Fluimucil solution for and/or inhalation. 100mg/ml 3ml amp 5 pcs

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Fluimucil solution for and/or inhalation. 100mg/ml 3ml amp 5 pcs

Pharmacological group:

Expectorant mucolytic agent.
Pharmacodynamics:
Mucolytic agent, dilutes sputum, increases its volume, facilitates sputum separation. The action is associated with the ability of free sulfhydryl groups of acetylcysteine ​​to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a decrease in viscosity/sputum. Remains active against purulent sputum.

Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates mucous cells of the bronchi, the secretion of which is lysed by fibrin. It has a similar effect on the secretions formed during inflammatory diseases of the ENT organs. It has an antioxidant effect due to the presence of an SH group that can neutralize electrophilic oxidative toxins. Acetylcysteine ​​easily penetrates into the cell and is deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant, cytoprotector that traps endogenous and exogenous free radicals and toxins. Acetylcysteine ​​prevents exhaustion and helps increase the synthesis of intracellular glutathione, which is involved in the redox processes of cells, thus promoting the detoxification of harmful substances. This explains the effect of acetylcysteine ​​as an antidote for paracetamol poisoning.

Protects alpha1-antitrypsin (elastase inhibitor) from the inactivating effects of HOC1, an oxidizing agent produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (by suppressing the formation of free radicals and reactive oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Pharmacokinetics:

With intravenous administration of 600 mg of acetylcysteine, the maximum plasma concentration is 300 mmol/l, the plasma half-life is 2 hours. The total clearance is 0.21 l/h/kg, and the volume of distribution at the plateau is 0.34 l/kg.

In the liver it is deacetylated to cysteine. In the blood, a mobile equilibrium of free acetylcysteine ​​and its metabolites (cysteine, cystine, diacetylcysteine) is observed, free and bound to plasma proteins. Acetylcysteine ​​penetrates into the intercellular space and is predominantly distributed in the liver, kidneys, lungs, and bronchial secretions.

It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is excreted unchanged through the intestines.

Penetrates through the placental barrier.

Fluimucil solution for injection and inhalation 100 mg/ml 3 ml ampoules, 5 pcs.

Manufacturer

Zambon S.p.A., Italy

Compound

Active ingredient:
acetylcysteine ​​300 mg;

Excipients:

disodium edetate – 3 mg;

sodium hydroxide – 74 mg;

water for injection – up to 3 ml

pharmachologic effect

Pharmgroup:

expectorant (mucolytic) agent. Pharmaceutical action:

Fluimucil is a mucolytic drug. Liquefies mucus, increases its volume and facilitates its separation. The action of acetylcysteine ​​is associated with the ability of its sulfhydryl groups to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a decrease in sputum viscosity. Remains active in the presence of purulent sputum.

Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates mucous cells of the bronchi, the secretion of which is lysed by fibrin. It has a similar effect on the secretions formed during inflammatory diseases of the ENT organs.

It has an antioxidant effect due to the presence of an SH group that can neutralize electrophilic oxidative toxins. Acetylcysteine ​​easily penetrates into the cell and is deacetylated to L-cysteine, from which intracellular glutathione is synthesized.

Glutathione is a highly reactive tripeptide, a powerful antioxidant and cytoprotector that neutralizes endogenous and exogenous free radicals and toxins. Acetylcysteine ​​prevents exhaustion and helps increase the synthesis of intracellular glutathione, which is involved in the redox processes of cells, promoting the detoxification of harmful substances. This explains the effect of acetylcysteine ​​as an antidote for paracetamol poisoning.

Protects alpha1-antitrypsin (elastase inhibitor) from the inactivating effects of HOCl, an oxidizing agent produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (by suppressing the formation of free radicals and reactive oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Indications

Respiratory diseases accompanied by the formation of high-viscosity sputum (acute and chronic bronchitis, pneumonia, bronchiectasis, cystic fibrosis, bronchial asthma).

Contraindications

Hypersensitivity to acetylcysteine, peptic ulcer of the stomach and duodenum in the acute stage,

The drug should be prescribed with caution to patients with liver and kidney diseases.

Side effects

From the digestive system: rarely - heartburn, nausea, vomiting, diarrhea, stomatitis.

