Propofol 1% fresenius

Package leaflet: Information for the user

PROPOFOL 1% FRESENIUS, 10 mg/ml, emulsion for injection or infusion
Propofolum
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 further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Propofol 1% Fresenius is and what it is used for
2. What you need to know before using Propofol 1% Fresenius
3. How to use Propofol 1% Fresenius
4. Possible side effects
5. How to store Propofol 1% Fresenius
6. Contents of the pack and other information

1. What Propofol 1% Fresenius is and what it is used for

Propofol 1% Fresenius belongs to a group of medicines called general anaesthetics. General anaesthetics are used to cause loss of consciousness (sleep) so that surgery or other procedures can be performed. These medicines may also be used to achieve sedation (a state in which the patient is sleepy but not fully unconscious).
Propofol 1% Fresenius is used for:

• induction and maintenance of general anaesthesia in adult patients, adolescents, and children over 1 month of age;
• sedation of mechanically ventilated patients over 16 years of age requiring intensive care;
• sedation of adult patients, adolescents, and children over 1 month of age during diagnostic and surgical procedures, either as a single agent or in combination with other medicines used to induce local or regional anaesthesia.

2. Important information before using Propofol 1% Fresenius

When not to use Propofol 1% Fresenius

• if the patient is allergic (hypersensitive) to propofol or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic (hypersensitive) to soy or peanuts (see “Propofol 1% Fresenius contains soybean oil and sodium” at the end of section 2 of this leaflet);
• for sedation of patients aged 16 years or younger requiring intensive medical care.

Warnings and precautions
Please consult a doctor, pharmacist, or nurse before administering Propofol 1% Fresenius, and if any of the situations listed below currently apply or have previously applied to the patient.
Propofol 1% Fresenius should not be used or should only be used with special caution and intensive monitoring in patients:

• with advanced heart failure;
• with other severe heart diseases;
• undergoing electroconvulsive therapy (electroconvulsive therapy, used in psychiatric treatment).

Propofol 1% Fresenius should be used with caution in elderly and debilitated patients.
Before administering Propofol 1% Fresenius, inform the anaesthesiologist or intensive care physician if the patient has:

• heart disease;
• lung disease;
• kidney disease;
• liver disease;
• seizures (epilepsy);
• increased intracranial pressure (elevated intracranial pressure); when combined with low blood pressure, blood flow to the brain may be reduced;
• altered blood fat levels; if the patient is receiving total parenteral nutrition (nutrition via a vein), blood fat levels should be monitored;
• significant fluid loss from the body (dehydration).

The following conditions must be treated prior to administration of Propofol 1% Fresenius:

• heart failure;
• inadequate tissue perfusion (circulatory failure);
• severe breathing difficulties (respiratory failure);
• dehydration (hypovolemia);
• seizures (epilepsy).

Propofol 1% Fresenius may increase the risk of:

• seizures;
• vagal reflex causing slowed heart rate (vagotonia, bradycardia);
• changes in blood flow to the patient's body organs (hemodynamic effects on the cardiovascular system), particularly in overweight patients who have received high doses of Propofol 1% Fresenius.

During sedation with Propofol 1% Fresenius, involuntary movements may occur. The physician will consider how this may affect the surgical procedure performed under sedation and take necessary precautions.
Very rarely, after general anaesthesia, a postoperative period of unconsciousness may occur, accompanied by increased muscle tone. The patient should be observed, but no additional treatment is required. Recovery of consciousness occurs spontaneously.
Injection of Propofol 1% Fresenius may be painful. To reduce pain, a locally acting anaesthetic may be used, but this may cause adverse effects.
The patient may leave the hospital only after full recovery of consciousness.
If the patient is discharged home shortly after receiving propofol, another person should accompany them.

Children and adolescents
Propofol 1% Fresenius is not recommended for use in neonates and children under 1 month of age.
Propofol 1% Fresenius must not be used for sedation in children and adolescents under 16 years of age in intensive care units, as the safety of propofol use for this indication has not been established in this age group.

