Plofed 1%

Package Leaflet: Information for the Patient

PLOFED 1%, 10 mg/ml, emulsion for injection/infusion

Propofol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Plofed 1% and what is it used for
• 2. Important information before using Plofed 1%
• 3. How to use Plofed 1%
• 4. Possible side effects
• 5. How to store Plofed 1%
• 6. Contents of the pack and other information

1. What is Plofed 1% and what is it used for

Plofed 1% contains propofol - a substance belonging to the so-called general anesthetics.
Plofed 1% is administered intravenously by a doctor, usually an anesthesiologist, for:

• inducing and maintaining sleep in adults and children over one month of age during surgery or other procedures;
• sedation in patients over 16 years of age during intensive care;
• inducing sedation during surgery or other procedures in adults and children over one month of age; Plofed 1% may be administered as the sole agent or in combination with other drugs used in local and regional anesthesia.

2. Important information before using Plofed 1%

When not to use Plofed 1%:

• if the patient is allergic to propofol or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to peanuts or soybeans, as Plofed 1% contains soybean oil;
• if the patient is pregnant (see "Pregnancy and breastfeeding");
• for sedation in intensive care in patients under 16 years of age. Tell your doctor or nurse if any of the above applies to you (even if you are not sure).

Warnings and precautions

Before starting treatment with Plofed 1%, discuss it with your doctor or pharmacist or nurse.
Plofed 1% is administered by anesthesiologists or doctors specialized in intensive care. During treatment, they will provide the patient with proper care, and in case of problems, they will administer oxygen therapy (oxygen supply) and take other appropriate actions to maintain vital functions.
Therefore, it is very important that before using Plofed 1%, the doctor knows about all the patient's health problems, especially if:

• the patient has ever had seizures or epileptic seizures;
• the patient has had a head injury;
• the patient is taking high doses of one or more of the following drugs: vasoconstrictors, steroids;
• the patient has a very high level of fats in the blood or lipid metabolism disorders;
• the patient is dehydrated, i.e. has lost a lot of water from the body;
• the patient has had or has health problems: with the heart, breathing, kidneys, or liver (e.g. kidney or liver failure);
• the patient is weakened or has been feeling unwell recently;
• the patient has a mitochondrial disease.

Patients with severe heart or respiratory problems, as well as the elderly and weakened, should be under special medical care.
At the beginning of the administration of the medicine, the patient may experience a significant decrease in blood pressure and transient respiratory difficulties (apnea), which the doctor will prevent by administering intravenous fluids and reducing the rate of administration of the medicine.
The medicine may cause a slowing of heart rate, sometimes severe, even to the point of cardiac arrest - in such a situation, the doctor will administer another medicine to counteract these symptoms.
After surgery, in which Plofed 1% was used, sexual arousal (sexual excitement) may occur.
The impairment of consciousness caused by Plofed 1% usually does not last longer than 12 hours. The effect of the medicine, the procedure, the medicines used at the same time, the patient's age, and condition should be taken into account.
The doctor will advise the patient on:

• the need for someone to accompany the patient when leaving the place where the medicine was administered;
• the time to return to performing complex or risky tasks, such as driving vehicles;
• the use of other agents that may have a sedative effect (e.g. benzodiazepines, opioids, alcohol).

Children and adolescents

Plofed 1% is not recommended for use in newborns.
The doctor may use Plofed 1% in children who have completed one month of life to induce general anesthesia in the child during surgery or a procedure.
See also the subsection "When not to use Plofed 1%" above.
Animal studies indicate that general anesthetics may have a negative impact on the development of the child's brain. The doctor will assess the benefits and risks of using this medicine.

Plofed 1% and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Strong painkillers (including opioids), alcohol, and anesthetics may enhance the sedative effect of Plofed 1% and cause serious respiratory and circulatory problems.
Severe hypotension has been reported after anesthesia with propofol in patients treated with rifampicin.
It has been observed that patients taking valproate require smaller doses of propofol.
In the case of concomitant use of both medicines, a reduction in the dose of propofol may be considered.

