LEVOBUPIVACAINA 1.25 мг/мл Инфузионный раствор

Содержание инструкции

1. Levobupivacaina Kabi 0.625 mg/ml solution for infusion, 1.25 mg/ml solution for infusion
   1. What is Levobupivacaina Kabi and what is it used for
   2. What you need to know before using Levobupivacaina Kabi
   3. How to use Levobupivacaina Kabi
   4. Possible side effects
   5. How to store Levobupivacaina Kabi
   6. Content of the pack and other information
2. Levobupivacaina Kabi 2.5 mg/ml injectable solution/ for infusion, 5.0 mg/ml injectable solution/ for infusion
   1. What is Levobupivacaina Kabi and what is it used for
   2. What you need to know before using Levobupivacaina Kabi
   3. How to use Levobupivacaina Kabi
   4. Possible side effects
   5. How to store Levobupivacaina Kabi
   6. Contents of the pack and other information
3. Levobupivacaina Kabi 7,5 mg/ml injectable solution/ infusion solution
   1. What is Levobupivacaina Kabi and what is it used for
   2. What you need to know before using Levobupivacaina Kabi
   3. How to use Levobupivacaina Kabi
   4. Possible side effects
   5. How to store Levobupivacaina Kabi
   6. Contents of the pack and other information

Levobupivacaina Kabi 0.625 mg/ml solution for infusion, 1.25 mg/ml solution for infusion

Generic medicine
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 any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

The name of the medicine is Levobupivacaina Kabi 0.625 mg/ml or 1.25 mg/ml solution for
Contents of this leaflet:

• 1. What Levobupivacaina Kabi is and what it is used for
• 2. What you need to know before you use Levobupivacaina Kabi
• 3. How to use Levobupivacaina Kabi
• 4. Possible side effects
• 5. How to store Levobupivacaina Kabi
• 6. Contents of the pack and other information

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

Levobupivacaina Kabi belongs to a group of medicines called local anesthetics. This type of
medicine is used to make a part of the body insensitive or to eliminate pain.
Levobupivacaina Kabi solution for infusion is used only in adults.
Levobupivacaina Kabi is used as an analgesic:

• after major surgical procedures
• during labor.

2. What you need to know before using Levobupivacaina Kabi

Do not take Levobupivacaina Kabi:

• if you are allergic (hypersensitive) to levobupivacaine, to any similar local anesthetic or to any of the other ingredients of this medicine (see section 6)
• if you have very low blood pressure
• for anesthetizing an area by intravenous injection of Levobupivacaina Kabi.
• as pain relief by injection into the area around the cervix (cervical block) during the initial stage of labor

Warnings and precautions
Tell your doctor before you are given Levobupivacaina Kabi if you have any of the
diseases or conditions described below. You may need to undergo more accurate checks or
be given a lower dose of the drug.

• if you suffer from a heart condition
• if you suffer from diseases that affect the nervous system
• if you are weak or ill
• if you are elderly
• if you suffer from a liver disease

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

Other medicines and Levobupivacaina Kabi
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicines. In particular, tell them if you are taking medicines for the treatment of:

• irregular heartbeat (such as mexiletine)
• infections due to the presence of fungi (such as ketoconazole) as this may affect the time Levobupivacaina Kabi remains in your body
• asthma (such as theophylline) as this may affect the time Levobupivacaina Kabi remains in your body

Pregnancy and Breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before taking this medicine.
Levobupivacaina Kabi should not be administered during labor as an analgesic by injection
into the area around the cervix (cervical block).
The effect of Levobupivacaina Kabi on the baby during the early stages of pregnancy is unknown.
Therefore, Levobupivacaina Kabi should not be used during the first three months of pregnancy unless
your doctor thinks it is necessary.
It is not known whether levobupivacaine passes into breast milk. However, based on experience with a similar
medicine, it is believed that only small amounts of levobupivacaine may pass into breast milk.
Consequently, breastfeeding is possible after administration of a local anesthetic.

