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About the medicine

How to use PROPOFOL LIPURO 5 mg/ml INJECTABLE EMULSION AND INFUSION SOLUTION

Contents of the leaflet

  1. Introduction
  2. What is Propofol Lipuro and what is it used for
  3. What you need to know before you start using Propofol Lipuro
  4. What you need to know before you start using Propofol Lipuro
  5. How to use Propofol Lipuro
  6. Possible side effects
  7. Storage of Propofol Lipuro
  8. Contents of the pack and further information

Introduction

Package Leaflet: Information for the User

Propofol Lipuro 5mg/ml injectable emulsion and for infusion

Propofol

Read all of this leaflet carefully before you start usingthismedicine, 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 experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

  1. What is Propofol Lipuro and what is it used for
  2. What you need to know before you start using Propofol Lipuro
  3. How to use Propofol Lipuro
  4. Possible side effects
  5. Storage of Propofol Lipuro
  6. Contents of the pack and further information

1. What is Propofol Lipuro and what is it used for

Propofol Lipuro belongs to a group of medicines called general anesthetics. General anesthetics are used to produce unconsciousness (sleep) so that surgical operations or other procedures can be performed. They can also be used to sedate you (to make you drowsy but not completely asleep).

Propofol Lipuro is used for:

  • inducing general anesthesia in adults and children over 1 month of age,
  • sedating adult patients during diagnostic and surgical procedures for a short period of time, alone or in combination with local or regional anesthesia,

inducing sedation in adults and children over 1 month of age during diagnostic and surgical procedures

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you start using Propofol Lipuro

What you need to know before you start using Propofol Lipuro

Do not use Propofol Lipuro

  • If you are allergic to propofol, soy, peanut or any of the other components of this medicine (listed in section 6).
  • For maintenance of general anesthesia or sedation in diagnostic and surgical procedures in children
  • For sedation in intensive care.

Warnings and precautions

Talk to your doctor or pharmacist before you start receiving Propofol Lipuro.

Special care should be taken

  • if you have severe head injuries,
  • if you have mitochondrial disease, if you have a disorder in which your body does not handle fats properly,
  • if you have any other health problem that requires great caution in the use of fat emulsions,
  • if your blood volume is too low (hypovolemia),
  • if you have low protein levels in your blood (hypoproteinemia),
  • if you are very weak or if you have heart, kidney, or liver problems,
  • if you have high pressure in the skull,
  • if you have any respiratory problems,
  • if you have epilepsy,
  • if you are undergoing procedures where spontaneous movements are especially undesirable.

Tell your doctor if you have any of these diseases or disorders.

If you are receiving other lipids by infusion in your vein at the same time, your doctor will pay special attention to your total daily fat intake.

Propofol will be administered to you by a doctor specializing in anesthesia or intensive care. You will be constantly monitored during anesthesia and the recovery period.

If you experience signs of the so-called "propofol infusion syndrome" (see section 4, "Possible side effects", "You should call a doctor immediately if any of the following effects occur") your doctor will immediately stop the administration of propofol.

See also in the section "Driving and using machines" the precautions you should take after using propofol.

Children and adolescents

The use of Propofol Lipuro is not recommended in newborns.

Other medicines and Propofol Lipuro

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

Propofol has been used effectively for different regional anesthesia techniques, which numb only a part of the body (epidural and spinal anesthesia).

It has also been shown to be safe in combination with

  • medicines you receive before an operation,
  • other medicines, such as muscle relaxants,
  • anesthetic medicines that can be inhaled,
  • analgesics.

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

Your doctor should be aware that the administration of propofol together with other medicines that have an inhibitory effect on the central nervous system may increase the effects of propofol. Special attention should be paid if you are receiving an antibiotic containing rifampicin at the same time - you may develop a deep drop in blood pressure.

Your doctor may reduce the dose if you are also receiving treatment with valproate (an anticonvulsant).

Use ofPropofol Lipuro and alcohol

Your doctor will inform you about alcohol consumption before and after using Propofol Lipuro.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Propofol Lipuro should not be used during pregnancy unless it is absolutely necessary. It crosses the placenta and can depress the baby's vital functions.

