BUPIVACAINE 5 mg /Ml Solution

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER
2. Bupivacaine Claris 5 mg/ml, solution for injection
   1. Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.
3. What is Bupivacaine Claris and what is it used for
4. Important information before using Bupivacaine Claris
   1. When not to use Bupivacaine Claris:
   2. Warnings and precautions
   3. Children
   4. Bupivacaine Claris and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Bupivacaine Claris contains sodium
5. How to use Bupivacaine Claris
   1. Use in children and adolescents
   2. Use of a higher than recommended dose of Bupivacaine Claris
   3. Missed dose of Bupivacaine Claris
6. Possible side effects
   1. The patient should immediately inform their doctor if they experience sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially if it involves the whole body).
   2. Severe side effects
   3. If the patient experiences any of the following side effects, they should immediately contact their doctor:
   4. Very common
   5. Common
   6. Uncommon
   7. Rare
   8. Additional side effects in children and adolescents
   9. Reporting side effects
7. How to store Bupivacaine Claris
8. Contents of the packaging and other information
   1. What Bupivacaine Claris contains
   2. What Bupivacaine Claris looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. Importer
   5. Date of last revision of the leaflet:
   6. Other sources of information:
   7. The following information is intended for healthcare professionals only:

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Bupivacaine Claris 5 mg/ml, solution for injection

Bupivacaine hydrochloride

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor, pharmacist, or nurse. If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• Table of contents of the leaflet:
• 1. What is Bupivacaine Claris and what is it used for
• 2. Important information before using Bupivacaine Claris
• 3. How to use Bupivacaine Claris
• 4. Possible side effects
• 5. How to store Bupivacaine Claris
• 6. Contents of the packaging and other information

1. What is Bupivacaine Claris and what is it used for

Bupivacaine Claris contains the active substance bupivacaine hydrochloride.
Bupivacaine Claris is a local anesthetic. It belongs to a group of medicines called local anesthetics of the amide type. It causes loss of sensation or feeling, which is limited to one part of the body.
Bupivacaine Claris is used to induce numbness (anesthesia) of specific parts of the body. It is used to prevent pain and to relieve pain. It can be used for:

• anesthesia of specific parts of the body during surgical procedures in adults and adolescents,
• pain relief in adults, infants, and children over 1 year of age,
• surgical operations, including obstetric operations, such as cesarean section
• relief of acute pain, including labor pain or post-operative pain

2. Important information before using Bupivacaine Claris

When not to use Bupivacaine Claris:

If the patient is allergic to bupivacaine hydrochloride, local anesthetics of the amide type, or any of the other ingredients of this medicine (listed in section 6).
for local anesthesia by injection into a vein of a limb that has been isolated from circulation with a tourniquet (a technique called intravenous regional anesthesia or Bier's block)
if a patient has been given a cervical block in obstetrics (a type of anesthesia during childbirth).
with adrenaline for special techniques (e.g., penile block, Oberst block) for anesthesia of a body part, if the anesthesia involves the end arteries.
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In the case of epidural anesthesia, the following general contraindications should be considered:

• active diseases of the central nervous system with an acute course, such as meningitis, tumors, Heine-Medina disease, and intracranial hemorrhage,
• narrowing of the spinal canal and active spinal disease (e.g., spinal arthritis, tuberculosis, tumors) or recent injury (e.g., fractures),
• sepsis,
• malignant anemia associated with subacute bone marrow degeneration,
• purulent skin infection at the injection site or in its vicinity,
• cardiogenic or hypovolemic shock,
• coagulation disorders or ongoing anticoagulant therapy.

There are no specific contraindications for children and adolescents.

Warnings and precautions

Before starting treatment with Bupivacaine Claris, the patient should discuss it with their doctor or nurse:
The doctor will pay special attention if the patient has:

• any liver function disorder,
• blood infection (sepsis),
• very low or very high blood pressure,
• dehydration or recent vomiting, diarrhea, or blood loss,
• heart disease,
• tumor or fluid accumulation in the abdominal cavity,
• pleural effusion (fluid in the lungs) and sepsis (blood poisoning).

