Levobupivacaine Kabi
Italy
Table of Contents
- PACKAGE LEAFLET: INFORMATION FOR THE USER
- Levobupivacaine Kabi 0.625 mg/ml solution for infusion, 1.25 mg/ml solution for infusion
- PACKAGE LEAFLET: INFORMATION FOR THE USER
- Levobupivacaine Kabi 2.5 mg/ml injection solution / for infusion, 5.0 mg/ml injection solution / for infusion
- INSTRUCTION LEAFLET: INFORMATION FOR THE USER
- Levobupivacaine Kabi 7.5 mg/ml solution for injection/infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Levobupivacaine Kabi 0.625 mg/ml solution for infusion, 1.25 mg/ml solution for infusion
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, inform your doctor or nurse. See section 4.
The name of the medicine is Levobupivacaine Kabi 0.625 mg/ml or 1.25 mg/ml solution for
infusion; throughout the rest of this leaflet it will be referred to as "Levobupivacaine Kabi".
Contents of this leaflet:
- What Levobupivacaine Kabi is and what it is used for
- What you need to know before using Levobupivacaine Kabi
- How to use Levobupivacaine Kabi
- Possible side effects
- How to store Levobupivacaine Kabi
- Contents of the pack and other information
1. What Levobupivacaina Kabi is and what it is used for
Levobupivacaina Kabi belongs to a group of medicines called local anaesthetics. This type of
medicinal product is used to numb a part of the body or to relieve pain.
Levobupivacaina Kabi solution for infusion is used only in adults.
Levobupivacaina Kabi is used as an analgesic:
- after major surgical procedures
- during childbirth.
2. What you need to know before using Levobupivacaine Kabi
Do not take Levobupivacaine Kabi:
- if you are allergic (hypersensitive) to levobupivacaine, to any other local anaesthetic of similar chemical structure, or to any of the other ingredients of this medicine (see section 6)
- if you have very low blood pressure
- to anaesthetize an area by intravenous injection of Levobupivacaine Kabi
- for pain relief by injection around the neck of the uterus (cervix) during early labour (paracervical block)
Warnings and precautions
Inform your doctor before Levobupivacaine Kabi is administered if you have any of the following diseases or conditions. You may require closer monitoring or a lower dose of the medicine.
- 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
Children
This medicine should not be given to children, as safety and efficacy for pain treatment in children have not been established.
Other medicines and Levobupivacaine Kabi
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. In particular, inform them if you are taking medicines for:
- irregular heartbeat (such as mexiletine)
- fungal infections (such as ketoconazole), as this may affect how long Levobupivacaine Kabi remains in your body
- asthma (such as theophylline), as this may affect how long Levobupivacaine Kabi remains in your body
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Levobupivacaine Kabi must not be administered during childbirth as an analgesic by injection around the neck of the uterus or cervix (paracervical block).
The effect of Levobupivacaine Kabi on the unborn child during early pregnancy is unknown.
Therefore, Levobupivacaine Kabi should not be used during the first three months of pregnancy unless your doctor considers it necessary.
It is not known whether levobupivacaine passes into breast milk. However, based on experience with 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 Kabi may have a significant effect on the ability to drive or use machinery.
Do not drive or operate machinery until the effects of Levobupivacaine Kabi and the immediate effects of the surgical procedure have worn off.
Make sure you receive appropriate advice from your treating doctor or nurse before leaving the hospital.
Levobupivacaine 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 for patients on a low-sodium diet.
3. How to use Levobupivacaine Kabi
Your doctor will administer Levobupivacaine Kabi through a small catheter inserted into your back
(epidural). Your doctor and nurse will closely monitor you while you are receiving
Levobupivacaine Kabi.
Dosage
Adults:
The amount of Levobupivacaine Kabi you will be given and the frequency of administration will depend on the reason why this medicine is being used, as well as on your health status, age and weight. The lowest effective dose required to anaesthetize the part of the body to be treated will always be used. Your doctor will carefully assess the appropriate dose for you.
When Levobupivacaine Kabi is used as an analgesic during childbirth, particular care must be taken to accurately control the dose administered.
