Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products.
Il Comitato di Valutazione del Rischio per la Farmacovigilanza dell’EMA (PRAC) ritiene basso il rischio di gravi reazioni allergiche con i medicinali contenenti ambroxol e bromexina.
Pregnant women urged to discuss all medicines with their health care professionals before using them.
Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection.
An air leak between cuff and tracheal wall may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.
Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator.
There have been reports of serious adverse events associated with the use of certain of these products.
80.211.154.110