Propofol eignapharma

Package leaflet: Information for the user

Propofol Eignapharma, 10 mg/mL, injection emulsion / for infusion
Propofolum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult 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.

Table of contents

1. What Propofol Eignapharma 10 mg/mL is and what it is used for
2. Important information before using Propofol Eignapharma 10 mg/mL
3. How to use Propofol Eignapharma 10 mg/mL
4. Possible side effects
5. How to store Propofol Eignapharma 10 mg/mL
6. Contents of the pack and other information

1. What Propofol Eignapharma 10 mg/mL is and what it is used for

Propofol Eignapharma 10 mg/mL contains the active substance called propofol. It belongs to a group of
medicines known as general anaesthetic agents. These medicines are used to induce loss of
consciousness (deep sleep), thereby enabling surgical procedures or other interventions to be performed.
They may also be used to achieve so-called sedation (a state in which the patient is drowsy but not fully unconscious).
Propofol Eignapharma 10 mg/mL is administered by injection by a doctor.
In adults and children over 1 month of age, it is used for:

• induction of anaesthesia prior to surgery or other procedures,
• maintenance of anaesthesia during surgery or other procedures,
• sedation during surgical and diagnostic procedures, either as a single agent or in combination with other medicines used to induce local or regional anaesthesia.

In patients aged over 16 years, it is also used for:

• sedation of mechanically ventilated patients in intensive care settings.

2. Information before using Propofol Eignapharma 10 mg/mL

When not to use Propofol Eignapharma 10 mg/mL

• If the patient is allergic to propofol or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to peanuts or soya. Propofol Eignapharma 10 mg/mL contains soya oil.
• For sedation in intensive care settings in patients aged 16 years or younger.

If any of the above apply to the patient, Propofol Eignapharma 10 mg/mL must not be used and the doctor, anaesthetist or nurse should be informed.
If in doubt whether any of the above conditions apply to the patient, please speak with a doctor, anaesthetist or nurse before administering this medicine.

Warnings and precautions

Propofol Eignapharma 10 mg/mL is not recommended for use in neonates. This should be discussed with the doctor, anaesthetist or nurse before starting treatment. Before starting treatment with Propofol Eignapharma 10 mg/mL, the following conditions should be discussed with the doctor, anaesthetist or nurse:

• If the patient has ever had a convulsion or seizures.
• If the patient has ever had very high levels of lipids (fats) in the blood.
• If it has ever been established that the patient has disorders in fat metabolism.
• If there is significant fluid loss (the patient is dehydrated).
• If the patient has other health problems such as heart disease, breathing difficulties, kidney or liver disease.
• If the patient has generally felt unwell for some time.
• If the patient has a mitochondrial disease.

If in doubt whether any of the above apply to the patient, please consult a doctor or nurse before using Propofol Eignapharma 10 mg/mL.

Propofol Eignapharma 10 mg/mL and other medicines

Tell the doctor about all medicines the patient is currently taking, has recently taken or might take, including over-the-counter medicines and herbal remedies.

Specifically, inform the doctor, anaesthetist or nurse if the patient is taking any of the following medicines:

• rifampicin (a medicine used to treat tuberculosis)
• other anaesthetic medicines (administered intrathecally or by inhalation)
• certain premedication medicines (the anaesthetist will know which ones are relevant)
• suxamethonium (a muscle relaxant)
• neostigmine (a medicine used in the treatment of myasthenia gravis)
• cyclosporine (a medicine used to prevent transplant rejection)
• analgesics (painkillers)
• valproate (propofol dose reduction may be considered)

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Propofol Eignapharma 10 mg/mL should not be used during pregnancy unless absolutely necessary.

Breastfeeding must be avoided during treatment with Propofol Eignapharma 10 mg/mL. Milk expressed within 24 hours after administration of propofol must be discarded.

Driving and operating machinery

After receiving Propofol Eignapharma 10 mg/mL, the patient may continue to feel drowsy for some time. The patient must not drive or operate machinery until fully recovered from the effects of the medicine.

• If the patient is discharged home soon after receiving Propofol Eignapharma 10 mg/mL, he/she should not drive or operate machinery.
• Ask the doctor when it is safe to resume these activities and when it is safe to return to work.

Propofol Eignapharma 10 mg/mL contains soya oil. Do not use if the patient has a known hypersensitivity to peanuts or soya.

The medicine contains less than 1 mmol (23 mg) of sodium per mL; this means the medicine is considered "sodium-free".

3. How to use Propofol Eignapharma 10 mg/mL

Propofol Eignapharma 10 mg/mL is administered by a doctor. The medicine is given as an intravenous injection, usually into the back of the hand or forearm.

