Levobupivacaine Kabi 1.25 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Levobupivacaíne Kabi 1.25 mg/ml solution for infusion EFG

Levobupivacaine hydrochloride

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

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

Leaflet contents:

1. What Levobupivacaíne Kabi is and what it is used for
2. What you need to know before being administered Levobupivacaíne Kabi
3. How Levobupivacaíne Kabi will be administered to you
4. Possible adverse effects
5. How to store Levobupivacaíne Kabi
6. Contents of the pack and other information

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

Levobupivacaine 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.

Levobupivacaine Kabi solution for infusion is for use in adults only.

Levobupivacaine Kabi is used for the treatment of pain:

• after major surgery,
• during childbirth.

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 any similar local anaesthetic, 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.
• for pain relief by administration via injection around the cervix during early labour (paracervical block).

Warnings and precautions

Tell your doctor before Levobupivacaine Kabi is administered to you 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.

Children

Do not administer this medicine to children, as the safety and efficacy of this medicine for pain treatment in children has not been established.

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), as they may affect the metabolism of Levobupivacaine Kabi.
• asthma (such as theophylline), as they 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 for pain relief 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 your doctor considers it necessary.

It is not known whether levobupivacaine passes into breast milk. However, based on experience with similar drugs, 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 operate machinery. You must not drive or operate machinery until all effects of Levobupivacaine Kabi and the effects of surgery have worn off. Before leaving the hospital, consult your doctor or nurse whether you are allowed to drive or use machines.

Levobupivacaine Kabi contains sodium

This medicine contains 3.6 mg of sodium (the 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 through a small tube inserted into your back (epidural). Your doctor and nurse will carefully monitor you while Levobupivacaína Kabi is being given.

Dosage

Adults:

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

When Levobupivacaína Kabi is used to relieve labor pain, the administered dose will be carefully controlled.

Children:

Not recommended.

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 respiratory arrest), 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 manage 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 anaemia)
• 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 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
• somnolence
• blurred vision
• respiratory arrest
• cardiac block or cardiac arrest
• localized tingling
• numb tongue
• muscle weakness or tremors
• loss of control of urine and faeces
• 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 (black centre of the eye), sunken eye socket, sweating and/or redness on one side of the face.

Bradycardia, tachycardia, and changes in heart rhythm that may have been 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 stated on the container after EXP. The expiry date is 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 see 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 container and additional information

Composition of Levobupivacaine Kabi

• The active substance is levobupivacaine (as hydrochloride).

Levobupivacaine Kabi 1.25 mg/ml solution for infusion:

1 ml of solution contains 1.25 mg of levobupivacaine (as hydrochloride).

Each 100 ml bag contains 125 mg of levobupivacaine as levobupivacaine hydrochloride.

Each 200 ml bag contains 250 mg of levobupivacaine as levobupivacaine hydrochloride.

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

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

pH: 4.0 – 6.0

Osmolarity: 271 – 332 mOsmol/l

Appearance of the medicine and contents of the pack

This medicine is a clear, colourless solution in a polyolefin bag with a transparent overwrap. It is supplied in packs of 5, 24 or 60 bags of 100 ml, or packs of 5, 12 or 32 bags of 200 ml of solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi España S.A.U
C/ Marina 16-18, planta 17
08005-BARCELONA

Manufacturer:

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway

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

Levobupivacaine Kabi 1.25 mg/ml solution for infusion

Date of the last review of this summary: October 2018

Detailed and up-to-date 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 1.25 mg/ml solution for infusion EFG

Instructions for use / handling

Levobupivacaine Kabi 1.25 mg/ml solution for infusion is for single use only and for epidural administration; it must not be administered intravenously. Use only if the solution is clear and the container is intact. Any unused solution must be discarded.

Like all parenteral medications, the solution/dilution must be inspected visually before use. Only clear solutions without visible particles should be used.

Period of validity after dilution:

Chemical and physical in-use stability of levobupivacaine solution for infusion has been demonstrated:

• with 8.4 µg/ml clonidine hydrochloride, 50 µg/ml morphine sulphate, 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 should normally not exceed 24 hours at 2–8°C, unless the mixture has been prepared under controlled and validated aseptic conditions.

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

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

Method of administration

Levobupivacaine must be administered only by a physician with appropriate training and experience, or under their supervision.

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

Careful aspiration before injection is recommended to prevent intravascular injection. If toxic symptoms occur, the injection must be stopped immediately.