Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
LEVOBUPIVACAINE
Abbott Laboratories Ireland Ltd
0.625
Solution for Infusion
2003-11-18
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 Perskaitykite visą dokumentą