THIOPENTAL 1000 mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Thiopental VUAB 0.5 g, powder for solution for injection
3. Thiopental VUAB 1.0 g, powder for solution for injection
   1. You should carefully read the contents of the leaflet before using the medicine.
   2. Table of contents of the leaflet:
4. What is Thiopental VUAB and what is it used for
5. Important information before using Thiopental VUAB
   1. When not to use Thiopental VUAB
   2. Warnings and precautions
   3. Thiopental VUAB may only be used with special caution in the following cases:
   4. Before administering Thiopental VUAB, you should inform your doctor if any of the above conditions apply to the patient, as it may be necessary to adjust the dose.
   5. Thiopental VUAB and other medicines
   6. Using Thiopental VUAB with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Pregnancy
   9. Breastfeeding
   10. Driving and using machines
   11. Thiopental VUAB contains sodium
6. How to use Thiopental VUAB
   1. Use in anesthesia
   2. Use in convulsive states
   3. Use in patients after neurosurgical procedures with increased intracranial pressure
   4. Using a higher dose of Thiopental VUAB than recommended
7. Possible side effects
   1. Reporting side effects
8. How to store Thiopental VUAB
9. Contents of the packaging and other information
   1. What Thiopental VUAB contains
   2. What Thiopental VUAB looks like and what the pack contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Date of last revision of the leaflet:
   6. Special precautions for the preparation of the medicinal product for use
   7. CALCULATIONS FOR DIFFERENT CONCENTRATIONS FOR INTRAVENOUS ADMINISTRATION
   8. Rectal administration (in children)
   9. Special precautions for storage

Leaflet attached to the packaging: patient information

Thiopental VUAB 0.5 g, powder for solution for injection

Thiopental VUAB 1.0 g, powder for solution for injection

Thiopental sodium

You should carefully read the contents of the leaflet before using the medicine.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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. See section 4.

Table of contents of the leaflet:

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

1. What is Thiopental VUAB and what is it used for

Thiopental VUAB is a powder for solution for injection that contains thiopental sodium as the active substance in a quantity of 500 mg or 1000 mg. Thiopental VUAB is an anesthetic from the barbiturate group and is used:

• as a single anesthetic agent for short surgical procedures,
• for the induction of general anesthesia before the use of other anesthetic agents,
• as a supplement to local anesthesia,
• to provide a hypnotic effect during balanced anesthesia using other agents administered to achieve an analgesic or muscle relaxant effect,
• to control convulsive states during or after inhalation anesthesia, local anesthesia, or occurring for other reasons,
• in patients after neurosurgical procedures with increased intracranial pressure, provided that adequate ventilation is ensured.

Thiopental VUAB should only be used by specialists in the field of anesthesiology.

2. Important information before using Thiopental VUAB

When not to use Thiopental VUAB

If the patient has any of the following conditions:

• allergy to thiopental sodium or other barbiturates (medicines used in patients with convulsions and for anesthesia) or any of the other components of this medicine (listed in section 6);
• porphyria (a severe disease caused by a disorder of hemoglobin synthesis);
• expected difficulties in maintaining the patency of the upper airways and lack of equipment for immediate resuscitation;
• asthmatic status (life-threatening breathing difficulties caused by bronchial constriction);
• difficulty waking up after anesthesia that has occurred in the past.

In the case of rectal administration of the medicine:

• tumors and inflammatory diseases of the intestines;
• local inflammatory conditions or irritation of the anus;
• severe thrombocytopenia (significantly reduced platelet count).

Warnings and precautions

Before starting to use Thiopental VUAB, you should discuss it with your doctor. During the use of Thiopental VUAB, access to equipment and medicines for resuscitation, endotracheal intubation, and oxygen should be ensured, and the patient's airways should be kept open at all times.

Thiopental VUAB may only be used with special caution in the following cases:

• hypovolemia (low blood volume due to blood or fluid loss);
• cardiovascular diseases (heart muscle disease, valve stenosis, pericarditis, tamponade, congestive heart failure, coronary heart disease, QT interval prolongation, and heart block, high resting potential, or myocardial ischemia) and other circulatory system diseases (malignant hypertension);
• hypotension (low blood pressure) or shock (sudden circulatory failure);
• obstructive respiratory disease (breathing difficulties caused by bronchial constriction, e.g., in asthma or chronic obstructive pulmonary disease);
• impaired respiratory function, airway obstruction;
• liver or kidney disease;
• muscle weakness or atrophy (myasthenia gravis, myotonic dystrophy);
• metabolic disorders (myxedema, adrenal insufficiency);
• endocrine disorders (including hyperpituitarism, hyperthyroidism, hyperadrenalism, or hyperinsulinism);
• paralysis or weakness of the eye muscles;
• abscess of the oral cavity, sepsis (general infection of the body);
• obesity.

