国: ニュージーランド
言語: 英語
ソース: Medsafe (Medicines Safety Authority)
Bupivacaine hydrochloride monohydrate 5 mg/mL
Baxter Healthcare Ltd
Bupivacaine hydrochloride monohydrate 5 mg/mL
0.5 %
Solution for injection
Active: Bupivacaine hydrochloride monohydrate 5 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection
Vial, glass, single dose, clear Type I, 20 mL, with synthetic bromobutyl rubber stopper; 1 vial in a carton, 20 mL
Prescription
Prescription
Moehs Catalana SL
Surgical anaesthesia - Epidural block for surgery
Package - Contents - Shelf Life: Vial, glass, single dose, clear Type I, 20 mL, with synthetic bromobutyl rubber stopper; 1 vial in a carton - 20 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Clarion 1 site 30 months from date of manufacture stored at or below 30°C protect from light. Clarion 2 site - Vial, glass, single dose, clear Type I, 10 mL, with synthetic bromobutyl rubber stopper; 5 vials in a blister tray and carton - 50 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Clarion 1 site 30 months from date of manufacture stored at or below 30°C protect from light. Clarion 2 site - Vial, glass, single dose, clear Type I, 20 mL, with synthetic bromobutyl rubber stopper; 5 vials in a carton - 100 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Clarion 1 site 30 months from date of manufacture stored at or below 30°C protect from light. Clarion 2 site
2012-01-09
NEW ZEALAND DATA SHEET BUPIVACAINE‐BAXTER Data Sheet 9 April 2019 Page 1 of 12 Baxter Healthcare Ltd 1 BUPIVACAINE‐BAXTER (solution for injection) Bupivacaine‐Baxter 0.25% (2.5mg/mL) solution for injection. Bupivacaine‐Baxter 0.5% (5mg/mL) solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION There are four presentations in two concentrations and two vial sizes: - 2.5mg/mL (0.25%) Bupivacaine Hydrochloride Ph Eur 25mg in 10mL and 50mg in 20mL - 5mg/mL (0.5%) Bupivacaine Hydrochloride Ph Eur 50mg in 10mL and 100mg in 20mL. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Bupivacaine‐Baxter is a clear, colourless, particle‐free, sterile, isotonic, pH adjusted solution of Bupivacaine Hydrochloride Ph Eur conforming to Bupivacaine Injection BP. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Production of local or regional anaesthesia and analgesia in individuals as follows: - Surgical anaesthesia: epidural block for surgery; field block (minor and major nerve blocks and infiltration). - Analgesia: continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration). The choice of four presentations i.e. 25mg in 10mL, 50mg in 20mL, 50mg in 10mL and 100mg in 20mL makes it possible to vary the degree of motor blockade. 4.2 Dose and method of administration As with all local anaesthetics, the dosage varies and depends upon the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anaesthesia and degree of muscle relaxation required, individual tolerance, the technique of anaesthesia and the physical condition of the patient. The lowest dosage that results in effective anaesthesia should be used. In general, surgical anaesthesia requires the use of higher concentrations and doses than those required for analgesia. The volume of medicine used will affect the extent of spread of anaesthesia. Bupivacaine‐ 完全なドキュメントを読む