However, propofol can be used during an induced abortion.

If you are breastfeeding, you should stop and discard breast milk for 24 hours after receiving Propofol Lipuro. Studies in breastfeeding women have shown that propofol passes into breast milk in small amounts.

Driving and using machines

Do not drive or operate tools or machines for a period of time after receiving an injection or infusion of Propofol Lipuro.

Your doctor will tell you

  • if you should be accompanied when leaving,
  • when you can drive and use machines again,
  • the use of other sedative medicines (e.g. tranquilizers, potent analgesics, alcohol).

Propofol Lipuro contains sodium and soybean oil

This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml; i.e. it is essentially "sodium-free".

Propofol Lipuro contains soybean oil. Do not use this medicine if you are allergic to peanut or soy.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

3. How to use Propofol Lipuro

Propofol Lipuro will only be administered by persons who have received training in the administration of anesthesia or by specially trained doctors in a hospital or a properly equipped day treatment unit.

Posology

The dose you receive will vary, depending on your age, body weight, and physical condition. Your doctor will administer the correct dose to start anesthesia or to achieve the desired level of sedation, by carefully observing your responses and vital signs (pulse, blood pressure, breathing, etc.).

Your doctor will observe the maximum administration time if necessary.

Propofol Lipuro will only be administered for a maximum of 1 hour.

Method of administration

You will receive Propofol Lipuro by intravenous injection or infusion, i.e. through a small needle or a small tube placed in one of your veins. If administered by infusion, it can be diluted beforehand.

Your circulation and breathing will be constantly monitored while you receive the injection or infusion.

If you have received more Propofol Lipuro than you should

This is unlikely to happen because the doses you receive are carefully controlled.

However, if you accidentally receive an overdose, this could lead to depression of cardiac and respiratory function. In this case, your doctor will immediately use the necessary treatment.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

.

4. Possible side effects

Like all medicines, Propofol Lipuro 5 mg/ml can cause side effects, although not everybody gets them.

You should call a doctor immediately if you experience any of the following effects

Frequent (may affect between 1 and 10 in 100 people):

  • Drop in blood pressure that may occasionally require the administration of fluids and a reduction in the rate of propofol administration.
  • Very slow heartbeats, which can be severe in rare cases.

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

  • Seizures as in epilepsy

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

  • Allergic reactions up to anaphylactic shock, such as swelling of the face, tongue, or throat, wheezing, skin redness, and low blood pressure.
  • There have been cases of postoperative loss of consciousness. Therefore, you will be carefully observed during the recovery period.
  • Fluid in the lungs (pulmonary edema) after administration of propofol.
  • Pancreatitis.

Frequency not known (cannot be estimated from the available data):

  • Isolated cases of adverse reactions have been reported, which present as a combination of the following symptoms: muscle tissue breakdown, accumulation of acidic substances in the blood, abnormally high potassium levels in the blood, high fat levels in the blood, abnormal ECG (Brugada-type ECG), liver enlargement, irregular heartbeat, kidney failure, and heart failure. This has been called the "propofol infusion syndrome". Some of the reported cases have had a fatal outcome. These effects have only been observed in patients in intensive care, mainly in patients with severe head injuries and in children with respiratory tract infections who received doses higher than 4 mg of propofol per kg of body weight and per hour. See also section 2, "Warnings and precautions".
  • Hepatitis (inflammation of the liver), acute liver failure (symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and liver sensitivity (indicated by pain below the front of the rib cage on the right side), sometimes with loss of appetite).

Other side effects are the following:

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

  • Pain at the injection site, which occurs during the first injection. The pain can be reduced by injecting propofol into the large veins of the forearm. The simultaneous injection of lidocaine (a local anesthetic) and propofol also helps to 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 the veins or inflammation of the veins at the injection site

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

  • Loss of sexual control during recovery
  • Abnormal urine color after prolonged administration of propofol
  • Cases of fever after an operation
  • Tissue damage after accidental injection of the medicine outside the vein

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

  • Involuntary movements
  • Abnormally good mood
  • Drug abuse and dependence
  • Heart failure
  • Cardiac arrest
  • Shallow breathing
  • Prolonged and painful erection of the penis
  • Pain and/or swelling at the injection site after accidental injection of the medicine outside the vein
  • Breakdown of muscle tissue has been reported very rarely in cases where propofol was administered in doses higher than those recommended for sedation in intensive care units.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Propofol Lipuro

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. The expiry date is the last day of the month stated.