Propofol 1% Fresenius and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the attending physician, anaesthesiologist, or nurse if the patient is taking any of the following medicines:

• rifampicin (a medicine used to treat tuberculosis);
• midazolam (a medicine used to induce sedation (a deep state of calmness, drowsiness, or sleep), relieve anxiety symptoms, and reduce muscle tension).

Special caution is required if the patient is taking and/or concurrently receiving any of the following medicines:

• medicines used for premedication (the anaesthesiologist will know which medicines may interact with Propofol 1% Fresenius);
• other anaesthetics, including general, regional, and local anaesthetics, and inhalational anaesthetic agents (the anaesthesiologist may decide to reduce the dose of Propofol 1% Fresenius);
• analgesics (painkillers);
• strong painkillers (fentanyl or opioids);
• parasympatholytic medicines (used for painful spasms, asthma, and Parkinson's disease);
• benzodiazepines (sedatives);
• suxamethonium (a muscle relaxant);
• medicines or beverages containing alcohol;
• neostigmine (a medicine used to treat muscle weakness);
• cyclosporine (a medicine used to prevent transplant rejection);
• valproate (a medicine used to treat epilepsy and psychiatric disorders).

Propofol 1% Fresenius with food, drink, and alcohol
After administration of Propofol 1% Fresenius, the patient should not eat, drink, or consume alcohol until full consciousness is regained.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Propofol 1% Fresenius should not be administered to pregnant women unless absolutely necessary.
Mothers should discontinue breastfeeding and discard milk collected for 24 hours after administration of Propofol 1% Fresenius.

Driving and operating machinery
Drowsiness may occur for some time after administration of Propofol 1% Fresenius. Do not drive, operate equipment, or machinery until you are certain that the effects of the medicine have completely worn off.
If the patient is discharged home shortly after receiving propofol, they should not drive or leave the hospital without an accompanying person.
Ask your doctor when it is safe to resume these activities and return to work.

Propofol 1% Fresenius contains soybean oil and sodium
Propofol 1% Fresenius contains soybean oil. If the patient is allergic to soy or peanuts, this medicine should not be used.
The medicine contains less than 1 mmol (23 mg) of sodium per 100 ml; therefore, the medicine is considered "sodium-free".

