Bupivacaine spinal grindeks

Package leaflet: Information for the patient

Bupivacaine Spinal Grindeks, 5 mg/mL, solution for injection
isobaric solution
Bupivacaini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Leaflet contents

1. What Bupivacaine Spinal Grindeks is and what it is 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 pack and other information

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

Bupivacaine Spinal Grindeks is an isobaric solution for injection intended for single use, containing bupivacaine hydrochloride – a local anaesthetic substance.
Bupivacaine Spinal Grindeks is used to produce spinal (intrathecal) anaesthesia lasting 2-4 hours in the appropriate region of the spine, in order to anaesthetize specific parts of the body:

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

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 closely related local anaesthetics, this should be reported to the doctor;
• if the patient has blood clotting disorders or is currently taking anticoagulant medicines;
• if the patient has diseases which, in the doctor's opinion, are contraindications to the use of Bupivacaine Spinal Grindeks, for example:
  • meningitis, tumours, inflammation of the spinal cord grey matter, intracranial haemorrhage;
  • spinal diseases (e.g. inflammation, tumour) or recent spinal trauma (e.g. fracture);
  • sepsis (systemic infection);
  • subacute degeneration of the spine due to pernicious anaemia;
  • skin infection at or near the injection site;
• cardiogenic shock (inadequate organ perfusion to sustain life due to a sudden drop in blood pressure caused by heart failure) or hypovolemic shock (related to reduced circulating blood volume).

Warnings and precautions

Before starting treatment with Bupivacaine Spinal Grindeks, discuss this with the doctor or nurse.

Before using Bupivacaine Spinal Grindeks, inform the doctor about:

• all the patient's medical conditions, especially heart, liver or kidney diseases;
• all medicines the patient is currently taking regularly.

Special caution is required:

• in patients with generally poor health;
• in elderly patients;
• in patients with impaired liver or kidney function;
• in patients with advanced pregnancy;
• in patients with hypovolemia (too low circulating blood volume) – sudden and significant drop in blood pressure may occur. This is rare in children under 8 years of age.

Bupivacaine Spinal Grindeks is an isobaric solution; therefore, the extent of the anaesthetized segments may be difficult to predict.

Anaesthesia should be performed only in appropriately equipped centres with adequately trained personnel, a permanently available anaesthesiologist, and appropriate equipment and medicines for monitoring and resuscitation of the patient.

When using bupivacaine, as with other local anaesthetics, signs of toxic effects on the central nervous system and cardiovascular system may occur, especially in case of accidental intravascular administration. Symptoms include: ventricular arrhythmia, ventricular fibrillation, circulatory collapse and death. However, when recommended doses are used in spinal anaesthesia, high blood concentrations of the anaesthetic agent have not been observed.

Very high or total spinal anaesthesia is a rare but serious adverse effect of the medicine, which may occur after spinal anaesthesia, resulting in circulatory failure (hypotension and bradycardia) and respiratory failure.

The risk of high or total spinal anaesthesia is higher in elderly patients and in patients with advanced pregnancy. In these patients, the dose of the medicine should be reduced.

Neurological complications after spinal anaesthesia are rare.

Such complications include: sensory disturbances, loss of sensation, motor dysfunction and paralysis. In some cases, these changes may be permanent.

There are no data on the occurrence of adverse effects after spinal anaesthesia in patients with neurological disorders such as multiple sclerosis, hemiplegia, transverse myelitis and neuromuscular disorders. Appropriate precautions should be taken in such conditions.

Bupivacaine Spinal Grindeks and other medicines

Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

Other medicines, for example other local anaesthetics and antiarrhythmics (used in heart rhythm disorders), may affect the action of Bupivacaine Spinal Grindeks and the choice of the appropriate dose.

Bupivacaine Spinal Grindeks with food, drink and alcohol

Not applicable.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or nurse before using this medicine.

Current information on the use of bupivacaine in pregnant women does not indicate that bupivacaine has harmful effects on pregnancy.

However, there are no significant epidemiological data, nor have adequate studies been conducted in humans.

Animal studies have shown that administration of high doses of bupivacaine during pregnancy resulted in reduced fetal survival in rats and adverse effects on embryonic 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 anaesthetic should be reduced in patients with advanced pregnancy.

Bupivacaine may pass into human milk, but in such small amounts that it does not pose a risk to the breastfed infant.

Driving and using machines

After injection of Bupivacaine Spinal Grindeks, the patient should not drive or operate machinery, 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, meaning the medicine is considered "sodium-free".

