Bupivacaine noridem

Bupivacaini Noridem, 2.5 mg/mL, solution for injection
Bupivacaini Noridem, 5 mg/mL, solution for injection
bupivacaine hydrochloride
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents

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

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

Bupivacaini Noridem contains an active substance called bupivacaine hydrochloride. It belongs to a group of medicines known as amide-type local anaesthetics.
It is a medicine used to relieve pain (anaesthetize) specific parts of the body. It is used for pain relief and may be administered for:

• anaesthetizing specific parts of the body during surgical procedures in adults and adolescents over 12 years of age,
• relief of labour pain,
• pain relief in adults, infants, and children above 1 year of age.

2. Important information before using Bupivacaini Noridem

When not to use Bupivacaini Noridem

• 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 any other local anaesthetic medicines of the same group (such as lidocaine or ropivacaine),
• if the patient has a skin infection at or near the injection site,
• if the patient has so-called cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body),
• if the patient has so-called hypovolemic shock (very low blood pressure leading to fainting),
• if the patient has problems with blood clotting (coagulation disorders) or is receiving anticoagulant treatment,
• if the patient has diseases of the brain or spine, such as meningitis, polio or ankylosing spondylitis,
• if the patient has severe headache caused by bleeding within the skull (intracranial haemorrhage),
• if the patient has spinal damage caused by tuberculosis, tumour or recent trauma,
• if the patient has blood poisoning (septicaemia or sepsis),
• if the patient has recently experienced trauma, tuberculosis or tumour of the spine,
• if the patient has received cervical epidural anaesthesia (a type of anaesthesia used during childbirth).

Do not use Bupivacaini Noridem in any of the above cases. If in
doubt, consult a doctor or nurse before starting to use this medicine.
Warnings and precautions
Before using Bupivacaini Noridem, discuss this with your doctor or
nurse if:

• the patient has heart, kidney or liver problems, as the doctor may need to adjust the dose of Bupivacaini Noridem,
• the patient has a distended stomach due to excessive fluid,
• the patient has a stomach tumour,
• the patient has reduced blood volume (hypovolemia),
• the patient has fluid in the lungs,
• the patient suffers from epilepsy,
• the patient is to receive bupivacaine with adrenaline by injection into areas supplied by end arteries. If in doubt whether any of the above points apply, discuss this with a doctor or nurse before using Bupivacaini Noridem.

Children

• The use of Bupivacaini Noridem for regional anaesthesia during surgical procedures has not been established in children under 12 years of age.
• The safety and efficacy of Bupivacaini Noridem have not been established in children under 1 year of age.

Bupivacaini Noridem and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes herbal medicines and medicines obtained without a prescription. This is because Bupivacaini Noridem may affect the action of certain medicines and certain medicines may affect Bupivacaini Noridem.
In particular, inform the doctor if the patient is taking any of the following medicines:

• medicines for irregular heartbeat (antiarrhythmics), such as lidocaine, mexiletine or amiodarone,
• medicines that slow blood clotting (anticoagulants).

The doctor must be aware of all medicines the patient is taking in order to determine the appropriate dose of Bupivacaini Noridem.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult a doctor before using this medicine.
Pregnancy
Data on the use of bupivacaine in pregnant women are lacking or limited.
Breastfeeding
Bupivacaine passes into breast milk, so if the patient is breastfeeding, she should discuss this with her doctor.
Effect on fertility
There are no data on the effect of bupivacaine hydrochloride on fertility in humans.
Driving and operating machinery
Bupivacaini Noridem may cause drowsiness and affect reaction speed. After receiving Bupivacaini Noridem, do not drive or use tools or operate machinery until the following day.
Bupivacaini Noridem contains sodium
5 mL ampoules:
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".
10 mL and 20 mL ampoules:
The medicine contains 3.31 mg of sodium (main component of table salt) in each 1 mL. This corresponds to 0.17% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Bupivacaini Noridem

This medicine will be administered by a doctor. The doctor is familiar with the correct method of administering this medicine.
The prescribed dose depends on the type of anaesthesia required by the patient and the site of injection. It also depends on body weight, age, and physical condition. Usually, a single dose is sufficient, but it may need to be repeated during prolonged surgical procedures.
Bupivacaini Noridem will be administered by injection or infusion (intravenous drip). The injection site depends on the purpose of administering Bupivacaini Noridem. The doctor may administer the medicine at one of the following sites:

• near the area to be anaesthetized,
• away from the area to be anaesthetized, in the case of epidural injection (injection near the spinal cord).

