BUPIVACAINI 5 mg /Ml Solution

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Patient Information Leaflet: User Instructions
3. Bupivacaini Noridem, 2.5 mg/mL, solution for injection
4. Bupivacaini Noridem, 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
5. What is Bupivacaini Noridem and what is it used for
6. Important information before taking Bupivacaini Noridem
   1. When not to take Bupivacaini Noridem
   2. Warnings and precautions
   3. Children
   4. Bupivacaini Noridem and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Bupivacaini Noridem contains sodium
   8. Ampoules of 5 mL:
   9. Ampoules of 10 mL and 20 mL:
7. How to take Bupivacaini Noridem
   1. Overdose of Bupivacaini Noridem
8. Possible side effects
   1. Severe allergic reactions (rare: may occur in less than 1 in 1000 patients)
   2. Other possible side effects: very common: may occur in more than 1 in 10 patients
   3. Other possible side effects observed with the use of other local anesthetics, which may also be caused by Bupivacaini Noridem, include:
   5. Reporting side effects
9. How to store Bupivacaini Noridem
10. Contents of the pack and other information
    1. What Bupivacaini Noridem contains
    2. What Bupivacaini Noridem looks like and contents of the pack
    3. Marketing Authorization Holder and Manufacturer
    4. Marketing Authorization Holder:
    5. Manufacturer:
    6. This medicinal product is authorized in the Member States of the European Economic Area and in Northern Ireland under the following names:
    7. Date of last revision of the leaflet:
    8. Bupivacaini Noridem, 2.5 mg/mL, solution for injection
    9. Bupivacaini Noridem, 5 mg/mL, solution for injection
    10. Administration routes
    11. Instructions for use
    12. Storage

PATIENT INFORMATION LEAFLET

Patient Information Leaflet: User Instructions

Bupivacaini Noridem, 2.5 mg/mL, solution for injection

Bupivacaini Noridem, 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, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Bupivacaini Noridem and what is it used for
• 2. Important information before taking Bupivacaini Noridem
• 3. How to take Bupivacaini Noridem
• 4. Possible side effects
• 5. How to store Bupivacaini Noridem
• 6. Contents of the pack and other information

1. What is Bupivacaini Noridem and what is it used for

Bupivacaini Noridem contains the active substance bupivacaine hydrochloride. It belongs to a group of medicines called local anesthetics of the amide type.
It is a medicine used to relieve pain (anesthesia) in certain parts of the body. It is used to relieve pain. It can be used for:

• anesthesia of certain parts of the body during surgical procedures in adults and adolescents over 12 years of age,
• relief of labor pain,
• relief of pain in adults, infants, and children over 1 year of age.

2. Important information before taking Bupivacaini Noridem

When not to take Bupivacaini Noridem

Do not take Bupivacaini Noridem in any of the above cases. If you have any doubts, consult your doctor or nurse before starting treatment.

Warnings and precautions

Before starting treatment with Bupivacaini Noridem, discuss it with your doctor or nurse if:

• you have heart, kidney, or liver problems, as your doctor may need to adjust the dose of Bupivacaini Noridem,
• you have an overloaded stomach due to excessive fluid intake,
• you have a stomach tumor,
• you have reduced blood volume (hypovolemia),
• you have fluid in the lungs,
• you have epilepsy (seizures),
• you are to receive bupivacaine with adrenaline in an injection into areas that include terminal arteries. If you are unsure whether any of these points apply to you, consult your doctor or nurse before starting treatment with Bupivacaini Noridem.

Children

• The use of Bupivacaini Noridem in anesthesia of certain parts of the body during surgical procedures in children under 12 years of age has not been confirmed.
• The safety and efficacy of Bupivacaini Noridem in children under 1 year of age have not been established.

Bupivacaini Noridem and other medicines

Tell your doctor about all the medicines you are taking now or recently, as well as any medicines you plan to take. This includes herbal medicines and those available without a prescription.
This is because Bupivacaini Noridem may affect the action of some medicines, and some medicines may affect Bupivacaini Noridem.
In particular, tell your doctor if you are taking any of the following medicines:

• those that regulate irregular heartbeat (anti-arrhythmic), such as lidocaine, mexiletine, or amiodarone,
• those that slow down blood clotting (anticoagulants).

Your doctor needs to know what medicines you are taking to determine the right dose of Bupivacaini Noridem for you.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
There is limited data on the use of bupivacaine in pregnant women.
Breastfeeding
Bupivacaine passes into breast milk, so if you are breastfeeding, consult your doctor.
Fertility
There is no data on the effect of bupivacaine hydrochloride on human fertility.

Driving and using machines

Bupivacaini Noridem may cause drowsiness and affect your reaction speed. After taking Bupivacaini Noridem, do not drive or operate machinery until the next day.

