Provive

Leaflet attached to the packaging: information for the user

Provive

20 mg/ml, emulsion for injection/infusion

Propofol

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 packaging 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 procedures.
It can also be used to induce sedation (a state in which the patient is sleepy but not completely asleep).
Provive 20 mg/ml is used for:

• Induction and maintenance of general anesthesia in adults and children from 3 years of age.
• Sedation of adults and children from 3 years of age during diagnostic and surgical procedures, as the sole 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 should not be used to induce sedation in intensive care units in children under 16 years of age (see also "Warnings and precautions").

also “Warnings and precautions”).

Warnings and precautions

• Provive 20 mg/ml is not recommended for use in newborns.
• Provive 20 mg/ml is not recommended for use in children under 3 years of age.
• Provive 20 mg/ml should not be used to induce sedation in intensive care units 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, the patient should discuss with their doctor if:
• the patient has ever had a seizure or convulsion,
• the patient has ever had high levels of fat 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 mitochondrial disease. Provive may worsen the condition of such patients.
• 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 such cases, the patient will be monitored for cardiovascular and respiratory function.
• Prolonged use of Provive in intensive care units may cause some patients to need 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 has any of the following conditions, there is a risk of very rare side effects. These conditions include:
• reduced blood flow to tissues
• severe nerve damage
• blood infection (sepsis).

Provive and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available 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 drugs (the anesthesiologist will know which ones),
• muscle relaxants (such as suxamethonium or benzodiazepines),
• analgesics (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 they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Provive should not be given to pregnant women unless it is absolutely necessary.
For the safety of the baby, breastfeeding should be stopped during the use of Provive.

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. It should not be used in case of known hypersensitivity to peanuts or soy.

Provive contains egg yolk lecithin

In people with hypersensitivity 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 considered "sodium-free".

3. How to use Provive

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

In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Very common(may affect more than 1 in 10 people) :

• Pain at the injection site during anesthesia administration

Common(may affect up to 1 in 10 people) :

• Slow heart rate (bradycardia)
• Headache after waking up
• Transient changes in breathing (apnea) during anesthesia administration
• Nausea and vomiting after waking up
• Low blood pressure (hypotension)

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

• Blood clots in a vein or artery (thrombosis)
• Phlebitis

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

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

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

• Fluid accumulation in the lungs (pulmonary edema)
• Pancreatitis, which can cause severe abdominal pain radiating to the back, as well as nausea and vomiting (pancreatitis)
• Discoloration of urine (usually green)
• Postoperative fever
• Loss of consciousness after surgery
• Hypersensitivity to certain substances (anaphylaxis), which can cause: sudden fluid accumulation 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 cramps, 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)
• Liver enlargement (hepatomegaly)
• Muscle tissue breakdown, which can cause muscle cramps, fever, and reddish-brown urine discoloration (rhabdomyolysis)
• Kidney failure
• Pain at the injection site, swelling at the injection site (only if Provive is accidentally administered outside a vein)

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Provive)

• Changes in ECG recording (changes indicating Brugada syndrome)
• Prolonged and painful erection (priapism)
• 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 part of the ribcage, on the right side of the body), sometimes with loss of appetite].

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, phone: +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 gather more information on the safety of the medicine.

5. How to store Provive

The medicine should be stored out of 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.
Do not store above 25 °C.
Store in the original packaging to protect from light.
Do not store in the refrigerator or freeze.
After opening, the medicine should be used immediately.
The vial should be shaken before use.
Do not use the emulsion if two layers are visible after shaking.
Only use the medicine with a uniform consistency and undamaged packaging.
For single use only. Unused emulsion should be discarded.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

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What Provive 20 mg/ml contains

The active substance of Provive is propofol.
Each 1 ml of the injection emulsion contains 20 mg of propofol.
One vial of Provive with a capacity of 50 ml 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 20 mg/ml looks like and what the packaging contains

Provive 20 mg/ml is a white oil-in-water emulsion for injection or infusion.
This medicine is supplied in a colorless glass type II vial, closed with a gray rubber stopper and a plastic cap.
Pack sizes:
A colorless glass type II vial with a capacity of 50 ml with a gray rubber stopper, the packaging contains 1 vial.

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

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 update of the leaflet:July 31, 2024
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Information intended for healthcare professionals only:

Provive can only be administered in hospitals or in medical facilities 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 20 mg/ml should not be administered by the person performing the diagnostic or surgical procedure.
The vial should be shaken before use. Do not use the emulsion if two layers are visible after shaking.
Only use the medicine with a uniform consistency and undamaged packaging.
For single use only. Unused medicine should be discarded.
Before use, the rubber membrane should be cleaned with alcohol in a spray or swab.
After use, open vials should be discarded.
Provive 20 mg/ml is a fat emulsion that does not contain preservatives and may promote the growth of microorganisms.
The emulsion should be drawn up into a sterile syringe or infusion set immediately after the vial is opened. Administration of the medicine should be started immediately. During the entire infusion period, the sterility of Provive 20 mg/ml and the infusion set should be maintained. Any infusion fluids added to the infusion system through which Provive 20 mg/ml is administered should be administered close to the injection site. Do not administer Provive 20 mg/ml through infusion systems equipped with microbiological filters.
Provive 20 mg/ml and any infusion sets containing Provive 20 mg/ml are intended for single use in one patient. According to established guidelines for other lipid emulsions, the duration of a single infusion should not exceed 12 hours. After administration of the medicine, or 12 hours after the start of administration, whichever occurs sooner, the container with Provive 20 mg/ml or the infusion set should be disconnected or, if necessary, replaced with a new one.
Provive should not be mixed with other injection or infusion solutions. However, it is possible to administer a 5% glucose solution, a 0.9% sodium chloride solution, or a 0.18% sodium chloride and 4% glucose solution using appropriate accessories at the injection site.
In order to reduce pain at the injection site, Provive should be administered into a larger vein, and a lidocaine injection solution may be administered before inducing anesthesia with Provive.
Muscle relaxants such as atracurium and mivacurium should not be administered through the same infusion system as Provive without prior flushing of the system.
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