PRILOTEKAL Solution for injection Ref.[9271] Active ingredients: Prilocaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Sintetica Limited, 30<sup>th</sup> Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom

Product name and form

Prilotekal 20mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless solution.

The pH is between 5.0 and 6.0. The solution is hyperbaric with osmolality comprised between 490 and 540 mOsm/kg.

Qualitative and quantitative composition

1 ml of solution for injection contains 20 mg of prilocaine hydrochloride (equivalent to 2%).

1 ampoule with 5 ml solution, contains 100 mg of prilocaine hydrochloride.

Excipients: 0.0086 mg sodium per 1 ml.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Prilocaine

Prilocaine is a toluidine derivative and intermediate-acting amino amide with local anesthetic property. Prilocaine binds to the intracellular surface of sodium channels which blocks the subsequent influx of sodium into the cell. Action potential propagation and never function is, therefore, prevented. This block is reversible and when the drug diffuses away from the cell, sodium channel function is restored and nerve propagation returns.

List of Excipients

Glucose anhydrous or glucose monohydrate
Sodium hydroxide 1N (for pH adjustment)
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 46926/0002

27/01/2017

Drugs

Drug Countries
PRILOTEKAL Netherlands, Poland, United Kingdom

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