TIOPENTAL 1 g Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Thiopental Panpharma, 500 mg, powder for solution for injection
3. Thiopental Panpharma, 1 g, powder for solution for injection
4. Thiopental sodium with sodium carbonate
5. You should carefully read the contents of the leaflet before using the medicine, as it contains
   1. Table of contents of the leaflet:
6. What is Thiopental Panpharma and what is it used for
7. Important information before using Thiopental Panpharma
   1. Thiopental Panpharma should not be used if the patient:
   2. Warnings and precautions
   3. Children
   4. Thiopental Panpharma and other medicines
   5. Using Thiopental Panpharma with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Thiopental Panpharma contains sodium
8. How Thiopental Panpharma is administered
   1. Elderly patients
   2. Use in patients with kidney or liver disease
   3. In case of overdose of Thiopental Panpharma
9. Possible side effects
   1. Reporting side effects
10. How to store Thiopental Panpharma
11. Contents of the packaging and other information
    1. What Thiopental Panpharma contains
    2. What Thiopental Panpharma looks like and contents of the packaging
    3. Marketing authorization holder and manufacturer
    4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    5. Date of last revision of the leaflet: 20.12.2019
    6. Thiopental Panpharma, 500 mg, powder for solution for injection
    7. Thiopental Panpharma, 1 g, powder for solution for injection
    8. Special precautions for disposal and preparation of the medicine for use

Leaflet attached to the packaging: patient information

Thiopental Panpharma, 500 mg, powder for solution for injection

Thiopental Panpharma, 1 g, powder for solution for injection

Thiopental sodium with sodium carbonate

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 you can read it again if you need to.
If you have any further questions, you should ask your doctor or pharmacist.

• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Thiopental Panpharma is a medicine used for anesthesia from the barbiturate group.
Thiopental Panpharma is used:

• For short-term anesthesia without intubation (short-term anesthesia during surgical procedures that do not require any preparation for artificial respiration),
• For induction of general anesthesia with or without intubation (induction of longer anesthesia during surgical procedures with preparation of the patient for artificial respiration or without such preparation).

Note:As with all barbiturates, it is necessary to administer a pain-relieving medication
during anesthesia with Thiopental Panpharma.

2. Important information before using Thiopental Panpharma

Thiopental Panpharma should not be used if the patient:

• is allergic to thiopental sodium and sodium carbonate or other barbiturates (medicines that are similar in chemical structure to Thiopental Panpharma and are used in patients with convulsions and for anesthesia) or any of the other ingredients of this medicine (listed in section 6),
• has acute alcohol poisoning, sleeping pills, painkillers, and psychotropic drugs (medicines used to treat mental disorders),
• has porphyria (a severe disease caused by a disorder of hemoglobin synthesis), malignant hypertension (very high blood pressure), shock (sudden circulatory failure), and status asthmaticus (life-threatening breathing difficulties caused by narrowing of the small airways).

If any of these conditions apply to the patient, they should tell their doctor or nurse. Usually, they will decide to use a different medicine.

Warnings and precautions

Before starting to take Thiopental Panpharma, the patient should discuss it with their doctor or
pharmacist.
Thiopental Panpharma can only be used under certain conditions and with special caution. The patient should ask their doctor for detailed information. This also applies to situations where this information has ever applied to the patient in the past.
Thiopental Panpharma can only be used with special caution in the following cases:

• obstructive respiratory disease (breathing disorders due to narrowing of the airways, e.g., in bronchial asthma),
• hypovolemia (low blood volume due to blood or fluid loss),
• severe heart muscle damage,
• severe kidney or liver dysfunction,
• in infants,
• metabolic disorders, including diabetes.

