Prospecto: Information for the User

Levobupivacaína Kabi 1.25 mg/mL Solution for Infusion EFG

Levobupivacaine Hydrochloride

Read this prospectus carefully before starting to use this medicine,because it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any questions, consult your doctor or nurse.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prospectus. See section 4.

1.What is Levobupivacaína Kabi and how is it used

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

3.How Levobupivacaína Kabi will be administered

4.Possible adverse effects

5.Storage of Levobupivacaína Kabi

6.Contents of the package and additional information

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

Levobupivacaína Kabi solution for infusion isonly for use in adults.

Levobupivacaína Kabi is used for the treatment of pain:

•after major surgery,

•during childbirth.

No use Levobupivacaína Kabi:

·if you are allergic (hypersensitive) to levobupivacaine, to any other local anesthetic similar or to any of the other components of this medication (listed in section 6).

·if you have very low blood pressure

·for anesthetizing a part of the body by injecting Levobupivacaína Kabi intravenously.

·to relieve pain by administering it through injection in the area around the uterine cervix during the early stage of labor (paracervical block).

Warnings and precautions

Inform your doctor before they administer Levobupivacaína Kabi if you have any of the conditions or diseases listed below. You may need closer monitoring or a lower dose.

·if you have any heart disease

·if you suffer from a nervous system disease

·if you are weak or ill

·if you are an elderly person

·if you have liver disease.

Children

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

Use of Levobupivacaína Kabi with other medications

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication. Inform them especially if you are taking medications for:

·irregular heartbeats (such as mexiletine)

·fungus infections (such as ketoconazole) as they may affect the metabolism of Levobupivacaína Kabi.

·asthma (such as theophylline) as they may affect how long Levobupivacaína Kabi stays in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Levobupivacaína Kabi should not be administered to relieve pain by injection in the area around the uterine cervix or cervix during labor (paracervical block).

The effects of Levobupivacaína Kabi on the fetus during the early stages of pregnancy are unknown. Therefore, Levobupivacaína Kabi should not be used during the first three months of pregnancy, unless your doctor considers it necessary.

The passage of levobupivacaine through breast milk is unknown. However, based on experience with similar medications, it is expected that only small amounts of levobupivacaine will pass through breast milk. Breastfeeding is therefore possible after using a local anesthetic.

Driving and operating machinery

The use of Levobupivacaína Kabi may have a significant effect on your ability to drive and operate machinery. Do not drive or operate machinery until all the effects of Levobupivacaína Kabi and the effects of surgery have passed. Before leaving the hospital, consult your doctor or nurse if you can drive or operate machinery.

Levobupivacaína Kabi contains sodium

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

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

Dose

Adults:

The amount of Levobupivacaína Kabi that will be administered and the frequency at which it will be given will depend on the purpose of use and your physical condition, age, and weight. You will be given the minimum dose necessary to achieve anesthesia in the required area. The dose will be carefully calculated by your doctor.

When Levobupivacaína Kabi is used to relieve childbirth 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 tongue numbness, dizziness, blurred vision, muscle contraction, severe difficulty breathing (including respiratory arrest) and even seizures. If you notice any of these symptoms, inform your doctor immediately. In some cases, excessive administration of Levobupivacaína Kabi may also cause hypotension, bradycardia, tachycardia, and changes in your heart rhythm. Your doctor may administer other medications to help stop these symptoms.

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

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

Inform your doctor or nurse immediately if you consider you are experiencing any of the side effects listed below.Some of the side effects of Levobupivacaína Kabi can be severe.

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

·fatigue or weakness, difficulty breathing, paleness (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

Unknown frequency(frequency cannot be estimated from available data):

·severe allergic reactions (hypersensitivity) that cause severe difficulty breathing, difficulty swallowing, urticaria, 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

·apnea

·cardiac arrest or heart block

·localized numbness

·numb tongue

·muscle weakness or tremors

·loss of bladder and bowel control

·paralysis

·seizures

·tingling, numbness, or other unusual sensations

·prolonged erection of the penis, which may be painful

·nervous system disorders that may include drooping eyelids, small pupils (black center of the eye), sunken eye socket, sweating, and/or redness of one side of the face.

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

In very rare cases, some side effects may occur in the long term or become permanent.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Your doctor will store this medication for you.

The solution must be used immediately after its opening.

Do not use this medication if you observe particles within the solution.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Levobupivacaine Kabi

-The active ingredient 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 bag of 100 ml contains 125 mg of levobupivacaine as levobupivacaine hydrochloride.

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

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

This medicine contains a known excipient (sodium). See section 2 for more information.

pH: 4.0 – 6.0

Osmolarity: 271 – 332 mOsmol/l

Appearance of the product and contents of the package

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Fresenius Kabi España S.A.U

C/ Marina 16-18, planta 17

08005-BARCELONA

Manufacturer responsible:

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

This medicine is authorized in the member states of the European Economic Area with the following names:

Levobupivacaine Kabi 1.25 mg/ml solution for infusion

Last review date of this leaflet: October 2018

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Levobupivacaine Kabi1.25 mg/ml solution for infusion EFG

Instructions for use / handling

Levobupivacaine Kabi 1.25 mg/ml solution for infusion isonlyfor single use and by epidural route and must not be administered intravenously. Use only if the solution is transparent and the container is intact. Discard any unused solution.

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

Period of validity after dilution:

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

-with 8.4 µg/ml of clonidine hydrochloride, 50 µg/ml of morphine sulfate, and 2 - 4 µg/ml of citrate fentanyl during 30 days at 2-8°C or 20-22°C.

-with sufentanil added to a concentration of 0.4 µg/ml during 30 days at 2-8°C or during 7 days at 20-22°C.

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

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

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

Administration form

Administration of Levobupivacaine should be performed only by a doctor who has the necessary training and experience or under the supervision of the same.

For information on dosage, see the Product Technical Data Sheet.

It is recommended to perform careful aspiration before injection to prevent intravascular injection. If toxic symptoms appear, stop the injection immediately.