Tiobarbital B. Braun 0.5 g powder for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tiobarbital B. Braun 0.5 g powder for injectable solution

sodium thiopental

Package leaflet contents

1. What Tiobarbital B. Braun 0.5 g is and what it is used for
2. What you need to know before using Tiobarbital B. Braun 0.5 g
3. How to use Tiobarbital B. Braun 0.5 g
4. Possible side effects
5. Storage of Tiobarbital B. Braun 0.5 g
6. Contents of the pack and other information

1. What Tiobarbital B. Braun 0.5 g is and what it is used for

This medicine contains the active substance thiopental sodium in the form of thiopental sodium and sodium carbonate. It is a thiobarbiturate with rapid onset for intravenous administration.

Tiobarbital B. Braun is used in adults:

• for short surgical procedures as a sole anaesthetic agent for induction and maintenance of anaesthesia.
• in combination with other agents used in general anaesthesia for induction and maintenance of anaesthesia.
• to control seizures that may occur with certain types of anaesthesia or due to other causes.
• to induce emergency coma during prolonged epileptic seizures (refractory status epilepticus).
• to induce and maintain barbiturate coma aimed at reducing intracranial pressure in patients in whom pressure has increased and other therapeutic measures have failed.

Tiobarbital B. Braun is used in children:

• for short surgical procedures as a sole anaesthetic agent for induction and maintenance of anaesthesia.
• in combination with other agents used in general anaesthesia for induction and maintenance of anaesthesia.
• to control seizures that may occur with certain types of anaesthesia or due to other causes.
• to induce emergency coma during prolonged epileptic seizures (refractory status epilepticus).

2. What you need to know before using Tiobarbital B. Braun 0.5 g

Do not use Tiobarbital B. Braun:

• if you are allergic to barbiturates or to any of the components of this medicine (listed in section 6).
• if you have airway obstruction (respiratory obstruction).
• if you have acute asthma (severe asthma attack).
• if you suffer from hereditary muscle degeneration (myotonic dystrophy).
• if you are experiencing severe shock.
• if you have a metabolic disorder called porphyria (an inherited disease caused by deficiency in the enzymes involved in the synthesis of a component of hemoglobin found in red blood cells).

Warnings and precautions:

Talk to your doctor or pharmacist before using Tiobarbital B. Braun, especially if you have:

• increased intracranial pressure.
• asthma or another serious respiratory disease.
• inflammation of the mouth, jaw, and throat, which could lead to airway problems during thiopental use.
• any heart or blood vessel disease or high blood pressure.
• inflammation of the sac surrounding the heart (pericarditis).
• dehydration or reduced total blood volume circulating in the body (hypovolemia).
• severe hemorrhage or burns.
• myasthenia gravis (a condition in which muscles fatigue easily and become weak).
• reduced adrenal gland function, even when being treated with cortisone.
• weakness, malnutrition, and weight loss.
• elevated levels of urea, toxins, or potassium in the blood.
• severe anemia.
• shock.
• liver or kidney problems.
• any metabolic disorders, such as thyrotoxicosis, myxedema, and diabetes.
• alcohol or drug addiction.

Use of Tiobarbital B. Braun with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may affect or interact with thiopental:

• Aminophylline (used to treat asthma).
• Midazolam (a sedative medicine).
• Opioid analgesics (medicines used to treat severe pain).
• Probenecid (a medicine used to treat gout).
• Fentanyl (a medicine used to treat pain).
• Muscle relaxants.
• Monoamine oxidase inhibitors and tricyclic antidepressants (medicines used to treat depression), for example, citalopram, amitriptyline.
• Central nervous system depressants.
• Metoclopramide and droperidol (medicines used to treat nausea and vomiting).
• Medicines containing St. John’s wort or valerian.
• Androgens (used to treat male infertility).
• Medicines used to treat epilepsy.
• Corticosteroids (medicines that reduce inflammation and allergic reactions).
• Medicines used to treat bacterial infections such as metronidazole, sulfafurazole, isoniazid, and vancomycin.
• Estrogen (used to treat menopause).
• Oral antidiabetic medicines.
• Antihypertensives (medicines used to lower blood pressure), for example, captopril, enalapril, terazosin, felodipine, bisoprolol, hydralazine, losartan, methyldopa, moxonidine, nitrates, and diuretics.
• Acetylsalicylic acid (aspirin) and other pain medicines.
• Antipsychotic medicines such as lithium, promethazine, or quetiapine.
• Diazoxide (used to treat low blood sugar).
• Oral anticoagulants (medicines that thin the blood and prevent clot formation).

