Fluimucil antibiotic IT 500 mg / 4 ml 3's lyophilisates for solution for injection and inhalation in ampulahs sol.

Trade name
IT Fluimucil antibiotic

the International unlicensed name
Is not present

the Dosage form
Lyophilisate for preparation of solution for injections and inhalations, 500 mg complete with


the Structure One Bottle solvent
active agent - a tiamfenikola of the glitsinat atsetiltsisteinat contains 810 mg (it is equivalent a tiamfenikola of 500 mg),
excipient – dinatrium edetat.
Solvent - water for injections.

The description
White or light yellow lamellar weight with a light sulfuric smell.

Pharmacotherapeutic group
Antibacterial drugs for system use. Amfenikola. Tiamfenikol in a combination with other drugs.
The code of automatic telephone exchange J01BA52

the Pharmacological

Tiamfenikol Pharmacokinetics properties is quickly distributed in an organism, collects in tissues of airways in therapeutic concentration (a concentration ratio fabric/plasma makes about 1). The maximum concentration in plasma is reached in 1 hour after intramuscular introduction. Elimination half-life makes about 3 hours, the volume of distribution is 40 – 68 l. Linking with proteins of plasma up to 20%. It is removed by kidneys by means of glomerular filtration, in 24 hours after introduction the quantity of not changed tiamfenikol in urine is 50-70% of the entered dose. Gets through a placental barrier.
Acetylcysteinum after use is quickly distributed in an organism, elimination half-life makes 2 hours. In a liver it is deacetylated to cysteine. In blood the mobile balance free and Acetylcysteinum connected with proteins of plasma and its metabolites (cysteine, cystine, diacetylcysteinum) is observed. Acetylcysteinum gets into intercellular space, is mainly distributed in a liver, kidneys, lungs, a bronchial secret. It is removed by kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum), an insignificant part is allocated in not changed look through intestines. Gets through a placental barrier.

Tiamfenikol's pharmacodynamics glitsinat atsetiltsisteinat is the complex connection combining in the structure an antibiotic tiamfenikol and a mucolytic Acetylcysteinum. After absorption of a tiamfenikol glitsinat atsetiltsisteinat it is split on Acetylcysteinum and tiamfenikol.
Tiamfenikol is derivative chloramphenicol, the mechanism of action is connected with inhibition of synthesis of protein of a bacterial cell. Tiamfenikol possesses a wide range of antibacterial action, in vitro concerning the bacteria which are most often causing respiratory infections is effective: 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.).
Acetylcysteinum, breaking disulfide bridges of mukoproteid, quickly and effectively dilutes a phlegm, pus, reduces their viscosity and promotes an otkhozhdeniye. Acetylcysteinum facilitates penetration of an antibiotic of a tiamfenikol into tissues of lungs, oppresses adhesion of bacteria on an epithelium of airways.

Indications
For treatment of the respiratory bacterial infections caused by microorganisms, sensitive to drug, and which are followed mukostazy.
Topical administration:
- acute and chronic bronchitis, bronchial pneumonia and long pneumonia, obstructive emphysema, a bronchoectatic disease
- prevention and treatment of bronchopulmonary complications after thoracic surgical interventions (bronchial pneumonia, an atelectasis)
- nonspecific forms of respiratory infections in a pulmonary tuberculosis for improvement of drainage of the cavernous centers
- exudative average otitis, sinusitis, a nasopharyngitis, faringotrakheit
- prevention and treatment of obstructive and infectious complications after tracheostomy, preparation for a bronkhoskopiya, bronchography, a bronkhoaspiration
System use:
- in all above-mentioned cases of bronchopulmonary diseases when the doctor the combined antimicrobic and mucolytic treatment is recommended.

The route of administration and doses
enter IT Fluimucil antibiotic intramusculary, apply to inhalations, instillations, washing of cavities.
It is inhalation: the adult - on 250 mg (2 ml of solution) 1-2 times a day (500 mg of dry matter dissolve in 4 ml of water for injections).
Endotrakhealno: via the bronchoscope, an endotracheal tube, a tracheostoma - on 1-2 ml of solution (500 mg of dry matter dissolve in 4 ml of water for injections).
Locally: for introduction to near-nasal bosoms and also for washing of cavities after surgical interventions in a nose and a mastoid - on 1-2 ml of solution (500 mg of dry matter dissolve in 4 ml of water for injections).
In diseases of a nasopharynx and ear to dig in 2-4 drops in each nasal course or external acoustical pass.
Intramusculary: the adult - on 500 mg 2-3 times a day with regular intervals.
In need of a dose can be increased twice (in the first 2-3 days of treatment in especially hard cases). It is impossible to increase a dose at patients 65 years are more senior.