• The doctor will administer the injection using a needle or a thin plastic tube, known as a venflon.
• The doctor may also use an electric infusion pump, which automatically controls the rate of administration. This method may be used during prolonged surgery or in an intensive care unit.

The dose of Propofol Eignapharma 10 mg/mL varies for each patient. The required amount of Propofol Eignapharma 10 mg/mL depends on the patient's age, body weight, health status, and the required level of sedation or anaesthesia. The doctor will administer the appropriate dose to induce and maintain general anaesthesia or achieve the desired level of sedation, based on careful observation of the patient's response and vital signs (pulse, blood pressure, respiratory function, etc.).

To maintain sleep or sedation, analgesia, adequate patient respiration, and haemodynamic stability, it may be necessary to use several different medications. The doctor will decide which medications to use and when to administer them.

Adult and elderly patients:
General anaesthesia
For induction (initiation) of anaesthesia in most adult patients under 55 years of age, a dose of 1.5 to 2.5 mg propofol/kg body weight (bw) may be administered.
To maintain anaesthesia, doses of 4 to 12 mg propofol/kg bw per hour are usually given, or repeated bolus injections of 25 mg to 50 mg (using Propofol Eignapharma 10 mg/mL emulsion for injection/infusion).
Lower doses may be required in elderly patients.

Sedation
To achieve sedation in adults and adolescents over 16 years of age in intensive care settings, the dose should be adjusted according to the required level of sedation. A satisfactory level of sedation is usually achieved by administering propofol at a rate of 0.3 to 4.0 mg/kg bw per hour. The infusion rate should be adjusted according to the desired depth of sedation.
To ensure the required level of sedation during surgical and diagnostic procedures in adults, most patients will require an initial dose of 0.5 to 1 mg propofol/kg bw administered over 1 to 5 minutes. Maintenance of the desired level of sedation can be achieved by adjusting the infusion rate to 1.5 to 4.5 mg propofol/kg bw per hour.
If rapid deepening of sedation (drowsiness) is required, additional propofol may be administered as single bolus injections of 10 to 20 mg.

Use in children
General anaesthesia
For induction of anaesthesia in children over 1 month of age, the dose of Propofol Eignapharma 10 mg/mL should be gradually increased until clinical signs indicating the onset of anaesthesia appear.
The dose should be adjusted according to age and/or body weight. In most children over 8 years of age, the dose required to induce anaesthesia is approximately 2.5 mg propofol/kg bw.
In younger children, especially those aged 1 month to 3 years, a higher dose may be required (2.5 to 4 mg propofol/kg bw).

Sedation
In children over 1 month of age, doses and infusion rates should be adjusted according to the required depth of sedation and clinical response.
In most paediatric and adolescent patients, a dose of 1 to 2 mg propofol/kg bw is required to induce sedation. Maintenance of sedation can be achieved by gradually increasing the dose of Propofol Eignapharma 10 mg/mL to the desired level.
Most patients require an infusion rate of 1.5 to 9 mg propofol/kg bw per hour. If rapid deepening of sedation (drowsiness) is required, additional propofol may be administered as a single dose of up to 1 mg/kg bw.

Duration of treatment
The duration of treatment must not exceed 7 days.

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 following adverse reactions may occur during anaesthesia (during injection and while the patient is drowsy or fully unconscious). The doctor will monitor for these. If any of these adverse reactions occur, the doctor will provide appropriate treatment.

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

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

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

• Low blood pressure
• Changes in breathing pattern
• Slow heart rate

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

• Thrombosis and phlebitis

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

• Tremors, body jerks or convulsions (may also occur during emergence from anaesthesia)

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

• Allergic reactions
• Cardiac arrest
• Fluid accumulation in the lungs, causing severe breathing difficulty (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

Adverse reactions that may occur after emergence from anaesthesia
The following adverse reactions may occur after emergence from anaesthesia (during waking up or once the patient is awake):

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

• Nausea
• Vomiting
• Headache

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

• Swelling and redness along the vein or blood clots

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

• Sexual excitation
• High body temperature (postoperative fever)
• Redness or pain at the injection site
• Postoperative loss of consciousness (in such cases, patients returned to consciousness without problems)
• Tissue damage
• Pancreatitis

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

• Euphoria
• Irregular heartbeat
• Enlarged liver
• Kidney failure
• Muscle damage (rhabdomyolysis)
• Increased blood acidity, high potassium and fat levels in the blood, heart failure
• Respiratory depression (dose-dependent)
• Local pain and swelling after accidental extravascular administration
• Changes in ECG readings (Brugada syndrome)
• Abuse and dependence on Propofol Eignapharma 10 mg/mL, mainly among medical personnel
• Hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain and liver tenderness (indicated by pain under the front of the rib cage on the right side), sometimes with loss of appetite]

Other possible adverse reactions
The following adverse reactions have been observed when Propofol Eignapharma 10 mg/mL was used in intensive care units at doses higher than recommended.