Bupivacaini Noridem contains sodium

Ampoules of 5 mL:

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

Ampoules of 10 mL and 20 mL:

The medicine contains 3.31 mg of sodium (the main component of common salt) per 1 mL. This corresponds to 0.17% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Bupivacaini Noridem

This medicine will be administered by your doctor. Your doctor knows the correct way to administer this medicine.
The prescribed dose depends on the type of anesthesia the patient needs and the location of the injection. It also depends on the patient's weight, age, and physical condition. Usually, one dose is sufficient, but it may need to be repeated during long surgical procedures.
Bupivacaini Noridem will be administered by injection or infusion (drip). The injection site depends on the purpose of administering Bupivacaini Noridem. Your doctor may administer the medicine in one of the following locations:

• near the anesthetized part of the body,
• away from the anesthetized part of the body, in the case of epidural injection (injection near the spinal cord).

Administration of Bupivacaini Noridem in one of the above ways blocks the transmission of pain signals through the nerves to the brain. This condition gradually subsides after the procedure is completed.

Overdose of Bupivacaini Noridem

Severe side effects due to overdose of Bupivacaini Noridem are unlikely. They require special treatment, and the attending physician is trained for their occurrence. The first symptoms of overdose of Bupivacaini Noridem are usually:

• dizziness or a feeling of emptiness in the head,
• numbness of the lips and the area around the mouth,
• numbness of the tongue,
• hearing disturbances,
• vision disturbances (vision).

In order to reduce the risk of severe side effects, the doctor will stop administering Bupivacaini Noridem as soon as these symptoms occur. This means that if any of the above symptoms occur or if an overdose of Bupivacaini Noridem is suspected, you should immediately inform your doctor.
More severe side effects due to overdose of Bupivacaini Noridem include muscle twitching, seizures, and loss of consciousness.
If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Bupivacaini Noridem can cause side effects, although not everybody gets them.

Severe allergic reactions (rare: may occur in less than 1 in 1000 patients)

In case of a severe allergic reaction, inform your doctor immediately. Symptoms may include:

• sudden swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing,
• significant or sudden swelling of the hands, feet, or ankles,
• difficulty breathing,
• severe itching of the skin (with a rash).

Other possible side effects: very common: may occur in more than 1 in 10 patients

• low blood pressure, which may cause dizziness or a feeling of emptiness in the head,
• nausea (vomiting),

common: may occur in less than 1 in 10 patients

• vomiting,
• dizziness,
• a feeling of tingling,
• high blood pressure (hypertension),
• slow heart rate,
• urination disorders,

uncommon: may occur in less than 1 in 100 patients

• a feeling of emptiness in the head,
• seizures (convulsions),
• numbness of the tongue and the area around the mouth,
• a feeling of ringing in the ears or hypersensitivity to sounds,
• speech disorders,
• blurred vision,
• loss of consciousness,
• chills,
• muscle twitching,

rare: may occur in less than 1 in 1000 patients

• double vision,
• nerve damage, which may cause changes in sensation or muscle weakness (neuropathy); this may include peripheral nerve damage,
• a condition called arachnoiditis (inflammation of the membrane surrounding the spinal cord); symptoms include a stabbing or burning pain in the lower back or legs and tingling, numbness, or weakness of the legs,
• weakness or paralysis of the legs,
• irregular heartbeat (arrhythmia), which may be life-threatening,
• slow or stopped breathing or cardiac arrest, which may be life-threatening,

Other possible side effects observed with the use of other local anesthetics, which may also be caused by Bupivacaini Noridem, include:

• liver enzyme abnormalities, which may occur with long-term administration of this medicine,
• nerve damage, which may rarely cause permanent disorders,
• transient blindness or prolonged eye muscle disorders, which may occur with injections near the eyes.

Do not be too concerned about the above list of side effects, as they may not occur at all.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. Side effects can also be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Reporting side effects can help gather more information on the safety of this medicine.

5. How to store Bupivacaini Noridem

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule after "EXP". The expiry date refers to the last day of the month.
Do not use this medicine if you notice any discoloration of the contents or the presence of solid particles.
Do not store in the refrigerator or freeze.
After first opening, the product should be used immediately.
After dilution: the chemical and physical stability of the prepared solution for injection has been demonstrated for 7 days at 25 ± 2°C and for 24 hours at 2 to 8°C. From a microbiological point of view, the product should be used immediately. If the prepared solution for injection is not used immediately, the user is responsible for the storage time and conditions before administration, and this period should not exceed 24 hours at 2 to 8°C, unless the opening and dilution took place in controlled and validated aseptic conditions.
Usually, Bupivacaini Noridem is stored by the doctor or hospital staff, and they are responsible for the quality of the product after it is opened, if it is not used immediately.
They are also responsible for the proper disposal of unused residues of Bupivacaini Noridem.

6. Contents of the pack and other information

What Bupivacaini Noridem contains

• The active substance of the medicine is bupivacaine hydrochloride.

Bupivacaini Noridem, 2.5 mg/mL, solution for injection:
Each milliliter contains 2.5 mg of anhydrous bupivacaine hydrochloride.
Bupivacaini Noridem, 5 mg/mL, solution for injection:
Each milliliter contains 5 mg of anhydrous bupivacaine hydrochloride.

• Other ingredients are water for injections, sodium chloride, sodium hydroxide (for pH adjustment), and hydrochloric acid (for pH adjustment).