Children:
Not recommended.
If you use more Levobupivacaine Kabi than you should
If you are given an excessive dose of Levobupivacaine Kabi, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), and even seizures. If you notice any of these symptoms, inform your doctor immediately. Sometimes, an excessive dose of Levobupivacaine Kabi may also cause low blood pressure, a faster or slower heartbeat, and changes in heart rhythm. Your doctor may consider it necessary to administer other medicines to help relieve these symptoms.
If you have any doubts about using this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Immediately inform your doctor or nurse if you notice any of the side effects listed below.
Some side effects caused by the use of Levobupivacaine Kabi may be serious.
Very common (may affect more than 1 in 10 patients)
- 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 patients)
- dizziness
- headache
- vomiting
- fetal problems (fetal distress)
- back pain
- increased body temperature (fever)
- postoperative pain
Not known (frequency cannot be estimated from the available data)
- severe allergic reactions (hypersensitivity) causing severe breathing difficulties, difficulty swallowing, hives, and very low blood pressure
- allergic reactions (hypersensitivity) presenting as skin redness, itching, sneezing, excessive sweating, rapid heartbeat, fainting, or swelling of the face, lips, mouth, tongue, or throat
- loss of consciousness
- drowsiness
- blurred vision
- respiratory arrest
- cardiac block or cardiac arrest
- localized tingling
- tongue numbness
- muscle weakness or muscle contraction
- loss of bladder or bowel control
- paralysis
- seizures
- 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 have also been reported, including fast, slow or irregular heartbeat, and changes in heart rhythm that may be detected on an electrocardiogram.
Rarely, some of these effects may be long-term or permanent.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Levobupivacaine Kabi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 should be used immediately after opening.
Do not use this medicine if you notice visible particles.
This medicine requires no special storage conditions.
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 Kabi contains
The active substance 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 components are water for injections, sodium chloride, and small amounts of sodium
hydroxide and hydrochloric acid.
This medicine contains a excipient with 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 clear, 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 in packs of 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 European Economic Area Member States
under the following names:
| NL (RMS) | Levobupivacaine Fresenius Kabi 0.625 mg/ml solution for infusion Levobupivacaine Fresenius Kabi 1.25 mg/ml solution for infusion | Fresenius Kabi Nederland BV |
| BE | Levobupivacaine Fresenius Kabi 1.25 mg/ml solution for infusion | Fresenius Kabi nv |
| ES | Levobupivacaine Kabi 0.625 mg/ml solution for infusion Levobupivacaine Kabi 1.25 mg/ml solution for infusion | Fresenius Kabi España, S.A.U. |
| FR | Levobupivacaine Kabi 0.625 mg/ml, solution for infusion Levobupivacaine Kabi 1.25 mg/ml, solution for infusion | Fresenius Kabi France |
| IE | Levobupivacaine 0.625 mg/ml solution for infusion Levobupivacaine 1.25 mg/ml solution for infusion | Fresenius Kabi Limited |
| IT | Levobupivacaine Kabi | Fresenius Kabi Italia S.r.l. |
| NO | Levobupivacaine Fresenius Kabi 0.625 mg/ml infusion solution, solution Levobupivacaine Fresenius Kabi 1.25 mg/ml infusion solution, solution | Fresenius Kabi Norge AS |
| PL | Levobupivacaine Kabi | Fresenius Kabi Polska Sp. z o.o. |
| SI | Levobupivakain Kabi 1.25 mg/ml solution for infusion | Fresenius Kabi Deutschland GmbH |
| UK | Levobupivacaine 0.625 mg/ml solution for infusion Levobupivacaine 1.25 mg/ml solution for infusion | Fresenius Kabi Limited |
This summary of product characteristics was last approved in MM/YYYY
--------------------- ------------------------------- --------------------------------------------
The following information is intended exclusively for physicians or specialized healthcare personnel:
Levobupivacaine Kabi 0.625 mg/ml or 1.25 mg/ml infusion solution
Instructions for use and handling
Levobupivacaine Kabi 0.625 mg/ml or 1.25 mg/ml infusion solution is for single epidural use only and must not be used for intravenous administration. Do not use if the solution is not clear or if the container is damaged. Unused solution must be discarded.
