Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
LEVOBUPIVACAINE
Abbott Laboratories Ireland Ltd
LEVOBUPIVACAINE
5.0mg/ml Mg/Ml
Solution injection or concentrate for solution infusion
Withdrawn
2008-04-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains 5 mg levobupivacaine as levobupivacaine hydrochloride. Each ampoule contains 50 mg in 10 ml. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/concentrate for solution for infusion. Clear colourless solution, practically free of particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults _Surgical anaesthesia_ o Major, e.g. epidural (including for caesarean section), intrathecal, peripheral nerve block. o Minor, e.g. local infiltration, peribulbar block in ophthalmic surgery. _Pain management_ o Continuous epidural infusion, single or multiple bolus epidural administration for the management of pain especially post-operative pain or labour analgesia. Children Analgesia (ilioinguinal/iliohypogastric blocks). 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. The table below is a guide to dosage for the more commonly used blocks. For analgesia (e.g. epidural administration for pain management), the lower concentrations and doses are recommended. Where profound or prolonged anaesthesia is required with dense motor block (e.g. epidural or peribulbar block), the higher concentrations may be used. 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 c Preberite celoten dokument