Ampres 10mg/ml solution for injection

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Chloroprocaine hydrochloride

Prieinama:

Sintetica UK Limited

ATC kodas:

N01BA; N01BA04

INN (Tarptautinis Pavadinimas):

Chloroprocaine hydrochloride

Dozė:

10 milligram(s)/millilitre

Vaisto forma:

Solution for injection

Recepto tipas:

Product subject to prescription which may not be renewed (A)

Gydymo sritis:

Esters of aminobenzoic acid; chloroprocaine

Autorizacija statusas:

Not marketed

Leidimo data:

2012-07-13

Prekės savybės

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