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

• Heart failure
• Pancreatitis causing severe abdominal pain
• Increased blood acidity. This may cause faster breathing.
• Increased potassium levels in the blood
• High lipid levels in the blood
• Irregular heartbeat
• Enlarged liver
• Kidney failure

In children in intensive care units, the following adverse reactions have been observed after abrupt discontinuation of Propofol Eignapharma 10 mg/mL.

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

• "Withdrawal symptoms" including unusual behaviour, sweating, tremor, and feeling of anxiety
• Skin redness

Patients should not be overly concerned after reading this list of possible adverse reactions, as they may not occur.

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

• Euphoria
• Involuntary movements
• Abuse and dependence on Propofol Eignapharma 10 mg/mL, mainly among medical personnel
• Abnormal ECG readings
• Muscle damage (rhabdomyolysis)

If you suspect any adverse reaction or if any adverse symptoms not listed in this leaflet occur, inform your doctor or nurse immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell 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 can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Propofol Eignapharma 10 mg/mL

The medicine should be stored out of sight and reach of children.
The hospital doctor and pharmacist are responsible for the proper storage, use, and disposal of Propofol Eignapharma 10 mg/mL.
Do not use this medicine after the expiry date stated on the cardboard box and vial label following EXP.
There are no special storage requirements for this medicine. Do not freeze. After opening, the medicine must be used immediately.
Chemical and physical in-use stability has been demonstrated for 6 hours at a temperature below 25°C.
From a microbiological standpoint, the medicine should be used immediately unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions. If not used immediately, the user is responsible for the storage duration and conditions prior to use.
The medicine must not be diluted to a greater extent than 1:5 (2 mg of propofol in 1 mL of solution). Solutions must be prepared under aseptic conditions immediately before administration, which should occur within 6 hours of preparation.
Propofol 10 mg/mL may only be mixed with the following preparations: glucose 50 mg/mL (5%) solution for infusion, sodium chloride 9 mg/mL (0.9%) solution for infusion, a mixture of sodium chloride 1.8 mg/mL (0.18%) and glucose 40 mg/mL (4%) solution for infusion, or lidocaine 5 mg/mL (0.5%) or 10 mg/mL (1%) injection solution without preservatives.
Shake the container before use.
If, after shaking, two layers are visible in the emulsion, do not use the product.
Use only medicine with a homogeneous consistency and from undamaged packaging.
For single use only. Any unused portions of the emulsion must be discarded.
The anaesthesiologist and hospital pharmacist are responsible for the proper storage, use, and disposal of Propofol.

6. Contents of the package and other information

What Propofol Eignapharma contains
The active substance is propofol.
One mL of injection/infusion emulsion contains 10 mg of propofol.
Each 20 mL vial contains 200 mg of propofol.
Each 50 mL vial contains 500 mg of propofol.
The other ingredients are: purified soybean oil; glycerol; egg lecithin; disodium edetate; sodium hydroxide (for pH adjustment); water for injections.

What Propofol Eignapharma looks like and contents of the pack
Propofol Eignapharma 10 mg/mL is a white, milky emulsion for injection/infusion.
This medicinal product is supplied as an emulsion for injection/infusion in a vial made of colourless glass, with a bromobutyl rubber stopper and an aluminium flip-off seal, packed in a cardboard box.
Pack sizes:
The pack contains one 20 mL vial.
The pack contains one 50 mL vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Troikaa Pharmaceuticals Europe s.r.o.
Na Zlíchově 240/5, Hlubočepy
152 00 Prague 5
Czech Republic
e-mail: [email protected]

Manufacturer
Netpharmalab Consulting Services
Carretera de Fuencarral 22, Alcobendas 28108, Madrid
Spain

This medicinal product is authorised in the European Economic Area under the following names:
France: Propofol Eignapharma 10 mg/ml, émulsion injectable/pour perfusion
Germany: Propofol Eignapharma 10 mg/ml Emulsion zur Injektion/Infusion
Poland: Propofol Eignapharma
Portugal: Propofol Eignapharma

Information intended exclusively for healthcare professionals

Propofol may be administered only in hospitals or appropriately equipped day-care medical units by physicians trained in anaesthesiology or intensive care medicine.
Patients must be continuously monitored, and equipment for maintaining airway patency, artificial ventilation, administration of oxygen at increased concentration, and other resuscitation equipment must be readily available at all times. Propofol Eignapharma 10 mg/mL must not be administered by a person performing a diagnostic or surgical procedure.