Plofed 1% with alcohol

Do not consume alcohol before and for 8 hours after administration of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The safety of using propofol during pregnancy has not been established. Do not use Plofed 1% during pregnancy unless absolutely necessary.
Breastfeeding
Inform your doctor if you are breastfeeding. Studies in breastfeeding women have shown that small amounts of propofol pass into breast milk. Therefore, mothers should stop breastfeeding for 24 hours after receiving Plofed 1%. Breast milk collected during this time should be discarded.

Driving and using machines

After using Plofed 1%, drowsiness may occur for some time, making it impossible to drive vehicles and operate machinery. Do not perform these activities until the drowsiness has passed. Ask your doctor how long after the procedure you can drive vehicles and operate machinery. The impairment of consciousness caused by Plofed 1% usually does not last longer than 12 hours.

Plofed 1% contains soybean oil and sodium

The medicine contains soybean oil. Do not use if you are hypersensitive to peanuts or soybeans.
The medicine contains less than 1 mmol of sodium (23 mg) per 100 ml of emulsion, i.e. the medicine is considered "sodium-free".
The medicine may be diluted - see below "Information intended exclusively for healthcare professionals". The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution. To obtain accurate information about the sodium content in the solution used for dilution, refer to the Summary of Product Characteristics of the diluent used.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should 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.

3. How to use Plofed 1%

Plofed 1% is administered intravenously by a doctor, usually an anesthesiologist. The medicine can be injected into a vein or administered slowly, by intravenous infusion (using appropriate equipment with controlled speed).
Intravenous infusion is used in the case of long operations or in intensive care units.
The dose of Plofed 1% may vary from patient to patient. The doctor will determine the dose based on the patient's age, weight, health status, duration of the operation, and the desired level of sleep or sedation required for the operation, checking the level of anesthesia or sedation and the patient's vital functions (heart rate, blood pressure, breathing, etc.). The doctor will provide detailed information on the dosing of the medicine.

Using a higher dose of Plofed 1% than recommended

Plofed 1% is administered by a doctor, and therefore, it is unlikely that the patient will receive more medicine than they should. If symptoms of overdose occur, the doctor will administer appropriate treatment.
Using high doses of the medicine, exceeding the recommended ones, especially for many hours, may cause the occurrence of acidic metabolic products in the blood, e.g. carbohydrates (metabolic acidosis), excess potassium in the blood, and muscle pain (due to severe changes in muscle cells).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The type, severity, and frequency of side effects observed in patients taking propofol may be related to the patient's condition and the surgical and therapeutic procedure performed. During the administration of the medicine, the patient is under the care of medical personnel - if side effects occur, appropriate treatment will be administered.
Very common (more than 1 in 10 people):

• pain at the injection site (occurring during the injection of the medicine).

Common (between 1 in 10 and 1 in 100 people):

• headache during recovery;
• slowed heart rate (in individual cases, cardiac arrest);
• low blood pressure;
• changes in breathing rate, including transient respiratory difficulties (apnea) during induction of anesthesia;
• nausea and vomiting during recovery.

Uncommon (between 1 in 100 and 1 in 1,000 people):

• swelling and redness along the vein or thrombophlebitis.

Rare (between 1 in 1,000 and 1 in 10,000 people):

• tremors and seizures affecting the body or convulsive seizures (may occur during induction, maintenance, and recovery from anesthesia).

Very rare (less than 1 in 10,000 people):

• allergic reactions (symptoms: wheezing, facial swelling, lips, tongue, hives, rash, flushing, decreased blood pressure);
• prolonged recovery time;
• pulmonary edema;
• pancreatitis, the symptom of which is severe abdominal pain;
• abnormal urine color (after prolonged administration of the medicine);
• sexual arousal (sexual excitement);
• tissue necrosis after accidental extravascular administration of the medicine;
• postoperative fever.

