Propofol 10 mg / ml emulsion for injection/infusion – patient leaflet, side effects, dosage

1. What Propofol 10 mg/ml is and what it is used for 2. What you need to know before you are given Propofol

10 mg/ml

1. 3. How you are given Propofol 10 mg/ml
2. 4. Possible side effects
3. 5. How to store Propofol 10 mg/ml
4. 6. Contents of the pack and other information.
5. 1. What Propofol 10 mg/ml is and what it is used for

Propofol 10 mg/ml contains an active substance called propofol. Propofol 10 mg/ml belongs to a group of medications that are called general anaesthetics. General anaesthetics are used to trigger unconsciousness (a type of sleep), so that surgeries and other treatments can be performed. They can also be used for sedation (so that you are sleepy but are not really sleeping).

Propofol 10 mg/ml is used for:

• To put patients to sleep (called induction of

  anaesthesia) and to keep patients asleep (called maintenance of anaesthesia) in adults and children from 1 month of age,

• Sedation (calming) of ventilated patients over 16 years

  of age during intensive care,

• Sedation of adults and children from 1 month of age

  for surgical and diagnostic procedures, alone or in combination with local or regional anaesthesia (local anaesthetic).

2. What you need to know before you are given Propofol

10 mg/ml

Do not use Propofol 10 mg/ml :

• If you are allergic to propofol, soybeans, peanuts or

  any of the other ingredients of this medicine (listed in section 6).

• for the sedation of patients aged 16 years or younger

  as part of intensive care.

Warnings and precautions

Talk to your doctor, anaesthetist or nurse before using Propofol10 mg/ml:

• If you have ever had a fit or convulsion.

• If you have ever been told that you have very high

  levels of fat in your blood.

• If you have ever been told that your body has problems

  using fat.

• If your body has lost lots of water hypvolemia .

• If you have any other health problems, such as

  problems with your heart, breathing, kidneys or liver.

• If you have been generally unwell for some time.
• If you have mitochondrial disease.

You may feel affected after using Propofol. You should therefore be accompanied by someone when you leave the hospital.

Children and adolescent

The use of Propofol 10 mg/ml in newborns is not recommended, since this patient group has not been sufficiently evaluated.

Propofol may not be used for sedation in patients 16 years of age or younger during intensive care, since the safety and efficacy of Propofol has not been validated for sedation in this age group.

Elderly

In the case of elderly patients, smaller doses are required for the induction of anaesthesia with Propofol 10 mg/ml. The patient’s general state of health and age should be taken into account. The lowered dose should be administered more slowly and titrated according to the reaction.

Other medicines and Propofol 10 mg/ml

Tell your doctor if you are taking/using, have recently taken/used or might take/use any other medicines.

In particular, tell your doctor, anaesthetist or nurse if you are taking any of the following medicines:

• Rifampicin because it can cause low blood pressure in

  connection with general anesthesia.

• Certain sedative and analgesic medicines such as

  benzodiazepines and opiates as they may increase the effects of propofol

• Valproate as a reduction in the dose for propofol should

  be considered if it used concomitantly with propofol

Propofol 10 mg/ml with food, drink and alcohol

You may not ingest any alcohol after the administration of Propofol 10 mg/ml .

Pregnancy, 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

Package leaflet: Information for the user

Propofol 10 mg/ml Emulsion for injection/infusion

propofol

Pregnancy

Propofol 10 mg/ml should only be used during pregnancy if absolutely necessary.

Breast-feeding

Studies with breast-feeding women have shown that Propofol passes into breast milk in small quantities.

Therefore, mothers should suspend breast-feeding for up to 24 hours after administration of Propofol and discard the corresponding breast milk.

Driving and using machines

After having propofol, you may still feel sleepy for some time. Do not drive or use any tools or machines until you are sure the effects have worn off.

• If you are able to go home shortly after having Propofol

  10 mg/ml , do not drive a car or use any tools or machines.

