AMPRES

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CHLOROPROCAINE HYDROCHLORIDE

Available from:

CTS LTD

ATC code:

N01BA04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

CHLOROPROCAINE HYDROCHLORIDE 10 MG/ML

Administration route:

INTRATHECAL

Prescription type:

Required

Manufactured by:

SINTETICA SA , SWITZERLAND

Therapeutic area:

CHLOROPROCAINE

Therapeutic indications:

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

Authorization date:

2021-04-11

Summary of Product characteristics

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