As with all parenteral medicinal products, the solution/dilution must be visually inspected before use. Only clear solutions without visible particles may be used.
Stability after dilution:
Chemical and physical stability under conditions of use has been demonstrated for Levobupivacaine Kabi infusion solution
- 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 at 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 standpoint, the medicinal product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the mixing was carried out under 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 cause precipitation.
Experience regarding the safety of levobupivacaine for treatment periods longer than 24 hours is limited.
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 information on dosage.
Careful aspiration is recommended prior to infusion in order to avoid intravascular injection. In case toxic symptoms occur, the injection must be immediately discontinued.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Levobupivacaine Kabi 2.5 mg/ml injection solution / for infusion, 5.0 mg/ml injection solution / for infusion
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 side effects, including those not listed in this leaflet, please inform your doctor or nurse. See section 4.
The name of the medicine is Levobupivacaine Kabi 2.5 mg/ml and 5.0 mg/ml injection solution / for infusion; in the remainder of this leaflet it will be referred to as "Levobupivacaine Kabi".
Contents of this leaflet:
- What Levobupivacaine Kabi is and what it is used for
- What you need to know before using Levobupivacaine Kabi
- How to use Levobupivacaine Kabi
- Possible side effects
- How to store Levobupivacaine Kabi
- Contents of the pack and other information
1. What Levobupivacaine Kabi is and what it is used for
Levobupivacaine Kabi belongs to a group of medicines known as local anaesthetics. This type of
medicine is used to numb a part of the body or to relieve pain.
In adults and adolescents (12 years of age and older):
Levobupivacaine Kabi is used as a local anaesthetic to anaesthetize parts of the body before major
surgery (e.g. epidural anaesthesia for caesarean section) and minor surgery (such as eye and oral
procedures).
It is also used as an analgesic
- after major surgical procedures
- during childbirth.
In children (under 12 years of age):
Levobupivacaine Kabi may also be used in children to anaesthetize parts of the body before surgical
procedures and as an analgesic after minor surgery, such as repair of inguinal hernia.
2. What you need to know before using Levobupivacaine Kabi
Do not take Levobupivacaine Kabi:
- if you are allergic (hypersensitive) to levobupivacaine, to any other local anaesthetic of similar structure, or to any of the other ingredients of this medicine (see section 6)
- if you have very low blood pressure
- to anaesthetize an area by intravenous injection of Levobupivacaine Kabi
- for pain relief by injection around the neck of the uterus (cervix) during early labour (paracervical block)
Warnings and precautions
Tell your doctor before you are given Levobupivacaine Kabi if you have any of the following diseases or conditions. You may require closer monitoring or a lower dose of the medicine.
- 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 Kabi
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. In particular, inform them if you are taking medicines for:
- irregular heartbeat (such as mexiletine)
- fungal infections (such as ketoconazole), as this may affect how long Levobupivacaine Kabi remains in your body
- asthma (such as theophylline), as this may affect how long Levobupivacaine Kabi remains in your body
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Levobupivacaine Kabi must not be administered during childbirth as an analgesic by injection around the neck of the uterus or cervix (paracervical block).
The effect of Levobupivacaine Kabi on the unborn child during early pregnancy is unknown.
Therefore, Levobupivacaine Kabi should not be used during the first three months of pregnancy unless your doctor considers it necessary.
It is not known whether levobupivacaine passes into breast milk. However, based on experience with 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 Kabi may have a significant effect on your ability to drive or use machinery.
Do not drive or operate machinery until the effects of Levobupivacaine Kabi and the immediate effects of the surgical procedure have worn off.
Make sure you have received appropriate advice from your doctor or nurse before leaving the hospital.
Levobupivacaine 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 Levobupivacaine Kabi
Your doctor will administer Levobupivacaine Kabi by injection with a needle or through a small
catheter inserted into your back (epidural). Levobupivacaine Kabi 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 Levobupivacaine Kabi is being administered.
