Diprivan

Leaflet attached to the packaging: information for the user

DIPRIVAN, 10 mg/ml, emulsion for injection

Propofol

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and should not be given 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, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Diprivan and what is it used for

Diprivan belongs to a group of medicines called general anesthetics. General anesthetics are used to put the patient to sleep for surgical operations or other procedures. They are also used to induce a sedative effect.
Propofol, the active substance of Diprivan, is a short-acting agent used for general anesthesia. After administration of propofol, induction of anesthesia and recovery from anesthesia are usually rapid.
Diprivan is used for:

• induction and maintenance of general anesthesia in adult patients and children over 1 month of age;
• sedation of mechanically ventilated patients over 16 years of age in intensive care units;
• sedation with preserved consciousness in adult patients and children over 1 month of age undergoing diagnostic and surgical procedures, using propofol alone or in combination with other anesthetics.

2. Important information before using Diprivan

When not to use Diprivan:

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

Warnings and precautions

Tell your doctor about any worrying symptoms that have occurred after using a medicine containing propofol or any of the ingredients of Diprivan listed in section 6.
Also, tell your doctor about any worrying reactions that have occurred after taking other medicines.
Diprivan is not recommended for use in newborns.
Before using Diprivan, tell your doctor if you have:

• epilepsy or have had a seizure,
• high levels of lipids (fats) in the blood or disorders related to fat metabolism,
• dehydration, heart, respiratory, kidney, or liver disease, or have been feeling unwell for a long time,
• mitochondrial disease.

In rare cases, during prolonged administration of propofol, a condition called propofol infusion syndrome (PIS) may occur in the patient. This can lead to heart, muscle, kidney damage, and other serious disorders, and can be fatal.
Your doctor will closely monitor your condition and take appropriate preventive measures.

Children and adolescents

See above "When not to use Diprivan".
Use of Diprivan in newborns is not recommended.
Animal studies have shown that general anesthetics may have a negative impact on the development of a child's brain.
Your doctor will assess the benefits and risks of using this medicine.

Diprivan and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. This includes:

• sedatives (such as benzodiazepine derivatives), painkillers (such as fentanyl and opioids), or alcohol, as they may enhance the effect of Diprivan.
• rifampicin (an antibiotic), as it may lead to a decrease in blood pressure in connection with anesthesia.
• valproate (a medicine used to treat epilepsy, bipolar disorder, and to prevent migraine headaches), as it may be necessary to reduce the dose of Diprivan.
• midazolam [a medicine used to induce sedation (a state of deep relaxation, drowsiness, or sleep) and to relieve anxiety symptoms and reduce muscle tension].

Diprivan and alcohol

Do not drink alcohol for at least 8 hours before and 8 hours after administration of Diprivan.

Pregnancy, breastfeeding, fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Diprivan should not be used in pregnant women unless absolutely necessary.
A small amount of Diprivan passes into human milk. Do not breastfeed for 24 hours after using Diprivan, and discard the milk expressed during this time.

Driving and using machines

After administration of Diprivan, you may still feel drowsy for some time. Do not drive, operate machinery, or use appliances until you are sure that the effect of the medicine has worn off completely.
If you are to return home soon after using Diprivan, do not drive, operate machinery, or use appliances.
Ask your doctor when you can resume these activities and return to work.

Diprivan contains sodium, soybean oil, and disodium edetate

The medicine contains less than 1 mmol (23 mg) of sodium per ml, which means it is considered "sodium-free".
The medicine contains soybean oil. Do not use if you have a known hypersensitivity to peanuts or soy.
The medicine contains disodium edetate. During prolonged use of Diprivan, it may be necessary to administer zinc preparations. This applies especially to patients at risk of zinc deficiency, such as burn patients, patients with diarrhea, and (or) patients with generalized infections.

