. However, co-administration of Propofol-Lipuro 20 mg/
ml together with glucose 50 mg/ml (5 % w/v) solution or sodium chloride
9 mg/ml (0.9 % w/v)solution, or sodium chloride 1.8 mg/ml (0.18 % w/v)
and glucose 40 mg/ml (4 % w/v)solution via a Y-connector close to the
injection site is possible.
7 MARKETING AUTHORISATION HOLDER
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
8 MARKETING AUTHORISATION NUMBER(S)
PA 0736/018/003 (Ireland)
PL 03551/0066 (United Kingdom)
9

DATE OF FIRST AUTHORISATION / RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 09 March 2004 (Ireland)
06 November 2002 (United Kingdom)
Date of last renewal: 23 November 2010
10 DATE OF REVISION OF THE TEXT
February 2016

B|BRAUN
B. Braun Melsungen AG
34209 Melsungen, Germany

✁----------✁----------✁----------✁----------✁----------✁----------✁----------✁----------✁--------

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

If you received more Propofol-Lipuro 2 % (20 mg/ml) than you
should
It is unlikely that this occurs because the doses you receive are very carefully controlled.
Yet if you accidentally got an overdose, this could lead to depression of
heart function, and breathing. In this case your doctor will employ any
necessary treatment immediately.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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

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

5. How to store Propofol-Lipuro 2 % (20 mg/ml)

A doctor must be called immediately if the following happen

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
label and the carton after EXP. The expiry date refers to the last day of
that month.
Do not store above 25°C. Do not freeze.
Propofol-Lipuro 2 % (20 mg/ml) must be used immediately after opening
the vial.
Do not use Propofol-Lipuro 2 % (20 mg/ml) if two separate layers can be
seen after shaking the product.
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 protect the environment.

Common (may affect up to 1 in 10 people):
• Low blood pressure that might occasionally need infusion of fluids and
reduction of the speed of administration of propofol.
• Too low heartbeat that might be serious in rare cases.
Rare (may affect up to 1 in 1,000 people):
• Convulsions like in epilepsy
Very rare (may affect up to 1 in 10,000 people):
• Allergic reactions including swelling of the face, tongue or throat,
wheezing breath, skin redness and low blood pressure
• There have been cases of unconsciousness occurring after operations.
You will therefore be carefully observed during the waking-up time.
• Water on lungs (lung oedema) after administration of propofol
• Inflammation of the pancreas.
Not known (frequency cannot be estimated from the available data):
• There have been reports of isolated cases of severe adverse reactions
presenting as a combination of the following symptoms: breakdown of
muscle tissue, accumulation of acidic (sour) substances in the blood,
abnormally high blood potassium level, high blood fat levels, abnormalities in the electrocardiogram (Brugada-type ECG), liver enlargement, irregular heart-beat, kidney failure and heart failure. This has
been called the “propofol infusion syndrome”. Some of the affected
patients eventually died. These effects have only been seen in patients
in intensive care with doses higher than 4 mg of propofol per kg body
weight per hour. See also section 2, ‘Warnings and precautions’.

Other side effects are:
Very common (affects more than 1 treated patient of 10):
• Pain at the injection site occurring during the first injection. The pain
may be reduced by injecting propofol into larger veins of the forearm.
Injection of lidocaine (a local anaesthetic) and propofol at the same
time also helps to reduce the pain at the injection site.
Common (may affect up to 1 in 10 people):
• Short interruption of breathing
• Headache during the time of recovery
• Sickness or vomiting during the time of recovery
Uncommon (may affect up to 1 in 100 people):
• Blood clots in veins or inflammation of veins at the injection site
Very rare (may affect up to 1 in 10,000 people):
• Loss of sexual control during the time of recovery
• Abnormal colour of urine after longer lasting administration of propofol
• Cases of fever after an operation
• Tissue damage after the medicine was accidentally injected outside of
a vein
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

6. Contents of the pack and other information
What Propofol-Lipuro 2 % (20 mg/ml) contains
• The active substance is propofol.
Each millilitre of Propofol-Lipuro 2 % (20 mg/ml) contains 20 mg of
propofol.
1 vial with 50 ml contains 1000 mg propofol.
• The other ingredients are:
Soya-bean oil refined,
Medium-chain triglycerides,
Egg lecithin,
Glycerol,
Sodium oleate,
Water for injections.

What Propofol-Lipuro 2 % (20 mg/ml) looks like and contents
of the pack
It is an emulsion for injection or infusion.
It is a milky-white oil-in water emulsion.
It comes in glass vials of 50 millilitres, available in packs of one or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany

Postal address:
34209 Melsungen, Germany

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

This medicinal product is authorised in the Member States of the
EEA under the following names:
Propofol-Lipuro 2 % (20 mg/ml):

Czech Republic, Ireland, Latvia,
Portugal, Spain, United Kingdom,
Poland, Slovakia
Propofol “B. Braun” 20 mg/ml:
Denmark
Propofol B. Braun 2 % (20 mg/ml): Italy
Propofol-Lipuro 20 mg/ml:
Austria, Estonia, Finland, France,
Germany, Hungary, Lithuania,
Luxembourg, Netherlands, Norway,
Slovenia, Sweden
Propofol-Lipuro 2 %:
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.

B|BRAUN
B. Braun Melsungen AG
34209 Melsungen, Germany

12608212_Propofol2_GIF-210x980__GB-IE.indd 2

29.02.16 15:04

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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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