If the patient thinks that any of these points may apply to them, they should discuss it with their doctor.

Children

The safety and efficacy of Bupivacaine-Claris in children under 12 years of age for anesthesia of specific parts of the body during surgical procedures have not been established.
The safety and efficacy of the medicine in children under 1 year of age have not been established.

Bupivacaine Claris 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. This includes medicines that are available without a prescription.
Taking certain medicines at the same time may be harmful. It should be remembered that the hospital doctor may not have been informed if the patient has recently started treatment for another disease. In particular, the patient should tell their doctor if they are taking:

• other local anesthetics,
• medicines that regulate heart rhythm (such as lidocaine, mexiletine, or amiodarone),
• clonidine (used to treat high blood pressure or migraine),
• ketamine (an anesthetic).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
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The patient should not have a cervical block (a type of anesthesia during childbirth) while using this medicine.
Bupivacaine may pass into breast milk. If the patient is breastfeeding, they should discuss this with their doctor.

Driving and using machines

The patient should not drive or use tools or machines, as Bupivacaine Claris may interfere with their ability to perform these tasks safely. They should ask their doctor when they can resume these activities.

Bupivacaine Claris contains sodium

Bupivacaine Claris contains 3.15 mg/ml (0.14 mmol) of sodium in each dose. This should be taken into account in patients controlling their sodium intake.

3. How to use Bupivacaine Claris

Bupivacaine Claris will be administered by a doctor who has the necessary knowledge and experience in the technique of epidural anesthesia.
The medicine is intended for single use only.
Dosage:
The doctor will decide what dose is suitable for the patient. This will usually be 15-150 mg of bupivacaine hydrochloride. The dose will depend on the patient's size, health, the part of the body to be injected, and the purpose of the injection. Smaller doses are used in elderly patients, small children, and patients in poor health.
The patient may receive this medicine before a minor or major operation, as well as during childbirth. For minor surgical procedures, the injection is usually given near the part of the body to be operated on. The medicine prevents pain and causes numbness, which gradually wears off after the procedure. For major surgical procedures or childbirth, the patient may receive an injection in their back that will last for several minutes. This will prevent pain and cause numbness of the lower part of the body, which usually lasts from 3 to 4 hours.
In most cases, one dose is sufficient, but there may be a need to administer more doses if the procedure takes a long time.

Use in children and adolescents

Depending on the type of anesthesia required, Bupivacaine-Claris is injected slowly into the epidural space (part of the spine) or other parts of the body. This is performed by an anesthesiologist experienced in anesthesia techniques in children and adolescents. The dosage depends on the patient's age and body weight and will be determined by the anesthesiologist.
Method and route of administration:
The medicine is used only for epidural, spinal, or peripheral nerve anesthesia.
Epidural anesthesia involves injecting into the spine, which can cause both loss of sensation (anesthesia) and pain relief (analgesia) by blocking the transmission of pain signals through the nerves in the spinal cord or near it. It can be used as an anesthetic, as an analgesic (pain reliever) with general anesthesia, and as post-operative analgesia in procedures involving the lower limbs, perineum, pelvis, abdomen, and thorax.

Use of a higher than recommended dose of Bupivacaine Claris

It is unlikely that the patient will receive too much Bupivacaine-Claris, as it will be administered by a doctor. However, in case of doubt, the patient should immediately contact their doctor or nurse.

Missed dose of Bupivacaine Claris

If the patient suspects that a dose of the medicine has been missed, they should inform their doctor or nurse.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bupivacaine Claris can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor if they experience sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially if it involves the whole body).

Severe side effects

If the patient experiences any of the following side effects, they should immediately contact their doctor:

• seizures
• heart attack - rare

Side effects can be listed according to their frequency of occurrence:
The following side effects have also been reported:

Very common

Nausea, low blood pressure (the doctor may monitor this).

