1. NAME OF THE MEDICINAL PRODUCT ULTRACAINE 20 mg/ml Solution for injection in VIAL. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each one ml contains: Active ingredient: Lidocaine hydrochloride 20 mg For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Clear colorless Solution free from particulate matter. 4.1. Therapeutic indications ULTRACAINE 2 % VIAL is used as a local anaesthetic. 4.2. Posology and method of administration ULTRACAINE 2 % VIAL is used as a local anaesthetic when injected subcutaneously. This solution is not intended for use intravenously. Solutions of lidocaine, which contain preservatives, should not be used for spinal, epidural, caudal or intravenous regional anaesthesia. The dosage should be adjusted according to the response of the patient and the site of administration. The lowest concentration and the smallest dose producing the required effect should be given. The maximum dose for healthy adults should not exceed 200 mg corresponding to 10 mls. Children and elderly or debilitated patients require smaller doses, commensurate with age and physical status. The injection may be used for infiltration in volumes of 1 ml to 10 ml. 4.3. Contra-indications Know hypersensitivity to hydroxybenzoates and to anaesthetics of the amide type.