Driving and operating machinery
The use of Levobupivacaina Kabi may have significant effects on your ability to drive vehicles or operate
machinery.
Do not drive vehicles or operate machinery until the effects of Levobupivacaina Kabi and those immediately
following surgery have worn off.
Make sure you are informed about this by the doctor or nurse treating you before leaving
the hospital.

Levobupivacaina Kabi contains sodium
This medicine contains 15.65 mmol (or 360 mg) of sodium per 100 ml bag of solution and 31.3 mmol
(or 720 mg) of sodium per 200 ml bag of solution. This should be taken into consideration by those
patients who are on a low sodium diet.

3. How to use Levobupivacaina Kabi

The doctor will administer Levobupivacaina Kabi to you via a small catheter inserted into your back
(epidural). The doctor and nurse will closely monitor you while Levobupivacaina Kabi is administered.

Dosage
Adults:
The amount of Levobupivacaina Kabi that will be administered to you and the frequency of administration
will depend on the reason for which this medicine is being used and also on your state of health, age and
weight. However, the lowest dose necessary to anesthetize the part of the body that needs to be
treated will be used. The doctor will carefully evaluate which dose should be administered to you.
When Levobupivacaina Kabi is used as an analgesic during labor, it is particularly important to
carefully control the dose used.
Children.
Not indicated.

If you use more Levobupivacaina Kabi than you should
In the event that you are administered an excessive dose of Levobupivacaina Kabi, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle contractions, severe difficulty
breathing (including respiratory arrest) and even convulsions. If you should notice any of
these symptoms, inform your doctor immediately. Sometimes, an excessive dose of
Levobupivacaina Kabi can also cause a drop in blood pressure, an acceleration or a
slowing of the heartbeat and cause variations in heart rhythm. The doctor may consider
necessary to administer you other medicines that help eliminate these symptoms.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

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

Immediately inform your doctor or nurse if you notice any of the following side effects appearing.
Some side effects caused by the use of Levobupivacaina Kabi can be serious.

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

• feeling tired or weak, shortness of breath, paleness (these are all signs of anaemia)
• low blood pressure
• nausea

Common(may affect up to 1 in 10 people)

• dizziness
• headache
• vomiting
• problems affecting the fetus (fetal distress)
• back pain
• high body temperature (fever)
• post-operative pain

Not known(frequency cannot be estimated based on available data)

• severe allergic reactions (hypersensitivity) causing severe difficulty breathing, difficulty swallowing, hives and very low blood pressure
• allergic reactions (hypersensitivity) manifesting with reddened skin, itching, sneezing, excessive sweating, rapid heartbeat, fainting or swelling of the face, lips, mouth, tongue or throat
• loss of consciousness
• drowsiness
• blurred vision
• cessation of breathing
• heart block or cardiac arrest
• localized tingling
• numbness of the tongue
• muscle weakness or muscle contraction
• loss of bladder or bowel control
• paralysis
• convulsions
• tingling, numbness or other abnormal sensation
• prolonged erection of the penis which may be painful
• nervous system disorders that may include drooping of the eyelid, constriction of the pupil (black part in the centre of the eye), sunken orbit, sweating and/or redness on one side of the face

Side effects including fast, slow or irregular heartbeat and changes in heart rhythm that can be detected by an electrocardiogram have also been reported.
Rarely, some of these effects may be long-term or permanent.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaina Kabi

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is indicated on the label. The expiry date refers to the last day of the month.
Your doctor will store this medicine for you.
The solution must be used immediately after opening.
Do not use this medicine if you notice the presence of visible particles.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Levobupivacaine Kabi contains
The active ingredient is levobupivacaine (as levobupivacaine hydrochloride).
Levobupivacaine Kabi 0.625 mg/ml solution for infusion: 1 ml of solution contains 0.625 mg of
levobupivacaine (as levobupivacaine 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).
Levobupivacaine Kabi 1.25 mg/ml solution for infusion: 1 ml of solution contains 1.25 mg of
levobupivacaine (as levobupivacaine 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).
Each 200 ml bag contains 250 mg of levobupivacaine (as levobupivacaine hydrochloride).
The other ingredients are water for injections, sodium chloride and small amounts of sodium
hydroxide and hydrochloric acid.
This medicine contains an excipient with a known effect (sodium). See section 2 for further
information.
pH 4.0-6.0.
Osmolarity: 271-332 mOsm/l.