• Ask your doctor when you can start doing these activities again and when you can go back to work.

Propofol 10 mg/ml contains soya bean oil

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

Propofol 10 mg/ml contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

3. How to you are given Propofol 10 mg/ml

Propofol 10 mg/ml will be given to you as an injection or infusion into a vein. This is usually in the back of your hand or in your forearm.

Propofol 10 mg/ml may only be administered by doctors that have been trained in anaesthesiology or intensive care. Sedation or anaesthesia with Propofol 10 mg/ml and the surgical or diagnostic procedure may not be performed by the same person.

You may need several different medicines to keep you asleep or sleepy, free from pain, breathing in a healthy way and to keep your blood pressure steady. The doctor will decide which medicines you need and when you need them.

Dosage

The administered dose varies depending on the age, body weight, the general physical state of health and the premedication. The doctor will use appropriate dose for induction and maintenance of anaesthesia or for achieveing the required depth of sedation, while carefully observing the physical responses and vital signs (pulse, blood pressure, breathing, etc).

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

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

Possible side effects:

The induction and maintenance of anaesthesia and sedation with Propofol is normally gentle with only a few signs of excitation. The most frequently reported side effects are a decrease in blood pressure and impairment of the response from the breathing centre (respiratory depression). The type, severity and frequency of these effects, which were observed in patients that were receiving Propofol, are dependent on the patient’s state of health, the type of procedure and the therapeutic measures taken.

The following side effects were particularly observed:

Very common (may affect more than 1 in 10 people)

• Local pain during the first injection

Common (may affect up to 1 in 10 people)

• Spontaneous movements and muscle spasms during induction of anaesthesia, Headache during the waking phase
• Slowed pulse
• Decrease in blood pressure

• Condition in which you start to breathe very fast

  (Hyperventilation) and coughing during induction of anaesthesia, temporary ineffective breathing (respiratory arrest) during induction of anaesthesia

• Hiccups during the induction, nausea and vomiting during the waking phase
• Hot flushes during the induction of anaesthesia

Uncommon (may affect up to 1 in 100 people)

• Clotting of the blood in a part of the circulatory system

  (Thrombosis) and vein inflammation

• Coughing during maintenance of anaesthesia

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

• Feeling of dizziness, chills and perception of cold during the waking phase
• Episodes similar to epilepsy with seizures and spasm of the muscles causing backward arching of the head, neck, and spine (opisthotonus) during induction, maintenance and the
• Waking phase (very rarely delayed by hours to a few days)
• Coughing during the waking phase

Instructions for handling

Propofol 10 mg/ml may only be administered by doctors that have been trained in anaesthesiology orintensive care. Sedation or anaesthesia with Propofol 10 mg/ml and the surgical or diagnostic procedure may not be performed by the same person.

The heart, circulation and breathing should be continuously monitored (e.g., ECG, pulse oxymetry) The customary equipment forpossible accidents during anaesthesia or sedation must be ready for use at all times.

Instructions regarding shelf life after opening or after preparation

Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C.

Shelf life after dilution: The mixture should be prepared aseptically (controlled and validated conditions preserved) immediately prior to administration and must be administered within 12 hours after preparation.

After opening the product must be used immediately.

For single use only. Any unused emulsion must be discarded.

Instructions for use

Prior to use, the rubber stopper must be cleaned with alcohol spray or a swab dipped in alcohol.

The vials should be shaken before use.

Propofol 10mg/ml is administered intravenously, either undiluted from plastic syringes or glass vials or as a mixture with 5% glucose solution in PVC bags or glass vials.

Propofol 10mg/ml does not contain any antimicrobial preservation media and growth of microorganisms is facilitated due to its composition.

The emulsion must be drawn into a sterile syringe or a sterile administration device under aseptic conditions immediately after breaking the seal on the vial. The administration must be started immediately.

