POLPHARMA #Colds_and_flu #Bronchial #HEALTH_CARE
Product description
Benodil contains a powerful non-halogenating GCS - budesonide, intended for the treatment of bronchial asthma in patients for whom the use of inhalers with spraying of medicinal substances with compressed air or in the form of a dosage form of a dry powder is ineffective or impractical.
Benodil is also recommended for infants and children with croup (complications of an acute viral upper respiratory tract infection, also known as laryngotracheobronchitis or false croup), which is an indication for hospitalization.
Compound
Active substance: budesonide;
1 ml of suspension for nebulization contains 0.25 mg or 0.5 mg of budesonide;
Excipients: sodium chloride, sodium citrate, sodium edetate, polysorbate 80, citric acid, water for injection.
Contraindications
Hypersensitivity to budesonide or to any other ingredient in the preparation.
Mode of application
The preparation is intended for use by spraying through a compressor-type nebulizer.
Application features
Pregnant
Administration of budesonide during pregnancy requires careful weighing of the benefits to the woman versus the risks to the fetus.
Children
Benodil should be used in children over 6 months of age according to indications.
Drivers
Benodil does not affect or has little effect on the ability to drive vehicles and work with other mechanisms.
Overdose
Benodil contains 0.1 mg / ml sodium edetate, which has been shown to cause bronchoconstriction if the level exceeds 1.2 mg / ml. Acute overdose of Benodil, even when using excessive doses, most likely, will not present a clinically significant problem. Symptoms of acute budesonide intoxication are unknown. In case of acute overdose, suppression of the function of the hypothalamic-pituitary-adrenal system is possible. In cases of chronic overdose, adrenal atrophy may develop. Signs and symptoms of hypercortisolism may appear. It is also possible a violation of stress adaptation.
Overdose treatment. In case of chronic overdose, emergency treatment is not needed. Continuation of inhalation therapy with Benodil in the recommended dose is accompanied by the restoration of the function of the hypothalamic-pituitary-adrenal system within 1-2 days.
Under stress, there may be a need for "GCS protection" - an additional appointment of a high dose of hydrocortisone.
If atrophy of the adrenal cortex develops, the patient should be classified as steroid-dependent and a maintenance dose of systemic corticosteroids should be prescribed.
Benodil contains 0.1 mg / ml sodium B, which has been shown to cause bronchospasm at concentrations above 1.2 mg / ml.
Side effects
Description of selected adverse reactions. Oropharyngeal candidiasis occurs as a result of exposure to preparation residues. Rinsing the mouth with water after each use of the preparation will minimize this risk.
As with any inhalation therapy, the development of paradoxical bronchospasm is very rarely possible.
Interaction
Limited data on such interactions with high doses of inhaled budesonide show that with the simultaneous use of itraconazole at a dose of 200 mg 1 time per day, the administration of inhaled budesonide (a single dose of 1000 μg) leads to a significant increase in the concentration of the substance in the blood plasma (on average, 4 times) ...
Storage conditions
Store in its original packaging at a temperature not exceeding 30 ° C. Keep out of the reach of children.
An open container should be used within 12 hours.
After opening the envelope, the containers it contains should be used within 3 months.
Shelf life is 3 year
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