To enhance the production of pulmonary surfactant in premature infants and newborns with respiratory failure syndrome.
The daily dose is 30 mg / kg of body weight, divided into 4 injections per day.
The solution should be administered using an infusomat by intravenous infusion, for at least 5 minutes.
The solution can also be administered as a drip infusion with 5% glucose solution, 5% levulose solution, 0.9% sodium chloride solution, or Ringer's solution.
Hypersensitivity to ambroxol hydrochloride or other components of the preparation.
Gastrointestinal disorders: nausea, diarrhea, vomiting, dyspepsia, abdominal pain;
from the immune system, skin and subcutaneous tissue: anaphylactic reactions (including anaphylactic shock), rash, urticaria, angioedema, itching and other hypersensitivity reactions.
Very rarely, severe skin lesions have been reported - Stevens-Johnson and Lyell syndromes, temporarily associated with the use of mucolytic agents such as ambroxol. Basically, their appearance could be explained by the severity of the underlying disease or the use of concomitant preparations.
If lesions of the skin or mucous membranes appear, the therapy should be immediately reviewed and the use of ambroxol hydrochloride should be discontinued.
Patients with impaired renal function should take the preparation with caution. the concentration of sodium in one recommended dose is less than 1 mmol (23 mg).
There are no reports of pharmacological and clinical interactions with other preparations.
Incompatibility. Do not mix with any medicinal products other than those indicated in the APPLICATION section. Do not mix with other solutions, as this leads to the formation of mixtures with a pH level of more than 6.3, since ambroxol hydrochloride free base may precipitate due to an increase in pH.
There are no reports of specific overdose symptoms in humans. symptoms that occur with accidental overdose and / or medical error are similar to the known adverse reactions of the preparation when used at recommended doses and may require symptomatic treatment.
In original packaging to protect from light, at a temperature not exceeding 25 °C.
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