Dosage
The amount of Levobupivacaine Kabi you will receive and how often it is given will depend on the reason
this medicine is being used, as well as your general health, age and weight. The lowest effective dose
required to anaesthetize the body area to be treated will always be used. Your doctor will carefully assess
the appropriate dose for you.
When Levobupivacaine Kabi is used as an analgesic during labour or caesarean section (epidural),
particular care must be taken to accurately control the dose administered.
If you use more Levobupivacaine Kabi than you should
If you are given an excessive dose of Levobupivacaine Kabi, the following symptoms may occur:
numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including
respiratory arrest), and even seizures. If you notice any of these symptoms, inform your doctor immediately.
Sometimes, an excessive dose of Levobupivacaine Kabi may also cause a drop in blood pressure,
an increase or decrease in heart rate, and changes in heart rhythm. Your doctor may decide it is necessary
to give you other medicines to help relieve these symptoms.
If you have any doubts about using this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediately inform your doctor or nurse if you notice any of the side effects listed below.
Some side effects caused by the use of Levobupivacaine 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
- fetal problems (fetal distress)
- back pain
- increased body temperature (fever)
- post-operative pain
Not known (frequency cannot be estimated from the available data)
-
severe allergic reactions (hypersensitivity) causing severe breathing difficulties, difficulty swallowing, hives, and very low blood pressure
-
allergic reactions (hypersensitivity) presenting as redness of the skin,
itching, sneezing, excessive sweating, rapid heartbeat, fainting, or swelling of the
face, lips, mouth, tongue or throat -
loss of consciousness
-
drowsiness
-
blurred vision
-
breathing stops
-
cardiac block or cardiac arrest
-
localized tingling
-
numbness of the tongue
-
muscle weakness or muscle twitching
-
loss of bladder or bowel control
-
paralysis
-
seizures
-
tingling, numbness, or other abnormal sensations
-
prolonged penile erection which may be painful
-
neurological disorders which may include drooping eyelid, constricted pupil (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 fast, slow or irregular heartbeat and changes in heart rhythm detectable by electrocardiogram (ECG).
Rarely, some of these effects may be long-term or permanent.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 Levobupivacaine Kabi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 should 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 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 Kabi contains
The active substance 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 10 ml vial 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 10 ml vial 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 medicinal product 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 the contents of the pack
This medicinal product is a clear, colourless solution in sterile polypropylene vials in 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 European Economic Area countries
under the following names:
| NL (RMS) | Levobupivacaine Fresenius Kabi 2.5 mg/ml solution for injection/infusion Levobupivacaine Fresenius Kabi 5 mg/ml solution for injection/infusion | Fresenius Kabi Nederland BV |
| BE | Levobupivacaine Fresenius Kabi 2.5 mg/ml solution for injection/infusion Levobupivacaine Fresenius Kabi 5 mg/ml solution for injection/infusion | Fresenius Kabi nv |
| CZ | Levobupivacaine Kabi 5 mg/ml | Fresenius Kabi s.r.o., Želetavská 1525/1, 140 00 Prague 4, Czech Republic |
| ES | Levobupivacaine Kabi 2.5 mg/ml solution for injection and infusion Levobupivacaine Kabi 5 mg/ml solution for injection and infusion | Fresenius Kabi España, S.A.U. |
| FR | Levobupivacaine Kabi 2.5 mg/ml, solution for injection/perfusion Levobupivacaine Kabi 5 mg/ml, solution for injection/perfusion | Fresenius Kabi France |
| HR | Levobupivacaine Kabi 5 mg/ml solution for injection/infusion | Fresenius Kabi d.o.o. |
| IE | Levobupivacaine 2.5 mg/ml solution for injection/infusion Levobupivacaine 5 mg/ml solution for injection/infusion | Fresenius Kabi Limited |
| IT | Levobupivacaine Kabi | Fresenius Kabi Italia S.r.l. |
| NO | Levobupivacaine Fresenius Kabi 2.5 mg/ml injection/infusion solution Levobupivacaine Fresenius Kabi 5 mg/ml injection/infusion solution | Fresenius Kabi Norge AS |
| PL | Levobupivacaine Kabi | Fresenius Kabi Polska Sp. z o.o. |
| PT | Levobupivacaine Kabi | Fresenius Kabi Pharma Portugal, Lda. |
| RO | Levobupivacaine Kabi 2.5 mg/ml solution for injection/perfusion Levobupivacaine Kabi 5 mg/ml solution for injection/perfusion | S.C. Fresenius Kabi România S.R.L. |
| SI | Levobupivakain Kabi 2.5 mg/ml solution for injection/infusion Levobupivacaine Kabi 5 mg/ml solution for injection/infusion | Fresenius Kabi Deutschland GmbH |
| SK | Levobupivacaine Kabi 5 mg/ml | Fresenius Kabi s.r.o. |
| UK | Levobupivacaine 2.5 mg/ml solution for injection/infusion Levobupivacaine 5 mg/ml solution for injection/infusion | Fresenius Kabi Limited |
This patient information leaflet was last approved in MM/YYYY
--------------------- ------------------------------- --------------------------------------------
The following information is intended exclusively for physicians or specialized 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 for single use only.