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

• the occurrence of acidic metabolic products in the blood (metabolic acidosis), excess potassium in the blood (hyperkalemia), high levels of fats called lipids in the blood (hyperlipidemia), liver enlargement (hepatomegaly), muscle cell breakdown (rhabdomyolysis), kidney failure, heart rhythm disorders, ECG changes, rapidly progressing heart failure in adults - these are symptoms of "propofol syndrome" - may occur in critically ill patients at risk of developing them;
• euphoria, drug abuse, dependence on the medicine - mainly by medical personnel;
• involuntary, uncoordinated, and involuntary movements of the limbs or the whole body; disorders of voluntary movements (intentional) and (or) muscle tension;
• respiratory depression (exacerbated breathing difficulties), dose-dependent;
• pain, swelling at the injection site, after accidental extravascular administration of the medicine;
• hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain, and liver tenderness (indicated as pain in the front part of the chest, on the right side of the body), sometimes with loss of appetite].

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Plofed 1%

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Protect from light. Do not freeze.
Shelf life after first opening: the emulsion should be used immediately after opening the vial.
Shelf life of the diluted Plofed 1% product:
After dilution with 5% glucose solution (50 mg/ml), 0.9% sodium chloride solution (9 mg/ml), or a mixture of 0.18% sodium chloride solution (1.8 mg/ml) and 4% glucose solution (40 mg/ml) in polyethylene or glass containers, chemical and physical stability has been demonstrated for 12 hours at 25°C.
Dilutions should be prepared immediately before administration.
From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the user is responsible for the conditions and storage time. If necessary, the prepared mixture can be stored for a maximum of 12 hours at a temperature up to 25°C, provided that the dilution is prepared in controlled and validated aseptic conditions. The unused mixture should be discarded within 12 hours. The medicine does not require protection from light during storage.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should 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 pack and other information

What Plofed 1% contains

• The active substance of the medicine is propofol. Each ml contains 10 mg of propofol. Each vial contains 200 mg of propofol.
• The other ingredients are: glycerol, oleic acid, lecithin (purified from egg yolk), purified soybean oil, sodium hydroxide 0.1 M (to adjust pH), water for injections.

What Plofed 1% looks like and contents of the pack

Plofed 1% is an emulsion for injection/infusion. It is a non-transparent, white or almost white emulsion.
The medicine is available in vials containing 20 ml of solution, packed in cartons of 5 or 10 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24; 01-207 Warszawa

Date of last revision of the leaflet:

Detailed information about this medicine is available on the website www.urpl.gov.pl
Information intended exclusively for healthcare professionals:
PLOFED 1% 10 mg/ml, emulsion for injection/infusion
Propofol
Refer to the current Summary of Product Characteristics.

Method of administration

Plofed 1% does not have analgesic properties and therefore it is recommended to administer additional analgesics.
Plofed 1% can be administered:

• by intravenous injection (bolus) - undiluted,
• by intravenous infusion - using diluted or undiluted medicine.

The medicine can be administered in a diluted form. It can be diluted with the following infusion solutions: 5% glucose solution (50 mg/ml); 0.9% sodium chloride solution (9 mg/ml); a mixture of 0.18% sodium chloride solution (1.8 mg/ml) and 4% glucose solution (40 mg/ml) in glass or polyethylene containers.
To dilute the medicine, add 1 volume of propofol to 4 volumes of the above diluents. The concentration of propofol in the resulting mixture is 2 mg/ml. When preparing the mixture, aseptic conditions should be maintained.
Chemical and physical stability has been demonstrated for 12 hours at 25°C.
Dilutions should be prepared immediately before administration.
From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the user is responsible for the conditions and storage time. If necessary, the prepared mixture can be stored for a maximum of 12 hours at a temperature up to 25°C, provided that the dilution is prepared in controlled and validated aseptic conditions. The unused mixture should be discarded within 12 hours. The medicine does not require protection from light during storage.
It is recommended that when diluting Plofed 1%, the appropriate volume of the infusion solution should be removed from the container and replaced with an equal volume of Plofed 1%.
The diluted medicine can be administered using one of several methods for regulating the infusion rate. To avoid uncontrolled administration of a large volume of diluted medicine, a burette, drop counter, or volumetric infusion pump should be connected to the system. Even with maximum filling of the burette with diluted medicine, there is still a risk of uncontrolled infusion of the medicine.
If Plofed 1% is used undiluted to maintain anesthesia, it is recommended to use syringe pumps or volumetric pumps to adjust the infusion rate.
The medicine can be administered using a Y-connector (located as close as possible to the intravenous cannula) simultaneously with one of the following infusion solutions:

• 5% glucose solution (50 mg/ml);
• 0.9% sodium chloride solution (9 mg/ml);
• a mixture of 0.18% sodium chloride solution (1.8 mg/ml) and 4% glucose solution (40 mg/ml).