Use of Tiobarbital B. Braun with alcohol:

Before and even after anesthesia, you must not consume any beverage or food containing alcohol under any circumstances.

If you are dependent on alcohol or regularly consume large amounts of alcohol, a higher dose of thiopental may be required.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy:

Thiopental crosses the placental barrier. Limited data in pregnant women indicate that thiopental does not cause malformations or fetal/neonatal toxicity. However, you will only receive this medicine if your doctor considers it appropriate.

Breastfeeding:

Thiopental is excreted in breast milk; therefore, breastfeeding should be temporarily suspended (for at least 12 hours after thiopental use), or breast milk should be expressed and discarded before using this medicine.

Fertility:

There are no data on the effect of thiopental on human fertility.

Driving and using machines:

The effect of thiopental on the ability to drive and use machines is significant. You may experience dizziness (vertigo), disorientation, and sedation. Do not drive or operate machinery, especially during the first 24 to 36 hours after injection.

Tiobarbital B. Braun contains sodium:

This medicine contains 46 mg of sodium per vial, equivalent to 2.3% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

3. How to use Tiobarbital B. Braun 0.5 g

Follow exactly the administration instructions for this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

This medicine will be administered by specialized personnel experienced in the use of general anesthetics, who will remain constantly available throughout administration, as well as resuscitation equipment.

This medicine will be administered directly into a blood vessel, a vein (intravenously).

A test dose of 25 to 75 mg will be given to adjust the dose according to your individual needs.

Adults

General anesthesia

Your individual dose will be determined by the doctor and will be based on your age, sex, body weight, and general condition. You will receive an induction dose of 50 to 75 mg at 20 to 40 second intervals, and additional injections of 25 to 50 mg to maintain anesthesia.

Convulsive crises

Thiopental injection is 50 to 125 mg and should be administered as soon as possible after the onset of convulsions. Additional doses may be required to control seizures.

Cerebral hypertension

You will receive a dose of 1.5 to 3.5 mg per kg of body weight to reduce intracranial pressure (with controlled ventilation provided).

Impaired renal or hepatic function

Your doctor may reduce the thiopental injection dose if you have impaired renal or liver function.

Elderly patients

A greater effect is expected in elderly patients; therefore, the dose should be reduced.

Pediatric population

General anesthesia

The individual dose is adjusted according to the age, maturity, and general condition of the pediatric patient. You will receive an induction dose of approximately 3 to 6 mg per kg of body weight and additional injections of 1 mg per kg of body weight to maintain anesthesia.

Convulsive crises

An initial dose of 2 mg per kg of body weight is administered, followed by individual dose titration until the desired effect is achieved. Do not exceed the maximum dose of 5 mg/kg/h.

Cerebral hypertension

The safety and efficacy of thiopental in pediatric populations for the treatment of increased intracranial pressure has not yet been established.

If you use more Tiobarbital B. Braun than you should

This is unlikely to happen, as your doctor will determine the appropriate dose for you.

The most serious symptoms of overdose may occur between the first six hours and five days following sudden discontinuation of the drug. These symptoms are:

• severe drop in blood pressure
• severe breathing difficulty
• severe slow or irregular breathing

There is another type of less severe effects, which may appear between eight and twelve hours after the last dose and occur less frequently:

• prolonged drowsiness
• headache
• nausea, vomiting, and constipation

If any of these effects occur, your doctor will immediately stop the treatment and manage you according to the symptoms presented.

The most appropriate treatment for overdose consists of maintaining adequate ventilation, using assisted respiration and even administering oxygen if necessary. It is advisable to monitor vital signs. If kidney function allows, diuresis may be induced by alkalinizing the urine to promote elimination of the drug.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Consult your doctor immediately if you experience any of the following symptoms; you may require urgent medical treatment:

Frequency not known (cannot be estimated from available data)

• Difficulty breathing, wheezing, skin rash, itching, hives, and dizziness. These could be signs of a severe allergic reaction.

