Propofol Fresenius emulsion for injection 50 ml. 1 vial

WHAT PROPOFOL FRESENIUS IS 2% AND WHAT IT IS USED FOR
Propofol Fresenius 2% belongs to the group of medicinal products called general anesthetics. General anesthetics are used to induce a state of unconsciousness (sleep) for the purpose of conducting surgical operations or other procedures. They can also be used to sedate you (a state where you are sleepy, but not completely asleep).

Propofol Fresenius 2% is used to:
Introduction and maintenance of general anesthesia;
Sedation of patients on artificial respiration during intensive care.
2. BEFORE YOU USE PROPOFOL FRESENIUS 2%
DO NOT use Propofol Fresenius 2%:
If you are hypersensitive (allergic) to propofol or any of the other ingredients of the medicine (see section 6 "Further information" at the end of the leaflet);
If you are hypersensitive (allergic) to soy or peanuts (see "Important information about some of the ingredients of Propofol Fresenius 2%" at the end of item 2).
Propofol Fresenius 2% should not be used for sedation of children and adolescents under 16 years of age.

Take special care with Propofol Fresenius 2%
You should not be given Propofol Fresenius 2% or only with extreme caution and under medical supervision if:
You have a pronounced heart failure;
You have another serious heart disease;
You are on electroconvulsive therapy (EST, treatment of mental problems).
Propofol Fresenius 2% is not recommended for general anesthesia in children under one month of age. Special caution is also required when administering Propofol Fresenius 2% to children under the age of 3 years. However, currently available data do not indicate significant differences in safety compared to older children. When administered for sedation of children and adolescents under the age of 16, it has caused serious and, in some cases, fatal side effects.
In general, Propofol Fresenius 2% should be used with caution in elderly or poor patients.

Before you are given Propofol Fresenius 2%, tell your anesthetist or intensive care physician if you have:
Heart disease;
Pulmonary disease;
Kidney disease;
Liver disease;
Seizures (epilepsy);
Increased intracranial pressure (increased intracranial pressure). In combination with low blood pressure, the amount of blood reaching the brain can be reduced;
Altered fat levels in the blood. If you are on parenteral nutrition (feeding through the vein), fat levels in the blood should be monitored.
If you have any of the following conditions, they should be treated before putting Propofol Fresenius 2%:
heart failure;
If the amount of blood reaching the tissues is insufficient (circulatory insufficiency);
Severe breathing problems (respiratory failure);
Dehydration (hypovolaemia);
Seizures (epilepsy).
Propofol Fresenius 2% may increase the risk of:
Epileptic seizures;
Predominance of vague tone (vagotonia);
Slow heart rate (bradycardia);
Changes in blood flow to body organs (haemodynamic effects on the cardiovascular system);
If you are overweight and you get high doses of Propofol Fresenius 2%.
During sedation with Propofol Fresenius 2%, involuntary movements may occur. Physicians should consider how this could affect the surgical procedures performed under anesthesia and take the necessary precautions.

Very rarely, after anesthesia, a period of loss of consciousness associated with hardening of the muscles may occur. This requires observation by the medical staff, but without any other treatment. This state will pass spontaneously.
Injection of Propofol Fresenius 2% may be painful. A local anesthetic can be used to reduce this pain, but it can give its own side effects.
You will not be allowed to leave the hospital until you come to your full consciousness.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You should be especially careful if you also take some of the following medicines:
Premedications (Your anesthetist will know which drugs can interact with Propofol Fresenius 2%);
Other anesthetics, including general, regional and local and inhaled anesthetics (lower doses of Propofol Fresenius 2% may be required, your anesthetist will know this);
Analgesics (pain relievers);
Medicines that relax muscles, e.g. Sucamethonium;
Benzodiazepines (medicines to treat anxiety);
Medicines that affect many of the body's internal functions such as heart rate, such as atropine;
Strong painkillers, e.g. Fentanyl;
Alcohol;
Neostigmine (to treat muscle weakness);
Ciclosporin (used to prevent transplant rejection).
Use of Propofol Fresenius 2% with food and drink
After using Propofol Fresenius 2%, you should not drink alcohol until your full recovery.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Propofol Fresenius 2% should not be given to pregnant women unless it is necessary. Mothers should discontinue breast-feeding and dispose of breast milk for 24 hours after administering Propofol Fresenius 2%.

Driving and using machines
After using Propofol Fresenius 2%, you should not drive, operate machinery or operate in potentially hazardous environments. You do not have to go home alone.

Important information about some of the ingredients of Propofol Fresenius 2%
Propofol Fresenius 2% contains soybean oil. Rarely this can cause serious hypersensitivity (allergic) reactions (see "Do not use Propofol Fresenius 2%"). Tell your doctor if you know you are allergic to soybean oil.

The medicinal product contains less than 1 mmol (23 mg) of sodium per 100 ml.