Before administering Thiopental VUAB, you should inform your doctor if any of the above conditions apply to the patient, as it may be necessary to adjust the dose.

Thiopental VUAB can only be used if all the preliminary conditions have been met, including the availability of personnel and equipment to treat any potential emergencies, such as respiratory failure and respiratory arrest.Special caution should be exercised when using Thiopental VUAB in clinical conditions where the hypnotic effect may be prolonged or enhanced (e.g., excessive premedication, Addison's disease, increased blood urea levels, severe anemia). If the injection is accidentally administered into an artery or outside a vein, tissue necrosis (death) or very painful nerve inflammation may occur. The use of Thiopental VUAB may cause dependence.

Thiopental VUAB and other medicines

You should tell your doctor, pharmacist, or nurse about all the medicines the patient is currently taking or has recently taken, including those available without a prescription. The following medicines affect the action of Thiopental VUAB or Thiopental VUAB affects their action:

• aminophylline (a medicine used in asthma),
• diazoxide (a medicine used in pancreatic diseases),
• midazolam (a sedative),
• opioid analgesics (used in severe pain),
• probenecid (a medicine used in gout),
• metoclopramide (an antiemetic).

Using Thiopental VUAB with food, drink, and alcohol

Before and after anesthesia, under no circumstances should any beverages or foods containing alcohol be consumed.

Pregnancy and breastfeeding

Pregnancy

Thiopental VUAB passes through the placenta. Therefore, Thiopental VUAB should not be administered to pregnant women, except in situations where the doctor determines that the expected benefits to the mother outweigh the potential risk to the fetus.

Breastfeeding

Thiopental VUAB is excreted into human milk, so breastfeeding should not be done for 24 hours after the use of this medicine.

Driving and using machines

Thiopental VUAB has a significant impact on the ability to drive vehicles and operate machines, so patients should not perform these activities. You should ask your doctor to explain how long to take these precautions.

Thiopental VUAB contains sodium

Thiopental VUAB 0.5 g contains 43.51 mg of sodium (the main component of common salt) per vial, which corresponds to 2.2% of the maximum recommended daily intake of sodium in the diet for adults. Thiopental VUAB 1 g contains 87.02 mg of sodium (the main component of common salt) per vial, which corresponds to 4.4% of the maximum recommended daily intake of sodium in the diet for adults. The medicine may be dissolved in a 0.9% sodium chloride solution. The sodium content from the solvent should be taken into account when calculating the total sodium content in the prepared solution of the medicine. To obtain accurate information about the sodium content in the solution used to prepare the medicine, you should read the patient information leaflet of the solvent used.

3. How to use Thiopental VUAB

The medicine is administered by a doctor in a hospital. The medicine should be used in accordance with the recommended dosages below or as recommended by the doctor. The dose of Thiopental VUAB should be adjusted individually for each patient depending on their age, sex, weight, and desired depth of anesthesia. The concentrations of the medicine used for intravenous administration are from 2.5% to 5.0%. The 2.5% (500 mg in 20 mL) concentration is most commonly used. The 5% (500 mg in 10 mL) solution is used in exceptional cases.

Use in anesthesia

Healthy adults 4 - 6 mg/kg body weight Children and infants 5 - 7 mg/kg body weight Elderly patients 2 - 3 mg/kg body weight

Use in convulsive states

Immediately after the onset of convulsions, 75 mg to 125 mg (3 mL to 5 mL of 2.5% solution) should be administered.

Use in patients after neurosurgical procedures with increased intracranial pressure

Thiopental VUAB is administered in intermittent bolus doses of 1.5 to 3 mg/kg body weight. The maximum single dose is 1 g. The maximum daily dose is 2 g. It is recommended to administer a small "test" dose of 25 to 75 mg (1 to 3 mL of 2.5% solution) intravenously to assess tolerance or check if the patient is not hypersensitive to thiopental, and then discontinue the administration of the medicine to observe the patient's reaction for about 60 seconds. Thiopental VUAB is administered intravenously only in adult patients, and in children also rectally. Thiopental VUAB should only be used by anesthesiology specialists. The medicine is administered by slow injection to limit respiratory depression and the possibility of overdose.

Using a higher dose of Thiopental VUAB than recommended

Thiopental VUAB is administered by a doctor or under the supervision of a doctor, so it is unlikely that the patient will receive too much of this medicine. Nevertheless, if the patient has received a higher dose of Thiopental VUAB than they should have, they may experience a sudden drop in blood pressure, which can lead to shock. Additionally, overdose may cause breathing difficulties (respiratory arrest), which can be life-threatening without connection to artificial respiration. In case of any further doubts about the use of this medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, Thiopental VUAB can cause side effects, although not everybody gets them. Frequent(may occur in up to 1 in 10 patients):

• slow heart rate, low blood pressure, heart rhythm disorders;
• shallow breathing with decreased frequency, leading to respiratory arrest, difficult breathing (bronchospasm), laryngospasm, cough;
• feeling of coldness/shivering.