The solution may be administered using various infusion rate control techniques; however, the infusion set itself cannot prevent the risk of uncontrolled administration of large volumes of diluted propofol 10 mg/mL. The infusion line must include a burette, drip chamber, or volumetric infusion pump. The maximum volume of propofol 10 mg/mL in the burette must be determined with consideration of the risk of uncontrolled infusion.

The container must be shaken before use. If, after shaking, two layers are visible in the emulsion, the product must not be used.
Use only medicinal product with homogeneous appearance and from undamaged packaging.
For single use only. Any unused remnants of the emulsion must be discarded immediately after administration.
Before use, the rubber stopper of the vial must be disinfected with alcohol spray or an alcohol-impregnated swab. After puncturing the vial stopper, the vial must be discarded.

Propofol Eignapharma 10 mg/mL contains no antimicrobial preservatives and may support microbial growth.
Propofol Eignapharma 10 mg/mL must be withdrawn under aseptic conditions into a sterile syringe or infusion system immediately after puncturing the vial stopper. Administration must be initiated promptly. Aseptic technique must be maintained throughout the entire infusion period, both for Propofol Eignapharma 10 mg/mL and for the infusion equipment. Any infusion fluids administered simultaneously with Propofol Eignapharma 10 mg/mL via the same infusion line must be administered close to the cannulation site. Propofol Eignapharma 10 mg/mL must not be administered through an infusion line containing a microbiological filter.

Propofol Eignapharma 10 mg/mL and any syringe containing this medicinal product are intended for single-patient, single-use administration only. As with all types of lipid emulsions, the same infusion system used for continuous infusion of the medicinal product must not be used for longer than 12 hours. The infusion system and propofol container must be discarded and replaced with new ones at the end of the procedure or after 12 hours, whichever occurs first.

When Propofol Eignapharma 10 mg/mL is used in undiluted form for maintenance of anaesthesia, it is recommended to always use infusion control devices such as syringe pumps or volumetric infusion pumps to regulate the infusion rate.
Propofol may be administered as an undiluted or diluted infusion.

Propofol should only be mixed with the following solutions: glucose 50 mg/mL (5%) for injection, sodium chloride 9 mg/mL (0.9%) for injection, a mixture of sodium chloride 1.8 mg/mL (0.18%) and glucose 40 mg/mL (4%) for injection, or lidocaine 5 mg/mL (0.5%) or 10 mg/mL (1%) for injection without antimicrobial preservatives.
The final concentration of propofol must not be less than 2 mg/mL.

However, when administering propofol simultaneously with 50 mg/mL (5%) glucose infusion solution, 9 mg/mL (0.9%) sodium chloride infusion solution, or a mixture of glucose 40 mg/mL (4%) and sodium chloride 1.8 mg/mL (0.18%), the connection should be made using a Y-connector close to the injection site.
Propofol must not be administered through an infusion line containing a microbiological filter.

Propofol and any infusion equipment containing propofol are intended for single-patient, single-use administration only. After administration, any remaining solution must be discarded.

Undiluted propofol infusion
When using undiluted propofol, it is recommended to always use infusion control devices such as burettes, drip chambers, syringe pumps, or volumetric infusion pumps to regulate the infusion rate.
Propofol and any syringe containing propofol are intended for single-patient, single-use administration. As with all types of lipid emulsions, the same infusion system used for continuous infusion of propofol must not be used for longer than 12 hours. The infusion system and propofol container must be discarded and replaced with new ones at the end of the procedure or after 12 hours, whichever occurs first.

Diluted propofol infusion
For administration of diluted propofol, burettes, drip counters, or volumetric infusion pumps must always be used to control the infusion rate and avoid the risk of accidental uncontrolled infusion of large volumes of diluted propofol. This risk must be considered when determining the maximum dilution volume in the burette.
The maximum dilution must not exceed 1 part propofol to 4 parts of one of the following solutions: 5% (w/v) glucose for infusion, 0.9% (w/v) sodium chloride for infusion, or a mixture of 4% dextrose and 0.18% sodium chloride (with a minimum concentration of 2 mg propofol/mL). Solutions must be prepared under aseptic conditions (maintaining controlled and validated conditions) immediately before use and must be administered within 12 hours of preparation.

This medicinal product must not be mixed or co-administered with other medicinal products except those listed above.

To reduce pain at the injection site, lidocaine may be administered immediately before propofol, or propofol may be mixed directly before use with lidocaine for injection without antimicrobial preservatives under controlled and validated aseptic conditions [20 parts of propofol 10 mg/mL with up to 1 part of lidocaine 5 mg/mL (0.5%) or lidocaine 10 mg/mL (1%)]. The solution must be administered within 12 hours of preparation.

Neuromuscular blocking agents such as atracurium and mivacurium must not be administered through the same infusion line as propofol without first flushing the line.