DIPRIVAN 10 mg/ml Injectable Emulsion for Infusion

Introduction

Package Leaflet: Information for the User

Diprivan 10 mg/ml injectable emulsion and for infusion

Propofol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Diprivan is and what it is used for
2. What you need to know before you use Diprivan
3. How to use Diprivan
4. Possible side effects
5. Storage of Diprivan
6. Further information

1. What Diprivan is and what it is used for

Diprivan belongs to a group of medicines called “general anesthetics”. General anesthetics are used to produce unconsciousness (sleep) while surgery or other procedures are carried out. It can also be used to sedate you (make you feel drowsy but not completely asleep).

Diprivan 10 mg/ml is used for:

• induction and maintenance of general anesthesia in adults and children over 1 month of age.
• sedation of patients over 16 years of age with assisted ventilation in intensive care.
• sedation of adults and children over 1 month of age during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.

2. What you need to know before you use Diprivan

Before administering the anesthetic, the anesthesiologist, surgeon, or intensive care physician will assess your clinical condition and any treatment you are currently receiving.

Do not use Diprivan

• If you are allergic (hypersensitive) to propofol or any of the other components of this medicine (listed in section 6).
• If you are allergic to soy or peanuts. This is because Diprivan contains soybean oil.
• In patients 16 years or younger for sedation in intensive care.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Diprivan if:

• you have ever had a seizure or convulsion,
• you have ever been told you have very high levels of fat in your blood or that you have problems absorbing fats. In these cases, your doctor may need to check your blood fat levels,
• you have any other health problems, such as heart, respiratory, kidney, or liver problems, or if you have been unwell for some time,
• you are taking any other medicines, including those you have bought without a prescription
• your body has lost a lot of water (hypovolemia),
• you have prolonged and/or severe diarrhea,
• you have ever been told you have a disease called “mitochondrial disease”,
• you are elderly or debilitated,
• you have had a head injury along with high pressure in your head.

Before undergoing surgery or any other procedure that requires the administration of any type of anesthesia, it is essential that you inform your doctor if you have a disease called “hereditary predisposition to acute porphyria”.

In rare cases, if propofol is administered for a long time, you may develop a disease called propofol infusion syndrome (PRIS). This disease can damage the heart, muscles, or kidneys, cause other serious problems, and can even lead to death. However, your doctor will closely monitor you and take the necessary measures to prevent this from happening.

Children and adolescents

Diprivan is not recommended for use in newborns.

Other medicines and Diprivan

Tell your doctor, pharmacist, or nurse if you are taking or have recently taken or might take any other medicines.

Tell your doctor before using Diprivan if you are taking any of the following medicines:

• strong painkillers (opioid analgesics) for intense pain relief
• medicines called “parasympatholytics” (e.g., medicines used to treat cramps, asthma, Parkinson's disease, and other medicines in this group)
• benzodiazepines (medicines used to treat anxiety)
• neostigmine (medicine used to treat a disease called myasthenia gravis)
• cyclosporin (medicine used to prevent organ rejection in transplants)
• rifampicin (medicine used to treat tuberculosis)
• corticosteroids (medicines used to treat asthma, arthritis, immune system diseases, skin diseases, and other diseases)
• medicines that strengthen the heart, such as digoxin (for the treatment of heart failure)
• medicines used to treat epilepsy, such as phenytoin, phenobarbital, and others.
• suxamethonium (muscle relaxant)
• Midazolam (used to induce sedation [a very relaxed state of calm, drowsiness, or sleep] and to relieve anxiety and muscle tension).

Using Diprivan with food, drinks, and alcohol

You should avoid consuming alcohol at least 8 hours before and after the administration of Diprivan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before Diprivan is administered to you.

Diprivan should not be administered to pregnant women unless absolutely necessary.

If you are breastfeeding, you should not breastfeed while Diprivan is being administered to you and should discard breast milk for 24 hours after the administration of Diprivan.

Driving and using machines

Diprivan may affect your reaction ability. Your doctor or anesthesiologist will tell you how long you should wait before driving or using machines and will advise you to be accompanied when returning home. Generally, the effects of propofol disappear within 12 hours after the end of its administration.

