Medicinal Products

BECLOSPIN 800 μg / 2 mL

Generic drug of the therapeutic class: Pneumology
active ingredients: Beclometasone
laboratory: Chiesi SA

Suspension for inhalation by nebulizer
Box of 20 single-dose containers of 2 ml
All forms

Indication

Continuous anti-inflammatory treatment of severe persistent asthma in children.

Severe persistent asthma is defined as permanent symptoms, frequent seizures, frequent nocturnal asthma symptoms, physical activity limited by asthma symptoms, PEG or FEV1 less than 60% of predicted values., a variability of the DEP higher than 30%.

NB The administration of beclometasone dipropionate by means of a nebuliser (nebuliser device) should be reserved for the child and the infant in case of incapacity to use the other devices for inhalation (powder device or pressurized container with inhalation chamber and adapted mask).

Dosage BECLOSPIN 800 μg / 2 mL Suspension for inhalation by nebulizer Box of 20 Single-dose containers of 2 ml

Dosage

The initial dose will be determined according to the severity of the disease before treatment and will then be adjusted according to the individual results. The minimum effective dosage should always be sought.

In children, the recommended doses are 400 or 800 micrograms twice a day (ie 1 single-dose container of 800 μg / 2 ml twice a day) For the administration of 400 μg twice a day, there is a presentation Béclospin 400 μg / 1 ml better adapted to this posology).

After several days (or weeks) of this treatment, when the clinical condition is improved, symptoms have receded and asthma is controlled, the minimum effective dosage should be sought. In case of destabilization of asthma, the dose will be re-increased.

The contents of an opened single-dose container should be used immediately or discarded.

Administration mode

Inhaled route only.

This medication should be administered by inhalation with a compressed air (or pneumatic) nebulizer. Ultrasonic devices are not recommended as they may not be suitable for proper administration of this medicine.

Do not inject.

Use of each single-dose container:

1. Fold the single-dose container in both directions.

2. Carefully detach a new single-dose container from the blister, starting at the top. The other single-dose containers are to be put back in the bag.

3. Shake the single-dose container vigorously and flip it up and down to homogenize the suspension.

4. Open the single-dose container by rotating the upper part, being careful to always hold it upright.

5. Gently squeeze the single-dose container to pour the contents into the nebulizer chamber.

NEVER USE AN OPEN UNIDOSE CONTAINER.

The unit dose started will be used immediately or discarded.

Use of the nebuliser:

Comply with the directions for use in accordance with the manufacturer's instructions for the nebulizer (nebulizer) used.

A filler volume of the 2 to 4 ml nebulizer tank is suitable for most pneumatic devices.

The beclospin suspension is ready for use. Nevertheless, if it is necessary to dilute the unit dose to obtain a final volume adapted to the nebulizer used and the duration of the recommended nebulization session, only a sterile solution of 0.9% sodium chloride should be used. .

In the general case, the content of the nebulizer tank is pulsed by a flow of oxygen (4 to 8 liters / minutes) for about 10 to 15 minutes during which the patient breathes at its usual rate.

After inhalation, the unused suspension remaining in the vessel of the apparatus should be discarded.

Rinse mouth after inhalation of product and rinse face if using a face mask.

Against indications

Known hypersensitivity to corticosteroids or excipients.

Adverse effects Beclospin

· As with any other inhaled treatment, cough, or rarely bronchospasm with acute dyspnea may occur during administration. In this case, treatment should be discontinued and other therapies or other forms of administration prescribed.

· Frequently possibility of oropharyngeal candidiasis (thrush). It usually gives way spontaneously or to appropriate treatment and it is exceptional that it requires the discontinuation of inhaled corticosteroid therapy. Its risk of appearance increases with the dose used and the number of shots. It can be prevented by rinsing the mouth with water after inhalation.

· Possibility of occurrence of pharyngeal discomfort, dysphonia, raucousness of the way, can be prevented by rinsing the mouth after inhalation.

· Some cases of facial irritation after inhaled corticosteroids with a face mask have been described. It is recommended to rinse the face with water after using a face mask.

· Systemic effects may occur during long-term treatment with high doses (see Warnings and Precautions section ).

· Inhalant corticosteroid therapy has been reported with observations of skin thinning, subcutaneous hematoma, cataract and glaucoma, adrenal-induced depression (decreased plasma cortisol and 24-hour cortisoluria), and rarefaction of bone tissue. The clinical consequences of long-term administration, particularly on bone tissue and growth, are unclear. The administration of large doses in the long term may therefore require monitoring, especially in children and the elderly.

· Hypersensitivity reactions (rash, urticaria, pruritus and erythema, and angioedema) have been reported with inhaled beclometasone.

· Very rare frequency: cataract and glaucoma.

· Psychiatric disorders:

Frequency not known: psychomotor hyperactivity, sleep disorders, anxiety, depressive syndrome, aggressiveness, behavioral disorders (mainly observed in children).

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