Description of the appearance of Levobupivacaine Kabi and contents of the pack
This medicine is a transparent, colourless solution in a polyolefin bag with a transparent
overpouch. It is available 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 Authorisation Holder and manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona

Manufacturer
Fresenius Kabi Norge AS

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:

--------------------- ------------------------------- --------------------------------------------
The following information is intended exclusively for doctors or specialised healthcare
professionals:

Levobupivacaine Kabi 0.625 mg/ml or 1.25 mg/ml solution for infusion
Instructions for use and handling
Levobupivacaine Kabi 0.625 mg/ml or 1.25 mg/ml solution for infusion is exclusively for single
epidural useand must not be used for intravenous administration. Do not use if the
solution is not clear and if the container is damaged. Discard any unused solution.
As with all medicinal products for parenteral use, the solution/dilution must be visually inspected
before use. Only clear solutions without visible particles may be used.
Validity after dilution:
The chemical and physical stability under conditions of use has been demonstrated for Levobupivacaine Kabi solution for
infusion

• with clonidine hydrochloride 8.4 µg/ml, morphine sulfate 50 µg/ml and fentanyl citrate 2-4 µg/ml for 30 days at 2-8°C or 20°C-25°C.
• with sufentanil added to a concentration of 0.4 µg/ml for 30 days at 2-8°C or 7 days at 20°C-25°C.

From a microbiological point of view, the medicinal product must be used immediately. If not used
immediately, the storage times and conditions of use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the mixture has been prepared in a controlled and validated aseptic environment.
Levobupivacaine Kabi must not be mixed with other medicinal products except those listed above.
Dilution with alkaline solutions such as sodium bicarbonate may lead to precipitation.
Experience regarding the safety of levobupivacaine for periods of therapy longer than 24 hours is limited.

Route of administration
Levobupivacaine must only be administered by, or under the supervision of, a doctor who possesses
adequate training and specific experience.
Refer to the Summary of Product Characteristics for information relating to dosage.
Careful aspiration is recommended before infusion to avoid intravascular injection. If symptoms of toxicity occur, the injection must be stopped immediately.

Levobupivacaina Kabi 2.5 mg/ml injectable solution/ for infusion, 5.0 mg/ml injectable solution/ for infusion

Generic medicine
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 any side effect occurs, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

The name of the medicine is Levobupivacaina Kabi 2.5 mg/ml and 5.0 mg/ml injectable solution /
Contents of this leaflet:

• 1. What Levobupivacaina Kabi is and what it is used for
• 2. What you need to know before you use Levobupivacaina Kabi
• 3. How to use Levobupivacaina Kabi
• 4. Possible side effects
• 5. How to store Levobupivacaina Kabi
• 6. Contents of the pack and other information

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

Levobupivacaina Kabi belongs to a group of medicines called local anesthetics. This type of
medicine is used to make a part of the body insensitive or to eliminate pain.

In adultsand adolescents (12 years and older) :
Levobupivacaina Kabi is used as a local anesthetic to anesthetize parts of the body before
major (for example as an epidural anesthesia for cesarean section) and minor
surgical procedures (such as operations on the eyes and mouth).
It is also used as an analgesic

• after major surgical procedures
• during childbirth.

In children (under 12 years of age):
Levobupivacaina Kabi can also be used in children to anesthetize parts of the body before
surgical procedures and as an analgesic after minor surgical procedures, such as the treatment of an inguinal
hernia.

2. What you need to know before using Levobupivacaina Kabi

Do not use Levobupivacaina Kabi:

• if you are allergic (hypersensitive) to levobupivacaine, any similar local anesthetic or any of the other ingredients of this medicine (see section 6)
• if you have very low blood pressure
• to anesthetize an area by intravenous injection of Levobupivacaina Kabi.
• as pain relief by injection into the area around the cervix during the initial stage of labor (paracervical block)

Warnings and precautions
Tell your doctor before you are given Levobupivacaina Kabi if you have any of the
diseases or conditions described below. You may need to undergo more careful monitoring or
be given a lower dose of medication.

