Levobupivacaine Bioindustria L.I.M.: detailed information

PATIENT LEAFLET: INFORMATION FOR THE USER

Levobupivacaine Bioindustria L.I.M. 0.625 mg/ml solution for infusion for epidural use, 1.25 mg/ml solution for infusion for epidural use

Levobupivacaine
Generic Medicine
Please read this leaflet carefully before 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, including those not listed in this leaflet, tell your doctor or nurse. See section 4. Contents of this leaflet:
1. What Levobupivacaine Bioindustria L.I.M. is and what it is used for
2. What you need to know before being administered Levobupivacaine Bioindustria L.I.M.
3. How Levobupivacaine Bioindustria L.I.M. will be administered to you
4. Possible side effects
5. How to store Levobupivacaine Bioindustria L.I.M.
6. Package contents and other information

1. What Levobupivacaine Bioindustria L.I.M. is and what it is used for

Levobupivacaine Bioindustria L.I.M. belongs to a group of medicines called local anaesthetics. This
type of medicine is used to make a part of the body insensitive (anaesthetize) or to relieve
pain.
Levobupivacaine Bioindustria L.I.M. solution for infusion is used only in adults.
Levobupivacaine Bioindustria L.I.M. is used as an analgesic:

after major surgical procedures;
during childbirth.

2. What you should know before being administered Levobupivacaine Bioindustria L.I.M.

Do not use Levobupivacaine Bioindustria L.I.M.

if you are allergic 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;
as a type of analgesic administered by injection around the neck of the uterus (cervix) during early labour (paracervical block);
for anaesthetizing a region by intravenous injection.

Warnings and precautions
Please consult your doctor or nurse before receiving Levobupivacaine Bioindustria L.I.M.,
if you have any of the following diseases or conditions listed below, as you may require more careful monitoring or a lower dose of Levobupivacaine Bioindustria L.I.M.:

if you suffer from diseases affecting the nervous system;
if you are weak or ill;
if you are elderly;
if you have a disease affecting the liver.

Other medicines and Levobupivacaine Bioindustria L.I.M.
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or nurse if you are taking medicines for the treatment of:

irregular heartbeat (such as mexiletine);
fungal infections (such as ketoconazole), as these may affect how long Levobupivacaine Bioindustria L.I.M. remains in your body;
asthma (such as theophylline), as they may alter the duration of Levobupivacaine Bioindustria L.I.M. in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, inform your doctor or nurse before this medicine is administered.
Levobupivacaine Bioindustria L.I.M. must not be administered during childbirth as an analgesic via injection around the neck of the uterus or cervix (paracervical block).
The effect of Levobupivacaine Bioindustria L.I.M. on the unborn baby during early pregnancy is unknown. Therefore, this medicine 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 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 anaesthetic.

Driving and using machines
The use of Levobupivacaine Bioindustria L.I.M. may have a significant effect on your ability to drive or operate machinery. You must not drive or use machinery until all effects of Levobupivacaine Bioindustria L.I.M. and the immediate effects of the surgical procedure have completely worn off. Make sure you have received information about this from your treating doctor or nurse before leaving the hospital.

Levobupivacaine Bioindustria L.I.M. contains sodium
This medicine contains 3.6 mg of sodium (a main component of table salt) per ml of solution. This corresponds to 0.18% of the maximum recommended daily dietary intake of sodium for an adult. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.

3. How Levobupivacaine Bioindustria L.I.M. will be administered to you

This medicine will be administered to you in hospital by specially trained healthcare personnel. If you have any doubts, please consult your doctor or nurse.
Your doctor will administer Levobupivacaine Bioindustria L.I.M. through a small catheter inserted into your back (epidural). While you are receiving Levobupivacaine Bioindustria L.I.M., your doctor and nurse will closely monitor you.
Dosage
The amount of Levobupivacaine Bioindustria L.I.M. you will receive and the timing of administration will depend on the reason for which this medicine is being used, as well as your general health, age, and weight. The lowest effective dose required to anesthetize the part of the body to be treated will always be used. Your doctor will carefully evaluate the appropriate dose for you.
When Levobupivacaine Bioindustria L.I.M. is used as an analgesic during childbirth, particular care must be taken to accurately control the administered dose.
Use in children
The use of this medicine is not recommended in children.
If you receive more Levobupivacaine Bioindustria L.I.M. than you should
If you are given an excessive dose of Levobupivacaine Bioindustria L.I.M., the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), seizures, and in some cases, low blood pressure, increased or slowed heart rate, and changes in heart rhythm (see section "Possible side effects"). Your doctor may need to give you other medicines to help control these symptoms. If you have further questions about the use of this medicine, ask your doctor or nurse.
If you think you have been given too much of this medicine or if you notice any of these symptoms, contact your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects caused by the use of Levobupivacaine Bioindustria L.I.M. can be serious.
Inform your doctor or nurse immediately if you notice any of the following side effects:

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

feeling tired or weak, shortness of breath, paleness (symptoms of anaemia).

