AMPRES

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

CHLOROPROCAINE HYDROCHLORIDE

Verfügbar ab:

CTS LTD

ATC-Code:

N01BA04

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

CHLOROPROCAINE HYDROCHLORIDE 10 MG/ML

Verabreichungsweg:

INTRATHECAL

Verschreibungstyp:

Required

Hergestellt von:

SINTETICA SA , SWITZERLAND

Therapiebereich:

CHLOROPROCAINE

Anwendungsgebiete:

Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes

Berechtigungsdatum:

2021-04-11

Fachinformation

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