Allergic reactions: rarely - skin rash, itching, urticaria, bronchospasm.

Other: rarely - nosebleeds, tinnitus, collapse, decreased platelet aggregation.

Local reactions: with parenteral use, a slight burning sensation at the injection site is possible; when used by inhalation - reflex cough, local irritation of the respiratory tract, stomatitis, rhinitis; rarely - bronchospasm (in this case it is necessary to prescribe bronchodilators).

Interaction

The combined use of acetylcysteine ​​with antitussives may increase sputum stagnation due to suppression of the cough reflex.

When used simultaneously with antibiotics such as tetracyclines (excluding doxycycline), ampicillin, amphotericin B, they may interact with the thiol group of acetylcysteine, which leads to a decrease in the activity of both drugs.

Therefore, the interval between taking these drugs should be at least 2 hours.

The simultaneous use of acetylcysteine ​​and nitroglycerin can lead to an increase in the vasodilating and disaggregating effects of the latter.

Acetylcysteine ​​eliminates the toxic effects of paracetamol.

How to take, course of administration and dosage

The injection solution can be administered parenterally, inhalation, or endobronchially.

Adults, intramuscularly deep or intravenously - usually 300 mg (1 ampoule of 3 ml) 1-2 times a day. Children 6–14 years old – 1/2 dose for adults. The daily dose for children under 6 years of age is 10 mg/kg. The duration of treatment should be determined based on the results of changes in the patient's condition. High local and general tolerance to the drug allows for long courses of treatment.

Inhalations: usually 300 mg (1 ampoule) 1–2 times a day for 5–10 days or longer courses; the frequency of administration and dose size can be changed by the doctor depending on the patient’s condition and the therapeutic effect. Children are prescribed in the same dosage.

Endobronchial administration: Injected appropriately using indwelling tubes, bronchoscope, etc. 300–600 mg (1–2 ampoules) or more per day depending on clinical indications.

Overdose

Acetylcysteine, when taken in doses of 500 mg/kg per day, did not cause signs and symptoms of overdose.

Special instructions

Prescribed with caution to patients prone to pulmonary hemorrhage, hemoptysis, with liver disease, kidney disease, adrenal dysfunction, patients with bronchial asthma and obstructive bronchitis (and under systematic monitoring of bronchial patency).

When dissolving acetylcysteine, you must use glass containers and avoid contact with metal and rubber surfaces. When opening the package, there may be a smell of sulfur; this is the smell of the active substance, and not evidence of poor quality of the drug.

The Fluimucil ampoule is opened before use. An opened ampoule can be stored in the refrigerator for 24 hours. Using the drug from a previously opened ampoule for injection is prohibited.

Fluimucil solution should not come into contact with rubber and metal surfaces.

Release form

Fluimucil solution for injection and inhalation is transparent, colorless, with a faint sulfuric odor; After opening the ampoule, a faint pink-violet tint may appear upon prolonged contact with air.

Storage conditions

At room temperature (not higher than 25 °C).

Best before date

3 years.

Active substance

Acetylcysteine

Conditions for dispensing from pharmacies

On prescription

Dosage form

injection

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Sinusitis, Sinusitis, Chronic obstructive pulmonary disease, Cough, Pneumonia, Bronchitis, Tracheitis

Information in the State Register of Medicines

Go

Barcode and weight

Barcode: 4603619000025 Weight: 0.044 kg

Fluimucil-antibiotic IT powder for injection 500mg No. 3

Fluimucil-antibiotic IT powder for injection 500mg No. 3

Brief description FLUIMUCIL ANTIBIOTIC is a mucolytic agent that thins sputum, increases its volume, and facilitates the separation of sputum.