Common (may affect up to 1 in 10 people)

problems affecting the foetus (foetal distress).

Frequency not known (frequency cannot be estimated from the available data)

severe allergic reactions (hypersensitivity) causing severe breathing difficulties, difficulty swallowing, hives, very low blood pressure, swelling of the tongue or throat;
respiratory arrest;
cardiac arrest;
loss of consciousness;
paralysis;
convulsions.

Other side effects that may occur:
Very common (may affect more than 1 in 10 people)

low blood pressure;
nausea.

Common (may affect up to 1 in 10 people)

dizziness;
headache;
vomiting;
back pain;
elevated body temperature (fever);
postoperative pain.

Frequency not known (frequency cannot be estimated from the available data)

allergic reactions (hypersensitivity) manifesting as skin redness and itching, sneezing, excessive sweating, rapid heartbeat, fainting, or swelling of the face, lips, or mouth;
drowsiness;
blurred vision;
localized tingling;
tongue numbness;
muscle weakness or muscle contractions;
loss of bladder or bowel control;
tingling, numbness, or other abnormal sensations;
prolonged penile erection which may be painful;
neurological disturbances which may include: drooping eyelid, pupil constriction (the black part in the centre of the eye), sunken eye socket, sweating and/or flushing on one side of the face.

Side effects such as increased, decreased or irregular heartbeat and changes in heart rhythm, detectable by specific tests (electrocardiogram), have also been reported.
Rarely, some of these effects may be long-term or permanent.
Following the use of an excessive dose of this medicine, side effects described in section “If you use too much Levobupivacaine Bioindustria L.I.M.” may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaine Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Expiry”.
The expiry date refers to the last day of that month.
Your doctor will store this medicine for you.
This medicine must be administered immediately after opening and only after medical personnel have ensured that the solution is free from suspended particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levobupivacaine Bioindustria L.I.M. 0.625 mg/ml infusion solution for epidural use contains

The active substance is levobupivacaine hydrochloride. 1 ml contains 0.625 mg of levobupivacaine (equivalent to 0.704 mg of levobupivacaine hydrochloride).
The other components are water for injections, sodium chloride, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

What Levobupivacaine Bioindustria L.I.M. 1.25 mg/ml infusion solution for epidural use contains

The active substance is levobupivacaine hydrochloride. 1 ml contains 1.25 mg of levobupivacaine (equivalent to 1.408 mg of levobupivacaine hydrochloride).
The other components are water for injections, sodium chloride, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Marketing Authorisation Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A. (Bioindustria L.I.M. S.p.A.)
Via De Ambrosiis n. 2
15067 Novi Ligure (Alessandria)
Italy
--------------------- ------------------------------- --------------------------------------------
Package leaflet: information for the physician

Levobupivacaine Bioindustria L.I.M. 0.625 mg/ml infusion solution for epidural use, 1.25 mg/ml infusion solution for epidural use

