Medication Guide App

CHIROCAINE 0.625MG/ML SOLUTION FOR INFUSION

Active substance: LEVOBUPIVACAINE HYDROCHLORIDE

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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 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 or nurse.
In this leaflet:
1. What Chirocaine is and what it is used for
2. Before you are given Chirocaine
3. How you will be given Chirocaine
4. Possible side effects
5. How to store Chirocaine
6. Further information

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For Epidural use only
Levobupivacaine

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Chirocaine 0.625 mg/ml or 1.25 mg/ml solution for infusion

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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. BEFORE YOU ARE GIVEN CHIROCAINE
Do not use Chirocaine:
• if you are allergic (hypersensitive) to levobupivacaine, to any similar local anaesthetics or to any of the other ingredients in Chirocaine
(see 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.
Take special care with Chirocaine:
Tell your doctor 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.
Taking other medicines
Please, tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines you have obtained without a
prescription. 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.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding.
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. Breast-feeding is therefore possible after having a local anaesthesic.
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 controlled
sodium diet.

3. HOW YOU WILL BE GIVEN CHIROCAINE

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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.
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.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Chirocaine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if you notice any of the following side effects. Some side effects with Chirocaine can be serious.
very common:
common:
uncommon:
rare:
very rare:
not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data

Very common side effects are:
• feeling tired or weak, short of breath, looking pale (these are all signs of anaemia)
• low blood pressure
• nausea.
Common side effects are:
• dizziness
• headache
• vomiting
• problems (distress) for an unborn child
• back pain
• high body temperature (fever)
• pain after surgery.
Other side effects (frequency not known) are:
• 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 centre of the eye), sunken eye socket, sweating and/or redness on
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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse right away.

5. HOW TO STORE CHIROCAINE
• Keep out of the reach and sight of children.
• Do not use Chirocaine 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.

6. FURTHER INFORMATION
What Chirocaine contains
The active ingredient 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
In the UK: Abbott Laboratories Ltd, Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE, United Kingdom
In Ireland: Abbott Laboratories Ireland Ltd, 4051 Kingswood Drive, Citywest Business Campus, Dublin 24, Ireland
Manufacturer
Abb
Logistics B.V., Meeuwenlaan 4
BZ Zwolle, The Netherlands
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 August 2012.

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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 after opening. 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.
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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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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