AMPRES 10 mg/ml Solution for injection Ref.[7681] Active ingredients: Chloroprocaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Sintetica Limited, 30th Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom

Product name and form

Ampres 10 mg/ml solution for injection.

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.

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.

Active Ingredient Description
Chloroprocaine

Chloroprocaine is procaine in which one of the hydrogens ortho- to the carboxylic acid group is substituted by chlorine. Chloroprocaine, blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse and by reducing the rate of rise of the action potential. Chloroprocaine (like cocaine) has the advantage of constricting blood vessels which reduces bleeding, unlike other local anesthetics like lidocaine.

List of Excipients

Hydrochloric acid 1N (for pH adjustment)
Sodium chloride
Water for injection

Pack sizes and marketing

Type I clear colourless glass ampoule.

Box of 10 ampoules each containing 5 ml of solution for injection.

Marketing authorization holder

Sintetica Limited, 30th Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom

Marketing authorization dates and numbers

PL 46926/0001

Date of first authorisation: 19/04/2012
Date of latest renewal: 09/03/2017

Drugs

Drug Countries
AMPRES Austria, Spain, Finland, Ireland, Israel, Netherlands, Poland, United Kingdom

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