TREBON Powder for oral solution Ref.[49840] Active ingredients: Acetylcysteine

Source: Health Products Regulatory Authority (IE)  Publisher: UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A., 14th km National Road 1, GR-145 64 Kifissia, Greece

Product name and form

Trebon 600 mg powder for oral solution.

Pharmaceutical Form

Powder for oral solution.

White powder with lemon flavour.

Qualitative and quantitative composition

Each sachet with powder used for the preparation of oral solution contains 600 mg of acetylcysteine.

Excipients with known effect: Each sachet contains 2,167.9 mg sorbitol and 9.5 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Acetylcysteine

Acetylcysteine is N-acetyl derivative of cysteine. Used as a mucolytic agent to reduce the viscosity of mucous secretions.

List of Excipients

Citric acid (E330)
Lemon juice flavour in powder (contains: natural flavouring substances, maltodextrin (maize), modified starch (E1450) (waxy maize), sucrose)
Saccharin sodium (E954)
Macrogol (E1521)
Sorbitol (E420)

Pack sizes and marketing

Sachets consisting of paper, aluminum foil, and polyethylene.

Pack size: 10, 20 or 30 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A., 14th km National Road 1, GR-145 64 Kifissia, Greece

Marketing authorization dates and numbers

PA1732/003/001

Date of first authorisation: 19th June 2020

Drugs

Drug Countries
TREBON Hong Kong, Ireland

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.