Dispose of any unused solution.
Do not use if the container is damaged.
The solution/dilution must be visually inspected before use. Only clear solutions without visible particles should be used.
Select a blister-packaged vial when a sterile vial surface is required. The vial surface is not sterile if the packaging is not intact.
Dilutions of standard levobupivacaine solutions must be performed with sodium chloride 9 mg/ml (0.9%) 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%) for injection.
Shelf life after first opening: The medicinal product must be used immediately.
Shelf life after dilution:
Chemical and physical in-use stability has been demonstrated for diluted Levobupivacaine Kabi with sodium chloride 9 mg/ml (0.9%) at final concentrations of 0.625 mg/ml and 1.25 mg/ml respectively for 30 days at 2–8°C or 20–25°C.
Chemical and physical in-use stability has been demonstrated for diluted Levobupivacaine Kabi with sodium chloride 9 mg/ml (0.9%) at final concentrations of 0.625 mg/ml and 1.25 mg/ml respectively
- 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 20–25°C.
- with sufentanil added at a concentration of 0.4 µg/ml for 30 days at 2–8°C or 7 days at 20–25°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the dilution has been prepared under 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 cause precipitation.
Experience regarding the safety of levobupivacaine for treatment periods longer than 24 hours is limited.
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 information on dosage.
Careful aspiration before and during injection is recommended to avoid intravascular injection.
Aspiration should be repeated before and during administration of a bolus, which should be injected slowly, in incremental doses, at a rate of 7.5–30 mg/min, with careful monitoring of the patient’s vital functions and maintenance of verbal contact.
If toxic symptoms occur, the injection must be immediately discontinued.
Levobupivacaine Kabi
(levobupivacaine)
2.5 mg/ml and 5.0 mg/ml
Read instructions carefully. By shaking, bring any solution present in the neck of the vial down into the main content.
Hold the vial in the palm of your hand at waist level. Hold the arrow visible on the neck of the vial between thumb and index finger (thumb away from you, on the outside).
Rotate quickly and firmly in a counterclockwise direction.
Firmly push the Luer tip of the syringe into the vial.
Gently invert the vial, holding it with the index finger, and slowly aspirate the contents, taking particular care at the beginning.
INSTRUCTION LEAFLET: INFORMATION FOR THE USER
Levobupivacaine Kabi 7.5 mg/ml solution for injection/infusion
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, 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.
- The name of the medicine is Levobupivacaine Kabi 7.5 mg/ml solution for injection/infusion; throughout the rest of this leaflet it will be referred to as "Levobupivacaine Kabi".
Contents of this leaflet:
- What Levobupivacaine Kabi is and what it is used for
- What you need to know before using Levobupivacaine Kabi
- How to use Levobupivacaine Kabi
- Possible side effects
- How to store Levobupivacaine Kabi
- Contents of the pack and other information
1. What Levobupivacaine Kabi is and what it is used for
Levobupivacaine Kabi belongs to a group of medicines known as local anaesthetics. This type of
medicine is used to numb a part of the body or to relieve pain.