3. How to use Bupivacaine Spinal Grindeks

Bupivacaine Spinal Grindeks is always administered to the patient by a physician or by a nurse under the supervision of a physician. The physician determines the appropriate dose for the patient, taking into account the desired clinical outcome and the patient's health status.
Bupivacaine Spinal Grindeks is an isobaric solution. The range of anesthetized segments may be difficult to predict, especially when an isobaric solution is used.
Use in children and adolescents
The dose depends on the patient's age and body weight, and is determined by the physician.
Administration of a higher than recommended dose of Bupivacaine Spinal Grindeks
Severe adverse effects following overdose occur very rarely, but require specific treatment. The physician must be prepared for such a situation.
Symptoms of poisoning include: numbness of the tongue, dizziness, and muscle tremors. Subsequently, seizures and circulatory failure may occur. During epidural anesthesia, a so-called high spinal block or total spinal anesthesia may occur, which may manifest as respiratory arrest and (or) decreased arterial blood pressure.
If symptoms of overdose occur, the physician will immediately discontinue administration of the anesthetic drug, ensure adequate oxygenation of the patient, and initiate appropriate treatment.
If you have any further questions regarding the use of this medicine, consult your physician or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions have been classified according to frequency of occurrence:

Very common (occur in more than 1 in 10 patients):

• low blood pressure,
• slowed heart rate,
• nausea (feeling sick).

Common (occur in up to 1 in 10 patients):

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

Uncommon (occur in up to 1 in 100 patients):

• burning, pricking, tingling sensations in hands or feet,
• muscle weakness,
• abnormal, unpleasant sensation to stimuli,
• muscle weakness,
• back pain.

Rare (occur in up to 1 in 1,000 patients):

• cardiac arrest,
• allergic reactions,
• anaphylactic shock (a very severe allergic reaction),
• complete anaesthesia, bilateral paralysis, paresis,
• nervous system disorders,
• meningitis (inflammation of the membrane surrounding the central nervous system, into which Bupivacaine Spinal Grindeks is administered),
• respiratory depression.

You should immediately inform your doctor if you feel unwell during administration of
Bupivacaine Spinal Grindeks.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or nurse. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to collect more information on the safety of using the medicine.

5. How to store Bupivacaine Spinal Grindeks

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the outer carton:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
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 pack and other information

What Bupivacaine Spinal Grindeks contains

• The active substance is bupivacaine hydrochloride (Bupivacaini hydrochloridum). One mL of solution contains 5 mg of bupivacaine hydrochloride. One ampoule contains 20 mg of bupivacaine hydrochloride in 4 mL of solution.
• Other ingredients: sodium chloride, sodium hydroxide (for pH adjustment to 4.0–6.5), hydrochloric acid (for pH adjustment to 4.0–6.5), water for injections.

What Bupivacaine Spinal Grindeks looks like and contents of the pack
A clear, colourless isobaric solution.
Ampoules made of colourless glass (Type I) in a PVC blister, with or without a coloured ring,
containing 4 mL of solution.
Pack size: 5 ampoules in a cardboard box.
Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
e-mail: [email protected]

Information intended exclusively for healthcare professionals:

Dosage and method of administration
WARNING!
Bupivacaine Spinal Grindeks medicinal product is an isobaric solution. The range of
anesthetized segments may be difficult to predict, especially when an isobaric solution is used.

Dosage
Adults:
Prior to determining the dose, the patient's health status should be assessed, as well as whether the patient is taking any concomitant medicinal products.
The lowest effective dose of the medicinal product required to achieve adequate anesthesia should be administered.
The duration of anesthesia depends on the dose of the medicinal product.
In elderly patients or patients in advanced pregnancy, the dose should be reduced.
The table below presents recommended dosing for anesthesia and should be considered as guidance for administering anesthesia in an adult of average body build. The extent and duration of anesthesia should be individually evaluated.
RECOMMENDED DOSAGE

The recommended injection site is below the L3 level.
Children and adolescents
Children up to 40 kg body weight (kg b.w.):
The medicinal product Bupivacaine Spinal Grindeks may be used in children.
The difference between adults and children is manifested by a relatively large volume of cerebrospinal fluid in newborns and infants. For this reason, to achieve the same degree of blockade as in adults, it is necessary to use a relatively higher dose of the medicinal product per kilogram of the child's body weight.