3. How to use Propofol 1% Fresenius

Propofol 1% Fresenius will be administered to the patient only in a hospital or on an appropriate therapeutic ward by an anaesthesiologist or a doctor specialized in intensive care medicine, or under their direct supervision.
Dosage
The dose given will depend on the patient's age, body weight and condition, as well as on the premedication used (preparation for anaesthesia). The doctor will administer the appropriate dose to induce and maintain anaesthesia or achieve the required level of sedation, carefully monitoring the patient's responses and vital signs (pulse, blood pressure, respiration, etc.).
It may be necessary to use other medications to induce sedation or general anaesthesia, relieve pain, ensure proper respiration, and maintain stable blood pressure. The doctor will decide which medications should be used and when to administer them to the patient.
Adult patients
Most patients require 1.5 to 2.5 mg of propofol/kg body weight to induce anaesthesia (induction), followed by 4 to 12 mg of propofol/kg body weight/hour to maintain anaesthesia (maintenance). For achieving the required level of sedation, doses ranging from 0.3 to 4.0 mg of propofol/kg body weight/hour are usually sufficient.
To achieve the required level of sedation during surgical and diagnostic procedures in adult patients, a dose of 0.5 to 1 mg of propofol/kg body weight administered over 1 to 5 minutes is usually required in most patients. Maintenance of the required level of sedation can be achieved by adjusting the infusion rate of Propofol 1% Fresenius appropriately. In most patients, an infusion rate of 1.5 to 4.5 mg of propofol/kg body weight/hour will be required.
If a rapid increase in the level of sedation is required, the infusion may be supplemented by bolus administration of propofol at a dose of 10 to 20 mg of propofol (1 to 2 ml of Propofol 1% Fresenius).
For sedation of mechanically ventilated patients aged over 16 years receiving intensive care, the dose should be adjusted according to the required level of sedation. An adequate level of sedation is usually achieved with an infusion rate ranging from 0.3 to 4.0 mg of propofol/kg body weight/hour. Infusion rates exceeding 4.0 mg of propofol/kg body weight/hour are not recommended.
Elderly and debilitated patients
Lower doses may be required in elderly and debilitated patients.
Children and adolescents above 1 month of age
The use of Propofol 1% Fresenius is not recommended in children under 1 month of age.
Particular caution should also be exercised when administering Propofol 1% Fresenius to children under 3 years of age, although current data do not indicate that its use is less safe than in children aged over 3 years.
The dose should be adjusted according to age and/or body weight. In most children over 8 years of age, the dose required for induction of anaesthesia is approximately 2.5 mg/kg body weight of Propofol 1% Fresenius. In younger children, particularly those between 1 month and 3 years of age, a higher dose may be required (2.5 to 4 mg/kg body weight).
Doses ranging from 9 to 15 mg/kg body weight/hour usually allow achieving the required level of anaesthesia (maintenance). In younger children, particularly those between 1 month and 3 years of age, a higher dose may be required.
For induction of sedation during surgical and diagnostic procedures in children above 1 month of age, a dose of 1 to 2 mg/kg body weight of Propofol 1% Fresenius is usually required in most patients. Maintenance of the required level of sedation is achieved by adjusting the infusion rate of Propofol 1% Fresenius appropriately. In most patients, an infusion rate of 1.5 to 9 mg of propofol/kg body weight/hour is required. If a rapid increase in the level of sedation is required, the infusion may be supplemented by bolus administration of propofol at a dose of up to 1 mg/kg body weight.
Propofol 1% Fresenius must not be used for sedation in intensive care units in children and adolescents under 16 years of age, as the safety of propofol for this indication has not been established in this age group.
Method of administration
Propofol 1% Fresenius is intended for intravenous administration, usually into the back of the hand or forearm. The anaesthesiologist may use a needle or a cannula (a thin plastic tube). Propofol 1% Fresenius may be injected into the vein manually or using an electric pump. During prolonged operations and in intensive care, an electric pump may be used.
Duration of treatment
When Propofol 1% Fresenius is used for sedation, it must not be administered for longer than 7 days.
Administration of a higher than recommended dose of Propofol 1% Fresenius
The doctor will ensure that the patient receives the appropriate dose of Propofol 1% Fresenius depending on the procedure being performed.
However, different patients require different doses of the drug. If a patient receives too high a dose, the anaesthesiologist will initiate appropriate measures to ensure adequate cardiac and respiratory function. For this reason, anaesthetic drugs are administered only by doctors specialized in anaesthesiology or intensive care medicine.
If you have any further questions regarding the use of this medicine, please consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions occurring during anaesthesia
The adverse reactions listed below may occur during anaesthesia (during injection and when the patient is drowsy or completely unconscious). The doctor will monitor for these. If such adverse reactions occur, the doctor will provide appropriate treatment.
Very common (may affect more than 1 in 10 patients):

• Pain at the injection site (during injection, before the patient falls asleep).

Common (may affect less than 1 in 10 patients):

• Slow or fast heartbeat;
• Low blood pressure;
• Breathing changes (reduced breathing rate, respiratory arrest);
• Hiccups;
• Coughing (may also occur during emergence from anaesthesia).

Uncommon (may affect less than 1 in 100 patients):

• Swelling and redness along the vein where the medicine was administered, or blood clots.

Rare (may affect less than 1 in 1,000 patients):

• Body tremors, shivering, or convulsions (may also occur during emergence from anaesthesia).

