国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Chloroprocaine hydrochloride
Sintetica UK Limited
N01BA; N01BA04
Chloroprocaine hydrochloride
10 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Esters of aminobenzoic acid; chloroprocaine
Not marketed
2012-07-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ampres 10mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains 10 mg of chloroprocaine hydrochloride 1 ampoule with 5 ml solution, contains 50 mg of chloroprocaine hydrochloride Excipients with known effect: 1 ml of solution contains 2.8 mg sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. The pH of the solution is comprised between 3.0 and 4.0. The osmolality of the solution is comprised between 270 – 300 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Posology must be established on an individual basis in accordance with the characteristics of the specific case. When determining the dose, take into consideration the patient’s physical condition and the concomitant administration of other medicinal products. The duration of action is dose-dependent. The indications relating to recommended doses are valid in adults of average height and weight (approximately 70 kg) for obtaining an effective block with one single administration. There are wide individual variations with regard to extent and duration of action. The experience of the anaesthetist and knowledge of the patient’s general condition are essential for establishing the dose. With regard to posology the following guidelines are applied: _Posology Adults_ The maximum recommended dose is 50mg (=5ml) of chloroprocaine hydrochloride. _Special population_ It is advisable to reduce the dose in patients in a compromised general condition. In addition, in patients with established concomitant disorders (e.g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy) a reduced dose is indicated. _Extension of sensory_ _blockade required T10_ _ml_ _mg_ _Average duration of_ _action (minutes)_ 4 5 4 阅读完整的文件