Provive

Package Leaflet: Information for the User

Provive

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 package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, 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 package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

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

1. What is Provive and what is it used for

Provive is an injection solution that contains the active substance propofol. Propofol belongs to a group of medicines called anesthetics. These medicines are used to induce loss of consciousness (deep sleep) for surgical procedures or other interventions. It can also be used to achieve sedation (a state in which the patient is sleepy but not completely asleep). Provive is used for:

• Induction and maintenance of general anesthesia in adults and children over 1 month of age.
• Sedation of adults and children from 1 month of age during diagnostic and surgical procedures, as a single agent or in combination with local or regional anesthesia.
• Sedation of patients over 16 years of age who are mechanically ventilated and require intensive medical care.

2. Important information before using Provive

When not to use Provive

• If the patient is allergic to propofol or any of the other ingredients of this medicine (listed in section 6).
• Provive must not be used to achieve sedation in intensive care in children under 16 years of age (see also "Warnings and precautions").

If the patient experiences any of the following conditions, there is a risk of very rare side effects. These conditions include:

Warnings and precautions

• Provive is not recommended for use in newborns.
• Provive must not be used to achieve sedation in intensive care in children under 16 years of age, as the safety and efficacy of this medicine have not been established in this age group.
• Before starting treatment with Provive, discuss with your doctor if:
• the patient has ever had a seizure or convulsion,
• the patient has ever had a high level of fats in the blood or disorders of fat metabolism,
• the patient has any other diseases, such as heart, respiratory, kidney, or liver disease,
• the patient has been feeling unwell for some time,
• the patient has a mitochondrial disease. Provive may worsen the patient's condition.
• The person administering Provive will constantly monitor the patient's condition. Other medicines, such as sleeping pills and painkillers, can be used with Provive. In this case, the patient will be monitored for cardiovascular and respiratory function.
• Prolonged use of Provive in intensive care may cause some patients to require zinc supplementation (a microelement). The person administering Provive will decide when the patient needs it and what medicine to give. In exceptional cases, patients who have undergone surgery have experienced periods of loss of consciousness. These patients have recovered without complications.
• If the patient experiences any of the following conditions, there is a risk of very rare side effects. These conditions include:
• reduced blood flow to the tissues
• severe nerve damage
• blood infection (sepsis).

Provive and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, including those obtained without a prescription. If the patient is taking any of the following medicines, side effects may occur when used in combination with propofol. This includes:

• other anesthetics (given epidurally or by inhalation),
• premedication medicines (the anesthesiologist will know which ones),
• muscle relaxants (such as suxamethonium or benzodiazepines),
• painkillers (such as fentanyl),
• medicines that affect the heart (such as digoxin),
• rifampicin (an antibiotic).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before using this medicine. Provive should not be given to pregnant women unless absolutely necessary. Due to the safety of the baby during the use of Provive, breastfeeding should be stopped.

Driving and using machines

The ability to drive and use machines may be impaired for some time after the procedure due to the use of this medicine. If the patient returns home on the day of the procedure, they should not drive or operate machinery. If necessary, the patient should ask their doctor when they can return to work.

Provive contains soybean oil.

Provive contains soybean oil. Do not use if you are allergic to peanuts or soy.

Provive contains egg yolk lecithin

In people with an allergy to this ingredient, its presence may be a problem. This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially "sodium-free".

3. How to use Provive

• Provive is administered by an anesthesiologist or a doctor specializing in intensive care.
• Provive is given by injection into a vein on the back of the hand or forearm.
• Sometimes, a local anesthetic (such as lidocaine) may also be given at the injection site to reduce pain.
• The dose used will depend on the patient's age, weight, and health. The doctor will use the appropriate dose to induce and maintain anesthesia or to achieve the required level of sedation. The doctor will pay close attention to the patient's reaction and vital signs (heart rate, blood pressure, breathing, etc.).

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Provive can cause side effects, although not everybody gets them. The following side effects have been reported:

• Pain at the injection site during administration of anesthesia

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

• slow heart rate (bradycardia)
• headache after waking up
• transient changes in breathing (apnea) during anesthesia
• nausea and vomiting after waking up
• low blood pressure (hypotension)

Uncommon(may affect up to 1 in 100 people):

• formation of blood clots in a vein or artery (thrombosis)
• inflammation of the veins

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

• at the start of anesthesia, during, and after waking up: muscle twitching (movements similar to epilepsy), including convulsions/seizures

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

• fluid accumulation in the lungs (pulmonary edema)
• inflammation of the pancreas, which can cause severe abdominal pain radiating to the back, nausea, and vomiting (pancreatitis)
• discoloration of the urine (usually green)
• postoperative fever
• loss of consciousness after surgery
• allergic reaction (anaphylaxis), which can cause: sudden accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue), difficulty breathing, and (or) itching and rash (angioedema); shortness of breath caused by muscle spasms or airway constriction (bronchospasm); skin redness (flushing); low blood pressure (hypotension)
• vaginal discharge
• local tissue necrosis (only if Provive is accidentally administered outside a vein)

