BISOLVON Oral solution (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Bisolvon 4mg/5ml Oral Solution.
2. Qualitative and quantitative composition
Each 5 ml contains bromhexine hydrochloride 4 mg. Excipients: contains maltitol liquid. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution. A clear to almost clear, colourless to almost colourless solution with a fruity aromatic odour.
4.1. Therapeutic indications
As a mucolytic in the management of viscid mucoid secretions associated with bronchitis, bronchiectasis, sinusitis.
4.2. Posology and method of administration
Oral. Adults and children over 12 years: Recommended total daily dose: 10 ml (8 mg) three times daily. Recommended maximum daily dose: 15 ml (12 mg) four times daily. The recommended maximum daily dose ...
4.3. Contraindications
Bisolvon Oral Solution is contraindicated in patients known to be hypersensitive to bromhexine or other excipients of the formulation.
4.4. Special warnings and precautions for use
Bromhexine should be used with caution in patients with a history of, or existing, peptic ulceration. There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome ...
4.5. Interaction with other medicinal products and other forms of interaction
No clinically relevant unfavourable interactions with other medications, such as ampicillin, amoxicillin, oxytetracycline or erythromycin, have been reported (see section 5.1).
4.6. Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of bromhexine in pregnant women. Pre-clinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary ...
4.7. Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed with BISOLVON.
4.8. Undesirable effects
The following side effects have been reported based on clinical trials involving 3,992 patients. Frequencies: Very common ≥1/10 Common ≥1/100 <1/10 Uncommon ≥1/1,000 <1/100 Rare ≥1/10,000 <1/1,000 Very ...
4.9. Overdose
No specific overdose symptoms have been reported in man. Based on accidental overdose and/or medication error reports the observed symptoms are consistent with the known side effects of Bisolvon at recommended ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Expectorants, excl. combinations with cough suppressants ATC-Code: R05CB02 Bromhexine is a synthetic derivative of the herbal active ingredient vasicine. Preclinically, it has ...
5.2. Pharmacokinetic properties
Absorption Bromhexine is rapidly and completely absorbed from the gastrointestinal tract. After oral administration solid and liquid formulations show similar bioavailability. The absolute bioavailability ...
5.3. Preclinical safety data
No details on schedule.
6.1. List of excipients
Maltitol liquid (E965) Sucralose (E955) Benzoic acid (E210) Cherry aroma 96323-33 Chocolate aroma 96534-33 Levomenthol Water, purified
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Shelf life Unopened: 3 years. In use: Use within 12 months of opening bottle.
6.4. Special precautions for storage
Store in the original container.
6.5. Nature and contents of container
Bisolvon Oral Solution is available in amber type III glass bottles with tamper-evident polyethylene caps with low density polyethylene liners. The registered pack sizes are 100 ml, 200 ml, and 250 ml. ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA0540/180/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 14 November 1984 Date of last renewal: 01 April 2008
10. Date of revision of the text
March 2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