Very rare (may affect less than 1 in 10,000 patients):

• Severe allergic reactions causing breathing difficulties, skin swelling and redness, hot flushes;
• Fluid accumulation in the lungs, causing severe breathing difficulties (may also occur during emergence from anaesthesia);
• Change in urine colour (may also occur during emergence from anaesthesia).

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

• Involuntary movements;
• Severe skin and tissue reactions following accidental extravasation (injection outside the vein);
• Prolonged, often painful erection (priapism).

Adverse reactions that may occur after emergence from anaesthesia
The following adverse reactions may occur after emergence from anaesthesia (during awakening or once the patient is awake):
Common (may affect less than 1 in 10 patients):

• Headache;
• Nausea, vomiting;
• Coughing.

Rare (may affect less than 1 in 1,000 patients):

• Dizziness, chills, and feeling cold;
• Agitation.

Very rare (may affect less than 1 in 10,000 patients):

• Postoperative loss of consciousness (in such cases, patients regained consciousness without complications);
• Pancreatitis, causing severe abdominal pain (causal relationship not established);
• Postoperative fever.

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

• Euphoria;
• Sexual arousal;
• Irregular heartbeat;
• Changes in ECG pattern (corresponding to Brugada syndrome);
• Liver enlargement;
• Kidney failure;
• Muscle damage (rhabdomyolysis), increased blood acidity (metabolic acidosis), high blood potassium levels, high blood lipid levels, heart failure;
• Misuse of the medicine, primarily by healthcare professionals;
• Prolonged, often painful erection (priapism).

When Propofol 1% Fresenius is administered in combination with lidocaine (a local anaesthetic used to reduce injection site pain), the following adverse reactions may rarely occur:

• Dizziness;
• Vomiting;
• Drowsiness;
• Convulsions;
• Slow heartbeat (bradycardia);
• Irregular heartbeat (arrhythmia);
• Shock.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Propofol 1% Fresenius

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule/bottle and outer packaging following EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Do not freeze.
After opening, the medicine should be used immediately.
Administration sets used with undiluted Propofol 1% Fresenius should be replaced 12 hours after opening the ampoule or bottle. Dilutions of 50 mg/ml (5%) glucose solution or 9 mg/ml (0.9%) sodium chloride solution or with the addition of 10 mg/ml (1%) lidocaine solution for injection without preservatives (at least 2 mg of propofol per ml) must be prepared under aseptic conditions (controlled and validated) immediately before administration and administered within 6 hours of dilution.
Shake the container before use.
If, after shaking, two layers are visible in the emulsion, do not use it.
Use only medicine with a homogeneous consistency and from undamaged packaging.
For single use only. Any unused portions of the emulsion must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Propofol 1% Fresenius contains

• The active substance is propofol.

1 ml of emulsion contains 10 mg of propofol.
Each 20 ml ampoule contains 200 mg of propofol.
Each 50 ml vial contains 500 mg of propofol.
Each 100 ml vial contains 1000 mg of propofol.

• Other ingredients are: soybean oil, egg lecithin, glycerol, oleic acid, sodium hydroxide, water for injections.

What Propofol 1% Fresenius looks like and contents of the pack
Propofol 1% Fresenius is a white oil-in-water emulsion for injection or infusion.
Propofol 1% Fresenius is available in colourless glass ampoules or vials.
Glass vials are sealed with rubber stoppers.
Pack sizes:
5 glass ampoules containing 20 ml of emulsion in a cardboard box.
10 glass ampoules containing 20 ml of emulsion in a cardboard box.
1 glass vial containing 50 or 100 ml of emulsion in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria

For further information, please contact the representative of the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. +48 22 345 67 89

Information intended exclusively for healthcare professionals:

