Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
BUPIVACAINE HYDROCHLORIDE
Pfizer Healthcare Ireland
5.0 Mg/Ml
Solution for Injection
2011-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bupivacaine Pfizer 5mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 5 mg of Bupivacaine hydrochloride monohydrate Each vial with 10ml solution contains 50mg of bupivacaine hydrochloride monohydrate. Each vial with 20ml solution contains 100mg of bupivacaine hydrochloride monohydrate. Excipient: Each ml of the solution contains 3.15 mg of Sodium. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. A clear, colourless, aqueous, sterile solution. pH of the solution is between 4.0 and 6.5 and osmolarity is 290 mOsmol/l. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the production of local anaesthesia by peripheral nerve block(s) and central neural block (caudal or epidural), that is, for specialist use in situations where prolonged anaesthesia is required. Bupivacaine-Pfizer is also indicated for the relief of labour pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage varies and depends upon the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance and the technique of anaesthesia used. The lowest dosage needed to provide effective anaesthesia should be administered. For most indications, the duration of anaesthesia with Bupivacaine solutions is such that a single dose is sufficient. The maximum dosage must be determined by evaluating the size and physical status of the patient and considering the usual rate of systemic absorption from a particular injection site. Experience to date indicates a single dose of up to 150mg bupivacaine hydrochloride monohydrate. Doses of up to 50mg 2-hourly may subsequently be used. A maximum dose of 2mg/kg should no Izlasiet visu dokumentu