The patient should inform their doctor if any of the above apply to them.
In such cases, Thiopental Panpharma can only be used if all preliminary conditions have been met, including the availability of personnel and specialized equipment for the treatment of potential emergencies, such as respiratory failure and respiratory arrest.
There is a risk of severe low blood pressure in the event of rapid injection (e.g., bolus injection). Therefore, Thiopental Panpharma should be administered slowly. Thiopental Panpharma is not intended for continuous infusion. Tissue necrosis has been observed after continuous administration of Thiopental Panpharma in infusion lasting more than a few hours.
If the injection is accidentally given into an artery or outside a vein, tissue necrosis (death) or very painful nerve inflammation may occur. The entire arm should be immobilized and the doctor should take all measures to aspirate the previously injected solution using a permanently inserted cannula. The healing process can be accelerated by applying wet dressings, if possible soaked in alcohol. In the case of larger volumes, drugs that accelerate diffusion (e.g., hyaluronidase) can be used. Additionally, the adjacent perivenous area can be infiltrated with a 1% novocaine solution. To dilute the medicinal product Thiopental Panpharma that has penetrated the tissues, an isotonic sodium chloride solution should be administered subcutaneously.

Children

During diagnostic or therapeutic procedures in the upper respiratory tract, hyperreflexia (increased reflexes) and laryngospasm (laryngeal spasm) can be expected,
especially in children.

Thiopental Panpharma and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are taking,
including those bought without a prescription.
The following medicines affect Thiopental Panpharma:

• In combination therapy with other medicines that have a depressant effect on the central nervous system (e.g., benzodiazepines) or with alcohol, it should be considered that such use may cause additional depressant effects on the central nervous system. For the same reason, in combination therapy with other medicines that have a depressant effect on the respiratory center (such as opioids), additional depressant effects on the respiratory center may occur.

Additionally, substances that compete with Thiopental Panpharma for binding to plasma proteins, such as sulfonamides, may enhance the effect of Thiopental Panpharma and lead to a reduction in the required induction dose.

• The use of Thiopental Panpharma affects other medicines:
• If Thiopental Panpharma is used repeatedly at short intervals, it may have an inducing effect on liver enzymes. This may lead to accelerated breakdown of other medicines, such as coumarin derivatives, corticosteroids, and oral contraceptives, and consequently reduce their effectiveness.
• Additionally, it increases the toxic effect of methotrexate.

Using Thiopental Panpharma with food, drink, and alcohol

Before and after anesthesia, under no circumstances should the patient consume any drinks or
food containing alcohol.

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, pharmacist, or nurse before using this medicine.
Thiopental Panpharma passes through the placenta. Therefore, general anesthesia with Thiopental Panpharma in pregnant women can only be used if it is absolutely necessary and after a thorough assessment of the risk and benefits.
Thiopental Panpharma passes into human milk. The concentrations of this medicinal product in the blood of breastfed infants may be higher than in the mother due to immature metabolism. Thiopental Panpharma is detected in human milk up to 36 hours after injection. During this period, breastfeeding should not be done.

Driving and using machines

After administration of anesthesia with Thiopental Panpharma, the patient's ability to react quickly
and appropriately to unexpected and sudden events may be impaired. Therefore, the patient should not drive a car or other vehicle after outpatient surgery.
The patient should return home under supervision and under no circumstances consume alcohol.
The patient should ask their doctor to explain how long to take these precautions. During this time, patients should not operate any electrical equipment or machines or perform any work without a stable support point.

Thiopental Panpharma contains sodium

Thiopental Panpharma 500 mg powder for solution for injection contains 53 mg of sodium (main
component of common salt) per vial. This corresponds to 2.65% of the maximum recommended daily intake of sodium in the diet for adults.
Thiopental Panpharma 1 g powder for solution for injection contains 106 mg of sodium (main component of common salt) per vial. This corresponds to 5.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How Thiopental Panpharma is administered

