Levobupivacaine Kabi 5 mg/ml solution for injection and infusion EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levobupivacaína Kabi 5 mg/ml solution for injection and infusion EFG

levobupivacaine hydrochloride

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Levobupivacaína Kabi is and what it is used for
2. What you need to know before being administered Levobupivacaína Kabi
3. How Levobupivacaína Kabi is administered
4. Possible side effects
5. How to store Levobupivacaína Kabi
6. Package contents and additional information

1. What Levobupivacaína Kabi is and what it is used for

Levobupivacaína Kabi belongs to a group of medicines called local anaesthetics. This type of medicine is used to numb parts of the body or to relieve pain.

In adults and adolescents over 12 years of age:

Levobupivacaína Kabi is used as a local anaesthetic to numb parts of the body before major surgery (for example, as an epidural in caesarean sections) and minor surgery (such as in the eye or mouth).

It is also used for pain relief

• after major surgery
• during childbirth

In children (under 12 years of age):

Levobupivacaína Kabi may also be used in children under 12 years of age to numb parts of the body before surgery and for pain relief after minor surgery, such as inguinal hernia repair.

Levobupivacaína Kabi has not been studied in children under 6 months of age.

2. What you need to know before Levobupivacaine Kabi is administered to you

Do not use Levobupivacaine Kabi:

• if you are allergic (hypersensitive) to levobupivacaine, to other similar local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6).
• if you have very low blood pressure.
• to anaesthetize a part of the body by injecting Levobupivacaine Kabi intravenously.
• to relieve pain by administration via injection around the cervix during early labour (paracervical block).

Warnings and precautions

Tell your doctor before Levobupivacaine Kabi is administered if you have any of the following conditions or diseases. You may require closer monitoring or a lower dose.

• if you have any heart disease
• if you suffer from a nervous system disorder
• if you are weak or ill
• if you are elderly
• if you have liver disease

Use of Levobupivacaine Kabi with other medicines

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines. In particular, inform them if you are taking medicines for:

• irregular heartbeat (such as mexiletine)
• fungal infections (such as ketoconazole), since these may affect the metabolism of Levobupivacaine Kabi.
• asthma (such as theophylline), since these may affect how long Levobupivacaine Kabi remains in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Levobupivacaine Kabi must not be administered to relieve pain by injection around the cervix during labour (known as paracervical block).

The effects of Levobupivacaine Kabi on the fetus during early pregnancy are unknown. Therefore, Levobupivacaine Kabi should not be used during the first three months of pregnancy unless considered necessary by your doctor.

It is not known whether levobupivacaine passes into breast milk. However, based on experience with similar medicines, it is expected that only small amounts of levobupivacaine pass into breast milk. Breastfeeding is therefore possible after the use of a local anaesthetic.

Driving and using machines

The use of Levobupivacaine Kabi may have a considerable effect on the ability to drive and use machines. You must not drive or operate machinery until all effects of Levobupivacaine Kabi and the effects of surgery have completely worn off. Before leaving the hospital, consult your doctor or nurse to determine whether you are able to drive or use machinery.

Levobupivacaine Kabi contains sodium

This medicine contains 3.6 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 0.18% of the maximum daily recommended sodium intake for an adult.

3. How Levobupivacaína Kabi will be administered to you

Your doctor will administer Levobupivacaína Kabi by injection through a needle or through a small tube inserted into your back (epidural). Levobupivacaína Kabi may also be injected into other parts of the body to anaesthetize the area to be treated, such as the eye, arm, or leg.

Your doctor and nurse will carefully monitor you while Levobupivacaína Kabi is being administered.

Dosage

The amount of Levobupivacaína Kabi you will receive and how often it is given will depend on what it is being used for, and on your physical condition, age, and weight. You will be given the lowest dose that achieves anaesthesia in the required area. The dose will be carefully calculated by your doctor.

When Levobupivacaína Kabi is used to relieve labour pain or for caesarean section (via epidural), the administered dose will be carefully controlled.

If you are given more Levobupivacaína Kabi than you should

If you are given more Levobupivacaína Kabi than you should, you may experience numbness of the tongue, dizziness, blurred vision, muscle twitching, severe difficulty in breathing (including breathing pauses), and even seizures. If you notice any of these symptoms, inform your doctor immediately. In some cases, administration of an excessive amount of Levobupivacaína Kabi may also cause hypotension, bradycardia or tachycardia, and changes in your heart rhythm. Your doctor may administer other medications to help control these symptoms.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

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

Immediately inform your doctor or nurse if you think you are experiencing any of the adverse effects listed below. Some of the adverse effects of Levobupivacaine Kabi may be serious.

