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CHIROCAINE 5 MG/ML SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): LEVOBUPIVACAINE HYDROCHLORIDE

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Label Center Ludwigshafen
CR No.:
CR-0001769-2014
Commodity No.: 20002632
Draft No.:
3
Revision date: 18. Dec. 2014
Graphic Artist: G. Tittes

Customer:
Campoverde
Product name/Country: Chirocaine 2.5 mg/ml, 5.0 mg/ml / GB/IE
Size:
330 x 270 mm, folded 85 x 135 mm
Paper:
50 g/mq, presence of perforated line
Pharma code:
IXXI (21)

20002632

20002632

Package leaflet: Information for the user

Chirocaine® 2.5 mg/ml and 5.0 mg/ml
solution for injection/concentrate
for solution for infusion
Levobupivacaine
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor, pharmacist or nurse. See section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Chirocaine is and what it is used for
What you need to know before you are given Chirocaine
How you will be given Chirocaine
Possible side effects
How to store Chirocaine
Contents of the pack and other information

1. What Chirocaine is and what it is used for
Chirocaine 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.
Adults:
Chirocaine is used as a local anaesthetic to numb parts of the body before major
surgery (for example as an epidural for caesarean section) and minor surgery (such
as on the eye and mouth).
It is also used for pain relief:

after major surgery

during childbirth
Children:
Chirocaine can also be used with children to numb parts of the body before surgery
and for pain relief after minor surgery, such as the repair of a groin hernia.
Chirocaine has not been tested in children less than 6 months of age.

Min. text size: 8 pt
Colors:
Black

2. What you need to know before you use Chirocaine
Do not use Chirocaine:
• if you are allergic (hypersensitive) 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
• 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)
• to numb an area by injecting Chirocaine into a vein

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 Chirocaine 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 Chirocaine
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.

Warnings and precautions:
Important information about some of the ingredients of Chirocaine
Talk to your doctor, pharmacist or nurse before you are given Chirocaine 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 suffer from diseases of the nervous system
if you are weak or ill
if you are elderly
if you have liver disease.

Other medicines and Chirocaine:
Tell your doctor, pharmacist or nurse if you are taking, using or 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 Chirocaine
stays in your body
• asthma (such as theophylline) since this may affect how long Chirocaine stays in
your body.

This medicinal product contains 3.6 mg/mL sodium in the bag or ampoule solution
to be taken into consideration by patients on a controlled sodium diet.

3. How to use Chirocaine
Your doctor will give you Chirocaine by injection through a needle or into a small
tube in your back (epidural). Chirocaine can also be injected into other parts of the
body to numb the area that you will have treated, such as the eye, arm or leg.
Your doctor and nurse will watch you carefully while you are being given Chirocaine.
Dosage
The amount of Chirocaine 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.
When Chirocaine is used for pain relief during labour or for childbirth by caesarean
section (an epidural), the dose used should be particularly carefully controlled.

Pregnancy and breastfeeding

If you get more Chirocaine than you should

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

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

Chirocaine must not be a given for pain relief by injection into the area around the
neck of the womb or cervix during childbirth (paracervical block).
The effect of Chirocaine on the child during the early stages of pregnancy is not
known. Therefore, Chirocaine should not be used during the first three months of
your pregnancy, unless your doctor thinks it is necessary.

-----------------------------------------------------------------------------------------------------------------------------&----------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or health professionals only:
Chirocaine 2.5 mg/ml or 5.0 mg/ml solution for injection/concentrate for solution
for infusion.

Shelf life after dilution in sodium chloride solution 0.9%: Chemical and physical
in-use stability has been demonstrated for 7 days at 20-22°C.
As for all parenteral medicinal products, the solution/dilution should be inspected
visually prior to use. Only clear solutions without visible particles should be used.

Instructions for use and handling
Chirocaine 2.5mg/ml or 5.0mg/ml solution for injection/concentrate for solution for
infusion is intended for single use only. Discard any unused solution.
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.
There is limited safety experience with levobupivacaine therapy for periods
exceeding 24 hours.
Shelf life after first opening: The product should be used immediately.

20002632.indd 1

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.

