Instructions Flu-acyl broncho sterile solution for inhalation ampoule 5 ml No. 10
Composition
1 ampoule of 5 ml (ml) contains: active ingredients: N-acetylcysteine 300 mg (mg), sodium chloride 150 mg (mg); excipients: sodium hydroxide, sodium edetate, water for injection.
Description
Sterile solution for nebulizer and instillations "FLU-ACYL Broncho" is a medical product based on hypertonic saline solution and N-acetylcysteine.
Sterile solution for nebulizer and instillations "FLU-ACIL Broncho" liquefies thick viscous mucus due to the physical and mechanical effects of its components.
Sodium chloride.
Sterile buffered hypertonic sodium chloride solution. Hypertonic saline solutions applied directly to the mucosa of the upper respiratory tract draw water from the intracellular to the extracellular space by osmosis. This increases the percentage of water in the mucus lining the epithelium, thinning it and thus facilitating its removal.
N-acetylcysteine.
The acetylated variant of the amino acid cysteine exhibits mucolytic activity upon direct contact with mucus. This is due to the presence of sulfhydryl radicals in the molecule, which are capable of destroying disulfide bonds of acidic mucopolysaccharides of sputum (which give viscosity to mucus) by depolymerizing macromolecules. The agent retains activity in the presence of purulent sputum. It has an indirect antioxidant effect, which is associated with an increase in the synthesis of the antioxidant compound glutathione, as well as a direct antioxidant effect, protecting respiratory epithelial cells from damage by free radicals.
Indications for use
Sterile solution for nebulizer and instillations "FLU-ACIL Broncho" is a medical product in single-use ampoules, indicated for the treatment of respiratory diseases accompanied by hypersecretion of thick and viscous sputum: acute bronchitis, chronic bronchitis and its complications, pulmonary emphysema, cystic fibrosis, bronchiectasis, sinusitis, secretory otitis.
Contraindication
Hypersensitivity to the active components of the drug or any excipients, children under 2 years of age. Gastric and duodenal ulcer in the acute stage, hemoptysis, pulmonary hemorrhage.
During pregnancy or breastfeeding, the use of sterile solution for nebulizer and instillations "FLU-ACIL Broncho" is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child and under the direct supervision of a physician.
Method of administration and doses
Spraying through a nebulizer during inhalation to reach the bronchial mucosa;
direct instillation into the ear and nasal irrigation;
administration in small doses endobronchially through indwelling catheters, during bronchoscopy, etc.;
Nebulizer aerosol administration:
- adults - one ampoule per session 1-2 times a day for 5-10 days,
- children from 2 years old - up to 1 ampoule per session 1–2 times a day for 5–10 days.
The dose of the drug and the frequency of sessions can be changed by the doctor within a wide range depending on the clinical and therapeutic effect without the need to significantly differentiate the doses for adults or children.
Instillation and rinsing of ears and other cavities:
- ½ ampoule or 1 ampoule per session.
Endotracheal-bronchial instillations:
up to 1 ampoule per use, 1-2 times a day or as needed.
It is recommended to consult a doctor before use.
Overdose
Excessive doses of sterile solution for nebulizer and instillations "FLU-ACIL Broncho" during inhalation and endotracheal-bronchial administration of the drug can lead to voluminous and excessive secretion of liquid secretion, which in the case of patients with a suppressed cough reflex and expectoration, may lead to the need for bronchoalveolar lavage.
Side effects
Due to the high salt concentration, when using sterile solution for nebulizer and instillations "FLU-ACIL Broncho" it is possible to cause episodic localized irritant phenomena, which can cause bronchospasm, burning in the nasal mucosa, rhinorrhea, nausea, vomiting.
Among such phenomena, the cough reflex, within acceptable limits, should be perceived positively, as it contributes to expectoration and unblocking of the respiratory tract.
Side effects of using sterile solution for nebulizer and instillations "FLU-ACIL Broncho" usually disappear on their own after stopping use. If they do not disappear, you should consult a doctor.
Following the instructions for use reduces the risk of side effects.
Interaction with other tools and other types of interaction
Patients receiving nitroglycerin-based drugs should consult a doctor before using the sterile solution for nebulizer and instillations "FLU-ACIL Broncho", since the presence of N-acetylcysteine can lead to hypotension with dilation of the temporal artery. If it is necessary to use nitroglycerin and N-acetylcysteine simultaneously, the patient should be under the supervision of a doctor for the development of hypotension. The patient should be warned about the possibility of headache, in this case, the pressure should be monitored.
N-acetylcysteine should not be administered concurrently with antitussives, as suppression of the cough reflex may increase bronchial secretion congestion.
Sterile solution for nebulizer and instillations "FLU-ACIL Broncho" can be used simultaneously with conventional bronchodilators, vasoconstrictors, etc., but in this case it should be used for the shortest possible time.
It is not recommended to mix antibiotics with the sterile solution for nebulizer and instillations "FLU-ACIL Broncho".
Laboratory indicators
The use of N-acetylcysteine, contained in the sterile solution for nebulizer and instillations "FLU-ACIL broncho", may affect the results of the quantitative determination of salicylates by the colorimetric method and the results of the determination of ketones in urine. It is recommended to inform your doctor before using the sterile solution for nebulizer and instillations "FLU-ACIL broncho" if you have recently taken any other medications, including those obtained without a prescription.
Reservation
The last inhalation should be done no later than 3-4 hours before bedtime (approximately 6:00 p.m.) to allow time to evacuate phlegm before bedtime. To enhance hydration and the mucolytic effect, it is advisable to drink sufficient fluids.
When opening the ampoule of sterile solution for nebulizer and instillations "FLU-ACIL Broncho", a sulfurous odor is released, which does not affect the use of the drug in any way.
The N-acetylcysteine solution, when stored in open ampoules or transferred to aerosol equipment, may in rare cases acquire a slight pink color, which does not affect the effectiveness and tolerability of the drug.
N-acetylcysteine, especially at the beginning of therapy, can thin bronchial secretions and increase their volume. If the patient cannot cough up sputum effectively, postural drainage or bronchoaspiration should be performed to avoid sputum stagnation.
Patients with bronchial asthma should be under the supervision of a physician during therapy with sterile nebulizer solution and instillations of "FLU-ACIL Broncho". In the event of bronchospasm, N-acetylcysteine should be discontinued immediately and appropriate treatment should be initiated.
Packaging
Blister containing 10 ampoules of 5 ml (ml) in a box.
Expiration date
24 months from date of manufacture. The expiry date stated on the packaging refers to unopened packaging that has been properly stored. Do not use after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25℃ in a place inaccessible to children, protected from light and heat sources.
It is recommended to open the ampoule of sterile solution for nebulizer and instillations "FLU-ACIL Broncho" immediately before use, store opened ampoules in the refrigerator and use within the next 24 hours. The solution mixed with other drugs should be used as soon as possible and cannot be stored.
Producer
Pharma Line Srl, Via Bertani 2, 20154 Milan, Italy.
Authorized representative:
LLC "UNIVERSAL AGENCY "PRO-PHARMA" 9 Peremohy St., office 20, Kyiv, 03170, Ukraine.