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

• feeling tired or weak, difficulty breathing, paleness (these are all signs of anemia)
• low blood pressure
• nausea

Common (may affect up to 1 in 10 people):

• dizziness
• headache
• vomiting
• fetal distress
• back pain
• fever
• postoperative pain

Frequency not known (frequency cannot be estimated from the available data):

• severe allergic reactions (hypersensitivity) causing severe breathing difficulty, difficulty swallowing, hives, and very low blood pressure
• allergic reactions (hypersensitivity) characterized by red, irritated skin, sneezing, excessive sweating, increased heart rate, fainting, or swelling of the face, lips, mouth, tongue, or throat
• loss of consciousness
• drowsiness
• blurred vision
• respiratory arrest
• cardiac block or cardiac arrest
• localized tingling
• numb tongue
• muscle weakness or tremors
• loss of control of urine and feces
• paralysis
• seizures
• tingling, numbness, or other unusual sensations
• prolonged penile erection, which may be painful
• nervous system disorders that may include drooping eyelids, small pupils (the black center of the eye), sunken eye socket, sweating and/or redness on one side of the face.

Bradycardia, tachycardia, and changes in heart rhythm observed on an ECG (electrocardiogram) have also been reported as adverse effects.

In very rare cases, some adverse effects may occur long-term or become permanent.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levobupivacaine Kabi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Your doctor will store this medicine for you.

The solution should be used immediately after opening.

Do not use this medicine if you notice particles in the solution.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levobupivacaine Kabi

• The active substance is levobupivacaine (as hydrochloride)

Levobupivacaine Kabi 5 mg/ml solution for injection and for infusion: 1 ml of solution contains 5 mg of levobupivacaine (as levobupivacaine hydrochloride). Each 10 ml vial contains 50 mg of levobupivacaine as levobupivacaine hydrochloride.

• The other components are water for injections, sodium chloride, and small amounts of sodium hydroxide and hydrochloric acid.

This medicinal product contains an excipient with a known effect (sodium). See section 2 for more information.

pH: 4.0 – 6.0

Osmolality: 271 – 372 mOsmol/l

Appearance of the product and contents of the container

This medicine is a clear, colourless solution in polypropylene vials within sterile blister packs. Each vial contains 10 ml of solution. It is supplied in packs of 5, 10 or 20 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España S.A.U
C/ Marina 16-18,
08005-BARCELONA, Spain

Manufacturer:

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway

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

Date of the latest revision of this package leaflet: October 2018

Up-to-date detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Levobupivacaine Kabi 5 mg/ml solution for injection and infusion EFG

Instructions for use / handling

Levobupivacaine Kabi 5 mg/ml solution for injection and infusion is for single use only. Any unused solution must be discarded. Use only if the container is intact.

The solution/dilution must be inspected visually before use. Only clear solutions without visible particles should be used.

A sterile blister pack should be selected when a sterile ampoule surface is required. The ampoule surface is not sterile if the sterile blister is damaged.

Standard solutions of levobupivacaine should be diluted with 9 mg/ml (0.9%) sodium chloride injection solution using aseptic techniques.

It has been demonstrated that 8.4 µg/ml of clonidine, 50 µg/ml of morphine, 2–4 µg/ml of fentanyl, and 0.4 µg/ml of sufentanil are compatible with levobupivacaine in 9 mg/ml (0.9%) sodium chloride injection solution.

Shelf life after first opening: The product must be used immediately.

Shelf life after dilution:

Chemical and physical in-use stability has been demonstrated for Levobupivacaine Kabi diluted with 9 mg/ml sodium chloride (0.9%) to final concentrations of 0.625 mg/ml and 1.25 mg/ml, respectively, for 30 days at 2–8°C or 20–25°C.

Chemical and physical in-use stability has been demonstrated for Levobupivacaine Kabi diluted with 9 mg/ml sodium chloride (0.9%) to final concentrations of 0.625 mg/ml and 1.25 mg/ml, respectively,

• with 8.4 µg/ml clonidine hydrochloride, 50 µg/ml morphine sulfate, and 2–4 µg/ml fentanyl citrate for 30 days at 2–8°C or 20–22°C.
• with sufentanil added at a concentration of 0.4 µg/ml for 30 days at 2–8°C or for 7 days at 20–22°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless dilution and mixing were carried out under controlled and validated aseptic conditions.

Levobupivacaine Kabi must not be mixed with other medicinal products except those mentioned above. Mixing with alkaline solutions such as sodium bicarbonate may result in precipitation.

Experience regarding the safety of treatment with levobupivacaine for longer than 24 hours is limited.

Method of administration

Administration of Levobupivacaine must be performed only by a physician with appropriate training and experience, or under such a physician's supervision.

For dosage information, refer to the Summary of Product Characteristics.

Careful aspiration should be performed before and during injection to prevent intravascular injection.

Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly in incremental doses at a rate of 7.5–30 mg/min, while monitoring the patient's vital signs and maintaining verbal contact.

If toxic symptoms occur, discontinue the injection immediately.

Levobupivacaine Kabi®

(Levobupivacaine)

5 mg/ml

Read the instructions carefully. Shake to remove any content from the neck.

Hold the ampoule in the palm of your hand at waist level. Hold the arrow on the ampoule cap between thumb and index finger (with thumb pointing outward). Twist quickly and sharply toward you (counterclockwise).

Firmly push the Luer cone of the syringe into the ampoule

Gently push the ampoule toward you with your index finger and slowly withdraw the contents, taking special care at the beginning.