País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
BUPIVACAINE HYDROCHLORIDE, MONOHYDRATE
Baxter Healthcare Limited
2.5 Mg/Ml
Solution for Injection
2003-05-02
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bupivacaine Hydrochloride 2.5 mg/ml (0.25% w/v) Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bupivacaine Hydrochloride 2.5 mg/ml (0.25% w/v) Solution for Injection contains 2.5 mg bupivacaine hydrochloride per ml (as monohydrate). Each 5ml ampoule contains 12.5 mg bupivacaine hydrochloride. Each 10ml ampoule contains 25 mg bupivacaine hydrochloride. Each 20ml ampoule contains 50 mg bupivacaine hydrochloride. For excipients see 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o Local Infiltration. o Peripheral Nerve Blocks. o Central Nerve Blocks (Epidural and Spinal Anaesthesia). For local or regional anaesthesia and/or analgesia for surgical, diagnostic and obstetric procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: The following recommended bupivacaine doses (Table 1) serve as a guideline for an average adult with a body weight of approximately 70 kg. The dosage varies and depends upon the area(s) to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance and the anaesthetic technique that is to be used. The lowest dosage needed to provide effective anaesthesia and / or analgesia should always be administered. The maximum dosage must always be determined by evaluating the size and physical status of the patient, and by considering the usual rate of systemic absorption from a particular injection site. Based on body weight, the maximum recommended dose of bupivacaine hydrochloride is 2 mg/kg, and up to a maximum of 150 mg within a 4-hour period. The maximum recommended adult dose during a 24-hour period is 400 mg. CHILDREN: Bupivacaine Llegiu el document complet