Other adverse effects that may occur:

Frequent (may affect up to 1 in 100 people)

• Cardiac arrhythmias (disturbance in the normal heart rhythm).
• Heart problems (such as myocardial depression).
• Low blood pressure.
• Drowsiness.
• Delayed awakening from anaesthesia.
• Breathing difficulties.
• Slow or weak breathing.
• Difficulty swallowing, breathing, or speaking (laryngospasm).
• Cough.
• Snoring.
• Sneezing.
• Chills.
• Blood clot formation within blood vessels.
• Inflammation of a vein.
• Pain at the injection site.

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

• Severe allergic reaction.

Frequency not known (cannot be estimated from available data)

• Increased potassium levels in the blood (hyperkalemia).
• Decreased potassium levels in the blood (hypokalemia).
• Loss of appetite (anorexia).
• General malaise.
• Fatigue.
• Headache.
• Dizziness.
• Confusion.
• Memory loss.
• Allergic reactions, skin reactions, hypersensitivity.

At the beginning, when this medicine is administered, laryngospasm, cough, and sneezing may occur. After surgery and use of this medicine, vomiting is uncommon, but persistent drowsiness, confusion, memory loss (amnesia), and chills may occur.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tiobarbital B. Braun 0.5 g

Keep this medicine out of the sight and reach of children.

No special storage conditions are required. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

The contents of the vials must be used immediately after opening. After opening, discard any unused portion.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Tiobarbital B. Braun 0.5 g

• The active substance is thiopental sodium in the form of thiopental sodium and sodium carbonate. Each vial contains 0.5 g of thiopental sodium as thiopental sodium and sodium carbonate.

Appearance of the product and contents of the container

Tiobarbital B. Braun 0.5 g is a powder for injectable solution. It is a white or yellowish-white crystalline powder contained in glass vials.

It is packaged in boxes of 1 and 50 vials.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer:

• Braun Medical, S.A.

Ronda de los Olivares, Parcela 11

Polígono Industrial Los Olivares

23009-Jaén (Jaén)

Spain

Date of latest revision of this leaflet: April 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Solutions must be prepared aseptically using one of the following three diluents:

• sterile water for injection
• 0.9% sodium chloride solutions
• 5% dextrose solution

The clinical concentrations used for intermittent intravenous administration range between 2.0% and 5.0%.

A 2.0% or 2.5% solution is most frequently used. A 3.4% concentration in sterile water for injection is isotonic; concentrations below 2.0% in this diluent are not used because they cause haemolysis. For continuous intravenous infusion, concentrations of 0.2% or 0.4% are used. Solutions can be prepared by adding thiopental to a 5% dextrose solution or to a 0.9% sodium chloride solution.

CALCULATIONS FOR VARIOUS CONCENTRATIONS

Tiobarbital B. Braun solution must be prepared extemporaneously and aseptically.

Once the extemporaneous solution has been prepared, it should be administered within a maximum of 24 hours at a temperature between 2°C and 8°C. Discard any residual solution.

This medicinal product is administered only by intravenous route. Extravasation or intraarterial injection must be avoided. A qualified person experienced in the use of anaesthetics must be continuously available during administration of the drug. Endotracheal intubation equipment, oxygen, and resuscitation equipment must be readily available.

The following corrective measures have been suggested in case of intraarterial injection:

1. Dilute the injected thiopental by removing the tourniquet and any constricting garments.
2. Leave the intravenous cannula in place, if possible.
3. Inject a diluted solution of papaverine or lidocaine into the artery to inhibit smooth muscle spasm.
4. If necessary, perform a sympathetic block of the brachial plexus and/or stellate ganglion to relieve pain and assist in opening collateral circulation. Papaverine may be injected into the subclavian artery, if desired.
5. Unless contraindicated, treat with heparin to prevent thrombus formation.
6. Consider local infiltration of an alpha-adrenergic blocking agent such as phentolamine into the vasospastic area.
7. Provide additional symptomatic treatment as required.

The solution should only be used if the container closure is undamaged and the solution is clear.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 of the Summary of Product Characteristics.

Reconstituted solutions containing Tiobarbital may cause an alkaline reaction and are incompatible with volume replacement solutions and acidic adjuvant anaesthetic solutions, as this may lead to precipitation and blockage of the injection needle; likewise, chemical changes in the resulting solution cannot be excluded.