COMPOSITION :
Acystein® Inhalation fluid, each ml contains : N-Acetylcysteine 100 mg.
DESCRIPTIONS :
Acystein® contains N-Acetylcysteine as its active ingredients, available as inhalation fluid.
INDICATION :
Acystein® is use for treatment of respiratory affection characterized by thick and viscous hypersecretions.
DOSAGE AND ADMINISTRATIONS :
Aerosol administration :
Nebulise 1 ampoule each time, 1 – 2 time per day for 5 – 10 days.
OVERDOSAGE :
No particular toxic signs and symptoms have been observed, even in patients treated with high doses of NAC by systemic route. Very high doses of NAC by topical administration could produce an excessive and massive liquefaction of the muco-purulent secretions, particulary in subjects with inadequate coughing reflex or expectoration, in whom it may be necessary to use mechanical methods of bronchial suction.
CONTRAINDICATION :
Known hypersensitive to the NAC.
WARNINGS AND PRECAUTIONS :
Administration of NAC, particulary by aerosol, can at the beginning of treatment, liquify the bronchial secretions and simultaneously increase the volume. If patient is unable to properly expectorate it is necessary to clear the airways by postural drainage or eventually by bronchosuction, to avoid retention of secretions.
Patients suffering from bronchial atshma must be closely monitored as bronchospasm may occur during the treatment. In such event the treatment must be immediately suspended.
NAC aerosol may worsen cough in patients suffering from acute bronchial asthma.
A sulphur odour is felt on opening the ampoules or transferred to the aerosol equipment, may assume a pink colour, but it does not affect the efficacy and safety of the product.
KEEP OUT OF THE REACH OF CHILDREN.
DRUG INTERACTIONS :
Acetylcysteine may be administered concurrently with common bronchodilators, vasocontrictors etc. When local treatment with NAC and antibiotic is necessary, it is advisable to administer the two drugs separately since incompatibility between NAC and certain antibiotic may exist.
ADVERSE REACTIONS :
Use of product by systemic route, may occasionally be followed by hypersensitivity reactions such as urticaria and rarely bronchospasm. During administration by aerosol, nose-pharyngeal and gastro-intestinal irritation such as rhinorrea, stomatitis, nausea and vomiting may also be experienced.
PRESENTATION :
Acystein® Inhalation fluid Box, 5 ampoules @ 3 ml
Reg. No. DKL1902360268A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
