Propofol B. Braun: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Propofol B. Braun 5 mg/ml emulsion for injection or infusion

Propofol
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Propofol B. Braun 5 mg/ml is and what it is used for.
What you need to know before using Propofol B. Braun 5 mg/ml.
How to use Propofol B. Braun 5 mg/ml.
Possible side effects.
How to store Propofol B. Braun 5 mg/ml.
Contents of the pack and other information.

1. What Propofol B. Braun 5 mg/ml is and what it is used for

Propofol B. Braun belongs to a group of medicines called general anaesthetics. General anaesthetics are used to induce a state of unconsciousness (sleep) so that surgical operations or other procedures can be performed. They may also be used to sedate you (so that you are asleep but not completely unconscious).
Propofol is used for:

inducing general anaesthesia in adults and children over one month of age;
sedating patients over 16 years of age during short diagnostic and surgical procedures, either alone or in combination with local or regional anaesthesia;
inducing sedation in adults and children over one month of age during diagnostic and surgical procedures.

2. What you need to know before using Propofol B. Braun 5 mg/ml

Do not use Propofol B. Braun 5 mg/ml

if you are allergic (hypersensitive) to propofol, soy, peanuts, or any of the excipients in this medicine (listed in section 6);
for maintenance of general anaesthesia or sedation during diagnostic and surgical procedures in children;
for sedation during intensive care.

Warnings and precautions
Talk to your doctor or pharmacist before Propofol B. Braun 5 mg/ml is administered to you.
Special caution is needed:

in case of severe head injuries,
in case of a mitochondrial disease,
in case of lipid metabolism disorders,
in case of conditions requiring particular caution with lipid emulsions,
in case of reduced blood volume (hypovolemia),
in case of marked weakness (debilitation) or cardiac, renal, or hepatic diseases,
in case of increased intracranial pressure,
in case of respiratory disorders,
in case of epilepsy,
if you are undergoing procedures during which spontaneous movements must be avoided.

Inform your doctor if you have any of these conditions or diseases.
If you are simultaneously receiving other lipids via intravenous infusion, your doctor will take into account the total daily amount of fat you are receiving.
Propofol will be administered by a doctor experienced in anaesthesia or intensive care. Continuous monitoring will be performed during anaesthesia and recovery.
If you develop signs of the so-called "propofol infusion syndrome" (for a detailed list of symptoms, see section 4 “Possible side effects”; in such case, a doctor must be called immediately), your doctor will immediately stop the propofol infusion.
See also section “Driving and using machines” for precautions to be taken after using propofol.

Children and adolescents
The use of Propofol B. Braun 5 mg/ml is not recommended in neonates.

Other medicines and Propofol B. Braun 5 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Propofol has been successfully used in combination with various regional anaesthesia techniques that numb only a specific part of the body (epidural and spinal anaesthesia).
In addition, the safety of its use has been demonstrated in combination with:

drugs administered before surgery,
other medicines such as muscle relaxants,
inhaled anaesthetics,
analgesics. However, your doctor may administer lower doses of propofol if general anaesthesia or sedation is required in addition to regional anaesthesia techniques. Special attention must be paid if you are concurrently receiving an antibiotic containing rifampicin – you may develop severely low blood pressure.

Propofol B. Braun 5 mg/ml and alcohol
Your doctor will provide you with information regarding alcohol consumption before or after administration of Propofol B. Braun 5 mg/ml.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Propofol B. Braun 5 mg/ml should not be used during pregnancy unless strictly necessary.
It crosses the placenta and may depress vital functions in the newborn. However, propofol may be used during induced abortion.
If you are breastfeeding, you must stop breastfeeding and discard breast milk for 24 hours following administration of Propofol B. Braun 5 mg/ml. Studies conducted in breastfeeding women have shown that propofol is excreted in small amounts in breast milk.

Driving and using machines
You must not drive or operate machinery after injection or infusion of Propofol B. Braun.
Your doctor will explain to you:

whether you need to be accompanied when leaving,
when you may resume driving and using machinery,
how to manage other sedative medicines (e.g., tranquilizers, strong analgesics, alcohol).

Propofol B. Braun 5 mg/ml contains sodium and soybean oil
This medicine contains less than 1 mmol (23 mg) of sodium in 20 ml, i.e., essentially “sodium-free”.
Propofol B. Braun 5 mg/ml contains soy. If you are allergic to peanuts or soy, do not use this medicine.

