Propofol Baxter

Package Leaflet: Information for the User

Propofol Baxter, 20 mg/ml, Emulsion for Injection/Infusion

Propofol

Read the package leaflet carefully before taking the medicine because it contains important information for you.

• You should 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, talk to your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Propofol Baxter and what is it used for
• 2. Important information before taking Propofol Baxter
• 3. How to take Propofol Baxter
• 4. Possible side effects
• 5. How to store Propofol Baxter
• 6. Contents of the pack and other information

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

Propofol Baxter contains the active substance propofol. Propofol Baxter belongs to a group of medicines called general anesthetics. It is used to induce and maintain general anesthesia (deep sleep) to enable surgery or other procedures to be carried out.

Propofol Baxter is used for:

• induction and maintenance of general anesthesia in adults and children over 3 years of age,
• sedation (calming) of mechanically ventilated patients over 16 years of age in intensive care units,
• sedation in adults and children over 3 years of age during surgical and diagnostic procedures, alone or in combination with local or regional anesthesia (local anesthetics).

2. Important information before taking Propofol Baxter

When not to use Propofol Baxter

• if you are allergic to propofol, soybeans, peanuts, or any of the other ingredients of this medicine (listed in section 6),
• for sedation of patients under 16 years of age in intensive care units,
• for general anesthesia in children under 3 years of age.

Warnings and precautions

Before starting treatment with Propofol Baxter, discuss with your doctor, anesthesiologist, or nurse:

• if you have ever had a seizure or convulsion;
• if you have ever had a very high level of fat in your blood;
• if you have ever had problems with fat in your body;
• if your body has lost a lot of water (hypovolemia);
• if you have any other health problems, such as heart, breathing, kidney, or liver problems;
• if you have been feeling unwell for some time;
• if you have a mitochondrial disease.

After taking Propofol Baxter, you may experience its effects. You should not leave the hospital alone.

Children and adolescents

Propofol Baxter should not be used in children under 3 years of age, as the recommended gradual administration of Propofol Baxter to small children is a difficult task due to the extremely small volume required.

Older people

In elderly patients, smaller doses of Propofol Baxter are required for induction of anesthesia. The dose should be adjusted according to the patient's overall health and age. A reduced dose should be administered more slowly and titrated according to the patient's response.

Propofol Baxter with other medicines

Tell your doctor about all medicines you are taking, or have recently taken, and any you plan to take.

• Rifampicin, as it may lower blood pressure when used with general anesthesia.
• Certain sedatives and painkillers, such as benzodiazepines and opioids, as they may enhance the effects of propofol.
• Valproate, as the dose of propofol may need to be reduced if used together.

Taking Propofol Baxter with food, drink, and alcohol

Do not drink alcohol in any form after taking Propofol Baxter.

Pregnancy and breastfeeding

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

Driving and using machines

After taking propofol, you may still feel sleepy for some time. Do not drive or use tools or machines until the effects of the medicine have worn off.

• If you can go home soon after receiving Propofol Baxter, you should not drive a car or operate any tools or machines.
• You should ask your doctor when you can start doing these activities again and when you can return to work.

Propofol Baxter contains soybean oil

Propofol Baxter contains soybean oil. Do not use if you have a known allergy to peanuts or soybeans.

Propofol Baxter contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which is essentially sodium-free.

3. How to take Propofol Baxter

Propofol Baxter will be given to you by injection or infusion into a vein, usually on the back of your hand or forearm.

Dosage

The dose of Propofol Baxter used will depend on your age, weight, overall health, and any other medicines you are taking. Your doctor will decide the dose and monitor your response to the medicine.

4. Possible side effects

Like all medicines, Propofol Baxter can cause side effects, although not everybody gets them.

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

• Pain at the injection site when anesthesia is given

Common side effects (may affect up to 1 in 10 people)

• Spontaneous movements and muscle twitching during induction of anesthesia, headache during recovery.
• Slow heart rate.
• Low blood pressure.
• Rapid breathing (hyperventilation) and coughing during induction of anesthesia, temporary ineffective breathing (apnea) during induction of anesthesia.
• Hiccup during induction of anesthesia, nausea, and vomiting during recovery.
• Flushes during induction of anesthesia.

Uncommon side effects (may affect up to 1 in 100 people)

• Blood clots in the circulatory system (thrombophlebitis) and inflammation of the veins.
• Coughing during maintenance of anesthesia.

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

• Dizziness, shivering, and feeling cold during recovery,
• seizure-like episodes with convulsions and muscle spasms causing arching of the head, neck, and spine (opisthotonus) during induction, maintenance, and recovery (very rarely delayed for several hours to several days).
• Coughing during recovery.

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

• Severe allergic reactions (anaphylaxis), which can include angioedema, respiratory failure due to bronchospasm, skin rash, and low blood pressure.
• Loss of consciousness after surgery.
• Fluid accumulation in the lungs, which can cause shortness of breath (may also occur after recovery).
• Pancreatitis.
• Changes in urine color after prolonged administration of Propofol Baxter.
• Lack of sexual inhibition.
• Tissue damage.
• Postoperative fever.

