BUPIVACAINE 5 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Bupivacaine Spinal Grindeks, 5 mg/mL, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Bupivacaine Spinal Grindeks and what is it used for
4. Important information before using Bupivacaine Spinal Grindeks
   1. When not to use Bupivacaine Spinal Grindeks
   2. Warnings and precautions
   3. Bupivacaine Spinal Grindeks and other medicines
   4. Bupivacaine Spinal Grindeks with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Bupivacaine Spinal Grindeks contains sodium
5. How to use Bupivacaine Spinal Grindeks
   1. Use in children and adolescents
   2. Use of a higher dose of Bupivacaine Spinal Grindeks than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Bupivacaine Spinal Grindeks
8. Contents of the packaging and other information
   1. What Bupivacaine Spinal Grindeks contains
   2. What Bupivacaine Spinal Grindeks looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:
   5. Information intended for healthcare professionals only:
   6. Dosage and administration
   7. WARNING!
   8. Bupivacaine Spinal Grindeks is an isobaric solution. The range of anesthetized segments may be difficult to predict, especially if an isobaric solution is used.
   9. RECOMMENDED DOSAGE
   10. Special warnings and precautions for use
   11. WARNING!
   12. Bupivacaine Spinal Grindeks is an isobaric solution. The range of anesthetized segments may be difficult to predict, especially if an isobaric solution is used.
   13. Incompatibilities
   14. Special precautions for disposal and preparation of the medicinal product for administration
   15. Overdose

Leaflet accompanying the packaging: patient information

Bupivacaine Spinal Grindeks, 5 mg/mL, solution for injection

Isobaric solution
Bupivacaine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Bupivacaine Spinal Grindeks and what is it used for

Bupivacaine Spinal Grindeks is an isobaric solution for injection, intended for single use, containing bupivacaine hydrochloride - a local anesthetic.
Bupivacaine Spinal Grindeks is used to perform prolonged spinal anesthesia (2-4 hours) in the appropriate parts of the spine to anesthetize specific parts of the body:

• during procedures in the lower limbs, including the hip,
• in urological procedures,
• during procedures in the abdominal cavity.

2. Important information before using Bupivacaine Spinal Grindeks

When not to use Bupivacaine Spinal Grindeks

• if the patient is allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6). If the patient has allergic reactions to very similar anesthetics, inform the doctor;
• if the patient has blood coagulation disorders or is currently taking anticoagulant medications;
• if the patient has diseases that, in the doctor's opinion, are contraindications to the use of Bupivacaine Spinal Grindeks, such as: meningitis, tumors, inflammation of the spinal cord, intracranial bleeding; spinal diseases (e.g., inflammation, tumor) or recent spinal injury (e.g., fracture); sepsis (systemic infection); subacute degeneration of the spinal cord due to malignant anemia; skin infection at the injection site or nearby;

cardiogenic shock (insufficient blood circulation to maintain life due to a sudden drop in blood pressure caused by heart failure) or hypovolemic (related to a decrease in circulating blood volume).

Warnings and precautions

Before starting treatment with Bupivacaine Spinal Grindeks, discuss it with your doctor or nurse.
Before using Bupivacaine Spinal Grindeks, inform your doctor about:

• all the patient's diseases, especially heart, liver, or kidney diseases;
• all medications taken regularly by the patient.

Particular caution should be exercised:

• in patients in poor general health;
• in elderly patients;
• in patients with liver or kidney function disorders;
• in pregnant women in advanced pregnancy;
• in patients with hypovolemia (too little circulating blood) - a sudden and significant drop in blood pressure may occur. In children under 8 years of age, this happens rarely.