3. How to use Propofol B. Braun 5 mg/ml

Propofol B. Braun 5 mg/ml must be administered only by anaesthetists or specialist physicians
working in intensive care units.
Dosage
The dose to be administered depends on age, body weight and physical condition. The doctor
will administer the correct dose to induce anaesthesia or to achieve the desired level of sedation,
carefully monitoring the body's responses and vital signs (pulse, blood pressure,
respiration, etc.). If necessary, the doctor will also observe limits regarding duration of administration.
Propofol B. Braun 5 mg/ml is usually administered by injection to induce general anaesthesia. If used as a sedative,
it is generally administered by slow, continuous infusion using an appropriate device.
If administered by infusion, the medicinal product will be previously diluted.
The duration of administration of Propofol B. Braun 5 mg/ml must not exceed 1 hour.
Method of administration
Propofol B. Braun 5 mg/ml will be administered via intravenous injection or infusion, using a needle or a catheter inserted into a vein.
Circulation and respiration will be continuously monitored during injection or infusion.
If you have received more Propofol B. Braun 5 mg/ml than you should have
It is unlikely that this will occur, as administered doses are very carefully controlled.
However, accidental overdose may cause depression of cardiac and respiratory function. In such a case, the doctor will immediately take all necessary measures.
If you have any doubts about the use of Propofol B. Braun 5 mg/ml, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Call a doctor immediately if any of the following side effects occur
Common (may affect up to 1 in 10 people)

Low blood pressure, which in some cases may require fluid infusion and reduction of the propofol administration rate.
Slow heart rate, a serious event in rare cases.

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

Epileptic-type seizures.

Very rare (may affect up to 1 in 10,000 people)

Allergic reactions, including swelling of the face, tongue or throat, wheezing, flushed skin and low blood pressure.
Cases of postoperative unconsciousness have been reported. Patients will therefore be closely monitored during the recovery period.
Fluid in the lungs (pulmonary edema) after propofol administration.
Inflammation of the pancreas.

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

Isolated cases of serious adverse reactions characterized by a combination of the following symptoms have been reported: breakdown of muscle tissue, accumulation of acidic substances in the blood, excessively high potassium levels, elevated fat levels in the blood, changes in the electrocardiogram (Brugada-type ECG), liver enlargement, irregular heart rhythm, kidney failure and heart failure. This condition has been called "propofol infusion syndrome". Some affected patients have died. These effects have been observed only in intensive care patients receiving propofol doses exceeding 4 mg per kg of body weight per hour. See also section 2, "Warnings and precautions".

Other side effects:
Very common (affects more than 1 in 10 treated patients)

Pain at the injection site during the first injection. Pain can be reduced by injecting propofol into larger veins in the forearm. Simultaneous injection of lidocaine (a local anaesthetic) with propofol also helps reduce injection site pain.

Common (may affect up to 1 in 10 people)

Brief interruption of breathing.
Headache during the recovery period.
Nausea or vomiting during the recovery period.

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 inhibition during the recovery period.
Changes in urine colour following prolonged administration of propofol.
Cases of fever after surgery.
Tissue damage after accidental injection of the medicine outside the vein.

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

Involuntary movements.
Excessive feelings of euphoria.
Drug abuse and drug dependence.
Heart failure.
Weak breathing.
Pain and/or swelling at the injection site after accidental injection of the medicine outside the vein.
In very rare cases where propofol has been administered at doses higher than those recommended for sedation in intensive care units, breakdown of muscle tissue has been reported.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Propofol B. Braun 5 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "Exp.".
The expiry date refers to the last day of that month.
Store the vials in their outer packaging to protect them from light. Do not store above 25 °C. Do not freeze.
Propofol B. Braun 5 mg/ml should be used immediately after opening/dilution.
Do not use Propofol B. Braun 5 mg/ml if, after shaking the vial, two separate layers are visible.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Propofol B. Braun 5 mg/ml contains
The active substance is propofol.
Each millilitre of Propofol B. Braun 5 mg/ml contains 5 mg of propofol.
One 20 ml vial contains 100 mg of propofol.
The excipients are:
refined soybean seed oil,
medium-chain triglycerides,
egg lecithin,
glycerol,
sodium oleate,
water for injections.

