Diprivan

Package leaflet: Information for the user

DIPRIVAN, 10 mg/ml, injection emulsion
Propofolum
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Diprivan is and what it is used for
2. What you need to know before Diprivan is given
3. How Diprivan is given
4. Possible side effects
5. How to store Diprivan
6. Contents of the pack and other information

1. What Diprivan is and what it is used for

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

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

2. Important information before using Diprivan

When not to use Diprivan:

• 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 soy or peanuts,
• for sedation during intensive care in patients aged 16 years and younger.

Warnings and precautions
You must inform the doctor about any disturbing symptoms previously experienced after
administration of a medicine containing propofol or any of the ingredients of Diprivan
listed in section 6.
You should also inform the doctor about any disturbing reactions that occurred after taking
other medicines.
Use of Diprivan is not recommended in newborns.
Before administering Diprivan, inform the doctor if the patient has:

• epilepsy or a history of seizures,
• high levels of fat (lipids) in the blood or disorders related to fat metabolism in the body,
• dehydration, heart, respiratory, kidney or liver disease, or prolonged poor general condition,
• mitochondrial disease.

In rare cases, during prolonged administration of propofol, the patient may develop a condition
known as Propofol Infusion Syndrome (PIS). This may lead to damage of the heart, muscles, and kidneys, cause other serious disturbances, and may result in death.
The doctor will closely monitor the patient's 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 indicate that general anaesthetic agents may have negative effects on brain development in children.
The doctor will assess the benefits and risks of using this medicine.
Diprivan with other medicines
Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to use, including those available without a prescription. This includes:

• sedatives (such as benzodiazepines), painkillers (such as fentanyl and opioids), or alcohol consumption, as these may enhance the effect of Diprivan.
• dexmedetomidine [a medicine used to induce sedation (a deep state of calmness, drowsiness, or sleep)],
• rifampicin (an antibiotic), as this may lead to reduced blood pressure associated with anaesthesia.
• valproate (a medicine used to treat epilepsy, bipolar disorder, and migraine prevention), as a reduction in the dose of Diprivan may be necessary.
• midazolam [a medicine used to induce sedation (a deep state of calmness, drowsiness, or sleep), reduce anxiety, and decrease muscle tension].

Diprivan and alcohol
Do not consume alcohol at least 8 hours before and 8 hours after administration of Diprivan.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Diprivan should not be used during pregnancy unless absolutely necessary.
It has been shown that a small amount of Diprivan passes into human breast milk. Breastfeeding should be avoided for 24 hours after administration of Diprivan, and milk collected during this time should be discarded.
Driving and operating machinery
After administration of Diprivan, the patient may still feel drowsy for some time. Do not drive, operate tools, or machinery until you are certain that the effects of the medicine have completely worn off.
If the patient returns home shortly after receiving Diprivan, he or she should not drive, operate tools, or machinery.
Ask the doctor when it is safe to resume these activities and when you can return to work.
Diprivan contains sodium, soybean oil, and disodium edetate
The medicine contains less than 1 mmol (23 mg) of sodium per ml, meaning the medicine is considered "sodium-free".
The medicine contains soybean oil. Do not use if hypersensitivity to peanuts or soy has been diagnosed.
The medicine contains disodium edetate. During prolonged treatment with Diprivan, zinc supplementation may be necessary. This particularly applies to patients at increased risk of zinc deficiency, such as burn patients, patients with diarrhoea, and/or systemic infections.

3. How to use Diprivan

Diprivan is administered intravenously by an anaesthesiologist or a physician in an intensive care unit. A needle or a plastic cannula may be used for administration. Additionally, during prolonged surgical procedures or in intensive care settings, an electric pump may be used to control the propofol infusion rate.

The dose of Diprivan depends on the patient's age, body weight, and general condition. The physician will administer an appropriate dose to induce anaesthesia, maintain the anaesthetic effect, or achieve an adequate depth of anaesthesia, based on the patient's response to the drug and monitoring of vital signs (pulse, arterial pressure, respiratory function, etc.).

Administration of a higher than recommended dose of Diprivan
Diprivan is prepared and administered by an anaesthesiologist or nurse. Therefore, propofol overdose is unlikely. In the event of accidental administration of a dose higher than recommended, symptomatic treatment should be applied.

Missed dose of Diprivan
Diprivan is prepared and administered by an anaesthesiologist or nurse. The nature of agents used for general anaesthesia does not require regular dosing, e.g. twice daily. Therefore, a missed dose does not apply to Diprivan.

Discontinuation of Diprivan
Not applicable.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below are listed the adverse reactions observed in patients who have received propofol.
Induction and maintenance of anaesthesia or sedation usually proceed smoothly
with minimal signs of excitation. The most commonly occurring adverse reactions,
such as hypotension, are well-known effects of anaesthetic and sedative agents.
The type, severity and frequency of adverse reactions observed in patients
receiving Diprivan may be related to the patient's condition and to the surgical
and therapeutic procedures to which the patient has been subjected.

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 emergence
• low blood pressure
• transient apnoea during induction of anaesthesia
• slow heart rate
• nausea and vomiting during emergence

Uncommon (may affect up to 1 in 100 people)

• swelling, 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 angioedema, bronchospasm, erythema and hypotension
• pulmonary oedema
• prolonged time to emergence
• pancreatitis
• change in urine colour
• sexual excitation during emergence
• postoperative fever
• tissue necrosis following accidental extravascular administration

The anaesthetist or intensive care physician supervises the administration of Diprivan
to the patient. If adverse reactions occur, appropriate management will be initiated.

Frequency not known (cannot be estimated from available data)

• increased blood acidity (metabolic acidosis), which may cause rapid breathing
• elevated blood potassium levels
• high levels of lipids (fats) in the blood
• euphoria
• drug abuse and dependence
• involuntary movements
• cardiac arrhythmia
• heart failure
• cardiac arrest
• liver enlargement
• kidney failure
• muscle cell breakdown (rhabdomyolysis)
• changes in ECG recording
• anaphylactic shock
• breathing difficulties
• prolonged, often painful erection (priapism)
• local pain following accidental extravascular administration
• swelling at the injection site following accidental extravascular administration
• hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain and liver tenderness on palpation (indicated as pain under the front part of the rib cage on the right side of the body), sometimes with loss of appetite].

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions
at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diprivan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store below 25°C. Do not freeze.
Stability 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 package and other information

What Diprivan contains

• The active substance is propofol. One ml of 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 pre-filled syringe contains 500 mg of propofol.
• 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, in colourless glass, in a cardboard carton
• 1 vial of 50 ml, in colourless glass, in a cardboard carton
• 1 pre-filled syringe of 50 ml, in colourless glass, in a cardboard carton.

Marketing Authorisation 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
Detailed information about this medicinal product, including information intended for healthcare professionals, is available in the Summary of Product Characteristics on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
www.urpl.gov.pl