To alleviate the pain caused by the first injection of propofol, lidocaine can be added to it, preparing a mixture containing 20 parts of propofol and 1 part of 0.5% or 1% lidocaine hydrochloride solution without preservatives immediately before administration.

Additional precautions

• Plofed 1% is an emulsion for injection/infusion. The emulsion should be non-transparent, white or almost white. Do not use if the emulsion has visibly changed color.
• -Vials should be shaken before use. Do not use if the phases of the emulsion have separated.
• -Do not use if the vial is damaged.
• -Plofed 1% does not contain preservatives, which may promote the growth of microorganisms.
• -All procedures related to the withdrawal and administration of the medicine should be performed under aseptic conditions.
• Aseptic conditions should be maintained for both Plofed 1% and the equipment used during the infusion.
• -The emulsion should be drawn into a sterile syringe or infusion set immediately after opening the vial and administration should be started immediately.
• -Any other medicines or fluids added to the line with Plofed 1% should be administered as close as possible to the intravenous cannula.
• Plofed 1% should not be administered through microbiological filters.
• Plofed 1% and any syringe containing Plofed 1% are for single use and for one patient only.
• -In accordance with the established guidelines for other fat emulsions, a single infusion of propofol should not last longer than 12 hours. At the end of the procedure or after 12 hours, whichever comes first, both the propofol container and the infusion line must be replaced.
• -Immediately after propofol, without prior flushing of the infusion set, neuromuscular blocking agents (atracurium, mivacurium) should not be administered.
• The medicine is for single use. Any unused contents of the medicine should be destroyed.

Dosage

Induction of general anesthesia

Adults
Patients with or without premedication should be given propofol by injection (bolus) or by intravenous infusion, dosing according to the patient's response, until clinical signs of anesthesia occur (in a healthy patient, about 40 mg, or 4 ml of the medicine, every 10 seconds).

• For most adult patients under 55 years of age: a sufficient dose of propofol is usually 1.5 mg/kg to 2.5 mg/kg. The total dose required for anesthesia can be reduced by prolonging the time of administration and reducing the infusion rate to about 20-50 mg/min (2 to 5 ml/min).
• Patients over 55 years of age: the requirement for propofol is lower. In patients with 3 or 4 ASA physical status, smaller doses should be used, i.e. about 20 mg (2 ml) every 10 seconds.

Elderly
During the induction of general anesthesia, the doses of propofol in elderly patients are lower. The dose should be reduced, taking into account the patient's clinical condition and age. The reduced dose should be administered at a slower rate and adjusted according to the patient's clinical response.
Children and adolescents
Plofed 1% is not recommended for use in children under one month of age (see section 1).
When propofol is used to induce general anesthesia in children over one month of age, it should be administered slowly until clinical signs of anesthesia occur. The dose should be adjusted according to the age and (or) weight of the child.

• For most children over 8 years of age, a dose of about 2.5 mg/kg of propofol is usually sufficient to induce anesthesia. In younger children, especially between 1 month and 3 years of age, this dose may be higher (2.5 to 4 mg/kg).

Children and adolescents classified as 3 or 4 ASA physical status should receive smaller doses.

Maintenance of general anesthesia

Adults
To maintain the desired depth of anesthesia, propofol can be administered by infusion or by repeated injections (bolus). Recovery from anesthesia is rapid, and therefore, it is important to administer propofol to maintain anesthesia until the end of the procedure.