Description of the appearance of Propofol B. Braun 5 mg/ml and contents of the pack
It is a white, milky emulsion for injection or infusion.
It is an oil-in-water emulsion.
It is available in 20 ml vials, with packs containing 5 vials.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1, 34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Tel.: +49/5661/71-0
Fax: +49/5661/71-4567

This medicinal product is authorised in the European Economic Area countries under the following names:
Propofol-Lipuro 0.5% (5 mg/ml): Czech Republic, Spain, Ireland, Portugal, Slovakia, United Kingdom.
Propofol B. Braun 5 mg/ml: Italy.
Propofol “B. Braun” 5 mg/ml: Denmark.
Propofol-Lipuro 5 mg/ml: Finland, France, Hungary, Norway, Poland, Sweden.
Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion: Austria, Germany, Luxembourg.

This patient information leaflet was last updated on

The following information is intended exclusively for healthcare professionals:

The containers are intended for single use in a single patient.
Any remaining solution should be discarded after administration.
The containers must be shaken before use.
For complete information on this medicinal product, refer to the Summary of Product Characteristics.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Propofol B. Braun 1% (10 mg/ml) injectable or infusion emulsion

Propofol
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Propofol B. Braun 10 mg/ml is and what it is used for
What you need to know before using Propofol B. Braun 10 mg/ml
How to use Propofol B. Braun 10 mg/ml
Possible side effects
How to store Propofol B. Braun 10 mg/ml
Contents of the pack and other information

1. What Propofol B. Braun 10 mg/ml is and what it is used for

Propofol B. Braun 10 mg/ml belongs to a group of medicines called general anesthetics. General anesthetics are used to induce a state of unconsciousness (sleep) so that surgical operations or other procedures can be performed. They may also be used to sedate you (so that you are asleep but not completely unconscious).
Propofol B. Braun 10 mg/ml is used for:

inducing and maintaining general anesthesia in adults and children over one month of age;
sedating patients over 16 years of age who are on mechanical ventilation in intensive care;
sedating adults and children over one month of age during diagnostic and surgical procedures, either alone or in combination with local or regional anesthesia.

2. What you should know before using Propofol B. Braun 10 mg/ml

Do not use Propofol B. Braun 10 mg/ml

if you are allergic (hypersensitive) to propofol, soy, peanuts, or any of the excipients in this medicine (listed in section 6).

This medicine must not be used in patients under 16 years of age for intensive care sedation. Safety and efficacy in these age groups have not been established.

Warnings and precautions

Talk to your doctor or pharmacist before you are given Propofol B. Braun 10 mg/ml.

Special caution is needed

in case of severe head injury,
in case of mitochondrial disease,
in case of lipid metabolism disorders,
in case of conditions requiring particular caution with lipid emulsions,
in case of reduced blood volume (hypovolemia),
in case of marked weakness (debilitation) or cardiac, renal, or hepatic disease,
in case of increased intracranial pressure,
in case of respiratory disorders,
in case of epilepsy,
if you are undergoing procedures during which spontaneous movements must be avoided.

Inform your doctor if you have any of these diseases or conditions. If you are simultaneously receiving other lipid infusions intravenously, your doctor will take into account the total daily fat intake.

Propofol will be administered by a physician experienced in anesthesia or intensive care. Continuous monitoring will be performed throughout the anesthesia and recovery phases.

If you develop signs of so-called "propofol infusion syndrome" (for a detailed list of symptoms, see section 4, "Possible side effects"; in such case, a doctor must be called), your doctor will immediately discontinue the propofol infusion.

See also the section "Driving and using machines" for precautions to be taken after the use of propofol.

Children and adolescents

The use of Propofol B. Braun is not recommended in neonates.

This medicine must not be used in patients aged 16 years or younger for intensive care sedation (see section "Do not use Propofol B. Braun 10 mg/ml").

Other medicines and Propofol B. Braun 10 mg/ml

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

Propofol has been successfully used in combination with various regional anesthesia techniques that numb only a specific part of the body (epidural and spinal anesthesia).

Furthermore, the safety of its use in combination with the following has been demonstrated:

medications administered before surgery,
other medicines such as muscle relaxants,
inhaled anesthetics,
analgesics.

However, your doctor may administer lower doses of propofol if general anesthesia or sedation is required in addition to regional anesthesia techniques. Special attention must be paid if you are concurrently receiving an antibiotic containing rifampicin — you may develop severely low blood pressure.