• if you suffer from a heart condition
• if you suffer from diseases affecting the nervous system
• if you are weak or ill
• if you are elderly
• if you suffer from a liver condition

Other medicines and Levobupivacaina Kabi
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicines. In particular, tell them if you are taking medicines for the treatment of:

• irregular heartbeat (such as mexiletine)
• infections due to the presence of fungi (such as ketoconazole) as this may affect how long Levobupivacaina Kabi stays in your body
• asthma (such as theophylline) as this may affect how long Levobupivacaina Kabi stays in your body

Pregnancy and Breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine.
Levobupivacaina Kabi should not be given during labor as a painkiller by injection
into the area around the cervix (paracervical block).
The effect of Levobupivacaina Kabi on the baby during the early stages of pregnancy is unknown.
Therefore, Levobupivacaina Kabi should not be used during the first three months of pregnancy unless
your doctor thinks it is necessary.
It is not known whether levobupivacaine passes into breast milk. However, based on experience with a
similar medicine, it is believed that only small amounts of levobupivacaine may pass into breast milk.
Consequently, breastfeeding is possible after administration of a local anesthetic.

Driving and operating machinery
The use of Levobupivacaina Kabi may have significant effects on your ability to drive
vehicles or operate machinery.
Do not drive vehicles or operate machinery until the effects of Levobupivacaina Kabi and those immediately
following surgery have worn off.
Make sure you are informed about this by the doctor or nurse treating you before leaving
the hospital.

Levobupivacaina Kabi contains sodium
This medicine contains 1.57 mmol (or 36 mg) of sodium per 10 ml vial of solution. This should be
taken into consideration by patients who are on a low sodium diet.

3. How to use Levobupivacaina Kabi

The doctor will administer Levobupivacaina Kabi to you via an injection with a needle or with a small
catheter inserted into your back (epidural). Levobupivacaina Kabi can also be injected into other parts
of the body to anesthetize the area that needs to be treated, such as the eyes, arm, or leg.
The doctor and nurse will closely monitor you while Levobupivacaina Kabi is administered to you.

Dosage
The amount of Levobupivacaina Kabi that will be administered to you and the frequency of administration
will depend on the reason this medicine is being used and also on your state of health, age, and
weight. However, the lowest dose necessary to anesthetize the part of the body that needs to be
treated will always be used. The doctor will carefully assess which dose should be administered to you.
When Levobupivacaina Kabi is used as an analgesic during labor or during a cesarean section (epidural),
it is particularly important to carefully monitor the dose used.

If you use more Levobupivacaina Kabi than you should
If you are given an excessive dose of Levobupivacaina Kabi, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle contractions, severe difficulty
breathing (including respiratory arrest) and even convulsions. If you notice any
of these symptoms, inform your doctor immediately. Sometimes, an excessive dose of
Levobupivacaina Kabi can also cause a drop in blood pressure, an acceleration or a
slowing of the heartbeat, and cause changes in heart rhythm. The doctor may deem it
necessary to administer other medications to help eliminate these symptoms.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

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

Immediately inform your doctor or nurse if you notice any of the following side effects appearing.
Some side effects caused by the use of Levobupivacaina Kabi may be serious.

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

• feeling tired or weak, shortness of breath, paleness (these are all signs of anemia)
• low blood pressure
• nausea

Common(may affect up to 1 in 10 people)

• dizziness
• headache
• vomiting
• problems affecting the fetus (fetal distress)
• back pain
• high body temperature (fever)
• post-operative pain

Not known(frequency cannot be estimated from the available data)

• severe allergic reactions (hypersensitivity) causing severe difficulty in breathing, difficulty swallowing, hives and very low blood pressure
• allergic reactions (hypersensitivity) manifesting with reddened skin,

itching, sneezing, excessive sweating, rapid heartbeat, fainting or swelling of the
face, lips, mouth, tongue or throat

