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CHIROCAINE 0.625MG/ML SOLUTION FOR INFUSION

Active substance: LEVOBUPIVACAINE HYDROCHLORIDE

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Package leaflet: Information for the user
Chirocaine 0.625 mg/ml or 1.25 mg/ml solution for infusion
For Epidural use only
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. What Chirocaine is and what it is used for
2. What you need to know before you are given Chirocaine
3. How you will be given Chirocaine
4. Possible side effects
5. How to store Chirocaine
6. Contents of the pack and other information

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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.
Chirocaine Solution for Infusion is for adult use only.
Chirocaine is used for pain relief:
• after major surgery
• during childbirth

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
Warnings and precautions
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 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 heartbeats (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.
Pregnancy and breastfeeding
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.
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 stage 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.
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.
Important information about some of the ingredients of Chirocaine
This medicinal product contains 3.6 mg/ml sodium in the bag or ampoule solution to be taken into consideration by patients on a
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controlled sodium diet.

3. How to use Chirocaine
Your doctor will give you Chirocaine through a small tube in your back (epidural). Your doctor and nurse will watch you carefully
while you are being given Chirocaine.
Dosage
Adults:
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 childbirth the dose used should be particularly carefully controlled.
Children:
Not recommended.
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If you get more Chirocaine than you should
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.

4. Possible Side Effects
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)
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
• problems (distress) for an unborn child
• 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
• 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
• 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, you should 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

5. How to store Chirocaine
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date shown 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.
Medicines should not be disposed of through wastewater or household waste. These measures will help to protect the environment.

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LC-13-0824, LC-13-0825 and LC-13-0826

Material Code(+Baxter ELC package No.)

CB-30-01-892 (ELC-04470)

Draft number

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Date Draft created

12 DEC 2014

Country

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Colours

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Font

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Font size (min used)

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Dimensions

200mm wide x 285mm high

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6. Contents of the pack and other information
What Chirocaine contains
The active substance is levobupivacaine (as hydrochloride).
Chirocaine 0.625 mg/ml solution for infusion: One ml contains 0.625 mg levobupivacaine (as the hydrochloride).
Chirocaine 1.25 mg/ml solution for infusion: One ml contains 1.25 mg levobupivacaine (as the hydrochloride).
The other ingredients are water for injections, sodium chloride, sodium hydroxide and a small quantity of hydrochloric acid.
What Chirocaine looks like and contents of the pack
Chirocaine is a clear, colourless solution, in a flexible polyester bag with an aluminium over pouch. Each bag contains 100 ml or 200 ml solution. It
is supplied in packs of 5 bags of the 100 ml or 200 ml solution or 24 or 60 bags of the 100 ml solution and 12 or 32 bags of the 200 ml solution.
(Not all pack sizes may be marketed.)
Marketing Authorisation Holder
United Kingdom
Ireland
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AbbVie Limited,
Abbott House
Block B, Liffey Valley Office Campus, Quarryvale,
Vanwall Road
Co. Dublin,
Vanwall Business Park
Ireland
Maidenhead
Berkshire
SL6 4XE
Manufacturer
Baxter Healthcare S.A, Moneen Road, Castlebar, Ireland
This medicinal product is authorised in the Member States of the EEA under the following names:
Chirocaine: Norway, Italy, Sweden, Portugal, Switzerland, Latvia, Netherlands, Poland, France, UK, Ireland, Finland, Greece, Slovenia, Austria,
Belgium, Hungary, Bulgaria, Czech Republic, Luxembourg.
Chirocane: Spain
This leaflet was last revised in 19 November 2014

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

Chirocaine 0.625 mg/ml or 1.25 mg/ml solution for infusion.
Instructions for use and handling
Chirocaine 0.625 or 1.25 mg/ml solution for infusion is intended for single epidural use only and must not be used for intravenous administration.
Do not use unless the solution is clear and container is undamaged. Discard any unused solution.
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.
Shelf life after dilution in sodium chloride solution 0.9%:
Chemical and physical in-use stability has been demonstrated for both levobupivacaine 0.625 mg/ml and 1.25 mg/ml with 8.3 – 8.4 μg/ml
clonidine, 50 μg/ml morphine and 2 μg/ml fentanyl, stored for 30 days at either 2 – 8ºC or 20 – 22ºC. Chemical and physical in-use stability has
been demonstrated for both levobupivacaine 0.625 mg/ml and 1.25 mg/ml with sufentanil added in the concentration of 0.4 μg/ml and stored for
30 days at 2 – 8ºC or 7 days at 20 – 22ºC.
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 – 8ºC, unless the admix has been prepared in controlled
and validated aseptic conditions.
There is limited safety experience with levobupivacaine therapy for periods exceeding 24 hours.
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.
The Chirocaine 0.625 mg/ml and 1.25 mg/ml solution for infusion is packaged in an integral foil overpouch. Inside the integral foil overpouch
there is a gradient in relative humidity between that of the solution bag headspace and the space between the bag and overpouch. Due to this
phenomenon, a small amount of condensation or water beadlets between the foil overpouch and the bag surfaces may be observed on opening
the foil overpouch. This is considered normal for this product. In line with the product user instructions for parenteral medicinal products, the
primary bag should be checked for leaks on removal of the overpouch. If a leak is confirmed, discard the solution bag, as the sterility of solution
may be impaired.
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 infusion is recommended to prevent intravascular injection. If toxic symptoms occur, the injection should be stopped
immediately.

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EUROPEAN LABELLING CENTRE
AbbVie Technical Information

ARTWORK APPROVAL

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LC-13-0824, LC-13-0825 and LC-13-0826

Material Code(+Baxter ELC package No.)

CB-30-01-892 (ELC-04470)

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Date Draft created

12 DEC 2014

Country

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Colours

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TECHNICAL APPROVAL

Artwork has been technically approved
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DATE 12 Dec 2014

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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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