Propofol B. Braun 10 mg/ml and alcohol

Your doctor will provide you with information regarding alcohol consumption before or after administration of Propofol B. Braun 10 mg/ml.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Propofol B. Braun must not be used during pregnancy unless strictly necessary. It crosses the placenta and may depress vital functions in the newborn.

However, propofol may be used during induced abortion.

If you are breastfeeding, you must stop breastfeeding and discard breast milk for 24 hours following administration of Propofol B. Braun 10 mg/ml. Studies conducted in breastfeeding women have shown that propofol is excreted in small amounts in breast milk.

Driving and using machines

You must not drive or operate machinery after injection or infusion of Propofol B. Braun 10 mg/ml.

Your doctor will explain to you

whether you need to be accompanied when leaving,
when you may resume driving and operating machinery,
how to use other sedative medicines (e.g., tranquilizers, strong analgesics, alcohol).

Propofol B. Braun 10 mg/ml contains sodium and soybean oil

This medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, i.e., it is essentially "sodium-free".

Propofol B. Braun contains soy. If you are allergic to peanuts or soy, do not use this medicine.

3. How to use Propofol B. Braun 10 mg/ml

Propofol B. Braun 10 mg/ml must be administered only by anaesthetists or physicians specialised in intensive care units.
Dosage
The dose to be administered depends on age, body weight, and physical condition. The doctor will administer the appropriate dose to induce and maintain anaesthesia or to achieve the desired level of sedation, carefully monitoring the body's responses and vital signs (pulse, blood pressure, respiration, etc.). If necessary, the doctor will also observe the limits regarding duration of administration.
Propofol B. Braun 10 mg/ml is usually administered by injection to induce general anaesthesia and by continuous infusion (a longer, slower injection) when used to maintain general anaesthesia. It may be administered as either diluted or undiluted infusion. When used as a sedative, it is generally administered by infusion.
The duration of administration of Propofol B. Braun 10 mg/ml must not exceed 7 days.
Method of administration
Propofol B. Braun 10 mg/ml will be administered by intravenous injection or infusion, i.e. through a needle or a catheter inserted into a vein.
Since Propofol B. Braun 10 mg/ml does not contain preservatives, the infusion from a single vial of Propofol B. Braun 10 mg/ml must not last longer than 12 hours. The infusion from a container of diluted Propofol B. Braun 10 mg/ml must not last longer than 6 hours.
Circulation and respiration will be continuously monitored during injection or infusion.
If you have been given more Propofol B. Braun 10 mg/ml than you should have received
This is unlikely to occur, as administered doses are very carefully controlled.
However, accidental overdose may cause depression of cardiac and respiratory function. In such a case, the doctor will immediately take all necessary measures.
If you have any doubts about the use of Propofol B. Braun 10 mg/ml, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact a doctor immediately if any of the following side effects occur.
Common (may affect up to 1 in 10 people):

Low blood pressure, which in some cases may require fluid infusion and reduction of the propofol administration rate.
Slow heart rate, a serious event in rare cases.

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

Epileptic-type seizures.

Very rare (may affect up to 1 in 10,000 people):

Allergic reactions, including swelling of the face, tongue or throat, wheezing, red skin rash, and low blood pressure.
Cases of postoperative unconsciousness have been reported. Therefore, patients will be closely monitored during the recovery period.
Fluid in the lungs (pulmonary edema) after administration of propofol.
Inflammation of the pancreas.

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

Isolated cases of serious adverse reactions have been reported, characterized by a combination of the following symptoms: breakdown of muscle tissue, accumulation of acidic substances in the blood, excessively high potassium levels, elevated blood fat levels, changes in the electrocardiogram (ECG Brugada pattern), liver enlargement, irregular heartbeat, kidney failure, and heart failure. This condition has been called "propofol infusion syndrome". Some affected patients have died. These effects have been observed only in intensive care patients receiving propofol doses exceeding 4 mg per kg of body weight per hour. See also section 2, "Warnings and precautions".

Other side effects:
Very common (affects more than 1 in 10 treated patients):

Pain at the injection site during the first injection. Pain can be reduced by injecting propofol into larger veins in the forearm. Simultaneous injection of lidocaine (a local anaesthetic) with propofol also helps reduce pain at the injection site.