A sterile blister container should be chosen when a sterile ampoule surface is
required. Ampoule surface is not sterile if sterile blister is pierced.
Dilutions of levobupivacaine standard solutions should be made with sodium
chloride 9 mg/ml (0.9%) solution for injection using aseptic techniques.
Clonidine 8.4 μg/ml, morphine 0.05 mg/ml and fentanyl 4 μg/ml have been shown
to be compatible with levobupivacaine in sodium chloride 9 mg/ml (0.9%) solution for injection. Chemical and physical in-use stability with clonidine, morphine or
fentanyl has been demonstrated for 40 hours at 20-22°C.

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.

Chirocaine 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.

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4. Possible Side Effects

• 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

Like all medicines, this medicine can cause side effects, although not everybody
gets them. Some side effects with Chirocaine can be serious.
Tell 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, short of breath, looking pale (these are all signs of anaemia)

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

Common: may affect up to 1 in 10 people
• Problems (distress) for an unborn child
Not known: frequency cannot be estimated from the available data
• Serious allergic (hypersensitive) reactions which cause severe breathing
difficulties, difficulty in swallowing, hives, very low blood pressure, and swelling of
the tongue or throat.
• Breathing stopping
• Heart block or heart stopping
• Loss of consciousness
• Paralysis
• Fits (convulsions)
Other side effects that may also 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
• high body temperature (fever)
• pain after surgery
Not known; frequency cannot be estimated from the available data
• allergic (hypersensitive) reactions recognised by red itchy skin, sneezing, sweating
a lot, rapid heartbeat, fainting or swelling of the face, lips and, mouth
• drowsiness
• blurred vision
• localized tingling
• heart block or heart stopping
• numbness of the tongue
• muscle weakness or twitching
• loss of bladder or bowel control
• tingling, numbness or other abnormal sensation
• prolonged erection of the penis that may be painful

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 (see details below). By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion:
One ml contains 2.5 mg levobupivacaine (as hydrochloride). Each ampoule contains
25 mg in 10 ml.
Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion:
One ml contains 5 mg levobupivacaine (as hydrochloride). Each ampoule contains
50 mg in 10 ml.
The other ingredients are water for injection, sodium chloride, sodium hydroxide
and a small quantity of hydrochloric acid.
What Chirocaine looks like and contents of the pack
Chirocaine Solution for injection / concentrate for solution for infusion is available
in strengths containing 2.5 mg or 5.0 mg of levobupivacaine per ml. It is a clear,
colourless solution, in polypropylene ampoules. Each ampoule contains 25 mg or
50 mg levobupivacaine in a 10 ml ampoule. It is supplied in packs of 5, 10 or 20
ampoules.
Marketing Authorisation Holder
United Kingdom
AbbVie Ltd
Abbott House
Vanwall Road
Vanwall Business Park
Maidenhead
Berkshire
SL6 4XE

Ireland
AbbVie Limited
Block B
Liffey Valley Office Campus
Quarryvale,
Co. Dublin
Ireland

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

AbbVie S.r.l., S.R. 148 Pontina km 52 s.n.c., 04011 Campoverde di Aprilia (LT), Italy
This medicinal product is authorised in the Member States of the EEA under the following names:

Medicines should not be disposed of through wastewater or household waste.
These measures will help to protect the environment.

Chirocaine: Sweden, Portugal, Switzerland, Latvia, Netherlands, Poland, France,
UK, Ireland, Finland, Greece, Slovenia, Austria, Belgium, Hungary, Bulgaria, Czech
Republic, Luxembourg
Chirocane: Spain

6. Contents of the pack and other information

This leaflet was last revised in November 2014

What Chirocaine contains

Detailed information on this medicine is available from the websites below:
United Kingdom:

www.mhra.gov.uk

Ireland:

www.hpra.ie

The active substance is levobupivacaine (as hydrochloride).

---------------------------------------------------------------------------------------------------------------------------------------------------------&---------------------------------------------------------------------------------------------------------------------------------------------------------------

CHIROCAINE®
LEVOBUPIVACAINE HCL
2.5 mg/ml AND 5.0 mg/ml

2
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 (anticlockwise).

4-5
Gently push the ampoule towards you with the forefinger and
withdraw the content slowly, taking special care at first.

ADMINISTRATORS’ INSTRUCTIONS

1
Read the label carefully. Shake down any contents from the
neck.

3
Push firmly the tapered luer tip of syringe into ampoule.

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18.12.14 13:03

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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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