Bupivacaine Spinal Grindeks is an isobaric solution, so the range of anesthetized segments may be difficult to predict.
Anesthesia should be performed in properly equipped centers with appropriately trained staff, a constantly available anesthesiologist, and necessary equipment and medications for patient monitoring and resuscitation.
During the use of bupivacaine, as with other local anesthetics, symptoms of adverse effects on the central nervous system and cardiovascular system may occur, especially in the case of unintended intravascular administration. Symptoms include: ventricular arrhythmia, ventricular fibrillation, circulatory collapse, and death. However, when using the recommended doses in spinal anesthesia, no high concentration of the anesthetic has been observed in the blood.
Very high or total spinal anesthesia is a rare but serious side effect of the medicine, which may occur after spinal anesthesia, resulting in circulatory and respiratory failure.
The risk of high or total spinal anesthesia is higher in elderly patients and pregnant women. In these patients, the dose of the anesthetic should be reduced (see "Dosage and administration" below).
After spinal anesthesia, neurological complications are rare.
These complications include: sensory disturbances, loss of sensation, motor function disorders, and paralysis. In some cases, these changes are permanent.
There is no data on the occurrence of side effects after spinal anesthesia in patients with neurological disorders such as multiple sclerosis, hemiplegia, transverse paralysis, and neuromuscular disorders. In the case of these diseases, appropriate precautions should be taken.

Bupivacaine Spinal Grindeks and other medicines

Inform your doctor or nurse about all medications taken by the patient currently or recently, as well as medications that the patient plans to take.
Other medications, such as other local anesthetics and anti-arrhythmic medications (used in heart rhythm disorders), may affect the action of Bupivacaine Spinal Grindeks and the choice of its dose.

Bupivacaine Spinal Grindeks with food, drink, and alcohol

Not applicable.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or nurse before using this medicine.
From the available information on the use of bupivacaine in pregnant women, it does not appear that bupivacaine has a harmful effect on pregnancy.
However, there are no significant epidemiological data or appropriate human studies.
Animal studies have shown that during administration of high doses of bupivacaine during pregnancy, a decrease in fetal survival was observed in rats and an adverse effect on embryo development in rabbits.
Therefore, bupivacaine should not be administered to women in early pregnancy, unless the expected benefit outweighs the potential risk.
The dose of the anesthetic should be reduced in pregnant women in advanced pregnancy.
Bupivacaine may pass into breast milk, but in such small amounts that it does not pose a risk to the breastfed child.

Driving and using machines

After injection of Bupivacaine Spinal Grindeks, do not drive vehicles or operate machines, as the medicine may affect the ability to perform these activities.

Bupivacaine Spinal Grindeks contains sodium

At the recommended dosage, the medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Bupivacaine Spinal Grindeks

Bupivacaine Spinal Grindeks is always administered to the patient by a doctor or by a nurse under the supervision of a doctor. The doctor decides what dose is appropriate for the patient, taking into account the desired clinical effect and the patient's health status.
Bupivacaine Spinal Grindeks is an isobaric solution. The range of anesthetized segments may be difficult to predict, especially if an isobaric solution is used.

Use in children and adolescents

The dose depends on the patient's age and weight, and is determined by the doctor.

Use of a higher dose of Bupivacaine Spinal Grindeks than recommended

Severe side effects after overdose are very rare, but require special treatment. The doctor must be prepared for such a situation.
Symptoms of poisoning include: numbness of the tongue, dizziness, and muscle tremors. Then, convulsions and circulatory failure may occur. During epidural anesthesia, high spinal anesthesia or total spinal anesthesia may occur, with symptoms such as respiratory arrest and (or) hypotension.
In case of overdose symptoms, the doctor will immediately stop administering the anesthetic, ensure proper oxygenation of the patient, and initiate appropriate treatment.
In case of any further doubts about the use of this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are classified according to their frequency:

• Very common (occurring in more than 1 in 10 patients):
• low blood pressure,
• slow heart rate,
• nausea (vomiting).

Common (occurring in less than 1 in 10 patients):

• headache,
• vomiting,
• urinary retention,
• urinary incontinence.

Uncommon (occurring in less than 1 in 100 patients):

• burning, tingling, or numbness of the hands or feet,
• weakness,
• abnormal or unpleasant sensations,
• muscle weakness,
• back pain.