3. How to use Diprivan

Diprivan is administered intravenously by an anesthesiologist or a doctor in an intensive care unit. A needle or plastic cannula may be used for administration. Additionally, during longer surgical procedures or in an intensive care unit, an electric pump may be used to control the dosing of propofol.
The dose of Diprivan depends on the patient's age, weight, and overall condition. The doctor will administer the appropriate dose to induce anesthesia, maintain the anesthetic effect, or achieve the desired level of anesthesia, based on the patient's response to the medicine and observation of vital signs (heart rate, blood pressure, respiratory function, etc.).

Using a higher dose of Diprivan than recommended

Diprivan is prepared and administered by an anesthesiologist or nurse, so it is unlikely that an overdose of propofol will occur. In case of accidental administration of a higher dose than recommended by the doctor, symptomatic treatment is used.

Missing a dose of Diprivan

Diprivan is prepared and administered by an anesthesiologist or nurse.
The specifics of administering general anesthetics do not require their regular dosing, e.g., twice a day. Missing a dose does not apply to Diprivan.

Stopping the use of Diprivan

Not applicable.

4. Possible side effects

Like all medicines, Diprivan can cause side effects, although not everybody gets them.
The following side effects have been reported in patients who have used propofol.
Induction of anesthesia and its maintenance or sedation usually proceed smoothly with minimal signs of excitement. The most common side effects, such as hypotension, are known effects of anesthetics and sedatives.
The type, severity, and frequency of side effects observed in patients using Diprivan may be related to the patient's condition and the procedures and treatments they have undergone.

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

• pain at the injection site

Common (may affect up to 1 in 10 people)

• headache during recovery
• low blood pressure
• transient apnea during induction of anesthesia
• bradycardia
• nausea and vomiting during recovery

Uncommon (may affect up to 1 in 100 people)

• swelling and redness along the vein or thrombophlebitis

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

• seizures and tremors

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

• severe allergic reactions, such as anaphylaxis, bronchospasm, rash, and hypotension
• pulmonary edema
• prolonged recovery time
• pancreatitis
• change in urine color
• sexual arousal during recovery
• postoperative fever
• tissue necrosis after accidental extravascular administration

Your anesthesiologist or doctor in the intensive care unit will monitor the use of Diprivan and take appropriate action if side effects occur.

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

• increased blood acidity (metabolic acidosis), which may cause rapid breathing
• high potassium levels in the blood
• high lipid levels in the blood
• euphoria
• abuse and dependence on the medicine
• involuntary movements
• heart rhythm disorders
• heart failure
• cardiac arrest
• liver enlargement
• kidney failure
• muscle cell breakdown (rhabdomyolysis)
• changes in ECG tracing
• anaphylactic shock
• breathing difficulties
• prolonged, often painful, erection (priapism)
• local pain after accidental extravascular administration
• swelling at the injection site after accidental extravascular administration
• 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 upper right part of the chest), sometimes with loss of appetite].

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Diprivan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after: "Expiry date (EXP)". The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Do not freeze.
Shelf life after dilution
After dilution, the solution is stable for 6 hours.
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 packaging and other information

What Diprivan contains

• The active substance of Diprivan is propofol. One ml of the 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 50 ml prefilled syringe contains 500 mg of propofol.
• The other ingredients are: purified soybean oil, purified egg yolk phospholipids, glycerol (E 422), disodium edetate, sodium hydroxide, water for injections.

What Diprivan looks like and contents of the pack

Diprivan is a white, sterile, isotonic emulsion of the oil-in-water type.
Pack sizes:

• 5 ampoules of 20 ml, made of colorless glass, in a cardboard box
• 1 vial of 50 ml, made of colorless glass, in a cardboard box
• 1 prefilled syringe of 50 ml, made of colorless glass, in a cardboard box.

Marketing authorization holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: 0048 22 104 2100

Manufacturer/Importer

Corden Pharma S.P.A
Viale dell’ Industria 3
20867 Caponago
Italy

Date of last revision of the leaflet: 07/2024

Detailed information about this medicine, including information intended for healthcare professionals
only,can be found in the Summary of Product Characteristics available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
www.urpl.gov.pl