Levobupivacaine
Generic Medicine
The following information is intended exclusively for physicians or healthcare professionals
Instructions for use and handling
Levobupivacaine Bioindustria L.I.M. 0.625 mg/ml or 1.25 mg/ml infusion solution is for single use only and
is intended solely for epidural administration; it must not be used for intravenous administration.
Do not use if the solution is not clear or if the container is damaged. Discard any unused solution.
As with all parenteral medicines, the solution/dilution must be visually inspected before use. Only clear solutions without visible particles should be used.
Chemical and physical stability after dilution in 0.9% sodium chloride solution: Chemical and physical stability under clinical use conditions of levobupivacaine 0.625 mg/ml and 1.25 mg/ml has been demonstrated when combined with 8.3–8.4 μg/ml clonidine, 50 μg/ml morphine, and 2 μg/ml fentanyl, stored for 30 days both at 2–8 °C and at 20–22 °C.
Chemical and physical stability under clinical use conditions of levobupivacaine 0.625 mg/ml and 1.25 mg/ml has also been demonstrated when combined with sufentanil at a concentration of 0.4 μg/ml, stored for 30 days at 2–8 °C or for 7 days at 20–22 °C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the storage duration and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Experience regarding the safety of levobupivacaine for treatment durations exceeding 24 hours is limited.
Levobupivacaine Bioindustria L.I.M. must not be mixed with other medicinal products except those mentioned above.
Dilutions with alkaline solutions such as sodium bicarbonate may cause precipitation.
Method of Administration
Levobupivacaine must be administered only by, or under the supervision of, a physician with appropriate training and specific experience.
Refer to the Summary of Product Characteristics for dosage information.
Careful aspiration is recommended before administration to avoid intravascular injection.
If toxic symptoms occur, administration must be immediately discontinued.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levobupivacaine Bioindustria L.I.M. 2.5 mg/ml injectable solution / for infusion, 5 mg/ml injectable solution / for infusion

Levobupivacaine
Generic Medicine
Please read this leaflet carefully before using this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or nurse.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or nurse. See section 4.
Contents of this leaflet:

What Levobupivacaine Bioindustria L.I.M. is and what it is used for
What you need to know before Levobupivacaine Bioindustria L.I.M. is administered to you
How Levobupivacaine Bioindustria L.I.M. will be administered to you
Possible side effects
How to store Levobupivacaine Bioindustria L.I.M.
Package contents and other information

1. What Levobupivacaine Bioindustria L.I.M. is and what it is used for

Levobupivacaine Bioindustria L.I.M. belongs to a group of medicines called local anaesthetics.
This type of medicine is used to numb an area of the body (anaesthetize) or to relieve pain.
Adults:
Levobupivacaine Bioindustria L.I.M. is used as a local anaesthetic to numb parts of the body before major surgery (e.g. epidural anaesthesia for caesarean section) and minor surgery (such as eye or mouth procedures). It is also used as an analgesic: after major surgical procedures and during labour.
Children:
Levobupivacaine Bioindustria L.I.M. may also be used in children to anaesthetize parts of the body before surgical procedures and as an analgesic after minor surgery, such as inguinal hernia repair.
Levobupivacaine Bioindustria L.I.M. has not been studied in children under 6 months of age.

2. What you need to know before Levobupivacaine Bioindustria L.I.M. is administered to you

Do not use Levobupivacaine Bioindustria L.I.M.

if you are allergic to levobupivacaine, to any similar local anaesthetic, or to any of the other ingredients of this medicine (listed in section 6);
if you have very low blood pressure;
as a type of analgesic administered by injection around the cervix during early labour (paracervical block);
for anaesthetizing an area by intravenous injection.

Warnings and precautions
Talk to your doctor or nurse before Levobupivacaine Bioindustria L.I.M. is administered to you
if you have any of the following diseases or conditions. You may require closer monitoring or a lower dose of Levobupivacaine Bioindustria L.I.M.:

if you have a heart condition;
if you have diseases affecting the nervous system;
if you are weak or ill;
if you are elderly;
if you have a liver disease.

Other medicines and Levobupivacaine Bioindustria L.I.M.
Inform your doctor or nurse if you are taking, have recently taken, or might take any other
medicines.
In particular, inform your doctor or nurse if you are taking medicines for:

irregular heartbeat (such as mexiletine);
fungal infections (such as ketoconazole), as these may affect how long Levobupivacaine Bioindustria L.I.M. remains in your body;
asthma (such as theophylline), as they may alter the duration of Levobupivacaine Bioindustria L.I.M. in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
inform your doctor or nurse before this medicine is administered.
Levobupivacaine Bioindustria L.I.M. must not be administered during childbirth as an analgesic
by injection around the cervix (paracervical block).
The effect of Levobupivacaine Bioindustria L.I.M. on the unborn child during early pregnancy is
unknown. Therefore, this medicine 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 a similar medicine, it is believed that only small amounts of levobupivacaine may pass into breast milk.
Therefore, breastfeeding is possible after administration of a local anaesthetic.