Rare (occurring in less than 1 in 1,000 patients):

• cardiac arrest,
• allergic reactions,
• anaphylactic shock (a very severe allergic reaction),
• total anesthesia, bilateral paralysis, paralysis,
• neurological disorders,
• arachnoiditis (inflammation of the arachnoid membrane surrounding the central nervous system, under which Bupivacaine Spinal Grindeks is administered),
• respiratory depression.

Inform your doctor immediately if you feel unwell during the injection of Bupivacaine Spinal Grindeks.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, inform your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bupivacaine Spinal Grindeks

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after: Expiry date (EXP). The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Store in the original packaging to protect from light. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Bupivacaine Spinal Grindeks contains

• The active substance of the medicine is bupivacaine hydrochloride (Bupivacaine hydrochloride). One mL of the solution contains 5 mg of bupivacaine hydrochloride. One ampoule contains 20 mg of bupivacaine hydrochloride in 4 mL of solution.
• Other ingredients are: sodium chloride, sodium hydroxide (to adjust pH 4.0-6.5), hydrochloric acid (to adjust pH 4.0-6.5), water for injections.

What Bupivacaine Spinal Grindeks looks like and contents of the pack

Clear, colorless isobaric solution.
Ampoule made of colorless glass (type I) in a PVC mold, with a colored ring or without, containing 4 mL of solution.
Pack size: 5 ampoules, in a carton box.

Marketing authorization holder and manufacturer

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
e-mail: [email protected]

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Dosage and administration

WARNING!

Bupivacaine Spinal Grindeks is an isobaric solution. The range of anesthetized segments may be difficult to predict, especially if an isobaric solution is used.

Isobaric solution.
Dosage
Adults:
Before determining the dose, assess the patient's health status and determine if the patient is taking other medications.
Use the lowest dose of the medicine that produces effective anesthesia.
The duration of anesthesia depends on the dose of the medicine.
In elderly patients or pregnant women, reduce the dose of the medicine.
The following table shows the recommended dosages for anesthesia, which should be considered as recommended doses for performing anesthesia in an adult of average body build. The range and duration of anesthesia should be considered individually.

RECOMMENDED DOSAGE

The recommended injection site is below the level of L3.
Children and adolescents
Children up to 40 kg body weight (kg bw):
Bupivacaine Spinal Grindeks may be used in children.
The difference between adults and children is the relatively large volume of cerebrospinal fluid in newborns and infants. Therefore, to achieve the same level of blockade as in adults, a relatively higher dose of the medicine per kilogram of body weight is necessary in children.

Administration route
Spinal administration.

Special warnings and precautions for use

WARNING!

Bupivacaine Spinal Grindeks is an isobaric solution. The range of anesthetized segments may be difficult to predict, especially if an isobaric solution is used.

