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LEVOBUPIVACAINE 7.5 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): LEVOBUPIVACAINE HYDROCHLORIDE

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• if you suffer from diseases of the nervous system
• if you are weak or ill
• if you are elderly
• if you have liver disease.

01-59-12-xxx

Package leaflet: Information for the user

Other medicines and Levobupivacaine
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:
• irregular heart beats (such as mexiletine)
• fungal infections (such as ketoconazole) since this may affect how long Levobupivacaine
stays in your body
• asthma (such as theophylline) since this may affect how long Levobupivacaine stays in
your body.

Levobupivacaine 7.5 mg/ml
solution for injection/infusion
Levobupivacaine


Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is Levobupivacaine 7.5 mg/ml
solution for injection/infusion; in the rest of the leaflet it will be
called “Levobupivacaine ”

What is in this leaflet:

Levobupivacaine 7.5 mg/ml should not be given as pain relief during labour or as a local
anaesthetic during caesarean section.
The effect of Levobupivacaine on the child during the early stages of pregnancy is not known.
Therefore, Levobupivacaine should not be used during the first three months of your pregnancy,
unless your doctor thinks it is necessary.

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What Levobupivacaine is and what it is used for
1. What Levobupivacaine is and what it is used for
2. What you need to know before you are given Levobupivacaine
3. How to use Levobupivacaine
4. Possible side effects
5. How to store Levobupivacaine

1. What Levobupivacaine is and what it is used for

Levobupivacaine belongs to a group of medicines called local anaesthetics. This type of medicine
is used to make an area of the body numb or free from pain.
In adults:
Levobupivacaine is used as a local anaesthetic to numb parts of the body before major surgery
(except for caesarean section) and minor surgery.
It is also used for:
• pain relief after major surgery

2. What you need to know before you are given Levobupivacaine

Do not use Levobupivacaine :
• if you are allergic to levobupivacaine, to any similar local anaesthetics or to any of the other
ingredients of this medicine (listed in section 6).
• if you have very low blood pressure
• to numb an area by injecting Levobupivacaine into a vein
• as pain relief during labour
• as a type of pain relief given by injection into the area around the neck of the womb (the cervix)
during the early stage of labour (paracervical block).
• as a local anaesthetic for caesarean section.

It is not known if levobupivacaine passes into breast milk. However from the experience with
a similar drug, only small amounts of levobupivacaine are expected to pass into breast milk.
Breastfeeding is therefore possible after having a local anaesthetic.
Driving and using machines
The use of Levobupivacaine can have a considerable effect on the ability to drive or use
machines. You must not drive or operate machinery until all the effects of Levobupivacaine and
the immediate effects of surgery have worn off. Make sure you get advice about this matter from
the doctor or nurse who is treating you, before leaving hospital.
Levobupivacaine contains sodium
This medicinal product contains 1.57 mmol (or 36 mg) sodium per ampoule of 10 ml solution. To
be taken into consideration by patients on a controlled sodium diet.

3. How to use Levobupivacaine

Levobupivacaine can be injected into parts of the body to numb the area that you will have
treated, such as arm or leg.
Your doctor and nurse will watch you carefully while you are being given Levobupivacaine .
Dosage
The amount of Levobupivacaine you will be given and how often it is given will depend on why
it is being used and also on your health, age and weight. The smallest dose that can produce
numbness in the required area will be used. The dose will be carefully worked out by your doctor.
If you get more Levobupivacaine than you should
If you get more Levobupivacaine than you should, you may have numbness of the tongue,
dizziness, blurred vision, muscle twitching, severe breathing difficulties (including stopping
breathing) and even fits (convulsions). If you notice any of these symptoms, tell your doctor
immediately. Sometimes too much Levobupivacaine may also cause low blood pressure, fast
or slow heartbeats and changes in your heart rhythm. Your doctor may need to give you other
medicines to help stop these symptoms.

Warnings and precautions
Talk to your doctor before you are given Levobupivacaine if you have any of the diseases or
conditions below. You may need to be checked more closely or given a smaller dose.
• if you have a heart condition

If you have any further questions on the use of this medicine, ask your doctor or nurse.

The following information is intended for medical or health care professionals only:

Shelf life after dilution:
Chemical and physical in-use stability has been demonstrated for Levobupivacaine diluted with
sodium chloride 9 mg/ml (0.9%) solution to a final concentration of 0.625 mg/ml and 1.25 mg/ml,
respectively for 30 days either 2-8°C or 20°C – 25°C.
Chemical and physical in-use stability has been demonstrated for Levobupivacaine 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 8.4 µg/ml clonidine hydrochloride, 50 µg/ml morphine sulfate and 2-4 µg/ml fentanyl
citrate for 30 days at either 2-8°C or 20°C–25°C .
- With sufentanil added in the concentration of 0.4 µg/ml for 30 days at 2-8 °C or 7 days at
20 °C-25 °C.

Levobupivacaine 7.5 mg/ml solution for injection/infusion.
Instructions for use and handling
Levobupivacaine 7.5 mg/ml solution for injection/infusion is intended for single use only. Discard
any unused solution.
Do not use unless the container is undamaged
The solution/dilution should be inspected visually prior to use. Only clear solutions without visible
particles should be used.