Common (may affect up to 1 in 10 people):

Brief interruption of breathing
Headache during the recovery period
Nausea or vomiting during the recovery period

Uncommon (may affect up to 1 in 100 people):

Blood clots in veins or inflammation of the veins

Very rare (may affect up to 1 in 10,000 people):

Loss of sexual inhibition during the recovery period
Changes in urine colour following prolonged administration of propofol
Cases of fever after surgery
Tissue damage after accidental extravasation of the medicine (injection outside the vein)

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

Involuntary movements
Excessive elation
Drug abuse and drug dependence
Heart failure
Weak breathing
Pain and/or swelling at the injection site after accidental extravasation of the medicine
In very rare cases where propofol has been administered at doses higher than those recommended for sedation in intensive care units, breakdown of muscle tissue has been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Propofol B. Braun

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 carton after “Exp.”
The expiry date refers to the last day of that month.
Do not store above 25 °C. Do not freeze.
Propofol B. Braun 10 mg/ml should be used immediately after opening the vial or ampoule.
Diluted solutions of Propofol B. Braun 10 mg/ml must be used immediately after preparation.
Do not use Propofol B. Braun 10 mg/ml if, after shaking the product, two separate layers are visible.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Propofol B. Braun 10 mg/ml contains
The active substance is propofol.
Each millilitre of Propofol B. Braun 10 mg/ml contains 10 mg of propofol.
One 10 ml vial contains 100 mg of propofol.
One 20 ml vial contains 200 mg of propofol.
One 50 ml vial contains 500 mg of propofol.
One 100 ml vial contains 1,000 mg of propofol.

The excipients are:
refined soybean oil,
medium-chain triglycerides,
egg lecithin,
glycerol,
sodium oleate,
water for injections.

Description of the appearance of Propofol B. Braun 10 mg/ml and package contents
It is an injectable or infusion emulsion.
It is a white, milky, oil-in-water emulsion.
It is available in:

10 ml vials, packs of 10 vials
20 ml vials, packs of 5 vials
50 ml or 100 ml vials, packs of 1 or 10 vials
20 ml vials, packs of 10 vials

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Tel.: +49/5661/71-0
Fax: +49/5661/71-4567

This medicinal product is authorised in the European Economic Area Member States under the following names:
Propofol-Lipuro 1% (10 mg/ml): Czech Republic, Ireland, Malta, Poland, Portugal, Slovakia, United Kingdom.
Propofol B. Braun 1% (10 mg/ml): Italy.
Propofol “B. Braun” 10 mg/ml: Denmark.
Propofol-Lipuro 10 mg/ml: Austria, Estonia, Finland, France, Germany, Hungary, Latvia, Lithuania, Luxembourg, Netherlands, Slovenia, Spain, Sweden, Norway.
Propofol-Lipuro 1%: Cyprus, Greece.

This Patient Information Leaflet was last revised on

The following information is intended for healthcare professionals only:

The containers are for single use in a single patient only.
Any remaining solution should be discarded after administration.
The containers must be shaken before use.
For complete information on this medicinal product, refer to the Summary of Product Characteristics.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Propofol B. Braun 20mg/ml injectable emulsion for infusion

Propofol
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Propofol B. Braun 20 mg/ml is and what it is used for
What you need to know before using Propofol B. Braun 20 mg/ml
How to use Propofol B. Braun 20 mg/ml
Possible side effects
How to store Propofol B. Braun 20 mg/ml
Contents of the pack and other information

7. What Propofol B. Braun 20 mg/ml is and what it is used for

Propofol B. Braun 20 mg/ml belongs to a class of medicines called general anaesthetics.
General anaesthetics are used to induce a state of unconsciousness (sleep) so that surgical or other procedures can be performed.
These medicines may also be used for sedation (inducing a state of drowsiness, but not complete sleep).
Propofol B. Braun 20 mg/ml is used for:

Induction and maintenance of general anaesthesia in adults and children >3 years.
Sedation of patients >16 years who are on mechanical ventilation in intensive care.
Sedation of adults and children >3 years during diagnostic or surgical procedures, either alone or in combination with local or regional anaesthesia.

8. What you need to know before using Propofol B. Braun 20 mg/ml

Do not use Propofol B. Braun 20 mg/ml

if you are allergic (hypersensitive) to propofol, soy, peanuts, or any of the excipients in this medicine (listed in section 6). This medicine must not be used in patients under 16 years of age for sedation during intensive care therapy. Safety and efficacy in this age group have not been established.