Administering Bupivacaini Noridem in one of the above ways blocks the transmission of pain signals through nerves to the brain. This effect gradually wears off after completion of the procedure.
Overdose of Bupivacaini Noridem
Severe adverse effects resulting from overdose of Bupivacaini Noridem are unlikely. However, they require special treatment, and the attending physician is trained to manage such events should they occur. The first signs of overdose with Bupivacaini Noridem are usually:

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

To reduce the risk of severe adverse effects, the doctor will discontinue administration of Bupivacaini Noridem immediately upon occurrence of these symptoms. This means that if any of the listed symptoms occur, or if an overdose of Bupivacaini Noridem is suspected, the doctor must be informed immediately.
More severe adverse effects resulting from overdose of Bupivacaini Noridem include muscle tremors, seizures (convulsions), and loss of consciousness.
If you have any further questions or doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious allergic reactions (rare: may occur in up to 1 in 1,000 patients)
If a serious allergic reaction occurs, contact your doctor immediately. Symptoms may include sudden onset of:

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

Other possible adverse reactions:
Very common: may affect more than 1 in 10 patients

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

Common: may affect up to 1 in 10 patients

• vomiting,
• dizziness,
• tingling sensation,
• high blood pressure (hypertension),
• slowed heart rate,
• problems with urination,

Uncommon: may affect up to 1 in 100 patients

• feeling of emptiness in the head,
• seizures (convulsions),
• numbness of the tongue and area around the mouth,
• sensation of ringing in the ears or sound sensitivity,
• speech disturbances,
• blurred vision,
• loss of consciousness,
• chills,
• muscle tremors,

Rare: may affect up to 1 in 1,000 patients

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

Possible adverse reactions observed with other medicines used for local anaesthesia,
which may also occur with Bupivacaini Noridem, include:

• abnormalities related to liver enzymes, which may occur with long-term administration of this medicine,
• nerve damage, which rarely may cause permanent disturbances,
• transient blindness or prolonged impairment of eye muscle function, which may occur following injection near the eye.

Do not be unduly alarmed by this list of adverse reactions, as they may not occur at all.

Reporting of adverse reactions
If you experience any undesirable effects, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can also be reported directly to the Department of Monitoring 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 .
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bupivacaini Noridem

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
ampoule after "EXP". The expiry date refers to the last day of the stated month.
Do not use this medicine if any discoloration of the contents or presence of
particulate matter is observed.
Do not store in a refrigerator and do not freeze.
After first opening, the product should be used immediately.
After dilution: chemical and physical stability of the prepared solution for administration has been demonstrated for 7 days at 25 ± 2°C and for 24 hours at 2 to 8°C. From a microbiological standpoint, the product should be used immediately. If the ready-to-use injection solution is not used immediately, the user is responsible for the storage conditions and duration prior to use, which must not exceed 24 hours at 2 to 8°C, unless the opening and dilution were carried out under controlled and validated aseptic conditions.
Usually, the medicine Bupivacaini Noridem is stored by a physician or hospital staff, who are responsible for the product quality after opening, if it is not used immediately.
They are also responsible for the proper disposal of unused Bupivacaini Noridem leftovers.

6. Contents of the packaging and other information

What Bupivacaini Noridem contains

• The active substance is bupivacaine hydrochloride anhydrous.