In adults and adolescents (12 years and older):
Levobupivacaine Kabi is used as a local anaesthetic to numb parts of the body before
major surgical procedures (except caesarean section) and minor procedures (such as eye and
dental procedures).
It is also used as an analgesic
- after major surgical procedures
In children (under 12 years of age):
Levobupivacaine Kabi may also be used in children to numb parts of the body before
surgical procedures and as an analgesic after minor surgical procedures, such as inguinal hernia repair.
2. What you need to know before using Levobupivacaine Kabi
Do not take Levobupivacaine Kabi:
- if you are allergic (hypersensitive) to levobupivacaine, to any other similar local anaesthetic, or to any of the other ingredients of this medicine (see section 6)
- if you have very low blood pressure
- to anaesthetize an area by intravenous injection of Levobupivacaine Kabi
- for pain relief by injection around the cervix during early labour (paracervical block)
- for pain relief during labour
- as a local anaesthetic for caesarean section
Warnings and precautions
Inform your doctor before Levobupivacaine Kabi is administered if you have any of the following diseases or conditions. You may require closer monitoring or a lower dose of the medicine.
- 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 Kabi
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. In particular, inform them if you are taking medicines for:
- irregular heartbeat (such as mexiletine)
- fungal infections (such as ketoconazole), as this may affect how long Levobupivacaine Kabi stays in your body
- asthma (such as theophylline), as this may affect how long Levobupivacaine Kabi stays in your body
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Levobupivacaine Kabi 7.5 mg/ml must not be administered for pain relief during labour or as a local anaesthetic for caesarean section.
The effect of Levobupivacaine Kabi on the unborn child during early pregnancy is unknown.
Therefore, Levobupivacaine Kabi should not be used during the first three months of pregnancy unless your doctor considers it necessary.
It is not known whether levobupivacaine passes into breast milk. However, based on experience with 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 Kabi may have a significant effect on the ability to drive or use machinery.
Do not drive or operate machinery until the effects of Levobupivacaine Kabi and the immediate effects of surgery have worn off.
Make sure you have been properly informed by your treating doctor or nurse before leaving the hospital.
Levobupivacaine 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 for patients on a low-sodium diet.
3. How to use Levobupivacaine Kabi
Levobupivacaine Kabi 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 Kabi.
Dosage
The amount of Levobupivacaine Kabi you will receive and how often it is given 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 anaesthetize the part of the body to be treated will always be used. Your doctor will carefully assess the appropriate dose for you.
If you are given more Levobupivacaine Kabi than you should
If you are given an excessive dose of Levobupivacaine Kabi, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), and even convulsions. If you notice any of these symptoms, inform your doctor immediately. Sometimes, an excessive dose of Levobupivacaine Kabi may also cause low blood pressure, a faster or slower heartbeat, and disturbances in heart rhythm. Your doctor may consider it necessary to give you other medicines to help relieve these symptoms.
If you have any doubts about how to use this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediately inform your doctor or nurse if you notice any of the side effects listed below.
Some side effects caused by the use of Levobupivacaine 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
- increased body temperature (fever)
- postoperative pain
Not known (frequency cannot be estimated from the available data)
- severe allergic reactions (hypersensitivity) causing severe breathing difficulties, difficulty swallowing, hives, and very low blood pressure
- allergic reactions (hypersensitivity) presenting as skin redness, itching, sneezing, excessive sweating, rapid heartbeat, fainting, or swelling of the face, lips, mouth, tongue or throat
- loss of consciousness
- drowsiness
- blurred vision
- respiratory arrest
- cardiac block or cardiac arrest
- localized tingling
- numbness of the tongue
- muscle weakness or muscle contraction
- loss of bladder or bowel control
- paralysis
- seizures
- 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 reported include fast, slow or irregular heartbeat, and changes in heart rhythm that may be detected on an electrocardiogram (ECG).
Rarely, some of these effects may be long-term or permanent.
Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 Levobupivacaine Kabi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 should be used immediately after opening.
Do not use this medicine if you notice the presence of visible particles.
This medicine requires no special storage conditions.