Warnings and precautions
Talk to your doctor or pharmacist before you are given Propofol B. Braun 20 mg/ml.
Special caution is needed:

if you have severe head injuries,
if you have a mitochondrial disease,
if you have lipid metabolism disorders,
if you have conditions requiring particular caution with lipid emulsions,
if you have reduced blood volume (hypovolemia),
if you are weakened (debilitated) or have heart, kidney, or liver disease,
if you have increased intracranial pressure,
if you have respiratory disorders,
if you have epilepsy,
if you are undergoing procedures where spontaneous movements must be avoided. Inform your doctor if you have any of these conditions.

If you are simultaneously receiving other lipid infusions intravenously, your doctor will take into account the total daily fat intake. Propofol will be administered by a doctor experienced in anesthesia or intensive care. Continuous monitoring will be performed during anesthesia and recovery.
If you develop signs of so-called "propofol infusion syndrome" (for a detailed list of symptoms, see section 4, "Possible side effects"; in such case, a doctor must be called immediately), your doctor will stop the propofol infusion immediately.
See also the section "Driving and using machines" for precautions to be taken after using propofol.
Children and adolescents
The use of Propofol B. Braun is not recommended in children under 3 years of age.
This medicine must not be used in patients aged 16 years or younger for sedation in 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 B. Braun 20 mg/ml").
Other medicines and Propofol B. Braun 20 mg/ml
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Propofol has been successfully used in combination with various regional anesthesia techniques that numb only a part of the body (epidural and spinal anesthesia).
In addition, safety has been demonstrated when used in combination with:

preoperative medications,
other medicines such as muscle relaxants,
inhaled anesthetics,
painkillers. However, your doctor may administer lower doses of propofol if general anesthesia or sedation is required in addition to regional anesthesia techniques. Special attention must be paid if you are concurrently receiving an antibiotic containing rifampicin – you may develop severely low blood pressure.

Propofol B. Braun 20 mg/ml and alcohol
Your doctor will provide information regarding alcohol consumption before or after administration of Propofol B. Braun 20 mg/ml.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Propofol B. Braun 20 mg/ml is not recommended during pregnancy unless strictly necessary. It crosses the placenta and may depress vital functions in the newborn. However, propofol may be used during induced abortion.
Breastfeeding women are advised to stop breastfeeding and discard breast milk for 24 hours following administration of Propofol B. Braun 20 mg/ml. Studies in breastfeeding women have shown that propofol is excreted in small amounts in breast milk.
Driving and using machines
Do not drive or operate machinery after injection or infusion of Propofol B. Braun 20 mg/ml.
Your doctor will explain to you:

whether you need to be accompanied when leaving,
when you may resume driving and operating machinery,
how to manage other sedative drugs (e.g., tranquilizers, strong painkillers, alcohol).

Propofol B. Braun 20 mg/ml contains sodium and soybean oil
This medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, i.e., it is essentially "sodium-free".
Propofol B. Braun 20 mg/ml contains soy. If you are allergic to peanuts or soy, do not use this medicine.

9. How to use Propofol B. Braun 20 mg/ml

Propofol B. Braun 20 mg/ml must be administered only by anaesthetists or specialist physicians working in intensive care units.
Dosage
The dose to be administered depends on age, body weight, and physical condition. The doctor will administer the correct dose to induce and maintain anaesthesia or to achieve the desired level of sedation, carefully monitoring the body's responses and vital signs (pulse, blood pressure, respiration, etc.).
If necessary, the doctor will also observe limits regarding duration of administration.
Propofol B. Braun 20 mg/ml is usually administered by injection to induce general anaesthesia and by continuous infusion (a longer, slower injection) to maintain anaesthesia. When used as a sedative, it is generally administered by infusion.
The duration of administration of Propofol B. Braun 20 mg/ml must not exceed 7 days.
Method of administration
Propofol B. Braun 20 mg/ml will be administered via intravenous injection or infusion, using a needle or a small tube inserted into a vein.
Since Propofol B. Braun 20 mg/ml does not contain preservatives, the infusion from a single vial of Propofol B. Braun 20 mg/ml must not last longer than 12 hours.
Circulation and respiration will be continuously monitored during injection or infusion.
If you receive more Propofol B. Braun 20 mg/ml than you should
This is unlikely to occur, as the administered doses are very carefully controlled.
However, accidental overdose may cause depression of cardiac and respiratory function. In such a case, the doctor will immediately take all necessary measures.
If you have any doubts about the use of Propofol B. Braun 20 mg/ml, consult your doctor or pharmacist.

