Posology : מינונים

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 essential for establishing the dose.
With regard to posology the following guidelines are applied:
Posology Adults
Average duration of ml                   mg
Extension of sensory                                                  action (minutes) blockade required T10                4                  40                      80 5                  50                      100


The maximum recommended dose is 50mg (=5ml) of chloroprocaine hydrochloride.
The duration of action is dose-dependent.

Special population
The clinician's experience and knowledge of the patient's physical status are of importance when deciding the dose. 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.


Pediatric population
The safety and efficacy of Ampres in children and adolescents have not been established. No data are available (see section 5.1).


Method of administration
For intrathecal use.

Ampres should be injected via intrathecal route into the intervertebral space L2/L3, L3/L4 and L4/L5.
The entire dose should be injected slowly, after having aspirated a minimum quantity of CSF to confirm the correct position. The patient’s vital functions should be checked extremely carefully maintaining continuous verbal contact.
For single use.
The medicinal product has to be visually inspected prior to use. Only clear solutions practically free from particles should be used. The intact container must not be re-autoclaved.