Strict asepsis must be adhered to both Propofol 10 mg/ml and for the infusion equipment used during the period of infusion. The addition of drugs or fluids in to the ongoing infusion of Propofol 10 mg/ml must occur in close proximity to the cannula. When using Propofol 10mg/ml, no bacteria filters may be used.

In the case of simultaneous parenteral nutrition, the fat administered with Propofol 10 mg/ml should be taken into account. 1.0 ml Propofol 10 mg/ml contains 0.1 g of fat.

Infusion of undiluted Propofol 10 mg/ml

For an infusion of undiluted Propofol 10mg/ml, an infusion pump or a volumetric pump should be employed.

The duration of an infusion of Propofol 10 mg/ml from one infusion system may not exceed 12 hours, as is customary for fat emulsions. At the end of the infusion, but after 12 hours at the

latest, residual quantities of Propofol 10 mg/ml and the infusion system may not be further used; if necessary, the infusion system must be changed out.

Infusion of diluted Propofol 10 mg/ml

The infusion of diluted Propofol 10 mg/ml must occur by means of a controllable infusion system (burette or volumetric pump), in order to prevent the accidental administration of larger quantities of Propofol 10mg/ml.

Propofol should only be mixed with the following products: glucose 50 mg/ml (5%) solution for injection, sodium chloride 9 mg/ml (0.9%) solution for injection or sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) solution for injection, and preservative-free lidocaine 10 mg/ml (1%) solution for injection. Final propofol concentration must not be below 2 mg/ml.

Co-administration of Propofol 10 mg/ml together with glucose 50 mg/ml (5%) solution for injection, sodium chloride 9 mg/ml (0.9%) solution for injection or sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) solution for injection via Y-piece connector close to the injection site is possible.

The maximum dilution must not exceed 1 part of Propofol with 4 parts of 5% w/v glucose solution, 0.9% w/v sodium chloride solution, 0.18% sodium chloride & 4% dextrose solution (minimum concentration 2 mg propofol/ml). The mixture should be prepared aseptically (controlled and validated conditions preserved) immediately prior to administration and must be administered within 12 hours after preparation.

To reduce pain at the injection site, lidocaine may be injected immediately before the use of Propofol or Propofol may be mixed, immediately before use, with preservative free lidocaine injection (20 parts of Propofol with up to 1 part of 1% lidocaine injection solution) under controlled and validated aseptical conditions. The mixture has to be administered within 12 hours after preparation.

The muscle relaxants Atracurium and Mivacurium should not be administered through the same intravenous access as Propofol 10mg/ml without first rinsing it out.

The content of a vial and the infusion system are only intended for a single use in one patient. Any unused emulsion must be discarded.

Posology

Anaesthesia for adults

Induction of anaesthesia

For the induction of anaesthesia, Propofol 10mg/ml is administered, titrated at a speed of 20 - 40 mg Propofol every 10 seconds, until unconsciousness occurs. Most adults less than 55 years of age would normally require a total dose of 1.5 - 2.5 mg Propofol/kg of body weight.

For patients in risk groups ASA III and IV, especially in the case of prior cardiac damage and elderly patients, it may be necessary to reduce the total dosage of Propofol 10mg/ml down to 1 mg Propofol/kg of body mass, whereby Propofol 10mg/ml is administered at a slower infusion speed (approximately 20 mg

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

• Severe allergic reactions (anaphylaxis), which can

  include angiooedema, respiratory distress due to bronchial cramping, skin redness and a decrease in blood pressure

• Being unconsciousness after operation

• Buildup of fluid in the lungs which can make you very

  breathless (may also happen when you wake up).