• loss of consciousness
• drowsiness
• blurred vision
• cessation of breathing
• heart block or cardiac arrest
• localized tingling
• numbness of the tongue
• muscle weakness or muscle contraction
• loss of bladder or bowel control
• paralysis
• convulsions
• tingling, numbness or other abnormal sensation
• prolonged erection of the penis which may be painful
• nervous system disorders that may include drooping of the eyelid, narrowing of the pupil (the black part in the center of the eye), sunken orbit, sweating and/or redness on one side of the face

Side effects including fast, slow or irregular heartbeat and
changes in heart rhythm have also been reported, which can be detected by an electrocardiogram.
Rarely, some of these effects may be long-term or permanent.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili”. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaina Kabi

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is indicated on the label. The expiry date refers to the last day of the month.
Your doctor will store this medicine for you.
The solution must be used immediately after opening.
Do not use this medicine if you notice the presence of visible particles.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levobupivacaine Kabi contains
The active ingredient is levobupivacaine (as levobupivacaine hydrochloride).
Levobupivacaine Kabi 2.5 mg/ml solution for injection/infusion: 1 ml of solution contains 2.5 mg of
levobupivacaine (as levobupivacaine hydrochloride). Each vial of 10 ml contains 25 mg of levobupivacaine
(as levobupivacaine hydrochloride).
Levobupivacaine Kabi 5 mg/ml solution for injection/infusion: 1 ml of solution contains 5 mg of
levobupivacaine (as levobupivacaine hydrochloride). Each vial of 10 ml contains 50 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 a known effect (sodium). See section 2 for further
information.
pH 4.0-6.0.
Osmolarity: 271-372 mOsm/l.

Description of the appearance of Levobupivacaine Kabi and contents of the pack
This medicine is a transparent, colourless solution in polypropylene vials in sterile blisters. Each vial
contains 10 ml of solution. It is available in packs of 5, 10 or 20 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona

Manufacturer
Fresenius Kabi Norge AS

This medicine is authorised in the Member States of the European Economic Area
with the following denominations:

--------------------- ------------------------------- --------------------------------------------
The following information is intended exclusively for doctors or specialised healthcare
personnel:

Levobupivacaine Kabi 2.5 mg/ml or 5.0 mg/ml solution for injection/infusion
Instructions for use and handling
Levobupivacaine Kabi 2.5 mg/ml or 5.0 mg/ml solution for injection/infusion is exclusively
for single use. Discard any unused solution.
Do not use if the container is damaged.
The solution/dilution must be visually inspected before use. Only clear and particle-free
solutions can be used.
Choose a vial from a sterile blister when it is required that the surface of the vial is sterile. The surface
of the vial is not sterile if the packaging is not intact.
Dilutions of standard levobupivacaine solutions must be carried out with a sodium chloride 9 mg/ml
(0.9%) solution for injection under aseptic conditions.
Clonidine 8.4 µg/ml, morphine 0.05 mg/ml, fentanyl 2-4 µg/ml and sufentanil 0.4 µg/ml have been shown
to be compatible with levobupivacaine in sodium chloride 9 mg/ml (0.9%) solution for injection.
Validity after first opening: the medicine must be used immediately.
Validity after dilution:
the chemical and physical stability under conditions of use has been demonstrated for Levobupivacaine Kabi diluted with sodium
chloride 9 mg/ml (0.9%) to a final concentration of 0.625 mg/ml and 1.25 mg/ml respectively for 30
days at 2-8°C or 20°C-25°C.
The chemical and physical stability under conditions of use has been demonstrated for Levobupivacaine Kabi diluted with sodium
chloride 9 mg/ml (0.9%) to a final concentration of 0.625 mg/ml and 1.25 mg/ml respectively

• with clonidine hydrochloride 8.4µg/ml, morphine sulphate 50 µg/ml and fentanyl citrate 2-4 µg/ml for 30 days at 2-8°C or 20°C-25°C.
• with sufentanil added to a concentration of 0.4 µg/ml for 30 days at 2-8°C or 7 days at 20°C- 25°C.

