Sanergi Heavi

Leaflet attached to the packaging: patient information

Sanergy Heavy, 5 mg/mL, solution for injection

Bupivacaine hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Sanergy Heavy and what is it used for

Sanergy Heavy contains the active substance bupivacaine hydrochloride. It is a local anesthetic used for anesthesia (anesthesia) of the lower parts of the body during surgical procedures in adults and children of all ages. It is used, for example, for anesthesia of the lower limbs, undergoing operations, in urological procedures or in abdominal cavity procedures.
The medicine temporarily blocks nerve signals at the injection site and reduces sensation or causes numbness in a specific part of the body.

2. Important information before using Sanergy Heavy

When not to use Sanergy Heavy

• if the patient is allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other local anesthetics of the same group (such as mepivacaine, lidocaine).

Spinal anesthesia should not be used if:

• the patient has acute active brain or spinal cord diseases, such as meningitis, polio, or ankylosing spondylitis;
• the patient has severe headache caused by bleeding inside the skull (intracranial hemorrhage);
• the patient has blood infection (sepsis);
• the patient has a purulent infection at the injection site or in its vicinity;
• the patient has recently had a severe injury (e.g., spinal fracture);
• the patient has tuberculosis or spinal tumors;
• the patient has spinal canal stenosis (narrowing of the spinal canal);
• the patient is in a severe condition in which the heart is unable to deliver enough blood to the body (cardiogenic shock);
• the patient has very low blood pressure leading to fainting (hypovolemic shock)
• the patient has heart failure (circulatory failure);
• the patient's blood does not clot properly or if the patient is taking medications to prevent blood clots;
• the patient has a disease affecting the spinal cord along with anemia.

Warnings and precautions

Before starting to use Sanergy Heavy, the patient should discuss it with their doctor or nurse if they:

• have atrioventricular block II or III degree;
• have liver disease;
• have kidney disease;
• are elderly or weakened;
• are pregnant (especially in advanced pregnancy).

It is believed that neurological diseases do not worsen as a result of anesthesia, however, caution should be exercised.

Sanergy Heavy and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Sanergy Heavy may interact with other medicines, such as:

• other local anesthetics;
• medicines with a structure similar to that of Sanergy Heavy, e.g., medicines used in arrhythmias (antiarrhythmic medicines).

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 before using this medicine.
Sanergy Heavy can be used during pregnancy and breastfeeding. The dose will be adjusted by the doctor if the patient is in advanced pregnancy.

Driving and using machines

On the day of the procedure, the patient should not drive vehicles or operate machines, as Sanergy Heavy may affect their ability to react and coordinate movements.

Sanergy Heavy contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means it is considered "sodium-free".

3. How to use Sanergy Heavy

Sanergy Heavy will be administered to the patient by a doctor who will decide on the correct dose. It will be administered as an injection into the lower part of the patient's spine.
Dosage depends on the type of procedure, age, and body weight of the patient and will be determined by the doctor.

Use in children and adolescents

Sanergy Heavy is injected slowly into the spinal canal (part of the spine) by a doctor experienced in performing anesthesia in children.

Using a higher dose of Sanergy Heavy than recommended

It is unlikely that the patient will receive too much of this medicine, as it will be administered in a hospital and given by medical staff. If the patient is concerned that they have received too much or has any questions about the dose received, they should talk to their doctor or nurse.
Typically, the first symptoms of administering too much Sanergy Heavy are:

• High blood pressure;
• Low heart rate;
• Irregular heart rhythm;
• Dizziness or feeling of emptiness in the head;
• Numbness of the lips and surrounding area;
• Numbness of the tongue;
• Hearing problems;
• Vision problems.

To prevent serious side effects, the doctor will stop administering this medicine as soon as any of the overdose symptoms occur.
If the patient has any further doubts about using this medicine, they should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Sanergy Heavy can cause side effects, although not everybody gets them.