• Inflammation of the pancreas

• Discolouration of urine after longer periods of

  administration of Propofol 10 mg/ml

• Sexual disinhibition
• Tissue damage
• Fever after surgery

Not known: The frequency cannot be estimated on the basis of the available data

• Excess acid in the blood caused by metabolic functions

  (metabolic acidosis)

• Elevated potassium values in the blood
• Elevated blood lipid values
• Euphoric mood during the waking phase
• Abuse of the drug and dependency on the drug
• Involuntary movements
• Cardiac arrhythmia,
• Heart failure

• Ineffective breathing (Respiratory depression

  depending on the dosage)

• Liver enlargement
• Dissolution of striated muscle fibres (rhabdomyolysis)
• Kidney failure

• Local pain, swelling after erroneous extravascular

  application

• Prolonged, often painful erection (priapism)
• ECG changes

• Hepatitis (inflammation of the liver), acute liver failure

  (symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right-hand side), sometimes with loss of appetite).

After simultaneous administration of lidocaine, the following side effects can occur rarely:

• Dizziness
• Vomiting
• Drowsiness, convulsions
• Bradycardia
• Arrhythmia
• Shock.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 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

Website: www.hpra.ie

5. How to store Propofol 10 mg/ml

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

Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP. The expiry date refers to the last day of that month.

Store below 25° C.

Do not freeze.

After opening the product must be used immediately.

Dilutions with glucose 50 mg/ml (5%) solution for injection, sodium chloride 9 mg/ml (0.9%) solution for injection or sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) solution for injection and preservative-free lidocaine 10 mg/ml (1%) solution for injection. The mixture should be prepared aseptically (controlled and validated conditions preserved) immediately prior to administration and must be administered within 12 hours after preparation.

Containers should be shaken before use.

If two layers can be seen after shaking the emulsion should not be used.

Use only homogeneous preparations and undamaged containers.

For single use. Any unused emulsion must be discarded. Your anaesthetist and hospital pharmacist are responsible for the correct storage, use and disposal of Propofol.

6. Contents of the pack and other information

What Propofol 10 mg/ml contains:

The active substance is propofol.

Each ml of emulsion for injection/infusion contains 10 mg of propofol.

Each 20 ml vial contains 200mg of propofol

Each 50 ml vial contains 500mg of propofol

Each 100 ml vial contains1000mg of propofol.

The other ingredients are: Soya-bean oil refined, Medium-chain triglycerides, Glycerol, Egg lecithin, Sodium oleate, Sodium Hydroxide (for pH adjustment) and Water for injections.

What Propofol 10 mg/ml looks like and the content of the pack

White oil-in-water emulsion for injection/infusion. This medicinal product is supplied as:

Emulsion for injection/infusion in colourless glass vial (type II glass) with grey bromo butyl rubber stopper.

Pack sizes:

Colourless glass vial (type II) of 20 ml with grey bromobutyl rubber closure, packs of 1, 5 and 10 unit

Colourless glass vial (type II) of 50 ml with grey bromobutyl rubber closure, packs of 1 and 10 unit

Colourless glass vial (type II) of 100 ml with grey bromobutyl rubber closure, packs of 1 and 10 unit

Not all pack sizes may be marketed.

Marketing Authorisation Holder

United Kingdom

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk IP24 3SE, United Kingdom.

Ireland:

Baxter Holding B.V.

Kobaltweg 49,

3542CE Utrecht, Netherlands

Manufacturer:

Baxter

Boulevard René Branquart, 80

7860 Lessines

Belgium

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

This Leaflet was last revised in 08/2025.

Medical information leaflet The following information is only intended for healthcare professionals:

This informational leaflet is an abbreviated form of the summary of product characteristics (SPC). Please consult the full SPC for further information.

Propofol every 10 seconds).

Maintenance of anaesthesia

The anaesthesia can be maintained with a long-term infusion or repeated bolus injections of Propofol 10mg/ml.

Continuous infusion

For maintenance of anaesthesia by means of continuous infusion, the dosage and infusion speed must be adjusted for each individual. Normally, the dosage is 4 - 12 mg Propofol/kg of body mass per hour in order to maintain a satisfactory level of anaesthesia.