Driving and using machines
The use of Levobupivacaine Bioindustria L.I.M. may have significant effects on the ability to drive
and operate machinery. You must not drive or operate machinery until all effects of
Levobupivacaine Bioindustria L.I.M. and the immediate effects of the surgical procedure have worn off.
Ensure you receive advice on this matter from your treating doctor or nurse before leaving the hospital.

Levobupivacaine Bioindustria L.I.M. contains sodium
This medicine contains 3.6 mg of sodium (the main component of table salt) per ml of solution.
This corresponds to 0.18% of the maximum daily dietary intake recommended for an adult. This should be taken into account in patients with impaired renal function or those on a low-sodium diet.

3. How Levobupivacaine Bioindustria L.I.M. will be administered to you

This medicine will be administered to you in hospital by specially trained healthcare personnel. If you have any doubts, please consult your doctor or nurse.
Your doctor will administer Levobupivacaine Bioindustria L.I.M. by injection either with a needle or through a small catheter inserted into your back (epidural). Levobupivacaine Bioindustria L.I.M. may also be injected into other parts of the body to anaesthetize the area to be treated, such as the eyes, arm or leg.
Your doctor and nurse will closely monitor you while you are receiving Levobupivacaine Bioindustria L.I.M.
Dosage
The amount of Levobupivacaine Bioindustria L.I.M. you will receive and the timing of administration will depend on the reason why this medicine is being used, as well as on your general health, age and weight. The lowest effective dose required to anaesthetize the body part to be treated will always be used. Your doctor will carefully evaluate the appropriate dose for you.
When Levobupivacaine Bioindustria L.I.M. is used as an analgesic during labour or caesarean section (epidural), particular care must be taken to accurately control the administered dose.
If you are given more Levobupivacaine Bioindustria L.I.M. than you should
If you are accidentally given too high a dose of Levobupivacaine Bioindustria L.I.M., the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), seizures, and in some cases, low blood pressure, increased or slowed heart rate, and changes in heart rhythm (see section “Possible side effects”). Your doctor may need to administer other medicines to help control these symptoms. If you have further questions about the use of this medicine, ask your doctor or nurse.
If you think you have been given too much of this medicine, or if you notice any of these symptoms, contact your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Some of the side effects caused by the use of Levobupivacaine Bioindustria L.I.M. can be serious.
Inform your doctor or nurse immediately if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)

feeling tired or weak, shortness of breath, paleness (symptoms of anaemia).

Common (may affect up to 1 in 10 people)

problems affecting the foetus (foetal distress).

Frequency not known (cannot be estimated from the available data)

severe allergic reactions (hypersensitivity) causing severe breathing difficulties, difficulty swallowing, hives, very low blood pressure, and swelling of the tongue or throat;
respiratory arrest;
cardiac arrest or block;
loss of consciousness;
paralysis;
seizures.

Other side effects that may occur:
Very common (may affect more than 1 in 10 people)

low blood pressure;
nausea.

Common (may affect up to 1 in 10 people)

dizziness;
headache;
vomiting;
back pain;
elevated body temperature (fever);
postoperative pain.

Frequency not known (cannot be estimated from the available data)

allergic reactions (hypersensitivity) presenting as flushed skin and itching, sneezing, excessive sweating, rapid heartbeat, fainting, or swelling of the face, lips, or mouth;
drowsiness;
blurred vision;
localized tingling;
tongue numbness;
muscle weakness or muscle contractions;
loss of bladder or bowel control;
tingling, numbness, or other abnormal sensations;
prolonged penile erection which may be painful;
nervous system disturbances which may include: drooping eyelid, pupil constriction (the black part in the centre of the eye), sunken eye socket, sweating and/or flushing on one side of the face.

Side effects have also been reported including fast, slow or irregular heartbeat and changes in heart rhythm that can be detected by specific tests (electrocardiogram).
Rarely, some of these effects may be long-term or permanent.
Following the use of an excessive dose of this medicine, side effects described in section “If you use more Levobupivacaine Bioindustria L.I.M.” may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaine Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry".
The expiry date refers to the last day of that month.
Your doctor will store this medicine for you.
This medicine must be administered to you immediately after opening and only after medical personnel have ensured that the solution is free from suspended particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Levobupivacaine Bioindustria L.I.M. 2.5 mg/ml solution for injection/-for infusion contains

The active substance is levobupivacaine hydrochloride. Each 1 ml contains 2.5 mg of levobupivacaine (as hydrochloride). Each vial contains 25 mg of levobupivacaine (equivalent to 28.2 mg of levobupivacaine hydrochloride).
The other components are water for injections, sodium chloride, sodium hydroxide (pH regulator), hydrochloric acid (pH regulator).