Serious side effects

If the following symptoms occur, the patient should stop the treatment and immediatelycontact their doctor:

• Symptoms of central nervous system toxicity, such as numbness, tingling, limited range of motion (paresis), muscle weakness, or dysesthesia (abnormal sensation) (uncommon side effects, may occur in less than 1 in 100 people);
• Sudden and unexpected cardiac arrest with loss of consciousness (cardiac arrest) (rare side effect, may occur in less than 1 in 1,000 people);
• Slow breathing and shallow breathing (rare side effect, may occur in less than 1 in 1,000 people);
• Severe allergic reaction with symptoms such as difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure (anaphylactic shock) (rare side effect, may occur in less than 1 in 1,000 people).

Other side effects

Very common: (may occur in more than 1 in 10 people)

• Nausea;
• Low blood pressure;
• Slow heart rate (bradycardia).

Common: (may occur in less than 1 in 10 people)

• Headache;
• Vomiting;
• Difficulty urinating (urinary retention);
• Involuntary urination (incontinence).

Uncommon: (may occur in less than 1 in 100 people)

• Back pain;
• Tingling, burning, or numbness of the skin (paresthesia).

Rare: (may occur in less than 1 in 1,000 people)

• Unintentional nerve block in the spine (spinal block), which can cause temporary loss of sensation in the abdomen and/or lower body, respiratory depression, and even loss of consciousness;
• Bilateral paralysis, often in the lower body or in both legs (transverse paralysis);
• Pain and sensory disturbances caused by nerve inflammation (neuropathy);
• Loss of ability to move (paralysis);
• Inflammation of the membrane surrounding the spinal cord (arachnoiditis), which can cause back pain or pain, numbness, or weakness in the legs;
• Allergic reactions.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or nurse. 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, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Sanergy Heavy

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the label and on the carton after: "Expiry date (EXP)". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sanergy Heavy contains

• The active substance is bupivacaine hydrochloride. Each 1 mL of solution contains 5 mg of bupivacaine hydrochloride (in anhydrous form).
• The other ingredients are: glucose monohydrate, sodium hydroxide (to adjust pH), and water for injections.

What Sanergy Heavy looks like and contents of the pack

Ampoules made of colorless borosilicate glass of hydrolytic class with one break point. Ampoules are packed in a blister and placed in a cardboard box.
Pack size: 5 ampoules

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
tel.: +371 67083205
fax: +371 67083505
e-mail: grindeks@grindeks.com

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

Sweden
Bupivacaine Spinal Tung Grindeks 5 mg/ml injektionsvätska, lösning
Austria
Mofecet 5 mg/ml Injektionslösung
Bulgaria
Бемевакс 5 mg/ml инжекционен разтвор
Bemevax 5 mg/ml solution for injection
Czech Republic
Salvudex
Germany
Bupivacain hyperbar Grindeks 5 mg/ml Injektionslösung
Estonia
Bemevax
Hungary
Salvudex 5 mg/ml oldatos injekció
Italy
Salvudex
Latvia
Bupivacaine Grindeks 5 mg/ml šķīdums injekcijām ar glikozi
Lithuania
Mofecet 5 mg/ml injekcinis tirpalas
Netherlands
Bupivacaine Grindeks Glucose 5 mg/ml oplossing voor injectie
Poland
Sanergy Heavy
Romania
Bemevax 5 mg/ml soluție injectabilă
Slovakia
Salvudex 5 mg/ml injekčný roztok
Slovenia
Mofecet 5 mg/ml raztopina za injiciranje
Date of last revision of the leaflet:02/2025

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPLWMiPB):
http://www.urpl.gov.pl
--------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

The solution should be used immediately after opening.
As with all medicines administered parenterally, the solution should be inspected before use. Only clear solutions without visible particles should be used.
It is not recommended to add other substances to solutions administered into the subarachnoid space.
Medicines should not be disposed of via wastewater or household waste.