Diprivan contains soybean oil

Diprivan contains soybean oil. Do not use this medicine if you are allergic to peanuts or soy.

Diprivan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

3. How to use Diprivan

• Diprivan will be administered to you by, or under the supervision of, your anesthesiologist or intensive care physician.
• Diprivan is administered by injection or infusion (drip) into a vein, usually in the back of the hand or in the forearm. A needle or a thin plastic tube called a cannula may be used. For long surgical procedures and in intensive care, an electric pump may be used to control the rate of administration.
• You may be given a local anesthetic (lidocaine) at the site where Diprivan is injected to reduce the possibility of pain.

The dose of Diprivan will vary depending on your age, body weight, and physical condition. Your doctor will give you the correct dose to initiate and maintain anesthesia or to achieve the required level of sedation, carefully monitoring your responses and vital signs (pulse, blood pressure, breathing, etc.)

It may be necessary to use several medicines to make you sleep or feel drowsy, pain-free, breathing healthily, and maintaining your blood pressure stable. Your anesthesiologist or intensive care physician will decide which medicine to use and when it is necessary and will adjust the dose of Diprivan depending on the medicines used.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the induction and maintenance of anesthesia or sedation with Diprivan, the following side effects may occur (while the injection or infusion is being administered or when you are drowsy or asleep). Your doctor will be monitoring for the occurrence of side effects and, if they occur, will administer the appropriate treatment.

Very common: may affect more than 1 in 10 patients

Pain at the injection site (while the injection is being administered, before falling asleep).

Common: may affect up to 1 in 10 patients

• Headache during the recovery phase.
• A slower heart rate.
• Decrease in blood pressure (hypotension).
• Changes in your breathing pattern during induction.
• Nausea and vomiting during the recovery phase.

Uncommon: may affect up to 1 in 100 patients

• Thrombosis and phlebitis.
• Coughing during the maintenance of anesthesia.

Rare: may affect up to 1 in 1,000 patients

• Tics and contractions of your body or spasms that can occur during induction, maintenance, and recovery of anesthesia.

• Coughing during the induction of anesthesia.

Very rare: may affect up to 1 in 10,000 patients

• Severe allergic reaction, including anaphylactic shock.
• Unconsciousness after surgery.
• Fluid accumulation in the lungs.
• Pancreatitis (inflammation of the pancreas).
• Discoloration of urine.
• Sexual excitement.
• Fever after surgery.
• Tissue damage (necrosis) at the injection site.

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

• Metabolic acidosis, increased potassium levels, increased blood fat levels.
• Euphoria, abuse, and dependence on the medicine.
• Involuntary movements.
• Alteration of heart rhythm, loss of heart strength (heart failure), alteration of the nervous signal of your heart detected in the electrocardiogram.
• Increased liver size.
• Rhabdomyolysis (breakdown of muscle cells).
• Breathing difficulties.
• Prolonged and often painful erection (priapism).
• Pain and inflammation at the injection site when Diprivan is administered outside the vein.
• Kidney failure.
• Hepatitis (liver inflammation), acute liver failure (symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and liver sensitivity [indicated by pain below the front of the ribcage on the right side], sometimes with loss of appetite).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diprivan

Do not store above 25°C. Do not freeze.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

After dilution: Use within 6 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

Composition of Diprivan 10 mg/ml

• The active substance is propofol.
• The other ingredients are refined soybean oil, purified egg phosphatide, glycerol, sodium hydroxide, nitrogen, water for injection, and disodium edetate.

Appearance and packaging

This medicine is presented in boxes of 5 ampoules with 20 ml of emulsion.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus,

Dublin 24, Ireland

Tel: +34 952 010 137

Manufacturer:

Corden Pharma S.P.A.

Caponago

Milan (Italy)

Local representative:

ASPEN PHARMACARE ESPAÑA, S.L.

Avenida Diagonal, 512,

Planta Interior 1, Oficina 4,

Barcelona, 08006, Spain

Date of last revision of this leaflet: 08/2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/