From a microbiological point of view, the medicine must be used immediately. If not used
immediately, the storage times under conditions of use and the storage conditions before
use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the mixing has been carried out under controlled and validated aseptic conditions.
Levobupivacaine Kabi must not be mixed with other medicines except those listed above.
Dilution with alkaline solutions such as sodium bicarbonate may lead to precipitation.
Experience regarding the safety of levobupivacaine for periods of therapy longer than 24 hours is limited.

Route of administration
Levobupivacaine must only be administered by, or under the supervision of, a doctor who possesses
adequate training and specific experience.
Refer to the Summary of Product Characteristics for information relating to dosage.
Careful aspiration should be performed before and during the injection in order to avoid intravascular
injection.
Aspiration must be repeated before and during the administration of a bolus, which must be
injected slowly, in increasing doses, at a rate of 7.5-30 mg/min, carefully monitoring the patient's vital
functions and maintaining verbal contact.
If symptoms of toxicity occur, the injection must be stopped immediately.

Levobupivacaine Kabi
(levobupivacaine)
2.5 mg/ml and 5.0 mg/ml
Read the instructions carefully. Shake, and return any solution present in the neck of the vial
with the rest of the contents.

Hold the vial in the palm of your hand at waist height. Hold the arrow that appears
on the neck of the vial between your thumb and index finger (thumb away from you on the outside).
Quickly rotate with a firm, counter-clockwise movement.

Firmly push the tip of the Luer syringe into the vial

Gently turn the vial upside down, holding it with your index finger and slowly draw up the contents, taking
particular care at the beginning.

Levobupivacaina Kabi 7,5 mg/ml injectable solution/ infusion solution

Generic medicine
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 any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.
• The name of the medicine is Levobupivacaina Kabi 7,5 mg/ml injectable solution / infusion solution;

Contents of this leaflet:

• 1. What Levobupivacaina Kabi is and what it is used for
• 2. What you need to know before you use Levobupivacaina Kabi
• 3. How to use Levobupivacaina Kabi
• 4. Possible side effects
• 5. How to store Levobupivacaina Kabi
• 6. Contents of the pack and other information

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

Levobupivacaina Kabi belongs to a group of medicines called local anesthetics. This type of
medicine is used to make a part of the body insensitive or to eliminate pain.

In adults and adolescents (12 years and older):
Levobupivacaina Kabi is used as a local anesthetic to anesthetize parts of the body before
major (excluding cesarean section) and minor surgical procedures (such as procedures on the eyes and
mouth).
It is also used as an analgesic

• after major surgical procedures

In children (under 12 years of age):
Levobupivacaina Kabi can also be used in children to anesthetize parts of the body before
surgical procedures and as an analgesic after minor surgical procedures, such as the treatment of an inguinal
hernia.

2. What you need to know before using Levobupivacaina Kabi

Do not take Levobupivacaina Kabi:

• if you are allergic (hypersensitive) to levobupivacaine, to any similar local anesthetic or to any of the other ingredients of this medicine (see section 6)
• if you have very low blood pressure
• for anesthetizing an area by intravenous injection of Levobupivacaina Kabi.
• as pain relief by injection in the area around the cervix (cervical block) during the initial stage of labour.
• As pain relief during labour
• As a local anesthetic for caesarean section

Warnings and precautions
Tell your doctor before you are given Levobupivacaina Kabi if you have any of the
diseases or conditions described below. You may need to undergo more accurate checks or
be given a lower dose of the medicine.

• if you suffer from a heart condition
• if you suffer from diseases affecting the nervous system
• if you are weak or ill
• if you are elderly
• if you suffer from a liver condition

Other medicines and Levobupivacaina Kabi
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicines. In particular, tell them if you are taking medicines for the treatment of:

• irregular heartbeat (such as mexiletine)
• infections due to the presence of fungi (such as ketoconazole) as this may affect how long Levobupivacaina Kabi stays in your body
• asthma (such as theophylline) as this may affect how long Levobupivacaina Kabi stays in your body

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.
Levobupivacaina Kabi 7.5 mg/ml should not be given as pain relief during labour
or as a local anesthetic during caesarean section.
The effect of Levobupivacaina Kabi on the baby during the early stages of pregnancy is unknown.
Therefore, Levobupivacaina Kabi should not be used during the first three months of pregnancy unless
your doctor thinks it is necessary.
It is not known whether levobupivacaine passes into breast milk. However, from experience with a similar
medicine, it is believed that only small amounts of levobupivacaine may pass into breast milk.
Consequently, breastfeeding is possible after administration of a local anesthetic.