What Levobupivacaine Bioindustria L.I.M. 5 mg/ml solution for injection/-for infusion contains

The active substance is levobupivacaine hydrochloride. Each 1 ml contains 5 mg of levobupivacaine (as hydrochloride). Each vial contains 50 mg of levobupivacaine (equivalent to 56.3 mg of levobupivacaine hydrochloride).
The other components are water for injections, sodium chloride, sodium hydroxide (pH regulator), hydrochloric acid (pH regulator).

Description of the appearance of Levobupivacaine Bioindustria L.I.M. and contents of the pack
Levobupivacaine Bioindustria L.I.M. is a clear, colourless solution stored in type I glass vials. It is available in packs of 10 vials of 10 ml each.
Marketing Authorisation Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A. (Bioindustria L.I.M. S.p.A.)
Via De Ambrosiis n. 2
15067 Novi Ligure (Alessandria)
Italy
--------------------- ------------------------------- --------------------------------------------
Package leaflet: information for the physician

Levobupivacaine Bioindustria L.I.M. 2.5 mg/ml solution for injection/for infusion, 5 mg/ml solution for injection/for infusion

Levobupivacaine
Generic Medicinal Product
Instructions for Use and Handling
Levobupivacaine Bioindustria L.I.M. 2.5 mg/ml or 5.0 mg/ml solution for injection/for infusion is for single use only. Unused solution must be discarded.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the responsibility for storage conditions and duration of storage prior to use lies with the user.
Experience regarding the safety of levobupivacaine for treatment periods exceeding 24 hours is limited.
Shelf life after first opening: the medicinal product must be used immediately.
Shelf life after dilution with 0.9% sodium chloride solution: chemical and physical stability under in-use conditions has been demonstrated for 7 days at 20–22 °C.
As with all parenteral medicinal products, the solution/dilution must be visually inspected before use. Only clear solutions free from visible particles should be administered.
Dilutions of standard levobupivacaine solutions must be performed using 9 mg/ml (0.9%) sodium chloride injectable solution under aseptic conditions.
Clonidine 8.4 μg/ml, morphine 0.05 mg/ml, and fentanyl 4 μg/ml have demonstrated compatibility with levobupivacaine in 9 mg/ml (0.9%) sodium chloride injectable solution.
Chemical and physical stability under in-use conditions in combination with clonidine, morphine, or fentanyl has been demonstrated for 40 hours at 20–22 °C.
Levobupivacaine Bioindustria L.I.M. must not be mixed with other medicinal products except those mentioned above.
Dilution with alkaline solutions such as sodium bicarbonate may cause precipitation.

Method of Administration
Levobupivacaine must be administered only by, or under the supervision of, a physician with appropriate training and specific experience.
Refer to the Summary of Product Characteristics for dosage-related information.
Careful aspiration before and during administration is recommended to avoid intravascular injection.
Aspiration must be repeated before and during bolus administration, which should be injected slowly in incremental doses at a rate of 7.5–30 mg/min, with close monitoring of the patient's vital functions and maintenance of verbal contact.
If toxic symptoms occur, the injection must be immediately discontinued.

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Levobupivacaine Bioindustria L.I.M. 7.5 mg/ml solution for injection/infusion

Levobupivacaine
Generic Medicine
Please read this leaflet carefully before 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, consult your doctor or nurse.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or nurse. See section 4.
Contents of this leaflet:
1. What Levobupivacaine Bioindustria L.I.M. is and what it is used for
2. What you need to know before being administered Levobupivacaine Bioindustria L.I.M.
3. How Levobupivacaine Bioindustria L.I.M. will be administered
4. Possible side effects
5. How to store Levobupivacaine Bioindustria L.I.M.
6. Contents of the pack and other information

1. What Levobupivacaine Bioindustria L.I.M. is and what it is used for

Levobupivacaine Bioindustria L.I.M. belongs to a group of medicines called local anaesthetics.
This type of medicine is used to numb a part of the body (anaesthetize) or to relieve pain.
Adults:
Levobupivacaine Bioindustria L.I.M. is used as a local anaesthetic to numb areas of the body before major surgery (except caesarean section) and minor surgery (such as eye and mouth procedures). It is also used as an analgesic following major surgical procedures.
Children:
Levobupivacaine Bioindustria L.I.M. can also be used in children to anaesthetize parts of the body before surgical procedures and as an analgesic after minor surgery, such as inguinal hernia repair.
Levobupivacaine Bioindustria L.I.M. has not been studied in children under 6 months of age.