This injection is given by a doctor in a hospital. The medicine should be used in accordance with the
dosing recommendations given below or as recommended by the doctor.
Thiopental Panpharma should only be used when qualified personnel and necessary specialized equipment are available for resuscitation and endotracheal intubation to treat emergency medical conditions, such as respiratory failure and respiratory arrest.
The recommended dose is determined based on the individual patient's sensitivity and the desired depth of anesthesia. The following information provides general guidelines; the safest way to achieve optimal effect is by slow, repeated injection of small doses.
For induction of general anesthesia, the dose for intravenous injection is usually 5 mg of Thiopental Panpharma per kilogram of body weight. The duration of action is from 6 to 8 minutes. Typically, a dose of 100 to 200 mg of thiopental sodium is injected slowly over 20 seconds.
Administration of additional doses depends on the patient's sensitivity and the desired depth of anesthesia.
In the case of short-term anesthesia, the total dose should not normally exceed twice the induction dose of 100 to 200 mg of thiopental sodium.
The total dose required for a surgical procedure may be from 400 mg to 1 g of thiopental sodium.

Elderly patients

Due to slowed metabolism in elderly patients, an increased effect of the medicinal product should be expected. Therefore, the dose should be reduced accordingly.

Use in patients with kidney or liver disease

In patients with impaired liver or kidney function, the dose of the medicine must be adjusted according to the degree of impairment.

In case of overdose of Thiopental Panpharma

Treatment of overdose is symptomatic and should be carried out in intensive medical care and by qualified medical personnel or the treating doctor. Nevertheless, in the case of overdose, the following side effects may occur.
If the patient has received a larger dose of Thiopental Panpharma than they should have, they may experience a sudden drop in blood pressure, which can lead to shock. As a result of inadequate blood pumping by the heart, pulmonary edema may occur. A drop in blood pressure may also result from an allergic reaction; however, such a reaction usually occurs in combination with allergic skin reactions.
Additionally, overdose may cause breathing difficulties (persistent respiratory failure or respiratory arrest), which can be life-threatening without connecting the patient to artificial respiration. There is a sudden decrease in body temperature.
In case of any further doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

If the patient experiences any of the following symptoms, they should immediately tell their doctor -
they may need urgent medical attention:
difficulty breathing, wheezing, rash, hives, and dizziness. This may be a severe allergic reaction (frequency not known, cannot be estimated from the available data).
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since Thiopental Panpharma is practically always administered in combination with other anesthetics, it is not always possible to determine which of the anesthetics actually caused the observed side effects.
The patient should immediately tell their doctor or nurse if they notice any of the following side effects.
Common(may occur in up to 1 in 10 patients):
Breathing difficulties with short apneas
Hiccup during spontaneous breathing and mask breathing
Increased well-being and vivid dreams, sometimes nightmares
Allergic reactions, e.g., bronchial asthma and laryngeal spasm
Redness and swelling of the skin.
Very rare(may occur in up to 1 in 10,000 patients) include:

• Severe allergic reactions with sudden and severe conditions threatening cardiac arrest (sudden lack of heart activity) and respiratory arrest (lack of breathing)
• Allergic reactions related to a decrease in the number of red blood cells due to premature destruction of cells along with kidney damage.

Frequency not known(frequency cannot be estimated from the available data):
Nausea and vomiting (caused by another medicine given in combination)
Coughing and sneezing
Pain at the injection site after intravenous injection
Formation of blood clots
Phlebitis.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor, nurse, or pharmacist. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Thiopental Panpharma

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
For single use after reconstitution. Dispose of any unused residue after use.
After reconstitution:
The medicine should be used immediately after reconstitution. If the medicine is not used immediately, the user is responsible for the further storage period and conditions, which should not normally exceed 9 hours at a temperature below 25°C and 24 hours in a refrigerator at a temperature between 2°C and 8°C, unless the reconstitution of the medicine was performed in controlled and validated aseptic conditions. After reconstitution in water for injections and 0.9% sodium chloride solution, the physicochemical stability of the solution has been demonstrated for 9 hours at a temperature below 25°C and for 24 hours in a refrigerator at a temperature between 2°C and 8°C.
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 specified month.
Medicines should not be disposed of via wastewater or household waste. Medical personnel will dispose of the medicine when it is no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Thiopental Panpharma contains

The active substance of the medicine is thiopental sodium with sodium carbonate.
One vial of Thiopental Panpharma 500 mg powder for solution for injection contains 500 mg of thiopental sodium with sodium carbonate (which corresponds to 470 mg of thiopental sodium).
One vial of Thiopental Panpharma 1 g powder for solution for injection contains 1 g of thiopental sodium with sodium carbonate (which corresponds to 0.94 g of thiopental sodium).