Common

Slow heart rate, tingling, dizziness, vomiting, inability to urinate, and high blood pressure (the doctor may monitor this).
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Uncommon

Tingling around the mouth, numbness of the tongue, sensitivity to sound, visual disturbances, loss of consciousness, tremors, dizziness, ringing in the ears, and speech disorders.

Rare

Nerve damage or injuries, loss of movement, paralysis, double vision, and shallow breathing.

Additional side effects in children and adolescents

Side effects in children are similar to those in adults.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49 21 301, fax: 22 49 21 309,
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Bupivacaine Claris

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the ampoule and on the outer packaging after the symbol: "EXP". The expiry date refers to the last day of the specified month.
Store in a temperature below 30°C. Do not store in the refrigerator or freeze.
Shelf life after dilution:
Chemical and physical stability of the diluted solution has been demonstrated for 36 hours at 25°C.
From a microbiological point of view, the product should be used immediately.
After first opening, the product should be used immediately.
Only a clear solution without solid particles should be used. Do not use this medicine if the packaging is damaged.
Unused product should be disposed of.
Do not throw away medicines 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 Bupivacaine Claris contains

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The active substance of the medicine is bupivacaine hydrochloride.
Each 1 milliliter contains 5 mg of bupivacaine hydrochloride.
Each 10 ml ampoule contains 50 mg of bupivacaine hydrochloride.
Each 20 ml ampoule contains 100 mg of bupivacaine hydrochloride.
The other ingredients are sodium chloride, 0.4% sodium hydroxide, 0.85% hydrochloric acid, and water for injections.

What Bupivacaine Claris looks like and contents of the packaging

Bupivacaine Claris is a clear, colorless, sterile solution for injection supplied in 10 ml and 20 ml glass ampoules.
Pack sizes:
5 or 10 ampoules of 10 ml, solution for injection
1 ampoule of 20 ml, solution for injection
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Baxter Holding B.V.
Kobaltweg 49,
3542 CE Utrecht
Netherlands

Importer

Peckforton Pharmaceuticals Limited,
Crewe Hall, Crewe, Cheshire,
CW1 6UL, United Kingdom
UAB Norameda
Meistru 8a, 02189, Vilnius,
Lithuania

Date of last revision of the leaflet:

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
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The following information is intended for healthcare professionals only:

Unused solution should be disposed of in accordance with local regulations.

• 1. Method of administration

Solution for injection.
This medicinal product is intended for epidural, spinal, or peripheral nerve anesthesia only.
The maximum dose should be determined based on the assessment of the patient's body weight and physical condition, taking into account the typical rate of systemic absorption from the injection site.
A single dose of up to 150 mg of bupivacaine hydrochloride may be used.
Subsequent doses of up to 50 mg may be administered at intervals of two hours. A total dose of up to 500 mg of bupivacaine hydrochloride may be administered over 24 hours, not including the initial single dose (bolus). The dose should be reduced in young patients, elderly patients, or patients in poor health.

• 2. Instructions for handling the medicine

For single use only.
Only a clear solution without solid particles should be used. Unused solution should be disposed of.
Do not use Bupivacaine Claris after the expiry date stated on the ampoule and on the outer packaging after the symbol: "EXP". The expiry date refers to the last day of the specified month.
Bupivacaine is compatible with sodium chloride 0.9% (w/v) injection, Ringer's solution with lactate, or sufentanil 50 μg/ml. However, this medicinal product should not be mixed with other medicinal products.

• 3. Information on storage

Store in a temperature below 30°C. Do not store in the refrigerator or freeze.
After first opening, the product should be used immediately.
Shelf life after dilution:
Chemical and physical stability of the diluted solution has been demonstrated for 36 hours at 25°C.
From a microbiological point of view, the product should be used immediately.
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