10. Possible side effects

Low blood pressure, which in some cases may require fluid infusion and reduction of the propofol administration rate.
Slow heart rate, a serious event in rare cases.

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

Epileptic-type seizures

Very rare (may affect up to 1 in 10,000 people):

Allergic reactions, including swelling of the face, tongue or throat, wheezing, flushed skin and low blood pressure.
Cases of postoperative unconsciousness have been reported. Patients will therefore be closely monitored during the recovery period.
Fluid in the lungs (pulmonary edema) after propofol administration.
Inflammation of the pancreas.

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

Isolated cases of serious adverse reactions have been reported, characterized by a combination of the following symptoms: muscle tissue breakdown, accumulation of acidic substances in the blood, excessively high potassium levels, elevated fat levels in the blood, changes in the electrocardiogram (Brugada-type ECG), liver enlargement, irregular heart rhythm, kidney failure and heart failure. This condition has been termed "propofol infusion syndrome". Some affected patients have died. These effects have only been observed in intensive care patients receiving propofol doses exceeding 4 mg per kg of body weight per hour. See also section 2, "Warnings and precautions".

Other side effects:
Very common (affects more than 1 in 10 treated patients):

Pain at the injection site during the first injection. Pain may be reduced by injecting propofol into larger veins in the forearm. Simultaneous injection of lidocaine (a local anaesthetic) with propofol also helps reduce injection site pain.

Common (may affect up to 1 in 10 people):

Brief interruption of breathing.
Headache during the recovery period.
Nausea or vomiting during the recovery period.

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 inhibition during the recovery period.
Changes in urine colour following prolonged administration of propofol.
Cases of fever after surgery.
Tissue damage after accidental extravasation of the medicine (injection outside the vein).

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

Involuntary movements.
Excessively elevated mood.
Drug abuse and drug dependence.
Heart failure.
Weak breathing.
Pain and/or swelling at the injection site after accidental extravasation of the medicine.
In very rare cases where propofol was administered at doses higher than those recommended for sedation in intensive care units, muscle tissue breakdown has been reported.

11. How to store Propofol B. Braun 20 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP".
The expiry date refers to the last day of that month.
Do not store above 25 °C. Do not freeze.
Propofol B. Braun 20 mg/ml should be used immediately after opening the vial.
Do not use Propofol B. Braun 20 mg/ml if, after shaking the product, two separate layers are visible.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

12. Package contents and other information

What Propofol B. Braun 20 mg/ml contains
The active substance is propofol.
Each millilitre of Propofol B. Braun 20 mg/ml contains 20 mg of propofol.
One 50 ml vial contains 1,000 mg of propofol.
The excipients are:
refined soya oil,
medium-chain triglycerides,
egg lecithin,
glycerol,
sodium oleate,
water for injections.

Description of the appearance of Propofol B. Braun 20 mg/ml and contents of the pack
It is an injectable or infusion emulsion.
It is a white, milky, oil-in-water emulsion.
It is available in 50 ml vials, packs containing 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
Tel.: +49/5661/71-0
Fax: +49/5661/71-4567

This medicinal product is authorised in the European Economic Area countries under the following
names:
Propofol-Lipuro 2% (20 mg/ml): Czech Republic, Ireland, Latvia, Poland, Portugal, United Kingdom, Slovakia, Spain.
Propofol “B.Braun” 20 mg/ml: Denmark.
Propofol B. Braun 2%: Italy.
Propofol-Lipuro 20 mg/ml: Austria, Estonia, Finland, France, Germany, Lithuania, Luxembourg, Norway, Netherlands, Slovenia, Sweden, Hungary.
Propofol-Lipuro 2%: Greece.

This summary of product characteristics was last reviewed on

The following information is intended exclusively for healthcare professionals:

The containers are intended for single use in a single patient.
Any remaining solution residues must be discarded after administration.
The containers must be shaken before use.
For complete information on this medicinal product, refer to the Summary of Product Characteristics.