What Bupivacaini Noridem looks like and contents of the pack

Bupivacaini Noridem, solution for injection is a clear, colorless, and sterile solution. It is available in polypropylene ampoules.
Polypropylene ampoules of 5 mL, 10 mL, or 20 mL. The ampoules are placed in cardboard boxes.
Packaging contains 5, 10, and 50 ampoules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Noridem Enterprises Ltd
Makariou & Evagorou 1
Mitsi Building 3, Office 115
1065 Nicosia
Cyprus.

Manufacturer:

DEMO S.A., PHARMACEUTICAL INDUSTRY
21st km National Road Athens-Lamia
14568 Krioneri, Attiki, Greece.
T.: +302108161802
F.: +302108161587

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

France
BUPIVACAINE NORIDEM 2,5 mg/mL, solution injectable
BUPIVACAINE NORIDEM 5 mg/mL, solution injectable
Denmark
Bupivacaine Noridem
Bupivacaine Noridem
Greece
ΑΜΙΒΟΥΣΙΝ 2,5 mg / mL Ενέσιμο διάλυμα
ΑΜΙΒΟΥΣΙΝ 5 mg / mL Ενέσιμο διάλυμα
Bupivacaine 2.5 mg / mL Solution for injection
Bupivacaine 5 mg / mL Solution for injection
Ireland
Bupivacaine 2.5 mg / mL Solution for injection
Bupivacaine 5 mg / mL Solution for injection
Cyprus:
ΑΜΙΒΟΥΣΙΝ 2.5 mg / mL Ενέσιμο διάλυμα
ΑΜΙΒΟΥΣΙΝ 5 mg / mL Ενέσιμο διάλυμα
Norway
Bupivacaine Noridem
Bupivacaine Noridem
Poland:
Bupivacaini Noridem
Bupivacaini Noridem
Slovakia
Bupivacaine Noridem
Bupivacaine Noridem
Sweden
Bupivacaine Noridem
Bupivacaine Noridem
Czech Republic
Bupivacaine Noridem
Bupivacaine Noridem

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Bupivacaini Noridem, 2.5 mg/mL, solution for injection

Bupivacaini Noridem, 5 mg/mL, solution for injection

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
United Kingdom
(Northern Ireland)

Administration routes

Solution for injection.
This medicinal product is for injection only (infiltration anesthesia), peripheral nerve block, and central nerve block (including epidural or caudal block).
The required dose should be calculated based on the doctor's knowledge and experience and the patient's general condition. The smallest recommended dose should be used to achieve the desired level of anesthesia. The maximum total dose should not exceed 150 mg. A well-tolerated dose in most adult patients is 400 mg administered over 24 hours, which does not include initial bolus injections, and may be used routinely. In children and adolescents, the smallest recommended dose should be used to achieve the desired level of pain relief.

Instructions for use

For single use only.
Only clear solutions that are practically free of particles should be used. Any unused solution should be discarded.
The solution of Bupivacaini Noridem should not be stored in contact with metal devices, such as needles and syringes with metal parts. Metal ions may precipitate and cause swelling at the injection site. Do not use this medicine after the expiry date stated on the ampoule and carton. The expiry date refers to the last day of the month.
Preparation of a concentration of 1.25 mg/mL:
Bupivacaini Noridem, 2.5 mg/mL, solution for injection:

• Take 250 mL of solvent from a 500 mL bag or bottle that does not contain PVC and inject 250 mL of Bupivacaini Noridem solution for injection at a concentration of 2.5 mg/mL, which will give the expected concentration of 1.25 mg/mL.
• Gently shake the solvent bag or bottle to obtain a uniform solution of the medicine.

Bupivacaini Noridem, 5 mg/mL, solution for injection:

• Take 125 mL of solvent from a 500 mL bag or bottle that does not contain PVC and inject 125 mL of Bupivacaini Noridem solution for injection at a concentration of 5 mg/mL, which will give the expected concentration of 1.25 mg/mL.
• Gently shake the solvent bag or bottle to obtain a uniform solution of the medicine.

Preparation of a concentration of 2.5 mg/mL:
Bupivacaini Noridem, 5 mg/mL, solution for injection:

• Take 250 mL of solvent from a 500 mL bag or bottle that does not contain PVC and inject 250 mL of Bupivacaini Noridem solution for injection at a concentration of 5 mg/mL, which will give the expected concentration of 2.5 mg/mL.
• Gently shake the solvent bag or bottle to obtain a uniform solution of the medicine.

Bupivacaini Noridem is compatible with 0.9% w/v (9 mg/mL) sodium chloride solution for injection and Ringer's solution with lactate. Do not mix this medicinal product with other medicinal products.

Storage

Do not store in the refrigerator or freeze.
After first opening, the product should be used immediately.
Shelf life after dilution:
The chemical and physical stability of the prepared solution for injection has been demonstrated for 7 days at 25 ± 2°C and for 24 hours at 2 to 8°C. From a microbiological point of view, the product should be used immediately. If the prepared solution for injection is not used immediately, the user is responsible for the storage time and conditions before administration, and this period should not exceed 24 hours at 2 to 8°C, unless the opening and dilution took place in controlled and validated aseptic conditions.