2. What you need to know before being administered Levobupivacaine Bioindustria L.I.M.

Do not use Levobupivacaine Bioindustria L.I.M.

if you are allergic to levobupivacaine, to any similar local anaesthetic, or to any of the other ingredients of this medicine (listed in section 6);
if you have very low blood pressure;
for anaesthetizing an area by intravenous injection;
as an analgesic during labour.

Warnings and precautions
Please consult your doctor or nurse before receiving Levobupivacaine Bioindustria L.I.M.
if you have any of the following diseases or conditions. You may require closer monitoring or a lower dose of Levobupivacaine Bioindustria L.I.M.:

if you have a heart condition;
if you have diseases affecting the nervous system;
if you are weak or ill;
if you are elderly;
if you have a liver disease.

Other medicines and Levobupivacaine Bioindustria L.I.M.
Inform your doctor or nurse if you are currently taking, have recently taken, or might need to take any other
medicines.
In particular, inform your doctor or nurse if you are taking medicines for:

irregular heartbeat (such as mexiletine);
fungal infections (such as ketoconazole), as these may affect how long Levobupivacaine Bioindustria L.I.M. remains in your body;
asthma (such as theophylline), as these may alter the duration of Levobupivacaine Bioindustria L.I.M. in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, inform your doctor or nurse before this medicine is administered.
Levobupivacaine Bioindustria L.I.M. 7.5 mg/ml must not be administered as an analgesic during labour or as a local anaesthetic for caesarean section.
The effect of Levobupivacaine Bioindustria L.I.M. on the unborn baby during early pregnancy is unknown. Therefore, this medicine 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 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 anaesthetic.

Driving and using machines
The use of Levobupivacaine Bioindustria L.I.M. may have a significant effect on your ability to drive or operate machinery. You must not drive or use machinery until all effects of Levobupivacaine Bioindustria L.I.M. and the immediate effects of surgery have completely worn off.
Ensure you receive specific advice on this matter from your treating doctor or nurse before leaving the hospital.

Levobupivacaine Bioindustria L.I.M. contains sodium
This medicine contains 3.6 mg of sodium (a key component of table salt) per ml of solution.
This corresponds to 0.18% of the maximum daily recommended dietary intake for an adult. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.

3. How Levobupivacaine Bioindustria L.I.M. will be administered to you

This medicine will be administered to you in hospital by specialized healthcare personnel. If you have any doubts, please consult your doctor or nurse.
Levobupivacaine Bioindustria L.I.M. can be injected into specific areas of the body to anaesthetize the region to be treated, such as the eyes, arm or leg.
Your doctor and nurse will closely monitor you while Levobupivacaine Bioindustria L.I.M. is being administered.

Dosage
The amount of Levobupivacaine Bioindustria L.I.M. that you will receive and the timing of administration will depend on the reason for which this medicine is being used, as well as your health status, age and weight. The lowest effective dose required to anaesthetize the area to be treated will always be used. Your doctor will carefully evaluate the appropriate dose for you.

If you are given more Levobupivacaine Bioindustria L.I.M. than you should
If you are accidentally given an excessive dose of Levobupivacaine Bioindustria L.I.M., the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), seizures, and in some cases, low blood pressure, increased or slowed heart rate, and changes in heart rhythm (see section “Possible side effects”). Your doctor may need to administer other medicines to help control these symptoms. If you have further questions about the use of this medicine, ask your doctor or nurse.
If you think you have been given too much of this medicine, or if you notice any of these symptoms, contact your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. Some side effects caused by the use of Levobupivacaine Bioindustria L.I.M. can be serious.
Inform your doctor or nurse immediately if you notice any of the following side effects:

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

feeling tired or weak, shortness of breath, pallor (symptoms of anaemia).

Frequency not known (frequency cannot be estimated from the available data)

severe allergic reactions (hypersensitivity) causing severe breathing difficulties, difficulty swallowing, hives, very low blood pressure, and swelling of the tongue or throat;
respiratory arrest;
cardiac arrest or block;
loss of consciousness;
paralysis;
convulsions.

