FLUIBRON AER 20FL 15MG 2ML

FLUIBRON 15 MG/2 ML

active ingredients

100 ml of sterile solution contain: Active ingredient: Ambroxol hydrochloride 750 mg. A monodose container contains 15 mg of ambroxol hydrochloride. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium chloride, water for injectable preparations.

Therapeutic indications

Treatment of secretion turbs in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Severe liver and/or kidney alterations. First three months of pregnancy (see par. 4.6) Pediatric population The medicinal product is contraindicated in children under 2 years of age.

Population

Population Pediatric population FLUIBRON should not be used in children under 2 years of age due to safety issues (paragraph 4.8). Adults and children older than 5 years: a 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 doses. 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 using normal aerosol therapy devices. It can also be diluted in distilled water in ratio 1:1. For use, please do the following: 1) Flettere the monodose container in the two directions. 2) Take the monodose container from the strip first on and then to the center. 3) Open the single-dose container by turning the fin in the direction indicated by the arrow. 4) By exercising a moderate pressure on the walls of the single-dose container, bring out the medicine in the prescribed quantity and place it in the nebulizer amp. 5) In case of use of half a dose, the container can be closed as indicated in the leaflet. The container must be stored at a temperature between 2°C and 8°C (in refrigerator) and the remaining quantity must be used within 12 hours of the first opening.

Conservation

Monodose containers must be kept inside the protective envelope, protected from light. When using half a dose, the container must be stored at a temperature between 2 ° C and 8°C (in the refrigerator) and used within 12 hours.

Warnings

Pediatric population Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They must not be used in children under 2 years of age (see paragraph 4.3). Because in the too deep intake of aerosols it may arise coughs from irritation, it must be sought during inhalation to inhale and exhale normally. Particularly sensitive patients can recommend a preheating of inhalation at body temperature. For patients with bronchial asthma it is appropriate to resort to bronchial spasmolytic before inhalation. Fluibron should be administered with caution in patients carrying peptic ulcer. Cases of severe skin reactions such as multiform erythema, Stevens-Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized acute acute acute edema (AGEP) were reported. If there are symptoms or signs of progressive skin rash (sometimes associated with bladders or mucosa lesions), treatment with ambroxol must be stopped immediately and a doctor must be consulted. Most of these cases can be explained by the severity of the underlying disease of the patient and/or concomitant therapy. In addition, during the initial phase of Stevens-Johnson's or TEN's syndrome, patients may charge unspecified flu-like prodromas such as fever, muscle pain, rhinitis, cough and throat pain. Due to these misleading aspecific symil-fluid prodromas, a symptomatic treatment with cough and cold medicines can be established. Therefore, if new lesions of the skin or mucous membranes occur, you must immediately consult your doctor and precautionally stop the treatment with ambroxol hydrochloride. In the presence of mild or moderate kidney failure, Fluibron must be used only after consulting the doctor. As with any medication with liver metabolism followed by renal elimination, in case of severe renal failure, an accumulation of ambroxol metabolites generated in the liver may occur.

Interactions

Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxima, erythromycin) in bronchopolmonary secretions and saliva are increased. No interactions with other medicines have been observed.

Effects

The medicinal product is normally well tolerated at recommended doses. During therapy with ambroxol hydrochloride the undesirable effects reported below, with the frequencies: Very common ≥1/10 Municipality ≥1/100 and Classification for systems and organs Action against Frequency Disorders of the Immunition System Reactions of hypersensitivity Rare Anaphylactic reactions, including anaphylactic shock, angioedema and itching Notable Diseases of the nervous system Disgeusia (e.g. alteration of the sense of taste) Town Cefa Rare Respiratory, chest and mediastinic pathologies Hypoesthesia of the oral cable and pharynx Town Bronchial obstruction Notable Gastrointestinal diseases Nausea Town Vomito, diarrhea, dispepsia and abdominal pain, dry mouth Not common Dry gorge Notable Pathologies of skin and subcutaneous tissue Rash, hives Rare Severe skin adverse reactions (including multiform erythema, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis). Notable Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

You don't know cases of overdose with Fluibron for inhalation. Symptoms observed in cases of accidental overdose and/or in cases of errors in the administration of the medicinal product are consistent with the expected effects of ambroxol hydrochloride at recommended doses and may require symptomatic treatment.

Ambroxol Hydrochloride crosses the placental barrier. Animal studies showed no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth 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. In particular during the first quarter, the use of Fluibron is not recommended. Ambroxol Hydrochloride is secreted in breast milk. Although there are no undesirable effects on infants, the use of Fluibron is not recommended in nursing mothers.

Source: Farmadati