Refer to the Summary of Product Characteristics.
Propofol 1% Fresenius must not be mixed prior to administration with injectable or infusion solutions except with 50 mg/ml (5%) glucose solution, or 9 mg/ml (0.9%) sodium chloride solution, or 10 mg/ml (1%) lidocaine solution without preservatives for injection. The final concentration of propofol must not be less than 2 mg/ml.
For single use only. Any unused portions of the emulsion must be discarded.
Shake the container before use.
If, after shaking, two layers are visible in the emulsion, the product must not be used.
Use only medication with homogeneous consistency and from undamaged packaging.
Before use, clean the ampoule neck or rubber stopper with alcohol in aerosol form or with an alcohol-impregnated swab. Punctured containers must be discarded after use.
Propofol should be administered only by physicians specialized in anaesthesiology (or, if indicated, by physicians specialized in intensive care medicine).
Patients must be continuously monitored, and access to equipment for airway maintenance, artificial ventilation, administration of oxygen-enriched gas mixtures, and other resuscitation equipment must be ensured at all times. Propofol must not be administered by the same person who is performing the diagnostic or surgical procedure.
Cases of misuse and dependence on propofol have been reported, particularly among healthcare professionals. As with other general anaesthetic agents, administration of propofol without maintaining respiratory function may result in respiratory complications leading to death.
When propofol is used to achieve sedation in conscious patients during surgical and diagnostic procedures, early signs of arterial hypotension, airway obstruction, and hypoxia must be continuously monitored.
Propofol 1% Fresenius may be administered by infusion either undiluted or diluted with 50 mg/ml (5%) glucose solution for injection or 9 mg/ml (0.9%) sodium chloride solution for injection.
Propofol 1% Fresenius may be administered via the same infusion set as 50 mg/ml (5%) glucose solution, 9 mg/ml (0.9%) sodium chloride solution, or 1.8 mg/ml (0.18%) sodium chloride solution with 40 mg/ml (4%) glucose solution. Propofol 1% Fresenius must not be mixed with any other injectable or infusion solutions except those listed above. Other medications or fluids administered simultaneously with Propofol 1% Fresenius using the same infusion line should be given close to the cannula insertion site using a Y-connector or three-way stopcock.
Propofol 1% Fresenius is an emulsion containing lipids without antibacterial preservatives and may support rapid microbial growth.
The emulsion must be aseptically drawn into a sterile syringe and infusion set immediately after opening the ampoule or piercing the vial stopper. Administration must be started without delay.
Propofol 1% Fresenius and any infusion equipment containing this medicinal product must be handled aseptically throughout the entire duration of the infusion. Propofol 1% Fresenius must not be administered through a microbiological filter.

Infusion of undiluted Propofol 1% Fresenius
When Propofol 1% Fresenius is administered by infusion in undiluted form, burettes, drip counters, syringe pumps, or volumetric infusion pumps are recommended to control the infusion rate.
As is generally the case with lipid emulsions, infusion of Propofol 1% Fresenius must not be continued for longer than 12 hours using a single infusion set. Infusion sets for Propofol 1% Fresenius must be replaced at least every 12 hours.

Infusion of diluted Propofol 1% Fresenius
When administering Propofol 1% Fresenius by infusion, burettes, drip counters, or volumetric infusion pumps must always be used to control the infusion rate. Maximum dilution must not exceed 1 part of Propofol 1% Fresenius to 4 parts of 50 mg/ml (5%) glucose solution or 9 mg/ml (0.9%) sodium chloride solution (minimum concentration: 2 mg propofol per ml).
The diluted medicinal product must be prepared aseptically (under controlled and validated conditions) and administered within 6 hours of preparation.

To alleviate injection site pain, lidocaine solution may be added to Propofol 1% Fresenius (20 parts of Propofol 1% Fresenius and 1 part of preservative-free 1% lidocaine solution for injection). Lidocaine must not be used in patients with inherited acute porphyria.
Muscle relaxants such as atracurium and mivacurium may be administered through the same infusion line as Propofol 1% Fresenius only after prior flushing of the line.