What Thiopental Panpharma looks like and contents of the packaging

20 mL vials made of colorless glass (type III) with a bromobutyl rubber stopper coated with Teflon, an aluminum seal, and a blue or gray cap made of PP (blue for 500 mg and gray for 1 g), in a cardboard box.
Pack size: 1, 10, 25, and 50 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder
PANPHARMA
Z.I. du Clairay
35133 Luitré
France
Manufacturer
Panpharma
10 rue du Chênot
Parc d’Activité du Chênot
56380 Beignon
France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 20.12.2019

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Information intended only for healthcare professionals:

Thiopental Panpharma, 500 mg, powder for solution for injection

Thiopental Panpharma, 1 g, powder for solution for injection

Special precautions for disposal and preparation of the medicine for use

Thiopental Panpharma should not be mixed with other solutions for injection and infusion (except for those listed below). Additionally, the solution after reconstitution should not be administered with other solutions for injection or infusion. Solutions prepared with Thiopental Panpharma have a strongly alkaline pH and are incompatible with volume-expanding solutions and anesthetic adjuvants with an acidic pH, as precipitation and clogging of the needle during injection may occur. For the same reason, chemical changes in the added solution cannot be ruled out.
Preparation of the solution for injection:
Thiopental Panpharma 500 mg and 1 g is used as a 2.5% and 5% solution for injection.
In the case of a 2.5% solution for injection, the contents of one vial of Thiopental Panpharma 500 mg should be dissolved in 20 mL of water for injections or 0.9% sodium chloride solution.
In the case of a 5% solution for injection, the contents of one vial of Thiopental Panpharma 500 mg should be dissolved in 10 mL of water for injections or 0.9% sodium chloride solution.
In the case of a 2.5% solution for injection, the contents of one vial of Thiopental Panpharma 1 g should be dissolved in 40 mL of water for injections or 0.9% sodium chloride solution.
In the case of a 5% solution for injection, the contents of one vial of Thiopental Panpharma 1 g should be dissolved in 20 mL of water for injections or 0.9% sodium chloride solution.
Method of administration
In the case of anesthesia injection, Thiopental Panpharma is dissolved in water for injections or 0.9% sodium chloride solution and then slowly injected intravenously.
Multiple injections can be administered.
In a few cases, acute tolerance has been demonstrated, i.e., it may be necessary to administer a larger dose after the first effective anesthetic dose to repeat the same effect. On the other hand, if subsequent doses are administered, it should be remembered that the substance accumulates.
No solution of this medicinal product should be administered if a precipitate is visible. Solutions should be used immediately after preparation.
Any unused residue of the medicinal product or waste should be disposed of in accordance with local regulations.
Overdose:
The typical symptom of overdose is a sudden decrease in blood pressure, which can lead to shock. As a result of inadequate blood pumping by the heart, pulmonary edema may occur. A drop in blood pressure may also result from an allergic reaction; however, such a reaction usually occurs in combination with allergic skin reactions.
Overdose may cause persistent respiratory failure or respiratory arrest, which can be life-threatening without connecting the patient to artificial respiration. There is a sudden decrease in body temperature.
Treatment of overdose is symptomatic and should be carried out in intensive medical care and will be performed by qualified medical personnel or the treating doctor. Nevertheless, in the case of overdose, the following side effects may occur.
Treatment with infusion of volume-expanding solutions is indicated as a measure to counteract the decrease in blood pressure and as an anti-shock measure. Dopamine (from 2 to 5 μg/kg/min) or norepinephrine (noradrenaline from 0.1 to 0.2 μg/kg/min) can be added to the infusion solution. The body temperature should be brought back to normal.