3. HOW TO USE PROPOFOL FRESENIUS 2%
Propofol Fresenius 2% can only be given in hospital or profiled therapeutic areas by your anesthetist or intensive care physician.
The amount of Propofol Fresenius 2% you need depends on your age, physical and health condition, and the degree of sleepiness or sleep that is needed. This can also be affected by the other medications you take. In most people, 1.5-2.5 mg of propofol per kilogram of body weight is required to sleep (anesthetized) and then 4-12 mg of propofol per kilogram of body weight per hour to maintain sleep (maintenance of anesthesia). For sedation, doses of 0.3 to 4.0 mg of propofol per kilogram body weight per hour are usually sufficient.
Propofol Fresenius 2% is for intravenous use, usually in the intravenous vessels of the palm or forearm. Your anesthetist may use a needle or cannula (a fine plastic tube). An electric injection pump may be used for long operations and for use in intensive care.
Elderly and weaker patients may require lower doses.
Children are usually given slightly increased doses to inject and maintain anesthesia. The dose should be determined by age and / or body weight.
When used for sedation Propofol Fresenius 2% should not be used for more than 7 days.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Propofol Fresenius 2% can cause side effects, although not everyone gets them.

An assessment of side effects is based on the following incidence rates:
Very common: In more than 1 out of 10 treated patients;
Common: In less than 1 in 10 but more than 1 in 100 treated patients;
Uncommon: Less than 1 out of 100 but more than 1 in 1,000 treated patients;
Rare: In less than 1 in 1,000 but more than 1 in 10,000 treated patients;
Very rare: Less than 1 in 10,000 patients treated, including isolated cases.
If you think you have any of the side effects listed below, please tell your doctor as soon as possible.

Very common (in more than 1 in 10 patients treated):
Local pain during injection.
Common (in less than 1 of 10 patients treated):
Increased blood lipid levels (hypertriglyceridemia).
These side effects may occur during anesthesia:
Involuntary movements;
Muscle convulsions (myoclonus);
Muscle jitter (minimal excitability);
Low blood pressure (hypotension);
Low heart rate (bradycardia);
Rapid heart rhythm (tachycardia);
Hot waves;
Rapid breathing (hyperventilation);
Stop breathing (temporary apnea);
Cough after anesthesia;
Hiccup.
Uncommon (less than 1 out of 100 treated patients):
A serious form of low blood pressure (hypotension);
Coughing;
Pulse delay (progressive bradycardia).
Rare (less than 1 in 1000 patients treated):
Severe allergic reaction (anaphylaxis) including:
Puffiness of the skin of the face, mouth and throat (angioedema);
Narrowing of the airways in the lungs, which makes breathing difficult (bronchospasm);
Redness of the skin (erythema);
Low blood pressure (hypotension);
headache;
Dizziness (vertigo);
Epileptiform movements (involuntary movements similar to epilepsy), including convulsions and opistonus (stiff posture where the head is curved back);
Blood clots (thrombosis);
Inflammation of the blood vessels (phlebitis);
Discoloration of the urine;
Postoperative fever.
These rare side effects may occur during the recovery period (on waking):
Euphoria (feeling of happiness) and sexual arousal;
Chill and feeling of cold;
Irregular heart rhythm (arrhythmia);
Coughing;
Nausea or vomiting.
Very rare (less than 1 in 10,000 patients treated):
Delayed epileptiform attacks (involuntary movements similar to epilepsy after awakening);
Convulsions in epileptic patients;
Unconsciousness after anesthesia;
Fluid in the lungs (pulmonary edema);
Inflammation of the pancreas (pancreatitis);
Serious tissue response after accidental injection into tissues;
Rhabdomyolysis (muscular disorder);
Changes in blood acidity (metabolic acidosis);
High potassium level in the blood (hyperkalemia);
heart failure.
When Propofol Fresenius 2% is given in combination with lidocaine (a local anesthetic used to reduce pain at the injection site), certain side effects may rarely occur:
Dizziness;
Vomiting;
Insomnia;
Seizures;
Delayed heart rate (bradycardia);
Irregular cardiac rhythm (cardiac arrhythmia);
Shock.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PROPOFOL FRESENIUS 2%
Keep out of the reach and sight of children.
Do not use Propofol Fresenius 2% after the expiry date which is stated on the vial and the outer carton. The expiry date refers to the last day of that month.
Store below 25 ° C.
Do not freeze.
Once opened, the product should be used immediately.
The infusion system using Propofol Fresenius 2% should be replaced 12 hours after opening the vial.
Do not use if after shaking the emulsion two layers can be distinguished.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION
What Propofol Fresenius contains 2%
The active substance is propofol.
1 ml of emulsion contains 20 mg of propofol.
Each 50 ml vial contains 1000 mg propofol.

The other ingredients are soybean oil, refined, purified egg phosphatide, glycerol, oleic acid, sodium hydroxide, water for injections.

What Propofol Fresenius 2% looks like and contents of the pack
Injection / infusion emulsion
Propofol Fresenius 2% is a white oil-in-water emulsion.
Propofol Fresenius 2% is supplied in glass vials. The glass vials are sealed with rubber stoppers.

Packaging Content:
Packs containing 1 glass vial with 50 ml of emulsion.
Packs containing 10 glass vials with 50 ml of emulsion.
Not all pack sizes may be marketed.

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