Tiobarbital B. Braun 1 g powder for injection solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tiobarbital B. Braun 1 g powder for solution for injection

sodium thiopental

Package leaflet contents

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

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

This medicine contains the active substances sodium thiopental 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 for whom 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 1 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 a respiratory tract obstruction (respiratory obstruction),
• if you have acute asthma (severe asthma attack),
• if you suffer from hereditary muscle degeneration (myotonic dystrophy),
• if you have 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:

Consult your doctor or pharmacist before starting to use Tiobarbital B. Braun, especially if you have:

• increased intracranial pressure,
• asthma or another severe respiratory disease,
• inflammation in 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,
• dehydration or reduced total blood volume circulating in the body (hypovolemia),
• severe hemorrhages 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 disorder, 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 using, have recently used, or might need to use any other medicines.

The following medicines may affect or interact with thiopental:

• Aminophylline (for the treatment of asthma).
• Midazolam (a sedative medicine).
• Opioid analgesics (medicines for treating severe pain).
• Probenecid (a medicine for treating gout).
• Fentanyl (a medicine for treating pain).
• Muscle relaxants.
• Monoamine oxidase inhibitors and tricyclic antidepressants (medicines used to treat depression), for example, citalopram, amitriptyline.
• Central nervous system depressant substances.
• Metoclopramide and droperidol (medicines for treating nausea and vomiting).
• Medicines containing St. John's wort or valerian.
• Androgens (for the treatment of male infertility).
• Medicines for treating epilepsy.
• Corticosteroids (medicines that reduce inflammation and allergic reactions).
• Medicines for treating bacterial infections such as metronidazole, sulfafurazole, isoniazid, and vancomycin.
• Estrogen (for the treatment of menopause).
• Oral medicines for treating diabetes.
• Antihypertensives (medicines given to lower blood pressure), for example, captopril, enalapril, terazosin, felodipine, hydralazine, losartan, methyldopa, moxonidine, nitrates, and diuretics.
• Acetylsalicylic acid (aspirin) and other pain medicines.
• Antipsychotic medicines such as lithium, promethazine, or quetiapine.
• Diazoxide (for the treatment of 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 alcohol-dependent or regularly consume large amounts of alcohol, it may be necessary to increase the dose of thiopental.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Thiopental crosses the placental barrier. There is limited data in pregnant women indicating that thiopental does not cause malformations or fetal/neonatal toxicity.

If you are pregnant, you will receive this medicine only 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 before using this medicine.

Fertility

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

Driving and use of 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 92 mg of sodium per vial, equivalent to 4.6% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

3. How to use Tiobarbital B. Braun 1 g

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed 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 continuously present during administration, along with resuscitation equipment.

This medicine is 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 intervals of 20 to 40 seconds, and additional injections of 25 to 50 mg to maintain anesthesia.

Convulsive crises

Thiopental injection of 50 to 125 mg should be administered as soon as possible after the onset of seizure. 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 kidney 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 pediatric patient's age, maturity, and general condition. 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 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 include:

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

There is another type of less severe side 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 discontinue treatment and manage your symptoms accordingly.

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

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 may cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following symptoms, as you may require urgent medical treatment:

Frequency not known (cannot be estimated from available data)

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

Other adverse effects that may occur:

Frequent (may affect up to 1 in 10 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).
• Coughing.
• 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, coughing, 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 1 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 packaging 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 packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tiobarbital B. Braun 1 g

• The active substance is thiopental sodium in the form of thiopental sodium and sodium carbonate. Each vial contains 1 g of thiopental sodium in the form of thiopental sodium and sodium carbonate.

Appearance of the product and contents of the container

Tiobarbital B. Braun 1 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:

• 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 the most recent revision of this leaflet: April 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (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 concentration of 3.4% in sterile water for injection is isotonic; concentrations below 2.0% in this diluent should not be used as they may cause haemolysis. For continuous intravenous infusion, concentrations of 0.2% or 0.4% are used. Solutions may 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 must be administered within a maximum period of 24 hours at a temperature between 2°C and 8°C. Discard any residual volume of solution.

This medicinal product is administered intravenously only. Extravasation or intra-arterial injection must be avoided. A qualified person experienced in the use of anaesthetics must be constantly available during administration of the medicinal product. Endotracheal intubation equipment, oxygen, and resuscitation equipment must be readily available.

The following corrective measures have been suggested in case of intra-arterial 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 into the artery a diluted solution of papaverine or lidocaine to inhibit smooth muscle spasm.
4. If necessary, perform a brachial plexus and/or stellate ganglion sympathetic block 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 necessary.

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 anaesthetic adjuvant solutions, as this may lead to precipitation and blockage of the injection needle; likewise, chemical changes in the resulting solution cannot be excluded.