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

• The 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, colourless, sterile solution. It is available in polypropylene ampoules.
Polypropylene ampoules with a capacity of 5 mL, 10 mL or 20 mL. The ampoules are placed in cardboard boxes.
Pack sizes contain 5, 10 and 50 ampoules.
Polypropylene ampoules with a capacity of 5 mL, 10 mL or 20 mL. Each ampoule is individually placed in a polypropylene plastic blister. The blisters are placed in cardboard boxes.
Pack sizes contain 5, 10 and 50 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised for marketing in the European Economic Area and Northern Ireland under the following names:
France BUPIVACAINE NORIDEM 2.5 mg/mL, solution for injection
BUPIVACAINE NORIDEM 5 mg/mL, solution for injection
Denmark Bupivacaine Noridem
Bupivacaine Noridem
Greece AMIΒUSIN 2.5 mg / mL Ενέσιμο διάλυμα
AMIΒUSIN 5 mg / mL Ενέσιμο διάλυμα
United Kingdom Bupivacaine 2.5 mg / mL Solution for injection
(Northern Ireland) Bupivacaine 5 mg / mL Solution for injection
Ireland Bupivacaine 2.5 mg / mL Solution for injection
Bupivacaine 5 mg / mL Solution for injection
Cyprus: AMIΒUSIN 2.5 mg / mL Ενέσιμο διάλυμα
AMIΒUSIN 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

Information intended exclusively for medical professionals:
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 regulations.

Administration methods
Solution for injection.
This medicinal product is intended only for infiltration anaesthesia (infiltration anaesthesia), regional nerve block, peripheral nerve block, and central nerve block (including epidural or caudal).
The required dose should be calculated based on the physician’s knowledge and experience and the patient’s general condition. The lowest recommended doses necessary to achieve adequate anaesthesia should be used. The total maximum dose of 150 mg should not be exceeded. A well-tolerated dose in most adult patients is 400 mg administered over 24 hours, excluding initial intermittent bolus doses, and may be used routinely. In children and adolescents, the lowest recommended doses necessary to achieve adequate pain relief should be used.

Instructions for use
For single use only.
Only clear solutions practically free from particulate matter should be used. Any unused portion of the solution must be discarded.
The medicinal product Bupivacaini Noridem solution must not be stored in contact with metallic devices such as needles and syringes containing metal components. Metal ions may precipitate and cause swelling at the injection site. Do not use this medicinal product after the expiry date stated on the ampoule and outer carton. The expiry date refers to the last day of the stated month.

Preparation of 1.25 mg/mL concentration:
Medicinal product Bupivacaini Noridem, 2.5 mg/mL, solution for injection:

• Withdraw 250 mL of diluent from a 500 mL bag or bottle that does not contain PVC and inject into it 250 mL of Bupivacaini Noridem medicinal product solution for injection at a concentration of 2.5 mg/mL, resulting in the desired concentration of 1.25 mg/mL.
• Gently shake the diluent bag or bottle to obtain a homogeneous medicinal solution.

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

• Withdraw 125 mL of diluent from a 500 mL bag or bottle that does not contain PVC and inject into it 125 mL of Bupivacaini Noridem medicinal product solution for injection at a concentration of 5 mg/mL, resulting in the desired concentration of 1.25 mg/mL.
• Gently shake the diluent bag or bottle to obtain a homogeneous medicinal solution.

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

• Withdraw 250 mL of diluent from a 500 mL bag or bottle that does not contain PVC and inject into it 250 mL of Bupivacaini Noridem medicinal product solution for injection at a concentration of 5 mg/mL, resulting in the desired concentration of 2.5 mg/mL.
• Gently shake the diluent bag or bottle to obtain a homogeneous medicinal solution.

The medicinal product Bupivacaini Noridem is compatible with 0.9% w/v (9 mg/mL) sodium chloride solution for injection and Ringer's lactate solution. 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.
Duration of storage after dilution:
Chemical and physical stability has been demonstrated for the prepared solution 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 ready-to-use solution for injection is not used immediately, the user is responsible for the storage conditions and duration prior to administration, which must not exceed 24 hours at 2 to 8°C, unless the opening and dilution were performed under controlled and validated aseptic conditions.