Fluibron Aerosol 15mg Ambroxol 2ml 20 Vials

WARNINGS
Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children younger 'less than 2 years. Since irritation cough may arise in too deep inhalation of aerosols, one should try to inhale and exhale normally. In particularly sensitive patients, a pre-heating of the inhaled to body temperature can be recommended. For patients suffering from bronchial asthma it is advisable to resort to a bronchial spasmolytic before inhalation. Administer with caution in patients with peptic ulcer. There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of ambroxol. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxol should be discontinued immediately and a physician consulted. Most of these cases can be explained by the severity of the patient's underlying disease and / or by concomitant therapy. In addition, during the initial phase of Stevens-Johnson syndrome or TEN, patients may experience nonspecific flu-like prodromes such as fever, muscle aches, rhinitis, cough, and sore throat. Because of these misleading nonspecific flu-like prodromes, symptomatic treatment with cough and cold medicines is possible. Therefore, if new lesions of the skin or mucous membranes occur, it is necessary to consult a doctor immediately and to stop the treatment with ambroxol hydrochloride as a precaution. In the presence of mild or moderate renal insufficiency, the product should only be used after consulting your doctor. In severe renal insufficiency, accumulation of the metabolites of ambroxol generated in the liver may occur.
PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with cough suppressants; mucolytic.
STORAGE
The single-dose containers must be kept inside the protective bag, protected from light. In case of use of half dose, the closed container should be stored at a temperature between 2 degrees C and 8 degrees C (in the refrigerator) and used within 12 hours.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Severe hepatic and / or renal disorders. First three months of pregnancy. Pediatric population: the drug is contraindicated in children aged less than 2 years.
NAME
FLUIBRON 15 MG / 2 ML SOLUTION TO NEBULIZE
EXCIPIENTS
Sodium chloride, water for injections.
SIDE EFFECTS
At the recommended doses the medicine is normally well tolerated. Undesirable effects frequencies: very common> = 1/10, common> = 1/100 and <1/10, uncommon> = 1 / 1,000 and <1/100, rare> = 1 / 10,000 and <1 / 1,000, very rare <1 / 10,000, not known. Disorders of the immune system. Rare: hypersensitivity reactions'; not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Nervous system disorders. Common: dysgeusia (eg altered sense of taste); rare: headache. Respiratory, thoracic and mediastinal disorders. Common: hypoesthesia of the oral cavity and pharynx; not known: bronchial obstruction. Gastrointestinal disorders. Common: nausea; uncommon: vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth; not known. dry throat. Skin and subcutaneous tissue disorders. Rare: rash, hives; not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous exanthem). Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
Ambroxol hydrochloride crosses the placental barrier. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryonal / fetal development, parturition or postnatal development. Clinical studies and extensive clinical experience after the 28th week of pregnancy showed no evidence of harmful effects on the fetus. However, it is recommended to observe the usual precautions regarding the use of medicines during pregnancy. Particularly during the first trimester, use is not recommended. Ambroxol hydrochloride is secreted in breast milk. Although undesirable effects on infants are not expected, its use is not recommended in nursing mothers.
INDICATIONS
Treatment of secretion disorders in acute and chronic bronchopulmonary diseases.
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.
DOSAGE
Adults and children over 5 years of age: one single-dose container, 2 times a day. Children aged 2 to 5 years: half a container or a single-dose container, 1-2 times 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. Method of administration: the solution can be administered by inormal aerosol therapy devices. It can also be diluted in distilled water in the ratio 1: 1. To use it carry out the following operations: flex the single-dose container in both directions; detach the single-dose container from the strip first above and then in the center; open the single-dose container by rotating the flap in the direction indicated by the arrow; by exerting moderate pressure on the walls of the single-dose container, release the medicine in the prescribed quantity and put it in the nebulizer ampoule; in case of use of a half dose, the container can be closed again as indicated in the package leaflet. The closed container must be stored at a temperature between 2 degrees C and 8 degrees C (in the refrigerator) and the remaining quantity must be used within 12 hours of first opening.
ACTIVE PRINCIPLES
100 ml of sterile solution contain 750 mg ambroxol hydrochloride.