Isobaric solution.
Anesthesia should be performed in properly equipped centers with appropriately trained staff, a constantly available anesthesiologist, and necessary equipment and medications for patient monitoring and resuscitation.
Before performing spinal anesthesia, ensure access to the patient's vein.
The anesthesiologist should exercise particular caution to avoid intravascular injection and should be properly trained and familiar with the methods of diagnosing and treating side effects, toxicity symptoms, and other complications. In case of acute toxicity symptoms or total spinal anesthesia, immediately stop administering the anesthetic (see "Overdose" below).
Particular caution should be exercised when using local anesthesia in patients in poor general health due to age or liver or kidney function disorders, even though regional anesthesia is the optimal solution for this group of patients.
Bupivacaine, like all local anesthetics, can cause symptoms of toxicity in the central nervous system (CNS) and cardiovascular system, especially if local anesthesia results in high blood concentrations of the medicine. This applies especially to cases of unintended intravascular administration.
At high concentrations of bupivacaine in the blood, cases of ventricular arrhythmia, ventricular fibrillation, circulatory collapse, and death have been reported. However, when using the recommended doses in spinal anesthesia, no high concentration of the anesthetic has been observed in the blood.
Very high or total spinal anesthesia is a rare but serious side effect of the medicine, which may occur after spinal anesthesia, resulting in circulatory and respiratory failure. Circulatory failure is caused by extensive blockade of the sympathetic nervous system, with symptoms including significant hypotension and bradycardia or even cardiac arrest. Respiratory failure is caused by paralysis of the respiratory muscles (due to blockade of the nerves innervating the respiratory muscles), including the diaphragm.
The risk of high or total spinal anesthesia is higher in elderly patients and pregnant women. In these patients, the dose of the anesthetic should be reduced (see "Dosage and administration" above).
In patients with hypovolemia, spinal anesthesia may cause a sudden and significant drop in blood pressure, regardless of the anesthetic used. In children under 8 years of age, hypotension after spinal anesthesia is rare.
After spinal anesthesia, neurological complications are rare.
These complications include: sensory disturbances, loss of sensation, motor function disorders, and paralysis. In some cases, these changes are permanent.
There is no data on the occurrence of side effects after spinal anesthesia in patients with neurological disorders such as multiple sclerosis, hemiplegia, transverse paralysis, and neuromuscular disorders. In the case of these diseases, appropriate precautions should be taken.
Before performing spinal anesthesia, consider the potential risks and benefits for the patient.

Incompatibilities

It is not recommended to add other substances to solutions for injection into the subarachnoid space.

Special precautions for disposal and preparation of the medicinal product for administration

Bupivacaine Spinal Grindeks does not contain preservatives.
Each ampoule is intended for single use. Do not reuse unused portions of the solution.
Do not resterilize.
Dispose of any unused medicinal product or waste in accordance with local regulations.

Overdose

Bupivacaine administered in high doses may cause acute symptoms of toxicity in the central nervous system and cardiovascular system, especially if administered intravascularly.
After administration of the recommended doses of Bupivacaine Spinal Grindeks during spinal anesthesia, no increased concentration of the anesthetic in the blood has been observed that would cause symptoms of systemic toxicity.
However, if other local anesthetics are administered simultaneously, their toxic effects may be additive and cause symptoms of systemic toxicity.
General symptoms of toxicity and their treatment
General symptoms of toxicity include: numbness of the tongue, dizziness, and muscle tremors. Then, convulsions and circulatory failure may occur.
In case of acute systemic overdose symptoms, immediately stop administering the anesthetic.
If the systemic symptoms of toxicity are mild, treatment is not necessary.
In case of convulsions, treatment is necessary to stop the seizure and ensure adequate oxygenation of the patient by administering oxygen and, if necessary, using assisted or controlled ventilation.
In some cases, convulsions can be controlled by ensuring adequate ventilation of the lungs without using additional measures.
If the convulsions do not stop within 15 to 20 seconds, administer 100 mg to 150 mg of thiopental or 5 mg to 10 mg of diazepam intravenously.
You can also administer 50 mg to 100 mg of succinylcholine intravenously, but in this case, the patient should be intubated and full treatment should be initiated as in the case of muscle relaxation.
Cardiac arrest requires immediate initiation of resuscitation measures, including electrical defibrillation. The return of hemodynamically efficient cardiac function may require prolonged resuscitation efforts.
Symptoms of total spinal anesthesia and their treatment
During epidural anesthesia, high spinal anesthesia or total spinal anesthesia may occur, with symptoms such as respiratory arrest and (or) hypotension.
In such a case, immediately stop administering the anesthetic and administer oxygen to the patient, and use assisted or controlled ventilation.
In case of hypotension, administer a vasoconstrictor intravenously, e.g., 10 mg to 15 mg of ephedrine - the dose can be repeated until improvement is achieved.
To increase blood pressure, you can also administer electrolyte solutions or colloids intravenously.
Always ensure proper oxygenation, breathing, and circulation, and initiate treatment of acidosis.
Children and adolescents
The doses of medications used to treat overdose of Bupivacaine Spinal Grindeks in children should be adjusted according to their age and body weight.