PEYONA Solution

Active ingredients: Caffeine

Product name and form

Peyona 20 mg/ml solution for infusion and oral solution.

Pharmaceutical Form

Solution for infusion.

Oral solution.

Clear, colourless, aqueous solution at pH=4.7.

Qualitative and quantitative composition

Each ml contains 20 mg caffeine citrate (equivalent to 10 mg caffeine).

Each 1 ml ampoule contains 20 mg caffeine citrate (equivalent to 10 mg caffeine)

Each 3 ml ampoule contains 60 mg caffeine citrate (equivalent to 30 mg caffeine).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Caffeine is structurally related to the methylxanthines theophylline and theobromine. Caffeine’s main action is as a CNS stimulant.

List of Excipients

Citric acid monohydrate
Sodium citrate
Water for injections

Pack sizes and marketing

Type I clear glass 1 ml ampoule.

Type I clear glass 3 ml ampoule.

Pack size of 10 ampoules.

Marketing authorization holder

CHIESI FARMACEUTICI SpA, Via Palermo 26/A, 43122, Parma, ITALY

Marketing authorization dates and numbers

EU/1/09/528/002 1ml ampoules

EU/1/09/528/001 3ml ampoules

Date of first authorisation: 02/07/2009

Date of latest renewal: 03/03/2014

Drugs

Drug
Countries
Austria, Brazil, Canada, Spain, Hong Kong, Ireland, Lithuania, Netherlands, United Kingdom