LEVOBUPIVACAINE KABI 0.625 mg/mL SOLUTION FOR INFUSION

2. What you need to know before you are given Levobupivacaine Kabi

Do not use Levobupivacaine Kabi:

• if you are allergic (hypersensitive) to levobupivacaine, to any other local anesthetic or to any of the other ingredients of this medicine (listed in section 6).
• if you have very low blood pressure
• to numb a part of the body by injecting Levobupivacaine Kabi into a vein.
• to relieve pain by injecting it into the area around the cervix during the early stages of childbirth (paracervical block).

Warnings and precautions

Tell your doctor before you are given Levobupivacaine Kabi if you have any of the following conditions or diseases. You may need to be monitored more closely or be given a lower dose.

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

Children

Do not give this medicine to children because the safety and efficacy of this medicine for the treatment of pain in children have not been established.

Using Levobupivacaine Kabi with other medicines

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. Tell them especially if you are taking medicines for:

• irregular heartbeats (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 stays in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levobupivacaine Kabi should not be used to relieve pain by injecting it into the area around the cervix during childbirth (paracervical block).

The effects of Levobupivacaine Kabi on the fetus during the first stages of pregnancy are not known. 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 will pass into breast milk. Breastfeeding is therefore possible after using a local anesthetic.

Driving and using machines

The use of Levobupivacaine Kabi may have a considerable effect on your ability to drive and use machines. You should not drive or use machines until all the effects of Levobupivacaine Kabi and the effects of the surgery have passed. Before you leave the hospital, ask your doctor or nurse if you can drive or use machines.

Levobupivacaine Kabi contains sodium

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

3. How Levobupivacaine Kabi will be given to you

Your doctor will give you Levobupivacaine Kabi through a small tube inserted into your back (epidural). Your doctor and nurse will monitor you closely while you are being given Levobupivacaine Kabi.

Dose

Adults:

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

When Levobupivacaine Kabi is used to relieve pain during childbirth, the dose given will be carefully controlled.

Children:

Not recommended.

If you are given too much Levobupivacaine Kabi

If you are given too much Levobupivacaine Kabi, you may experience numbness of the tongue, dizziness, blurred vision, muscle twitching, severe difficulty breathing (including respiratory arrest) and even convulsions. If you notice any of these symptoms, tell your doctor immediately. In some cases, the administration of too much Levobupivacaine Kabi may also cause low blood pressure, slow or fast heart rate, and changes in heart rhythm. Your doctor may give you other medicines to help stop these symptoms.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you think you are experiencing any of the following side effects.Some of the side effects of Levobupivacaine Kabi can be serious.

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

• feeling tired or weak, difficulty breathing, pale skin (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) that cause severe difficulty breathing, difficulty swallowing, hives, and very low blood pressure
• allergic reactions (hypersensitivity) recognizable by having red and 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
• heart block or cardiac arrest
• localized tingling
• numb tongue
• muscle weakness or tremors
• loss of control of urine and feces
• paralysis
• convulsions
• tingling, numbness, or other unusual sensation
• prolonged erection of the penis, which can be painful
• nervous disorders that can include drooping eyelids, small pupils (black center of the eye), sunken eye socket, sweating, and/or flushing of one side of the face.

Bradycardia, tachycardia, and changes in heart rhythm that can be seen on an ECG (electrocardiogram) have also been reported as side effects.

In very rare cases, some side effects may occur after a long time or become permanent.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side 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 carton after EXP. The expiry date is the last day of the month shown.

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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further 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 ingredients are water for injections, sodium chloride, and a small amount of sodium hydroxide and hydrochloric acid.

This medicine contains a known excipient with a potential effect (sodium). See section 2 for further information.

pH: 4.0 – 6.0

Osmolality: 271 – 332 mOsmol/l

Appearance and packaging

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi España S.A.U

C/ Marina 16-18, 17th floor

08005-BARCELONA

Manufacturer:

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

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

Levobupivacaine Kabi 0.625 mg/ml solution for infusion

Date of last revision of this leaflet: October 2018

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

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This information is intended only for healthcare professionals:

Levobupivacaine Kabi0.625 mg/ml solution for infusion EFG

Instructions for use/manipulation

Levobupivacaine Kabi 0.625 mg/ml solution for infusion is for single use only and should be administered via the epidural route and not intravenously. Use only if the solution is clear and the packaging is intact. Discard any unused solution.

As with all parenteral medicines, the solution/dilution should be inspected visually before use. Only clear solutions without visible particles should be used.

Shelf life after dilution:

The chemical and physical stability of levobupivacaine solution for infusion has been demonstrated

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

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 24 hours at 2-8º C, unless the mixture has been prepared in controlled and validated aseptic conditions.

Levobupivacaine Kabi should not be mixed with other medicines except those mentioned above. Dissolution with alkaline solutions such as sodium bicarbonate may cause precipitation.

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

Method of administration

Levobupivacaine Kabi should only be administered by a doctor who has the necessary training and experience or under their supervision.

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

Careful aspiration should be performed before injection to prevent intravascular injection. If toxic symptoms appear, the injection should be stopped immediately.