Other possible side effects:

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

low blood pressure;
nausea.

Common (may affect up to 1 in 10 people)

dizziness;
headache;
vomiting;
back pain;
elevated body temperature (fever);
postoperative pain.

Frequency not known (frequency cannot be estimated from the available data)

allergic reactions (hypersensitivity) presenting as skin redness and itching, sneezing, excessive sweating, rapid heartbeat, fainting, or swelling of the face, lips, or mouth;
drowsiness;
blurred vision;
localized tingling;
tongue numbness;
muscle weakness or muscle contractions;
loss of bladder or bowel control;
tingling, numbness, or other abnormal sensations;
prolonged penile erection which may be painful;
neurological disturbances which may include: drooping eyelid, pupil constriction (the black part in the centre of the eye), sunken eye socket, sweating and/or flushing on one side of the face.

Other side effects that have also been reported include increased, slowed, or irregular heartbeat, and changes in heart rhythm detectable by specific tests (electrocardiogram). Rarely, some of these effects may be long-term or permanent.

Following administration of an excessive dose of this medicine, side effects described in the section “If you use more Levobupivacaine Bioindustria L.I.M.” may occur.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaine Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Expiry”.
The expiry date refers to the last day of that month.
Your doctor will store this medicine for you.
This medicine must be administered to you immediately after opening and only after healthcare professionals have ensured that the solution is free from suspended particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levobupivacaine Bioindustria L.I.M. 7.5 mg/ml solution for injection/for infusion contains

The active substance is levobupivacaine hydrochloride. 1 ml contains 7.5 mg of levobupivacaine (as hydrochloride). Each vial contains 75 mg of levobupivacaine (equivalent to 84.4 mg of levobupivacaine hydrochloride).
The other components are water for injections, sodium chloride, sodium hydroxide (pH regulator), hydrochloric acid (pH regulator).

Description of the appearance of Levobupivacaine Bioindustria L.I.M. and contents of the pack
Levobupivacaine Bioindustria L.I.M. is a clear, colourless solution presented in type I glass vials. It is available in packs of 10 vials of 10 ml each.
Marketing Authorisation Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A. (Bioindustria L.I.M. S.p.A.)
Via De Ambrosiis n. 2
15067 Novi Ligure (Alessandria)
Italy
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Package leaflet: information for the physician

Levobupivacaine Bioindustria L.I.M. 7.5 mg/ml solution for injection/infusion

Levobupivacaine
Generic Medicine
The following information is intended exclusively for physicians or healthcare professionals
Instructions for use and handling
Levobupivacaine Bioindustria L.I.M. 7.5 mg/ml solution for injection/infusion is for single use only. Unused solution must be discarded.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the responsibility for storage duration and conditions prior to use lies with the user.
Experience regarding the safety of levobupivacaine for treatment periods exceeding 24 hours is limited.
Shelf-life after first opening: the medicinal product must be used immediately.
Shelf-life after dilution with 0.9% sodium chloride solution: chemical and physical stability under recommended conditions of use has been demonstrated for 7 days at 20–22 °C.
As with all parenteral medicinal products, the solution/dilution must be visually inspected before use. Only clear solutions without visible particles should be administered.
Dilutions of standard levobupivacaine solutions must be performed using 9 mg/ml (0.9%) sodium chloride for injection under aseptic conditions.
Clonidine 8.4 μg/ml, morphine 0.05 mg/ml, and fentanyl 4 μg/ml have shown compatibility with levobupivacaine in 9 mg/ml (0.9%) sodium chloride for injection.
Chemical and physical stability under recommended conditions of use with clonidine, morphine, or fentanyl has been demonstrated for 40 hours at 20–22 °C.
Levobupivacaine Bioindustria L.I.M. must not be mixed with other medicinal products except those mentioned above.
Dilution with alkaline solutions such as sodium bicarbonate may cause precipitation.
Method of Administration
Levobupivacaine must be administered only by, or under the supervision of, a physician with adequate training and specific experience.
Refer to the Summary of Product Characteristics for dosage-related information.
Careful aspiration before and during administration is recommended to avoid intravascular injection.
Aspiration should be repeated before and during the administration of a bolus dose, which must be injected slowly, in incremental doses, at a rate of 7.5–30 mg/min, with close monitoring of the patient's vital functions and maintenance of verbal contact.
If toxic symptoms occur, the injection must be immediately discontinued.