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

• sudden, life-threatening allergic reactions affecting the whole body (anaphylactic reactions).
• low potassium levels in the blood during the administration of the medicine and high potassium levels in the blood after discontinuation of the medicine.

After rectal administration of the medicine, the following side effects may occur: anal irritation, uncontrolled bowel movement, prolonged drowsiness, nausea, vomiting, clumsiness.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or 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 Thiopental VUAB

The medicine should be stored in a place that is out of sight and reach of children. Do not use Thiopental VUAB after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for the storage of the medicine. For single use only after reconstitution. After reconstitution:

The medicine should be used immediately after preparation. If the medicine is not used immediately, the user is responsible for the time and conditions of storage of the medicine before its use, but this period should not be longer than 24 hours at a temperature of 2°C to 8°C. Unused solution should be discarded after 24 hours. Prepared solutions should not be sterilized by steam. The solutions that can be used as a solvent are water for injections or 0.9% sodium chloride solution. The reconstituted Thiopental VUAB is a clear, yellowish solution and practically does not contain undissolved particles. Dissolution of the powder after addition of the appropriate solvent occurs within a few seconds. Medicines should not be disposed of via wastewater or household waste. Medical personnel should dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Thiopental VUAB contains

The active substance of the medicine is thiopental sodium. 1 vial of Thiopental VUAB 0.5 g contains 530 mg of thiopental sodium and sodium carbonate, which corresponds to 500 mg of thiopental sodium. 1 vial of Thiopental VUAB 1.0 g contains 1060 mg of thiopental sodium and sodium carbonate, which corresponds to 1000 mg of thiopental sodium. The other ingredient is sodium carbonate.

What Thiopental VUAB looks like and what the pack contains

Thiopental VUAB is a yellowish-white powder. The vial is made of colorless glass (type II class) with a bromobutyl rubber stopper and an aluminum seal or aluminum seal, with a plastic cap of the tear-offtype, in a cardboard box. Thiopental VUAB 0.5 g: the packaging contains 1 vial with a gray closure. Thiopental VUAB 1.0 g: the packaging contains 1 vial with a red closure.

Marketing authorization holder:

VUAB Pharma a.s. Vltavska 53 252 63 Roztoky Czech Republic

Manufacturer:

VUAB Pharma a.s. Vltavská 53 252 63 Roztoky Czech Republic

Date of last revision of the leaflet:

___________________________________________________________________________
Information intended only for healthcare professionals:

Special precautions for the preparation of the medicinal product for use

The solutions that can be used as a solvent are water for injections or 0.9% sodium chloride solution. Thiopental VUAB does not contain a bacteriostatic agent, so special care should be taken when preparing the solution and handling it to prevent contamination of the solution with microorganisms. The reconstituted Thiopental VUAB is a clear, yellowish solution and practically does not contain undissolved particles. Dissolution of the powder after addition of the appropriate solvent occurs within a few seconds. The solution for administration to the patient is prepared by adding the solvent, in accordance with the information contained in the tables below, and shaking to dissolve the contents of the vial.

CALCULATIONS FOR DIFFERENT CONCENTRATIONS FOR INTRAVENOUS ADMINISTRATION

Rectal administration (in children)

A 5% or 10% solution of thiopental in a dose of 25 - 40 mg/kg body weight is administered rectally to the child to induce general anesthesia.

Special precautions for storage

Original packaging: there are no special precautions for the storage of the medicinal product. Fresh solutions of Thiopental VUAB should be prepared and used immediately. Unused solution should be discarded after 24 hours. Prepared solutions should not be sterilized by steam. Shelf-life after reconstitution The chemical and physical stability of the solutions after reconstitution has been determined for 24 hours at a temperature of 2°C - 8°C. From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the time and conditions of storage of the product before its use, but this period should not be longer than 24 hours at a temperature of 2°C to 8°C, unless the preparation of the medicinal product was carried out under controlled aseptic conditions. Overdose Overdose may occur as a result of too rapid injection or repeated injections. It may cause: a sudden drop in blood pressure, apnea, occasional laryngospasm, cough, and other respiratory disorders, including respiratory depression. It may also cause cardiovascular collapse, and treatment should be aimed at restoring normal blood volume by appropriate measures: increasing fluid volume and (or) administering vasoconstrictor agents. In case of suspected or apparent overdose, the administration of the medicinal product should be discontinued, the airways should be cleared (if necessary, intubation should be performed) or their patency should be maintained, and oxygen should be administered using assisted ventilation.