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

• acidosis (metabolic acidosis), high levels of potassium in the blood (hyperkalemia; may cause muscle spasms, diarrhea, nausea, or headache), high levels of fat in the blood (hyperlipidemia)
• excessive euphoria
• drug abuse
• involuntary movements
• irregular heartbeat (arrhythmia), abnormal heart function (heart failure)
• respiratory depression (depending on the amount of Provive administered)
• enlargement of the liver (hepatomegaly)
• breakdown of muscle tissue, which can cause muscle spasms, fever, and reddish-brown urine (rhabdomyolysis)
• kidney failure
• pain at the injection site, swelling at the injection site (only if Provive is accidentally administered outside a vein)
• changes in the ECG recording (changes that can cause Brugada syndrome)
• prolonged and painful erection (priapism)
• Liver inflammation, 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 rib cage, 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 package leaflet, tell your doctor, 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, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Provive

Keep this medicine out of the sight and reach of children. Provive is stored in a hospital. The hospital staff is responsible for the proper storage, use, and disposal of Provive. Do not use this medicine after the expiry date stated on the packaging after (EXP). The expiry date refers to the last day of the month stated. Do not store above 25°C. Store in the original packaging to protect from light. Do not store in a refrigerator or freeze. After first opening, use immediately. Shake the vial before use. Do not use the emulsion if two layers are visible after shaking. Only use medicine with a uniform consistency and undamaged packaging. For single use only. Discard any unused emulsion. 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 Provive contains

The active substance is propofol. Each 1 ml of emulsion for injection contains 10 mg of propofol. One vial of 10 ml of the medicine contains 100 mg of propofol. One vial of 20 ml of the medicine contains 200 mg of propofol. One vial of 50 ml of the medicine contains 500 mg of propofol. One vial of 100 ml of the medicine contains 1000 mg of propofol. The other ingredients are purified soybean oil, glycerol, egg yolk lecithin, sodium oleate, sodium hydroxide (for pH adjustment), and water for injections.

What Provive looks like and contents of the pack

Provive 10 mg/ml is a white emulsion for injection or infusion. The medicine is provided in a colorless glass type II vial, closed with a gray rubber stopper and a plastic cap. The pack sizes are: 10 ml colorless glass type II vial with a gray rubber stopper, pack contains 1 vial. 20 ml colorless glass type II vial with a gray rubber stopper, pack contains 1, 5, or 10 vials. 50 ml colorless glass type II vial with a gray rubber stopper, pack contains 1 vial. 100 ml colorless glass type II vial with a gray rubber stopper, pack contains 1 vial. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Baxter Holding B.V. Kobaltweg 49, 3542 CE Utrecht, Netherlands

Manufacturer/Importer

Tramco Sp. z.o.o Wolskie, ul. Wolska 14, 05-860 Płochocin, Poland Bieffe Medital S.p.A. Via Nuova Provinciale, 23034 Grosotto (SO), Italy UAB Norameda, Meistru 8a, 02189, Vilnius, Lithuania Date of last revision of the package leaflet:31 July 2024

Information intended for healthcare professionals only:

Provive can only be administered in hospitals or in medical institutions equipped with adequate equipment by doctors specializing in anesthesiology or intensive care. The patient's cardiovascular and respiratory functions should be continuously monitored, and equipment for maintaining airway patency, artificial ventilation, oxygen administration, and other resuscitation equipment should be available at all times. Provive 10 mg/ml should not be administered by the person performing the diagnostic or surgical procedure. The infusion set should include a burette, drop counter, or volumetric infusion pump to prevent the risk of uncontrolled administration of large volumes of diluted Provive 10 mg/ml. The vial should be shaken before use. Do not use the emulsion if two layers are visible after shaking. Only use medicine with a uniform consistency and undamaged packaging. For single use only. Discard any unused medicine. Before use, clean the rubber membrane with alcohol in a spray or swab. After use, discard opened vials. Provive 10 mg/ml is a fat emulsion that does not contain preservatives and may support the growth of microorganisms. The emulsion should be drawn up into a sterile syringe or infusion set immediately after piercing the vial cap. Administration of the medicine should be started immediately. During the entire infusion period, the sterility of Provive and the infusion set should be maintained. Any infusion fluids added to the infusion system through which Provive is administered should be given close to the site of venflon insertion. Do not administer Provive through infusion systems equipped with microbiological filters. Provive 10 mg/ml and any infusion sets containing Provive 10 mg/ml are intended for single use in one patient. Any unused Provive 10 mg/ml should be discarded.