Levobupivacaine Kabi 0.625 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Levobupivacaine Kabi 0.625 mg/ml solution for infusion EFG

Levobupivacaine hydrochloride

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

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

Leaflet contents:

1. What Levobupivacaine Kabi is and what it is used for
2. What you need to know before Levobupivacaine Kabi is administered to you
3. How Levobupivacaine Kabi will be administered to you
4. Possible side effects
5. How to store Levobupivacaine 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 adult use 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 other 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.
• to relieve pain by administering it 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 unwell
• 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 these may affect the metabolism of Levobupivacaine Kabi.
• asthma (such as theophylline), as 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 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 use machines. You should 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 able to drive or use machines.

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 through a small tube inserted into your back (epidural). Your doctor and nurse will carefully monitor you while Levobupivacaína Kabi is being administered.

Dosage

Adults:

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. The lowest dose required to achieve anesthesia in the required area will be administered. Your doctor will carefully calculate the dose.

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 breathing (including breathing pauses), and even seizures. If you notice any of these symptoms, inform your doctor immediately. In some cases, administering an excessive amount of Levobupivacaína Kabi may also cause hypotension, bradycardia or tachycardia, and changes in your heart rhythm. Your doctor may give you 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 experiences them.

Inform your doctor or nurse immediately 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 (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
• drowsiness
• 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
• neurological disorders which 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 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via 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 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 the packaging and any unused medicines. 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 0.625 mg/ml solution for infusion:

1 ml of solution contains 0.625 mg of levobupivacaine (as hydrochloride).

Each 100 ml bag contains 62.5 mg of levobupivacaine as levobupivacaine hydrochloride.

Each 200 ml bag contains 125 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 medicine contains an excipient with known effect (sodium). See section 2 for further 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 0.625 mg/ml solution for infusion

Date of the most recent review of this leaflet: October 2018

Updated and detailed information on this medicine is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Levobupivacaine Kabi 0.625 mg/ml solution for infusion EFG

Instructions for use / handling

Levobupivacaine Kabi 0.625 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 undamaged. Discard any unused solution.

As with 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 when mixed 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.
• 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 was prepared 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 levobupivacaine treatment for longer than 24 hours is limited.

Method of administration

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

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

Careful aspiration is recommended before injection to avoid intravascular injection. If toxic symptoms occur, discontinue the injection immediately.