Do not store above 25°C. Do not freeze.

Propofol Lipuro should be used immediately after opening/dilution.

Do not use Propofol Lipuro if you observe two separate layers after shaking the product or if it does not have a white milky color.

6. Contents of the pack and further information

Composition of Propofol Lipuro

  • The active substance is propofol.

Each milliliter of Propofol Lipuro 5 mg/ml contains 5 mg of propofol.

1 ampoule of 20 ml contains 100 mg propofol.

  • The other ingredients are:

Refined soybean oil,

Medium-chain triglycerides,

Egg phospholipids for injectable preparations,

Glycerol,

Sodium oleate,

Water for injectable preparations.

Appearance of Propofol Lipuro and contents of the pack

It is an injectable emulsion and for infusion.

It is an oil-in-water emulsion, white milky in color.

It is available in 20 ml glass ampoules, in packs of 5 ampoules.

Marketing authorization holder, manufacturer, and local representative

Marketing authorization holder and manufacturer

  • Braun Melsungen AG

Carl-Braun-Straße 1 Postal address:

34212 Melsungen 34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

Local representative

B Braun Medical, SA

Ctra Terrasa, 121.

08191 Rubí (Spain)

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion

Austria Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion

Denmark Propofol "B.Braun" 5 mg/ml

Slovakia Propofol Lipuro 0.5% (5 mg/ml)

Spain Propofol Lipuro 5 mg/ml

Finland Propofol Lipuro 5 mg/ml

France Propofol Lipuro 5 mg/ml

Hungary Propofol Lipuro 5 mg/ml

Ireland Propofol Lipuro 0.5% (5 mg/ml)

Italy Propofol B.Braun 0.5%

Luxembourg Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion

Norway Propofol Lipuro 5 mg/ml

Poland Propofol Lipuro 5 mg/ml

Portugal Propofol Lipuro 0.5% (5 mg/ml)

United Kingdom (Northern Ireland) Propofol Lipuro 0.5% (5 mg/ml)

Czech Republic Propofol Lipuro 0.5% (5 mg/ml)

Sweden Propofol Lipuro 5 mg/ml

Date of last revision of this leaflet:07/2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

The containers are for single use, in a single patient.

The containers should be shaken before use.

Before use, the neck of the ampoule should be cleaned with medicinal alcohol (in a spray or with a cotton swab).

Any unused emulsion should be discarded at the end of administration. The disposal of unused medicines and all materials that have come into contact with them will be carried out in accordance with local regulations.

To obtain complete information on this medicine, consult the summary of product characteristics.

Online doctors for PROPOFOL LIPURO 5 mg/ml INJECTABLE EMULSION AND INFUSION SOLUTION

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Hocine Lokchiri

General medicine21 years of experience

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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Dr. Lokchiri’s professional training includes:

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Jorge Correa Bellido

General medicine7 years of experience
Licence no. 464626297

Dr. Jorge Correa Bellido is a Spanish physician who offers online consultations in Spanish and English. He graduated from the University of La Laguna and has a solid background in clinical practice and international research.

Throughout his career, he has participated in various medical and academic projects, including a research fellowship in Spain, where he contributed to evidence-based studies in the field of family medicine. This experience allowed him to broaden his global perspective on healthcare and comprehensive patient care.

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Nuno Tavares Lopes

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Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies

  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management

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  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment

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Chikeluo Okeke

General medicine4 years of experience

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

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Anastasiia Shalko

General medicine13 years of experience
Licence no. 52891

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

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Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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Lizaveta Trafimchuk Takhvaniuk

DermatologyGeneral medicine10 years of experience
Licence no. 58788

Dr. Lizaveta Trafimchuk Takhvaniuk graduated in Medicine and subsequently specialized in Dermatology and Venereology. She has more than 10 years of clinical experience and is licensed to practice in Spain, where she focuses on the comprehensive diagnosis and treatment of dermatological conditions.