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

• Excessive acid in the blood due to metabolic disorders (metabolic acidosis),
• high levels of potassium in the blood,
• high levels of lipids in the blood.
• Euphoric mood during recovery;
• abuse and dependence on the medicine.
• Involuntary movements.
• Abnormal heart rhythm,
• heart failure.
• Ineffective breathing (dose-dependent respiratory depression).
• Enlargement of the liver.
• Breakdown of striated muscle fibers (rhabdomyolysis).
• Kidney failure.
• Pain and swelling at the injection site after accidental extravascular administration.
• Prolonged, often painful erection (priapism).
• Changes in ECG.
• Hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain, and liver tenderness (indicated as pain under the front of the ribcage, on the right side of the body), sometimes with loss of appetite].

When given together with lidocaine, the following side effects may rarely occur:

• dizziness
• vomiting
• drowsiness,
• seizures,
• bradycardia,
• arrhythmia, and
• shock.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +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.

5. How to store Propofol Baxter

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 carton and label after EXP. The expiry date refers to the last day of that month.

Store in a temperature not exceeding 25°C.

Do not freeze.

After first opening, the product should be used immediately.

Shake before use.

Do not use this medicine if you notice two layers after shaking.

Only use homogeneous solutions and undamaged vials.

For single use only. Unused emulsion should be discarded.

The anesthesiologist and pharmacist are responsible for the proper storage, use, and disposal of Propofol Baxter.

6. Contents of the pack and other information

What Propofol Baxter contains

The active substance is propofol.

1 ml of emulsion for injection/infusion contains 20 mg of propofol.

A 50 ml vial contains 1000 mg of propofol.

The other ingredients are purified soybean oil, medium-chain triglycerides, glycerol, egg lecithin, sodium oleate, sodium hydroxide (for pH adjustment), and water for injections.

What Propofol Baxter looks like and contents of the pack

White oil-in-water emulsion for injection/infusion.

Propofol Baxter is available in:

Emulsion for injection/infusion in a colorless glass vial (type II) with a gray rubber stopper.

Pack sizes:

50 ml colorless glass vial (type II) with a gray rubber stopper, pack containing 1 and 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder for Austria, Czech Republic, Estonia, Hungary, Ireland, Italy, Lithuania, Portugal, France, Denmark, Finland, Germany, Norway, Sweden, Latvia, Poland, Slovenia, Romania, Greece

Baxter Holding B.V.

Kobaltweg 49,

3542CE Utrecht, Netherlands

For the Netherlands

Baxter Holding B.V.

Kobaltweg 49,

3542CE Utrecht, Netherlands

For the United Kingdom

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk IP24 3SE, United Kingdom

Manufacturer

UAB Norameda, Vilnius, Lithuania

Bieffe Medital S.p.A.,

Via Nuova Provinciale

23034 Grossotto (SO), Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: 05.08.2024

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Package leaflet containing medical information

Information intended for healthcare professionals only

This package leaflet is a shortened version of the Summary of Product Characteristics (SPC).

Instructions for handling the medicinal product

Propofol Baxter may only be administered by persons with appropriate expertise in the use of anesthetic drugs, in a setting where full facilities for monitoring and maintenance of the patient are available.

Shelf life after opening or after reconstitution

Chemical and physical stability have been demonstrated for 12 hours at 25°C.

Use immediately after opening.

For single use only. Discard any unused product.

Instructions for use

Before administration, the rubber stopper of the vial should be disinfected using alcohol spray or an alcohol swab.

The vials should be shaken before use.

Propofol Baxter should be administered by injection or infusion into a vein, using glass vials or plastic syringes.

Propofol Baxter does not contain any antimicrobial preservatives and may be a potential vehicle for microbial growth.

Dosage

General anesthesia in adults

Induction of anesthesia

Propofol Baxter should be administered slowly (at a rate of 20-40 mg propofol per 10 seconds) until the clinical signs of induction are achieved.

The required dose is usually 1.5-2.5 mg propofol per kg body weight.

Maintenance of anesthesia

Maintenance of general anesthesia can be achieved by administering Propofol Baxter as a continuous infusion.

The dose and rate of infusion should be adjusted according to the patient's response.

General anesthesia in children over 3 years of age

Induction of anesthesia

Propofol Baxter should be administered slowly and carefully until clinical signs of anesthesia are achieved.

The required dose is usually 2.5-4 mg propofol per kg body weight.

Maintenance of anesthesia

Maintenance of anesthesia can be achieved by administering Propofol Baxter as a continuous infusion.

The required dose is usually in the range of 9-15 mg propofol per kg body weight per hour.

Sedation in adults during surgical and diagnostic procedures

During administration of Propofol Baxter, the patient should be continuously monitored for signs of hypotension, airway obstruction, and hypoxia, and standard resuscitative equipment should be available.

For induction of sedation, a dose of 0.5-1.0 mg propofol per kg body weight over 1-5 minutes is usually required.

For maintenance of sedation, the dose should be adjusted according to the level of sedation required and is usually in the range of 1.5-4.5 mg propofol per kg body weight per hour.

Sedation in children over 3 years of age during surgical and diagnostic procedures

The dose and rate of administration should be adjusted according to the level of sedation required and the patient's response.

A dose of 1-2 mg propofol per kg body weight is usually required to induce sedation.

Maintenance of sedation can be achieved by administering Propofol Baxter as a continuous infusion, usually in the range of 1.5-9 mg propofol per kg body weight per hour.

Overdose

Overdose may lead to cardiovascular and respiratory depression.

Respiratory depression requires artificial ventilation.

In case of cardiovascular depression, standard measures to reduce the position of the head and/or substitute blood volume and vasoconstrictor agents should be taken.

Duration of treatment

Propofol Baxter should not be used for more than 7 days.