Do not dispose of medicines 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 Kabi contains
The active substance 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 10 ml vial 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 medicinal product 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 package contents
This medicine is a clear, colourless solution in sterile blister packs containing polypropylene vials. 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 European Economic Area Member States
under the following names:
| NL (RMS) | Levobupivacaine Fresenius Kabi 7.5 mg/ml solution for injection/infusion | Fresenius Kabi Nederland B.V. |
| BE | Levobupivacaine Fresenius Kabi 7.5 mg/ml solution for injection/infusion | Fresenius Kabi N.V. |
| CZ | Levobupivacaine Kabi 7.5 mg/ml | Fresenius Kabi s.r.o., Želetavská 1525/1, 140 00 Prague 4, Czech Republic |
| ES | Levobupivacaine Kabi 7.5 mg/ml solution for injection and perfusion | Fresenius Kabi España, S.A.U. |
| FR | Levobupivacaine Kabi 7.5 mg/ml, solution for injection/perfusion | Fresenius Kabi France |
| IE | Levobupivacaine 7.5 mg/ml solution for injection/infusion | Fresenius Kabi Limited |
| IT | Levobupivacaine Kabi | Fresenius Kabi Italia S.r.l. |
| NO | Levobupivacaine Fresenius Kabi 7.5 mg/ml injection/infusion solution | Fresenius Kabi Norge AS |
| PL | Levobupivacaine Kabi | Fresenius Kabi Polska Sp. z o.o. |
| PT | Levobupivacaine Kabi | Fresenius Kabi Pharma Portugal, Lda. |
| RO | Levobupivacaine Kabi 7.5 mg/ml solution for injection/perfusion | S.C. Fresenius Kabi România S.R.L. |
| SI | Levobupivacaine Kabi 7.5 mg/ml solution for injection/infusion | Fresenius Kabi Deutschland GmbH |
| SK | Levobupivacaine Kabi 7.5 mg/ml | Fresenius Kabi s.r.o. |
| UK | Levobupivacaine 7.5 mg/ml solution for injection/infusion | Fresenius Kabi Limited |
This patient information leaflet was last approved in MM/YYYY
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The following information is intended exclusively for physicians or specialized healthcare personnel:
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. Unused solution must be discarded.
Do not use if the container is damaged.
The solution/dilution must be visually inspected before use. Only clear solutions without visible particles should be used.
Select a vial in a sterile blister when a sterile vial surface is required. The vial surface is not sterile if the packaging is not intact.
Dilutions of standard levobupivacaine solutions must be performed with 9 mg/ml (0.9%) sodium chloride 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 demonstrated compatibility with levobupivacaine in 9 mg/ml (0.9%) sodium chloride for injection.
Shelf life after first opening: The medicinal product must be used immediately.
Shelf life after dilution:
Chemical and physical in-use stability has been demonstrated for Levobupivacaine Kabi diluted with 9 mg/ml (0.9%) sodium chloride to a final concentration of 0.625 mg/ml and 1.25 mg/ml, respectively, for 30 days at 2–8°C or 20–25°C.
Chemical and physical in-use stability has been demonstrated for Levobupivacaine Kabi diluted with 9 mg/ml (0.9%) sodium chloride to a final concentration of 0.625 mg/ml and 1.25 mg/ml, respectively:
- 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 20–25°C.
- with sufentanil added at a concentration of 0.4 µg/ml for 30 days at 2–8°C or 7 days at 20–25°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally should not 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 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 treatment periods exceeding 24 hours is limited.
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 information on dosage.
Careful aspiration is recommended before and during injection to avoid intravascular injection.
Aspiration should be repeated before and during bolus administration, 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.
Levobupivacaine Kabi
(levobupivacaine)
7.5 mg/ml
Read instructions carefully. Shake gently to bring any solution present in the neck of the vial into the main body of the vial.
Hold the vial in the palm of your hand at waist level. Grasp the arrow on the neck of the vial between thumb and index finger (thumb pointing away from you).
Rotate quickly and firmly in a counterclockwise direction.
Firmly insert the tip of the luer syringe into the vial.
Gently invert the vial, holding it with the index finger, and slowly aspirate the contents, taking particular care at the beginning.