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Cristina Andrada Brazo

General medicineSleep medicine16 years of experience
Licence no. 264505958

Dr. Cristina Andrada Brazo is a highly experienced Spanish physician with more than 15 years of clinical practice in emergency medicine, urgent care, and clinical neurophysiology. She provides professional online medical consultations for patients across Spain, helping both residents and international visitors receive timely medical advice, diagnosis, treatment recommendations, and electronic prescriptions when clinically appropriate.

As a licensed physician fully integrated with the Spanish electronic prescription system, Dr. Andrada can issue legally valid e-prescriptions following a medical assessment during an online consultation. Whether you need help with an acute illness, prescription renewal, neurological symptoms, or travel-related healthcare, she offers convenient, patient-centered medical care without the need to visit a clinic.

Dr. Andrada combines extensive emergency medicine experience with advanced expertise in neurology, epilepsy, sleep medicine, and headache disorders. Her international clinical background includes several years working in Switzerland, where she collaborated with multidisciplinary teams in emergency departments and neurology services. This experience strengthened her commitment to evidence-based medicine, compassionate communication, and high-quality patient care.

She graduated in Medicine from the University of Seville and completed her residency in Clinical Neurophysiology at Hospital Virgen de la Salud and the National Hospital for Paraplegics in Toledo. She currently works as a Clinical Neurophysiology Specialist at Hospital San Pedro in Logroño.

To further expand her expertise, Dr. Andrada completed several postgraduate qualifications, including Master's degrees in Sleep Physiology and Medicine, Medical Professionalism and Clinical Practice, Epilepsy, and Clinical Management.

Patients appreciate her thorough consultations, practical treatment recommendations, and empathetic approach. She speaks Spanish, French, and Portuguese, allowing her to communicate comfortably with patients from different backgrounds.

Conditions Dr. Cristina Andrada Treats Online

Dr. Andrada provides online consultations for a wide range of common medical conditions, including:

  • Fever, flu, COVID-19 symptoms, sore throat and respiratory infections
  • Sinusitis, bronchitis, cough and seasonal allergies
  • Urinary tract infections (UTIs)
  • Migraine and tension headaches
  • Dizziness and vertigo
  • Epilepsy and seizure follow-up
  • Sleep disorders, including insomnia and circadian rhythm disturbances
  • Heartburn, gastritis, diarrhea and constipation
  • Back pain, muscle injuries and joint pain
  • Minor skin infections and allergic reactions
  • Fatigue and general medical assessment
  • Prescription renewals for appropriate chronic treatments
  • Follow-up consultations after surgery or previous medical treatment
  • Travel medicine advice and preventive healthcare
  • Interpretation of laboratory results and medical reports

If your condition requires urgent in-person assessment or emergency care, Dr. Andrada will advise you on the most appropriate next steps.

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Frequently Asked Questions

PROPOFOL LIPURO 5 mg/ml INJECTABLE EMULSION AND INFUSION SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in PROPOFOL LIPURO 5 mg/ml INJECTABLE EMULSION AND INFUSION SOLUTION is propofol. This information helps identify medicines with the same composition but different brand names.

PROPOFOL LIPURO 5 mg/ml INJECTABLE EMULSION AND INFUSION SOLUTION is manufactured by B. Braun Melsungen Ag. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Psychiatrists, Neurologists, General medicine doctors, Pain medicine doctors, Anaesthesiologists may assess whether PROPOFOL LIPURO 5 mg/ml INJECTABLE EMULSION AND INFUSION SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, PROPOFOL LIPURO 5 mg/ml INJECTABLE EMULSION AND INFUSION SOLUTION is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

Other medicines with the same active substance (propofol) include DIPRIVAN 10 mg/ml Injectable Emulsion for Infusion, DIPRIVAN 20 mg/ml EMULSION FOR INFUSION, PROPOFOL BAXTER 10mg/ml Injectable Emulsion for Infusion. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

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