Fluibron Aerosol 20 vials 15mg/2ml

Fluibron Aerosol 20 Vials is a nebulizing solution for inhalation use for adults and children. Indicated for the treatment of secretion disorders in acute and chronic bronchopulmonary diseases .

The active ingredient contained in Fluibron 20 Vials is ambroxol , an active ingredient from the mucolytic family, which acts quickly and effectively against the dense and viscous consistency of mucus , making it more fluid and easier to expectorate.

Fluibron vials can be used effectively in case of:

• Chesty cough : Fluibron Aerosol 20 Vials contains ambroxol which makes the mucus less dense, viscous and easier to eliminate .
  
  

• Acute and chronic sinusitis . Sinusitis is an inflammation of the mucosa of the paranasal cavities. It often occurs due to an accumulation of mucus in the sinuses. Fluibron Aerosol 20 Vials promotes the elimination of mucus and reduces the symptoms of sinusitis.
  
  

• Bronchitis

ACTIVE INGREDIENTS

Active ingredients contained in Fluibron Aerosol 20 Vials 15 mg/2 ml - What is the active ingredient of Fluibron Aerosol 20 Vials 15 mg/2 ml?

100 ml of sterile solution contains: ambroxol hydrochloride 750 mg. A single-dose container contains 15 mg of ambroxol hydrochloride.

EXCIPIENTS

Composition of Fluibron Aerosol 20 Vials 15 mg/2 ml - What does Fluibron Aerosol 20 Vials 15 mg/2 ml contain?

Sodium chloride, water for injections.

DIRECTIONS

Therapeutic indications Fluibron Aerosol 20 Vials 15 mg/2 ml - Why is Fluibron Aerosol 20 Vials 15 mg/2 ml used? What is it used for?

Treatment of secretion disorders in acute and chronic bronchopulmonary diseases.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Fluibron Aerosol 20 Vials 15 mg/2 ml - When should Fluibron Aerosol 20 Vials 15 mg/2 ml not be used?

Hypersensitivity to the active substance or to any of the excipients. Severe hepatic and/or renal alterations. First three months of pregnancy. Paediatric population: the medicinal product is contraindicated in children under 2 years of age.

DOSAGE

Quantity and method of taking Fluibron Aerosol 20 Vials 15 mg/2 ml - How do you take Fluibron Aerosol 20 Vials 15 mg/2 ml?

Dosage. Paediatric population. This medicine should not be used in children under 2 years of age due to safety concerns. 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 one 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 a 1:1 ratio. To use, perform the following operations: bend the single-dose container in both directions. Detach the single-dose container from the strip first at the top and then in the centre. 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 prescribed amount of medicine and put it into the nebuliser bulb. 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 degrees C and 8 degrees C (in the refrigerator) and the remaining quantity must be used within 12 hours of first opening.

CONSERVATION

Storage Fluibron Aerosol 20 Vials 15 mg/2 ml - How is Fluibron Aerosol 20 Vials 15 mg/2 ml stored?

Single-dose containers must be stored in the protective bag, away from light. If using half a dose, the closed container must be stored at a temperature between 2 degrees and 8 degrees C (in the refrigerator) and used within 12 hours.

WARNINGS

Warnings Fluibron Aerosol 20 Vials 15 mg/2 ml - About Fluibron Aerosol 20 Vials 15 mg/2 ml it is important to know that:

Paediatric population. Mucolytics may induce bronchial obstruction in children under 2 years of age. In fact, the capacity for bronchial mucus drainage 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. Since excessively deep inhalation of aerosols may cause irritation coughing, one should try to inhale and exhale normally during inhalation. In particularly sensitive patients, pre-warming of the inhaled product to body temperature may be recommended. For patients with bronchial asthma, it is advisable to use a bronchial spasmolytic before inhalation. This drug should be administered with caution to patients with peptic ulcer. Cases of serious skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) have been reported in association 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 stopped immediately and a doctor should be consulted. 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 non-specific flu-like prodromes such as fever, muscle aches, rhinitis, cough and sore throat. Due to these misleading non-specific flu-like prodromes, symptomatic treatment with cough and cold medicines may be initiated. Therefore, if new skin or mucosal lesions appear, it is necessary to consult a doctor immediately and discontinue treatment with ambroxol hydrochloride as a precaution. In the presence of mild or moderate renal insufficiency, this medicine should be used only after consulting a doctor. As with any medicine with hepatic metabolism followed by renal elimination, in case of severe renal insufficiency, accumulation of ambroxol metabolites generated in the liver may occur.

INTERACTIONS

Interactions Fluibron Aerosol 20 Vials 15 mg/2 ml - Which medicines or foods can modify the effect of Fluibron Aerosol 20 Vials 15 mg/2 ml?'

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

Like all medicines, Fluibron Aerosol 20 Vials 15 mg/2 ml can cause side effects - What are the side effects of Fluibron Aerosol 20 Vials 15 mg/2 ml?

At the recommended doses the medicine is usually well tolerated. During therapy with ambroxol hydrochloride the following undesirable effects have been observed, with the 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 not known (frequency cannot be estimated from the available data). Immune system disorders. Rare: hypersensitivity reactions; not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Nervous system disorders. Common: dysgeusia (e.g. altered sense of taste); rare: headache. Respiratory, thoracic and mediastinal disorders. Common: hypoaesthesia of the oral cavity and pharynx; not known: bronchial obstruction. Gastrointestinal disorders. Common: nausea; uncommon: vomiting, diarrhoea, dyspepsia and abdominal pain, dry mouth; not known: dry throat. Skin and subcutaneous tissue disorders. Rare: rash, urticaria; not known: serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis). Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Fluibron Aerosol 20 Vials 15 mg/2 ml.

Ambroxol hydrochloride crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonic/foetal development, parturition or postnatal development. Clinical studies and extensive clinical experience after the twenty-eighth week of pregnancy have not shown any evidence of harmful effects on the foetus. However, it is recommended to observe the usual precautions regarding the use of medicinal products during pregnancy. In particular during the first trimester, the use of this drug is not recommended. Ambroxol hydrochloride is secreted in breast milk. Although no undesirable effects on infants are expected, the use of this drug is not recommended in nursing mothers.