In the case of elderly patients in a poor general state of health or with hypovolemia and patients in the risk groups ASA III and IV, the dosage may be reduced down to 4 mg Propofol/kg of body mass per hour.

Repeated bolus injection

For maintenance of anaesthesia by means of repeated bolus injection, generally 25 - 50 mg Propofol (2.5 - 5 ml Propofol 10mg/ml) are subsequently injected.

Anaesthesia in children from 1 month of age

Induction of anaesthesia

For the induction of anaesthesia, Propofol 10mg/ml is titrated slowly until clinical signs can be seen that indicate the start of anaesthesia. The dose should be adjusted based on the age and/or body weight. Most children over 8 years of age require approximately 2.5 mg Propofol/kg of body mass for induction of anaesthesia. In the case of younger children, especially those in the age range of 1 month to 3 years, the required dose may be higher (2.5 - 4 mg Propofol/kg of body mass). Lower doses are recommended for patients in the risk groups ASA III and IV.

Maintenance of anaesthesia

Maintenance of the required depth of anaesthesia can be achieved with the administration of Propofol 10mg/ml by means of an infusion or repeated bolus administration. The required dosage rates vary considerably among patients, however a satisfactory state of anaesthesia is normally achieved at doses in the range of 9 - 15 mg Propofol/kg of body mass per hour. In the case of younger children, especially those in the age range of 1 month to 3 years, the required dose may be higher.

Lower doses are recommended for patients in the risk groups ASA III and IV.

Sedation of patients over 16 years of age during intensive care.

For the sedation of ventilated patients during intensive care, Propofol 10mg/ml should be administered as a continuous infusion. The dosage is based on the desired depth of sedation. Normally, the desired depths of sedation can be achieved with doses in the range of 0.3 - 4.0 mg Propofol/kg of body mass per hour.

Propofol 10mg/ml may not be used for the sedation of children aged 16 years or younger as part of intensive care. The administration of Propofol 10mg/ml by means of a TCI system is not recommended for sedation as part of intensive care.

Sedation of adults for surgical and diagnostic procedures

During the administration of Propofol 10mg/ml, the patient must be continually monitored for signs of a decrease in blood pressure, respiratory tract obstruction and oxygen deficiency and the customary emergency equipment for accidents must be kept ready.

For induction of anaesthesia, generally 0.5 - 1.0 mg Propofol/kg of body mass are administered for 1 - 5 minutes. For the maintenance of anaesthesia, the dosage is determined based on the desired depth of sedation and is generally in the range between 1.5 and 4.5 mg Propofol/kg of body mass per hour. In addition to the infusion, 10 - 20 mg may be injected as a bolus if a quick increase in the depth of sedation is necessary.

A lower dosage and slower administration may be necessary for patients in risk groups ASA III and IV.

A lower dosage may be necessary in patients over 55 years of age.

Sedation of children from 1 month of age for surgical and diagnostic procedures

The dosage and the periods between doses are selected based on the required depth of sedation and the clinical response. For the induction of sedation, a dose of 1 - 2 mg Propofol/kg of body weight is necessary for most children. Maintenance of the sedation is achieved with the titration of Propofol 10mg/ml via an infusion until the desired depth of sedation is reached. For most patients, 1.5 - 9 mg Propofol/kg of body mass per hour is required. The infusion can be supplemented with bolus administrations of up to 1 mg Propofol/kg of body mass, if a rapid increase in the depth of sedation is required. Lower doses may be necessary for patients in the risk groups ASA III and IV.

Propofol 10mg/ml may not be used for the sedation of children aged 16 years or younger as part of intensive care.

Overdose

An overdose can lead to circulatory and respiratory depression. Apnoea requires artificial ventilation. In the case of circulatory depression, the usual measures should be taken of lowering the head position or/and plasma substitution and vasoconstrictors.

Duration of use

Propofol 10 mg/ml may only be used in a patient for a maximum of 7 days.