Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Adrenaline acid tartrate 0.0227 mg/mL equivalent to 12.5 µg/mL adrenaline; Lidocaine hydrochloride 20 mg/mL; ;
AstraZeneca Limited
Adrenaline acid tartrate 0.0227 mg/mL (= 12.5 µg/mL adrenaline)
Solution for injection
Active: Adrenaline acid tartrate 0.0227 mg/mL equivalent to 12.5 µg/mL adrenaline Lidocaine hydrochloride 20 mg/mL Excipient: Hydrochloric acid as 2M solution for pH adjustment (pH 3.3-5.0) Methyl hydroxybenzoate Sodium chloride Sodium hydroxide as 2M solution for pH adjustment (pH 3.3-5.0) Sodium metabisulfite Water for injection
Vial, glass, multi-dose, 5 x 20mL vials, 100 mL
Prescription
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
Package - Contents - Shelf Life: Vial, glass, multi-dose, 5 x 20mL vials - 100 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1969-12-31
X YLOCAINE Data Sheet NEW ZEALAND DATA SHEET 1. PRODUCT NAME Xylocaine 1% Solution for Injection Xylocaine 2% Solution for Injection Xylocaine 1% with Adrenaline 1:100,000 Solution for Injection Xylocaine 1% with Adrenaline 1:200,000 Solution for Injection Xylocaine 2% with Adrenaline 1:200,000 Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xylocaine 1%: Each mL of solution for injection contains 10mg of lidocaine hydrochloride. Xylocaine 2%: Each mL of solution for injection contains 20mg of lidocaine hydrochloride. Xylocaine 1% with Adrenaline 1:100,000: Each mL of solution for injection contains 10mg of lidocaine hydrochloride and 10micrograms of adrenaline (epinephrine) as acid tartrate. Xylocaine 1% with Adrenaline 1:200,000: Each mL of solution for injection contains 10mg of lidocaine hydrochloride and 5micrograms of adrenaline (epinephrine) as acid tartrate. Xylocaine 2% with Adrenaline 1:200,000: Each mL of solution for injection contains 20mg of lidocaine hydrochloride and 5micrograms of adrenaline (epinephrine) as acid tartrate. (Note: Lidocaine is another name for lignocaine. Lidocaine is used in this document. Epinephrine is another name for adrenaline. Adrenaline is mostly used in this document.) For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM X YLOCAINE solution for injection is a sterile, isotonic aqueous solution. The pH of the solution is 5.0-7.0. The ampoules are free from preservatives and are intended for single use only. X YLOCAINE with adrenaline solution for injection is a sterile, isotonic aqueous solution. It contains sodium metabisulphite as an antioxidant. The pH of the solution is 3.3-5.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS X YLOCAINE solutions are indicated for the production of local or regional anaesthesia by the following techniques: • local infiltration • minor or major nerve blocks • epidural block • arthroscopy • intravenous regional anaesthesia X YLOCAINE Data Sheet Copyright 2 4.2 DOSE AND METHOD OF ADMINISTRA Read the complete document