Driving and operating machinery
The use of Levobupivacaina Kabi may have considerable effects on your ability to drive vehicles or operate
machinery.
Do not drive vehicles or operate machinery until the effects of Levobupivacaina Kabi and those immediately
following surgery have worn off.
Make sure you are informed about this by the doctor or nurse treating you before leaving
hospital.

Levobupivacaina Kabi contains sodium
This medicine contains 1.57 mmol (or 36 mg) of sodium per 10 ml vial of solution. This must be
taken into consideration by patients who are on a low-sodium diet.

3. How to use Levobupivacaina Kabi

Levobupivacaina Kabi can also be injected into other parts of the body to anesthetize the area that will need to
be treated, such as the eyes, arm, or leg.
The doctor and nurse will monitor you closely while Levobupivacaina Kabi is administered.

Dosage
The amount of Levobupivacaina Kabi that will be administered to you and the frequency of administration
will depend on the reason why this medicine is being used and also on your state of health, age and
weight. However, the lowest dose necessary to anesthetize the part of the body that needs to
be treated will always be used. The doctor will carefully assess which dose should be administered to you.

If you use more Levobupivacaina Kabi than you should
If you are given an excessive dose of Levobupivacaina Kabi, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle contractions, severe difficulty
breathing (including respiratory arrest) and even convulsions. If you notice any
of these symptoms, inform your doctor immediately. Sometimes, an excessive dose of
Levobupivacaina Kabi can also cause a drop in blood pressure, an acceleration or a
slowing of the heartbeat and cause changes in heart rhythm. The doctor may deem it
necessary to administer other medicines that help eliminate these symptoms.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

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

Immediately inform your doctor or nurse if you notice any of the following side effects appearing.
Some side effects caused by the use of Levobupivacaina Kabi can be serious.

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

• feeling tired or weak, shortness of breath, paleness (these are all signs of anaemia)
• low blood pressure
• nausea

Common(may affect up to 1 in 10 people)

• dizziness
• headache
• vomiting
• back pain
• high body temperature (fever)
• post-operative pain

Not known(frequency cannot be estimated based on available data)

• severe allergic reactions (hypersensitivity) causing severe difficulty breathing, difficulty swallowing, hives and very low blood pressure allergic reactions (hypersensitivity) manifesting with the presence of reddened skin, itching, sneezing, excessive sweating, rapid heartbeat, fainting or swelling of the face, lips, mouth, tongue or throat
• loss of consciousness
• drowsiness
• blurred vision
• cessation of breathing
• heart block or cardiac arrest
• localized tingling
• numbness of the tongue
• muscle weakness or muscle contraction
• loss of bladder or bowel control
• paralysis
• convulsions
• tingling, numbness or other abnormal sensation
• prolonged erection of the penis which may be painful
• nervous system disorders that may include drooping of the eyelid, constriction of the pupil (black part in the centre of the eye), sunken orbit, sweating and/or redness on one side of the face

Side effects such as fast, slow or irregular heartbeat and
changes in heart rhythm have also been reported, which can be detected by an electrocardiogram.
Rarely, some of these effects may be long-term or permanent.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili”. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaina Kabi

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month.
Your doctor will store this medicine for you.
The solution must be used immediately after opening.
Do not use this medicine if you notice the presence of visible particles.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levobupivacaine Kabi contains
The active ingredient is levobupivacaine (as levobupivacaine hydrochloride).
Levobupivacaine Kabi 7.5 mg/ml solution for injection/infusion: 1 ml of solution contains 7.5 mg of
levobupivacaine (as levobupivacaine hydrochloride). Each vial of 10 ml contains 75 mg of levobupivacaine
(as levobupivacaine hydrochloride).
The other ingredients are water for injections, sodium chloride and small amounts of sodium
hydroxide and hydrochloric acid.
This medicine contains an excipient with a known effect (sodium). See section 2 for further
information.
pH 4.0-6.0.
Osmolarity: 272-372 mOsm/l.