Method of administration
Intrathecal administration.
Special warnings and precautions for use
WARNING!
The medicinal product Bupivacaine Spinal Grindeks is an isobaric solution. The extent of
anesthetized segments may be difficult to predict, especially when an isobaric solution is used.
Anesthesia should be performed in appropriately equipped centers, where adequately trained personnel, a readily available anesthesiologist, appropriate equipment, and medicinal products necessary for patient monitoring and resuscitation are accessible.
Prior to performing intrathecal anesthesia, venous access in the patient must be ensured.
The physician administering anesthesia must take special precautions to avoid intravascular injection and must be adequately trained and familiar with methods for diagnosing and managing adverse reactions, signs of toxicity, and other complications. In the event of acute symptoms of toxicity or total spinal anesthesia, administration of the anesthetic agent must be immediately discontinued (see section "Overdose" below).
Special precautions should be taken when using local anesthesia in patients with poor general health due to age or impaired liver or kidney function, although regional anesthesia remains the optimal solution for this patient group during surgical procedures.
Bupivacaine, like all other local anesthetic agents, may cause symptoms of toxicity in the central nervous system (CNS) and cardiovascular system when its use in local anesthesia results in high blood concentrations of the drug. This is particularly relevant in cases of unintentional intravascular injection.
At high circulating concentrations of bupivacaine, cases of ventricular arrhythmias, ventricular fibrillation, cardiovascular collapse, and death have been reported. However, when recommended doses are used in intrathecal anesthesia, high blood concentrations of the anesthetic agent have not been observed.
Very high or total spinal anesthesia is a rare but serious adverse effect that may occur following intrathecal anesthesia, leading to circulatory and respiratory failure. Circulatory failure is caused by extensive sympathetic blockade, manifesting as profound hypotension and bradycardia or even cardiac arrest. Respiratory failure results from paralysis of respiratory muscles (due to blockade of nerve conduction in nerves innervating respiratory muscles), including the diaphragm.
The risk of high or total spinal anesthesia is higher in elderly patients and in women with advanced pregnancy. Therefore, the dose of anesthetic agent should be reduced in these patients (see section "Dosage and method of administration" above).
In patients with hypovolemia, a sudden and significant drop in blood pressure may occur during intrathecal anesthesia, regardless of the local anesthetic agent used.
In children under 8 years of age, hypotension after intrathecal anesthesia rarely occurs.
Neurological complications after intrathecal anesthesia are rare.
Such complications include sensory disturbances, loss of sensation, motor dysfunction, and paralysis.
In some cases, these changes may be permanent.
There are no data on the occurrence of adverse reactions after intrathecal anesthesia in patients with neurological disorders such as multiple sclerosis, hemiplegia, transverse myelitis, and neuromuscular disorders.
Appropriate precautions should be taken in patients with these conditions.
Prior to performing intrathecal anesthesia, the potential risks and benefits for the patient should be carefully considered.
Pharmaceutical incompatibilities
It is not recommended to add other substances to solutions administered into the intrathecal space.
Special precautions for disposal and preparation of the medicinal product for use
The medicinal product Bupivacaine Spinal Grindeks does not contain preservatives.
Each ampoule is intended for single use only. The unused portion of the solution should not be reused.
Re-sterilization is not permitted.
Any unused medicinal product or waste materials should be disposed of in accordance with local regulations.
Overdose
Bupivacaine administered in large doses may cause acute symptoms of toxicity in the central nervous system and cardiovascular system, particularly if administered intravascularly.
Following administration of recommended doses of the medicinal product Bupivacaine Spinal Grindeks during intrathecal anesthesia, serum concentrations have not increased to levels causing systemic toxic effects.
However, if other local anesthetic agents are administered concomitantly, their toxic effects may be additive and may lead to systemic toxic symptoms.
General symptoms of toxicity and their treatment
General symptoms of toxicity include numbness of the tongue, dizziness, and muscle tremors.
Subsequently, seizures and circulatory failure may occur.
In the event of symptoms of acute systemic overdose, administration of the anesthetic agent must be immediately discontinued.
If systemic toxic symptoms are mild, treatment may not be necessary.
In the case of seizures, treatment is required and consists of seizure termination and ensuring adequate oxygenation of the patient through oxygen administration and, if necessary, application of assisted or controlled ventilation.
In some cases, seizures may be controlled by ensuring adequate ventilation without the need for additional medication.
If seizures persist beyond 15 to 20 seconds, 100 mg to 150 mg of thiopental or 5 mg to 10 mg of diazepam should be administered intravenously.
Alternatively, 50 mg to 100 mg of succinylcholine may be administered intravenously; however, in such cases, the patient must be endotracheally intubated and full treatment for muscle relaxation must be initiated.
Cardiac arrest requires immediate initiation of resuscitation procedures—including electrical defibrillation. Restoration of hemodynamically effective cardiac function may require prolonged resuscitation efforts.
Symptoms of total spinal anesthesia and their treatment
During epidural anesthesia, so-called high spinal block or total spinal anesthesia may occur, manifesting as respiratory arrest and/or decreased arterial pressure.
In such cases, administration of the local anesthetic agent must be immediately discontinued, oxygen must be administered, and assisted or controlled ventilation should be initiated.
In the event of arterial hypotension, a vasoconstrictor agent should be administered intravenously, e.g., 10 mg to 15 mg of ephedrine—the dose may be repeated until improvement is achieved.
To increase arterial pressure, multi-electrolyte solutions or colloids may also be administered as a rapid intravenous infusion.
Adequate oxygenation, ventilation, and circulation must always be ensured, and treatment of acidosis should be initiated.
Children and adolescents
Doses of drugs used to treat overdose of the medicinal product in children must be adjusted according to age and body weight.