• Continuous intravenous infusion: the infusion rate required to maintain the desired depth of anesthesia varies greatly from patient to patient and is usually within the range of 4 mg/kg/h to 12 mg/kg/h.
• Repeated single injections (bolus): if the technique of repeated single injections is used, doses of 25 mg to 50 mg (2.5 to 5 ml) can be administered, depending on the clinical need.

Elderly
If propofol is used to maintain general anesthesia, the infusion rate should be reduced. Patients with 3 or 4 ASA physical status require reduced doses and infusion rates. In elderly patients, propofol should not be administered in the form of single or repeated injections, as respiratory and circulatory depression may occur.
Children and adolescents
Plofed 1% is not recommended for use in children under one month of age (see section 1).
To maintain anesthesia in children over one month of age, propofol can be administered by continuous intravenous infusion or by repeated injections.
The infusion rate may vary from patient to patient, usually within the range of 9 mg/kg/h to 15 mg/kg/h. Younger children, especially between 1 month and 3 years of age, may require higher doses of propofol.

• Children and adolescents classified as 3 or 4 ASA physical status may require smaller doses.

Induction of sedation in intensive care

Adults
If sedation of adult patients is necessary, propofol should be administered by continuous intravenous infusion. The infusion rate should be adjusted according to the desired level of sedation.
For most patients, a sufficient level of sedation is achieved with 0.3 mg/kg/h to 4.0 mg/kg/h of propofol. The use of Plofed 1% to induce sedation in intensive care in patients under 16 years of age is not recommended.
Plofed 1% can be diluted - see above "Method of administration".
It is recommended to monitor the level of fats in the blood during the administration of the medicine to patients at risk of fat overload. The administration of Plofed 1% should be modified if monitoring shows inadequate fat elimination from the body. If the patient is also receiving fats intravenously, the amount of fats administered should be reduced, taking into account the amount of fats supplied with the infusion of Plofed 1%.
1.0 ml of Plofed 1% contains approximately 0.1 g of fat.
If the duration of sedation exceeds 3 days, the level of fats in the blood should be monitored in all patients.
Elderly
If propofol is used for sedation, the infusion rate should be reduced. Patients with 3 or 4 ASA physical status require further reduction of doses and infusion rates. In elderly patients, propofol should not be administered in the form of single or repeated injections, as respiratory and circulatory depression may occur.
Children and adolescents
The use of propofol to induce sedation in intensive care in children and adolescents under 16 years of age is contraindicated.

Induction of sedation during diagnostic and surgical procedures

Adults
To induce sedation necessary for a diagnostic or surgical procedure, the dose of propofol should be adjusted individually, depending on the patient's clinical response.
For most patients, a sufficient level of sedation is achieved with a dose of 0.5 to 1.0 mg/kg, administered over 1 to 5 minutes.
To maintain the desired depth of sedation, the infusion rate of propofol should be adjusted - most patients will require 1.5 to 4.5 mg/kg/h. If rapid deepening of sedation is necessary, an additional single injection (bolus) of propofol can be administered in a dose of 10 to 20 mg.
In patients with 3 or 4 ASA physical status, the infusion rate and dose of propofol should be reduced.
Elderly
If propofol is used for sedation, the infusion rate or target concentration should be reduced. Patients with 3 or 4 ASA physical status require further reduction of doses and infusion rates. In elderly patients, propofol should not be administered in the form of single or repeated injections, as respiratory and circulatory depression may occur.
Children and adolescents
Plofed 1% is not recommended for use in children under one month of age (see section 1).
In children over one month of age, the dose and infusion rate should be adjusted according to the desired level of sedation and clinical response. For most children, a dose of 1 to 2 mg/kg of propofol is usually sufficient to induce sedation. To maintain sedation, propofol should be administered by infusion, adjusting the dose according to the desired level of sedation. For most patients, a dose of 1.5 to 9 mg/kg/h of propofol is used.
If rapid deepening of sedation is necessary, an additional single injection (bolus) of propofol can be administered in a dose of up to 1 mg/kg.
Children and adolescents classified as 3 or 4 ASA physical status may require smaller doses.