Description of the appearance of Levobupivacaine Kabi and contents of the pack
This medicine is a transparent, colourless solution in polypropylene vials in sterile blisters. Each vial
contains 10 ml of solution. It is available in packs of 5, 10 or 20 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona

Manufacturer
Fresenius Kabi Norge AS

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:

--------------------- ------------------------------- --------------------------------------------
The following information is intended exclusively for physicians or specialized healthcare
professionals:

Levobupivacaine Kabi 7,5 mg/ml solution for injection/infusion
Instructions for use and handling
Levobupivacaine Kabi 7.5 mg/ml solution for injection/infusion is for single use only. Discard any
unused solution.
Do not use if the container is damaged.
The solution/dilution must be visually inspected before use. Only clear and particle-free solutions
should be used.
Choose a vial from a sterile blister when the surface of the vial needs to be sterile. The surface of the
vial is not sterile if the packaging is not intact.
Dilutions of standard levobupivacaine solutions should be made with a sodium chloride 9 mg/ml (0.9%)
injection solution under aseptic conditions.
Clonidine 8.4 µg/ml, morphine 0.05 mg/ml, fentanyl 2-4 µg/ml and sufentanil 0.4 µg/ml have been shown
to be compatible with levobupivacaine in sodium chloride 9 mg/ml (0.9%) injection solution.
Validity after first opening: the medicinal product must be used immediately.
Validity after dilution:
The physicochemical stability under use conditions has been demonstrated for Levobupivacaine Kabi diluted
with sodium chloride 9 mg/ml (0.9%) to final concentrations of 0.625 mg/ml and 1.25 mg/ml respectively for 30
days at 2-8°C or 20°C-25°C.
The physicochemical stability under use conditions has been demonstrated for Levobupivacaine Kabi diluted
with sodium chloride 9 mg/ml (0.9%) to final concentrations of 0.625 mg/ml and 1.25 mg/ml respectively

• with clonidine hydrochloride 8.4µg/ml, morphine sulfate 50 µg/ml and fentanyl citrate 2-4 µg/ml for 30 days at 2-8°C or 20°C-25°C.
• with sufentanil added to a concentration of 0.4 µg/ml for 30 days at 2-8°C or 7 days at 20°C- 25°C.

From a microbiological point of view, the medicinal product must be used immediately. If not used
immediately, the storage times under use conditions and the storage conditions before use are the
responsibility of the user and should normally not exceed 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 medicinal products except those listed above.
Dilution with alkaline solutions such as sodium bicarbonate may lead to precipitation.
Experience regarding the safety of levobupivacaine for periods of therapy longer than 24 hours is limited.

Route of administration
Levobupivacaine must only be administered by, or under the supervision of, a physician who possesses
adequate training and specific experience.
Refer to the Summary of Product Characteristics for information relating to dosage.
Careful aspiration should be performed before and during injection to avoid intravascular injection.
Aspiration should be repeated before and during the administration of a bolus, which should be
injected slowly, in increasing doses, at a rate of 7.5-30 mg/min, carefully monitoring the patient’s vital
functions and maintaining verbal contact.
If toxic symptoms occur, the injection must be stopped immediately.

Levobupivacaine Kabi
(levobupivacaine)
7.5 mg/ml
Read the instructions carefully. Shaking, return any solution present in the neck of the vial
together with the rest of the contents.

Hold the vial in the palm of your hand at waist height. Hold the arrow that appears
on the neck of the vial between your thumb and index finger (thumb away from you on the outside).
Rotate quickly with a firm, counter-clockwise movement.

Firmly push the tip of the luer syringe into the vial

Gently turn the vial upside down, holding it with your index finger and slowly draw up the contents, taking
particular care at the beginning.