Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
CHLOROPROCAINE HYDROCHLORIDE
CTS LTD
N01BA04
SOLUTION FOR INJECTION
CHLOROPROCAINE HYDROCHLORIDE 10 MG/ML
INTRATHECAL
Required
SINTETICA SA , SWITZERLAND
CHLOROPROCAINE
Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes
2021-04-11
SUMMARY OF PRODUCT CHARACTERISTICS Ampres 10 mg/ml solution for injection 1. NAME OF THE MEDICINAL PRODUCT Ampres 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. 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 The equipment, medicinal products and personnel capable of dealing with an emergency, e.g. maintaining the patency of the airways and administering oxygen, must be immediately available, since in rare cases severe reactions, sometimes with a fatal outcome, have been reported after using local anaesthetics, even in the absence of individual hypersensitivity in the patient’s case history. The doctor in charge is responsible for taking the measures needed to avoid an intravascular injection and should be fully trained in emergency medicine and resuscitation to be ready to prevent and treat the side effects and complication of the procedure. Posology Posology must be established on an individual basis in accordance with the characteristics of the specific case. When determining the dose, the patient’s physical condition and the concomitant administration of other medicinal products should be taken into consideration. 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 ess Přečtěte si celý dokument