Fluibron aerosol 15 mg / 2 ml - for respiratory diseases 20 vials of 2 ml

Product Description

Composition

100 ml of sterile solution contain: Active ingredient: ambroxol hydrochloride 750 mg. One single-dose container contains 15 mg of ambroxol hydrochloride. For the full list of excipients, see section 6.1.

Excipients

Sodium chloride, water for injections.

Therapeutic indications

Treatment of secretion disorders in acute and chronic bronchopulmonary diseases.

Contraindications

The medicine is contraindicated in children under 2 years of age. Fluibron must not be used in subjects with hypersensitivity to the active substance or to any of the excipients and in those with severe liver and/or kidney disorders. First three months of pregnancy (see section 4.6).

Dosage

Adults and children over 5 years of age: one single-dose container, twice a day. Children aged 2 to 5 years: half a container or one single-dose container, once or twice a day. Do not exceed the recommended dose. Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor. The solution can be administered using standard aerosol therapy devices. It can also be diluted in distilled water in a 1:1 ratio. To use, follow these steps: 1) Flex the single-dose container in both directions. 2) Detach the single-dose container from the strip, first at the top and then in the center. 3) Open the single-dose container by rotating the flap in the direction indicated by the arrow. 4) By applying moderate pressure to the walls of the single-dose container, release the prescribed amount of medicine and pour it into the nebulizer bulb. 5) If half a dose is used, the container can be closed as indicated in the package leaflet. The closed container must be stored at a temperature between 2°C and 8°C (in the refrigerator) and the remaining amount must be used within 12 hours of first opening.

Warnings and precautions

Mucolytics can cause bronchial obstruction in children under 2 years of age. In fact, the ability to drain bronchial mucus is limited in this age group, due to the physiological characteristics of the airways. They should therefore not be used in children under 2 years of age (see section 4.3). Since inhaling aerosols too deeply can cause bronchial obstruction, the risk of bronchial obstruction may be increased. If an irritant cough occurs, try to inhale and exhale normally during inhalation. In particularly sensitive patients, prewarming the inhaled product to body temperature may be recommended. Patients with bronchial asthma should take a bronchial spasmolytic before inhalation. Fluibron should be administered with caution to patients with peptic ulcers. Extremely rare cases of serious skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) have been reported in temporary association with the administration of expectorants such as ambroxol hydrochloride. Most of these cases can be explained by the severity of the patient's underlying disease and/or concomitant therapy. Furthermore, during the initial phase of Stevens-Johnson syndrome or TEN, patients may experience nonspecific flu-like symptoms such as fever, muscle aches, rhinitis, cough, and sore throat. Due to these misleading, nonspecific flu-like symptoms, symptomatic treatment with cough and cold medications may be initiated. Therefore, if new skin or mucous membrane lesions appear, consult your doctor immediately and discontinue treatment with ambroxol hydrochloride as a precaution. In the presence of mild or moderate renal insufficiency, Fluibron should be used only after consulting your doctor. As with any medicinal product with hepatic metabolism followed by renal elimination, in cases of severe renal insufficiency, accumulation of ambroxol metabolites generated in the liver may occur.

Interactions

Following the administration of ambroxol, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased. No interactions with other medicinal products have been observed.

Side effects

At the recommended doses, the medicine is usually well tolerated. During therapy with ambroxol hydrochloride, the following side effects have been observed, with the following frequencies: very common