INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MISTABRON® AMPOULES

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MISTABRON® AMPOULES

A mucolytic agent for topical application

COMPOSITION:
Each 3 mL ampoule contains
Sodium 2-mercaptoethanesulphonate 600 mg.

PHARMACOLOGICAL CLASSIFICATION:
10.1 Antitussives and expectorants.

PHARMACOLOGICAL ACTION:
MISTABRON, acting in a manner similar to cysteine, breaks the disulphide links of the macromolecules responsible for the viscosity of the mucous secretions. Thus, Mistabron facilitates expectoration without any harmful effect upon the mucosa.

INDICATIONS:
Treatment of patients in post-operative stage combined with respiratory exercises, in order to facilitate expectoration and to prevent pulmonary complications due to bronchial obstruction.
Facilitation of expectoration in mucoviscidosis (fibrocystic disease), asthmatic bronchitis, chronic bronchitis, emphysema and bronchiectasis.
Treatment of obstructive pulmonary atelectasis caused by mucous plugs.
Prevention of mucous plugs and facilitation of bronchial aspiration during anaesthesia and in intensive care units.

CONTRA-INDICATIONS:
Asthma without mucous obstructions. Intolerance to aerosols. Unless bronchial aspiration can be carried out, this medication is contra-indicated in those patients who are extremely weak and cannot cough or expectorate. In these cases the possibility exists of an increase in liquefaction of the secretions and, consequent pooling of secretions in the lung.

WARNING:
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
Mistabron ampoules are to be used under medical supervision only.
By nebulization, preferably by means of a mouthpiece or under a mask or tent. The product may be given plain or diluted with on equal quantity of distilled water or physiological saline solution : 3 to 6 mL (1 to 2 ampoules) twice a day. In severe cases or during intensive care, this dosage can be increased up to a maximum of 24 mL (8 ampoules) a day.

The product can be nebulized:
•        either under atmospheric pressure by means of the De Vilbiss-type devices currently used in clinics and at home for administration of antibiotics brochodilators, sulphur drugs etc.

•        or under intermittent positive pressure by means of the Bird or Engström-type apparatuses currently used in clinics. The product can be given without any inconvenience in prolonged treatment sessions and over a very long period of time for example, in the treatment of mucoviscidosis. The duration of treatment in other chronic diseases of the airways will vary from a few days to several weeks according to need.

By instillation, through an endotracheal tube or a tracheotomy cannula every hour as needed : 1 or 2 mL of MISTABRON
® diluted with an equal quantity of physiological saline solution or distilled water.

MISTABRON
® can be used simultaneously with other therapeutic agents administered by the usual routes, such as antibiotics, corticoids, bronchodilators, etc. However, when these products are administered with MISTABRON® in the same aerosolization, a certain caution should be exerted.

Studies conducted in our laboratories have shown that most of the antibiotics (i.e. the group of penicillins and chloramphenicol) and bronchodilators (i.e. isoprenaline) are compatible. Antibiotics of the aminoglycoside group (streptomycin, kanamycin, neomycin, gentamycin) have their activity slightly decreased when they are administered locally in combination with the mucolytic agent.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Irritative cough. Bronchospasms may occur, particularly in asthmatic patients. Retrosternal burning may occur after nebulization of a 20 % concentration. In such cases the concentration may be reduced to 10%. To be used under medical supervision only.
The circuit through which MISTABRON passes should be of plastic or glass material.
Since the stability of the contents of an open ampoule cannot be guaranteed, it is advisable to open the ampoule directly before use and to throw away the quantify which is not used immediately.
In cases of asthma, paroxysms or status asthmaticus, the product should be administered only in the presence of a physician or in a hospital.

IDENTIFICATION:
A clear and colourless solution.

PRESENTATION:
Carton of 6 x 3 mL ampoules of a 20 % solution.

STORAGE INSTRUCTIONS:
Store below 25° C. Keep all medicines out of the reach of children.

REGISTRATION NUMBER:
D/10.1/250

NAME OF APPLICANT:
UCB S.A (PTY) LTD, 93 De Korte Street, BRAAMFONTEIN, Johannesburg

SHOULD ANY COMPLAINT ARISE ABOUT THE CONTENTS OF THIS PACKING, PLEASE MENTION THE LOT NO. INDICATED ON THE LABEL.

DATE OF PUBLICATION:
8/73 © UCB

        G1098192-D

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998