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A sterile blister container should be chosen when a sterile ampoule surface is required. Ampoule
surface is not sterile if sterile blister is pierced.

From a microbiological point of view, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 to 8c, unless the dilution and admix have taken
place in controlled and validated aseptic conditions.

Dilutions of levobupivacaine standard solutions should be made with sodium chloride 9mg/ml
(0.9%) solution for injection using aseptic techniques.

Levobupivacaine must not be mixed with any other medicinal products except those listed above.
Dilution with alkaline solutions such as sodium bicarbonate may result in precipitation.

Clonidine 8.4ug/ml, morphine 0.05mg/ml, fentanyl 2-4ug/ml and sufentail 0.4ug/ml have been
shown to be compatible with levobupivacaine in sodium chloride 9mg/ml (0.9%) solution for
injection.

There is limited experience with levobupivacaine therapy for periods exceeding 24 hours.

Shelf life after first opening: The product should be used immediately.

Method of administration
Levobupivacaine should be administered only by, or under the supervision of, a clinician having
the necessary training and experience.
Please refer to the summary of product characteristics for posology information.
Careful aspiration before and during injection is recommended to prevent intravascular injection.
Aspiration should be repeated before and during administration of a bolus dose, which should be
injected slowly and in incremental doses, at a rate of 7.5–30 mg/min, while closely observing the
patient’s vital functions and maintaining verbal contact.
If toxic symptoms occur, the injection should be stopped immediately.

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4. Possible side effects

5. How to store Levobupivacaine

Tell your doctor or nurse immediately if you notice any of the following side effects.
Some side effects with Levobupivacaine can be serious.
Very common (may affect more than 1 in 10 people):
• feeling tired or weak, short of breath, looking pale (these are all signs of anaemia)
• low blood pressure
• nausea

This medicinal product does not require any special storage conditions.

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

Common (may affect up to 1 in 10 people):

Keep this medicine out of the sight and reach of children.
Do not use Levobupivacaine after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.
Your doctor will store this medicine for you.
The solution should be used immediately after opening.
Do not use this medicine if there are visible particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

• dizziness
• headache
• vomiting
• back pain
• high body temperature (fever)
• pain after surgery

6. Contents of the pack and other information

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

• serious allergic (hypersensitive) reactions which cause severe breathing difficulties, difficulty in
swallowing, hives and very low blood pressure

• allergic (hypersensitive) reactions recognised by red itchy skin, sneezing, sweating a lot, rapid
heartbeat, fainting or swelling of the face, lips, mouth, tongue or throat.

• loss of consciousness
• drowsiness
• blurred vision
• breathing stopping
• heart block or heart stopping
• localised tingling
• numbness of the tongue
• muscle weakness or twitching
• loss of bladder or bowel control
• paralysis
• fits (convulsions)
• tingling, numbness or other abnormal sensation
• prolonged erection of the penis that may be painful
• nerve disorder which can include drooping of the eyelid, small pupil (black center of the eye),

sunken eye socket, sweating and/or redness in one side of the face
Fast, slow or irregular heartbeats, and heart rhythm changes that can be seen on an ECG, have
also been reported as side effects.
Rarely, some side effects may be long-term or permanent.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly:
For UK: via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

What Levobupivacaine contains
- The active substance is levobupivacaine (as levobupivacaine hydrochloride). Levobupivacaine
7.5mg/ml solution for injection/infusion: 1ml solution contains 7.5mg levobupivacaine (as
levobupivacaine hydrochloride). Each ampoule of 10ml contains 75mg levobupivacaine (as
levobupivacaine hydrochloride).
The other ingredients are water for injection, sodium chloride, and small quantity of sodium
hydroxide and hydrochloric acid.
This medicine contains an excipient with known effect (sodium). See section 2 for further
information.
pH 4.0-6.0
Osmolarity: 272 – 372 mOsmol/l
What Levobupivacaine looks like and contents of the pack
This medicine is a clear, colourless solution, in polypropylene ampoules in sterile blister pack.
Each ampoule contains 10 ml of solution. It is supplied in packs of 5, 10 or 20 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Limited,
Cestrian Court,
Eastgate Way,
Manor Park,
Runcorn,
Cheshire
WA7 1NT
United Kingdom
Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

For IE: Reports may be made by following the links to the online reporting
option accessible from the IMB homepage, or by completing the
downloadable report form also accessible from the IMB website, which may
be completed manually and submitted to the IMB via freepost, to the
following address:
FREEPOST
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

This leaflet was last revised in 03/2014

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By reporting side effects you can help provide more information on the safety of this medicine.

Levobupivacaine®
(levobupivacaine)
7.5 mg/ml

Read the label carefully. Shake down any contents from the neck.

Hold ampoule in palm of
hand waist height. Hold arrow
on ampoule held
between thumb and forefinger
(thumb away from you). Twist
quickly and sharply towards
you (anti-clockwise).

Push firmly the tapered luer
tip of syringe into ampoule.

Gently push the ampoule
towards you with the forefinger and withdraw the content
slowly, taking special care at
first.

01-59-12-xxx

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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