Pharmacological action Thiamphenicol glycinate acetylcysteinate is a complex compound that combines the antibiotic thiamphenicol and the mucolytic acetylcysteine. After absorption of thiaminephenicol, glycinate acetylcysteinate is split into acetylcysteine ​​and thiamphenicol. Thiamphenicol is a derivative of chloramphenicol, the mechanism of action is associated with inhibition of bacterial cell protein synthesis. Thiamphenicol has a wide spectrum of antibacterial action and is effective in vitro against bacteria that most often cause respiratory tract infections: gram-positive (Streptococcus pneumoniae, Corynebacterium diphtheriae, Staphylococcus spp., Streptococcus pyogenes, Listeria spp., Clostridium spp.) and gram-negative (Haemophilus influenzae, Neisseria spp., Salmonella spp., Escherichia coli, Shigella spp., Bordetella pertussis, Yersinia pestis, Brucella spp., Bacteroides spp.). Acetylcysteine, by breaking the disulfide bonds of mucoproteins, quickly and effectively dilutes sputum and pus, reduces their viscosity and promotes discharge. Acetylcysteine ​​facilitates the penetration of the antibiotic thiamphenicol into lung tissue and inhibits the adhesion of bacteria to the epithelium of the respiratory tract.

Indications: diseases of the upper respiratory tract and ENT organs: exudative otitis media, sinusitis, laryngotracheitis; - diseases of the lower respiratory tract: acute and chronic bronchitis, prolonged pneumonia, lung abscess, emphysema, bronchiectasis, cystic fibrosis, bronchiolitis, whooping cough; — prevention and treatment of bronchopulmonary complications after thoracic surgery (bronchopneumonia, atelectasis); — prevention and treatment of obstructive and infectious complications of tracheostomy, preparation for bronchoscopy, bronchoaspiration; — with concomitant nonspecific forms of respiratory infections to improve drainage, including cavernous lesions, with mycobacterial infections. Method of administration and dosage Fluimucil® antibiotic IT is administered intramuscularly, used for inhalation, application, and cavity rinsing. Inhalation: adults - 250 mg 1-2 times a day; children - 125 mg 1-2 times a day. Endotracheal: through a bronchoscope, endotracheal tube, tracheostomy - 1-2 ml of solution (for adults, dissolve in 4 ml of water for injection - 500 mg of dry matter, for children - 250 mg). Locally: for administration into the paranasal sinuses, as well as for washing cavities after surgical interventions in the area of ​​the nose and mastoid process, 1-2 ml of solution (for adults, dissolved in 4 ml of water for injection - 500 mg of dry matter, for children - 250 mg ). For diseases of the nasopharynx and ear, instill 2-4 drops into each nasal passage or external auditory canal. Intramuscularly: adults - 500 mg 2-3 times a day; children under 3 years old - 125 mg 2 times a day; 3-7 years - 250 mg 2 times a day; 7-12 years - 250 mg 3 times a day. For premature and newborn babies up to 2 weeks, the average dose is 25 mg/kg per day. If necessary, the dose can be increased by 2 times (in the first 2-3 days of treatment in particularly severe cases). Do not increase the dose in premature and newborn children, as well as in patients over 65 years of age. The course of treatment is no more than 10 days.

Side effects Allergic reactions. With intramuscular administration, a slight burning sensation at the injection site is possible, rarely - reticulocytopenia, anemia, leukopenia, neutropenia, thrombocytopenia. With inhalation administration - reflex cough, local irritation of the respiratory tract, stomatitis, rhinitis, nausea. Bronchospasm is possible, in which case bronchodilators are prescribed.

Contraindications - anemia; - leukopenia; - thrombocytopenia; - hypersensitivity to one of the components of the drug. With caution: with liver failure and chronic renal failure. In children of the first two years of life due to age-related characteristics of kidney function.

Overdose Symptoms: changes in bacterial flora, superinfections. It is possible that the side effects of the drug may increase (with the exception of allergic reactions). Maintenance therapy is recommended.

Special instructions During treatment, the peripheral blood picture should be monitored. If the number of leukocytes (less than 4 thousand/μl) and granulocytes (by more than 40%) decreases, the drug is discontinued. Fluimucil IT antibiotic solution should not come into contact with metal and rubber surfaces. Fluimucil® antibiotic IT does not affect the ability to drive vehicles and other mechanisms.

Interaction with other drugs The simultaneous administration of antitussives may increase sputum stagnation due to suppression of the cough reflex. It is not recommended to mix with other aerosol medications.

Storage conditions At temperatures from 15°C to 25°C. Keep out of the reach of children.

Shelf life: lyophilisate for the preparation of solution for injection and inhalation 500 mg (bottles) - 3 years; solvent: water for injection (ampoules) - 5 years; set - 3 years.

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