TREBON Powder for oral solution

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Trebon 600 mg powder for oral solution.

2. 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 ...

3. Pharmaceutical form

Powder for oral solution. White powder with lemon flavour.

4.1. Therapeutic indications

Trebon is indicated in adults as a mucolytic therapy in chronic bronchitis and other respiratory conditions associated with thick mucus hypersecretion.

4.2. Posology and method of administration

Posology In general the usual recommended dosage is: 600mg once daily. The dosage may be increased according to the instructions of the treating doctor based on the assessment of treatment outcomes. Duration ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The product should not be used in children under 2 years of age.

4.4. Special warnings and precautions for use

Serious skin reactions have been reported whilst taking acetylcysteine, but these occur rarely. For this reason, medical advice should be sought immediately and the patient should stop taking acetylcysteine ...

4.5. Interaction with other medicinal products and other forms of interaction

Antibiotics In vitro experiments report an inactivation of certain antibiotics (tetracyclines, aminoglycosides, fluoroquinolones, carbapenem, cephalosporins, penicillins) due to acetylcysteine ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of acetylcysteine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Trebon is not ...

4.7. Effects on ability to drive and use machines

Acetylcysteine has no influence on the ability to drive and use machines.

4.8. Undesirable effects

In the evaluation of side effects following frequencies are defined as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); ...

4.9. Overdose

There have been no cases of toxic overdose observed with orally-dosed acetylcysteine. Oral doses of up to 500mg/kg of acetylcysteine were tolerated without toxic effects. a) Symptoms of intoxication The ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Mucolytics ATC code: R05CB01 Mechanism of action The mechanisms of action of NAC in these respiratory indications include mucolytic effects. The mucolytic action ...

5.2. Pharmacokinetic properties

Absorption After oral administration acetylcysteine is rapidly and almost completely absorbed. The oral bioavailability of acetylcysteine is very low (between 6 and 10%) due to high first pass effect. ...

5.3. Preclinical safety data

Reproductive toxicology No evidence of teratogenicity was identified in non-standard embryo toxicity studies in rabbits and rats. Acetylcysteine crosses the placenta in rats and can be detected in amniotic ...

6.1. 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) ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years. After preparation, the solution should be used immediately.

6.4. Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

6.5. Nature and contents of container

Sachets consisting of paper, aluminum foil, and polyethylene. Pack size: 10, 20 or 30 sachets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

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

8. Marketing authorization number(s)

PA1732/003/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 19th June 2020

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