CHIROCAINE Solution for Infusion 0.625
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
LEVOBUPIVACAINE
Available from:
Abbott Laboratories Ireland Ltd
Dosage:
0.625
Pharmaceutical form:
Solution for Infusion
Authorization date:
2003-11-18
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chirocaine 0.625 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Levobupivacaine hydrochloride corresponding to 0.625 mg/ml Levobupivacaine.
Excipients: 3.6mg/ml of sodium per bag.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
_Pain management_
Continuous epidural infusion, for the management of post operative pain and labour analgesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Levobupivacaine should be administered only by, or under the supervision of, a clinician having the necessary training
and experience.
Chirocaine Solution for Infusion is for epidural use only. It must not be used for intravenous administration.
Careful aspiration before infusion is recommended to prevent intravascular injection. If toxic symptoms occur, the
injection should be stopped immediately.
Maximum dose
The maximum dosage must be determined by evaluating the size and physical status of the patient. The maximum
recommended dose during a 24 hour period is 400 mg.
Type of Block
Concentration
mg/ml
Infusion Rate Per Hour
ml
mg
_Continuous Infusion:_
Post operative pain
management
Lumbar epidural
(analgesia in labour)
0.625
0.625
20-30
8-20
12.5-18.75
5–12.5
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/11/2011_
_CRN 2092338_
_page number: 1_
For post-operative pain management, the dose should not exceed 18.75 mg/hour, however the accumulated dose for a
24 hour period should not exceed 400 mg. For labour analgesia by epidural infusion, the dose should not exceed
12.5 mg/ hour.
Children
The safety and efficacy of levobupivacaine
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