Prospect: Information for the User

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

levobupivacaaine hydrochloride

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

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

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

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

1.What is Levobupivacaína Kabi and how it is 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.

In adults and adolescents over 12 years:

Levobupivacaína Kabi is used as a local anesthetic to anesthetize parts of the body before major surgery (for example, as epidural in cases of cesarean section) and minor surgery (such as in the eye or mouth).

It is also used forpain relief

·after major surgery

·during childbirth

In children (under 12 years):

Levobupivacaína Kabi can also be used in children under 12 years to anesthetize parts of the body before an operation and for pain relief after minor surgery, such as inguinal hernia.

Levobupivacaína Kabi has not been tested in children under 6 months.

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.

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 through 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. 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 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 an injection via a needle or through a small tube inserted into your back (epidural). Levobupivacaína Kabi can also be injected into other parts of the body to anesthetize the area being treated, such as the eye, arm, or leg.

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

Dose

The amount of Levobupivacaína Kabi that will be administered and the frequency of administration will depend on the intended use and your physical condition, age, and weight. You will be administered the minimum dose required to achieve anesthesia in the affected area. The dose will be carefully calculated by your doctor.

When Levobupivacaína Kabi is used to relieve childbirth pain or for a cesarean delivery (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 tongue numbness, dizziness, blurred vision, muscle contraction, severe difficulty breathing (including respiratory arrest) or 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, or 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 immediatelyif 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 (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

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 flushing of one side of the face.

Also, bradycardia, tachycardia, and changes in heart rhythm that may be seen on an ECG (electrocardiogram) have 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 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 of 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 trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Levobupivacaína Kabi

-The active ingredient is levobupivacaine (as hydrochloride)

Levobupivacaína Kabi 5 mg/ml solution for injection and infusion: 1 ml of solution contains 5 mg of levobupivacaine (as hydrochloride of levobupivacaine). Each ampoule of 10 ml contains50 mg of levobupivacaine as hydrochloride of levobupivacaine.

-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 – 372 mOsmol/l

Appearance of the product and contents of the package

This medicine is a transparent and colorless solution, in polypropylene ampoules in sterile blister packs. Each ampoule contains 10 ml of solution. It is supplied in packs of 5, 10 or 20 ampoules.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Fresenius Kabi España S.A.U

C/ Marina 16-18,

08005-BARCELONA

Responsible for manufacturing:

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:

Last review date of thisleaflet:October 2018

The 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:

Levobupivacaína Kabi5 mg/ml solution for injection and infusion EFG

Instructions for use / handling

Levobupivacaína Kabi 5 mg/ml solution for injection and infusion is only for single use. Discard any unused solution. Use only if the packaging is intact.

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

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

Standard solution dilutions of levobupivacaine should be prepared with 0.9% sodium chloride injection using aseptic techniques.

It has been demonstrated that 8.4 µg/ml of clonidine hydrochloride, 50 µg/ml of morphine sulfate, and 2 - 4 µg/ml of fentanyl citrate and 0.4 µg/ml of sufentanil are compatible with levobupivacaine in a 0.9% sodium chloride injection.

The product should 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 not normally be greater than 24 hours at 2-8°C, unless the dilution and mixing have been prepared in controlled and validated aseptic conditions.

Levobupivacaína Kabi should not be mixed with other medications except those mentioned above. Dissolution with alkaline solutions such as sodium bicarbonate may lead to precipitation.

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

Administration form

Levobupivacaine administration should only be performed 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.

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

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

If toxic symptoms appear, stop the injection immediately.

Levobupivacaína Kabi®

(Levobupivacaine)

5 mg/ml

Read the instructions carefully. Shake until any contents from the neck are removed.

Hold the ampoule in the palm of your hand at waist height. Hold the arrow on the cap of the ampoule between your thumb and index finger (with your thumb outward). Twist quickly and forcefully towards you (in the opposite direction of the clock hands).

Push the Luer cone of the syringe firmly into the ampoule

Push the ampoule gently towards you with your index finger and remove the contents slowly, taking special care at the beginning