Side effects
At topical administration:
- reflex cough, local irritation of airways, a bronchospasm (mainly at patients with bronchial asthma)
- a rhinorrhea
- stomatitis
- nausea
- skin rash
At system use:
- at intramuscular introduction perhaps easy burning in the injection site - anemia, a leukopenia, thrombocytopenia
- an optic neuritis, a peripheral neuropathy (after prolonged use)
- nausea, vomiting, diarrhea
- anaphylactic reactions
- fever, skin rash
- dysbacteriosis,

Contraindication superinfection
- hypersensitivity to drug components
- insufficiency of function of marrow in the anamnesis: anemia, a leukopenia, thrombocytopenia
- a peptic ulcer of a stomach and duodenum in an aggravation stage
- a pneumorrhagia, pulmonary bleeding
- pregnancy and the period of a lactation
With care: a peptic ulcer of a stomach and duodenum in a remission stage, a gullet varicosity, bronchial asthma (at in in introduction risk of development of a bronchospasm), diseases of adrenal glands, a liver and/or renal failure, arterial hypertension.

Medicinal interactions
Co-administration of antibechics can increase stagnation of a phlegm because of suppression of a tussive reflex.
It is not recommended to mix with other drugs for inhalation.

Special instructions
As well as other antibiotics, IT Fluimucil antibiotic it has to be applied only before full removal of a bacterial infection. If it is necessary to continue mucolytic therapy, then therapy can be continued by the drugs containing N-Acetylcysteinum as the only active agent.
IT fluimucil antibiotic – has to be applied with the same precautions, as an antibiotic tiamfenikol. Injection tiamfenikol can cause the passing changes of a picture of blood (mainly, oppression of an erythrogenesis) which are expressed by a reticulopenia and anemia rarely a leukopenia and thrombocytopenia. These changes are reversible and depend on concentration of a tiamfenikol in blood, that is to a large extent depend on a dose and duration of treatment. Changes of indicators of blood are more significant in case of overdose, especially patients with insufficiency have functions of kidneys, and patients with insufficiency have functions of marrow in the anamnesis.
It is recommended to apply tiamfenikol only to treatment of the infections caused by bacteria, sensitive to it, avoiding its use for prevention or for treatment of the most widespread bacterial infections.
Duration of treatment should not exceed ten days if longer course of treatment is necessary, then it is necessary to control periodically a pattern of peripheral blood, and to stop administration of drug if the quantity of leukocytes and granulocytes decreases to 4000/mkl and 40% respectively.
In case of an average or heavy renal failure it is recommended to appoint a mucolytic and an antibiotic separately as the dose of a tiamfenikol has to be reduced because of reduced function of kidneys. Tiamfenikol can be used in case of an abnormal liver function as he does not form conjugates with glucuronic acid.
Prescribing of N-Acetylcysteinum by inhalation introduction in particular can dilute a bronchial secret in an initiation of treatment, at the same time increasing its volume. If at the patient it is complicated otkhozhdeny phlegms it is necessary to clean airways by a postural drainage in order to avoid a delay of department of a phlegm.
Patients with bronchial asthma have to be under strict supervision of the doctor because of possibility of a bronchospasm. In this case treatment has to be immediately stopped. Administration of drug can be continued again after reception of a bronkhodilyatator.
Solution of IT Fluimucil antibiotic should not contact to metal and rubber surfaces.
It is necessary to appoint drug with care in a liver failure and chronic kidney disease.
Use at children
At children the drug IT Fluimucil antibiotic by a dosage 250 mg (pediatric) is used.
Features of influence on ability to run the vehicle and potentially dangerous mechanisms
IT Fluimucil antibiotic does not influence a possibility of control of vehicles and other mechanisms.

Overdose
Symptoms: change of bacterial flora, superinfection. Strengthening of side effect of drug is possible (except for allergic reactions).
Treatment: maintenance therapy is recommended.

A form of release and packing
On 810 mg of lyophilisate in the bottles of colourless glass (type I) corked by a chlorbutylrubber stopper and an aluminum cap under a running in.
On 4.0 ml of solvent in ampoules from colourless glass (type I) with the color ring specifying the line of a break.
On 3 bottles of lyophilisate complete with 3 ampoules of solvent in a plastic pallet together with the instruction for use in the state and Russian languages place in a pack cardboard.

Storage conditions
At a temperature not above 25 °C.
To store out of children's reach!



A period of storage
3 years




Lyophilisate for preparation of solution
for injections and inhalations 500 mg (bottles)

3 years


Solvent: water for injections (ampoule)

5 years


the Set

3 years
the Note: The expiration date of a set is determined by a component with the smallest expiration date.
Not to use drug after an expiration date.

Prescription status
According to the prescription


the Producer Zambon S.P.A.
Via della Chimica, 9 - Vicenza, Italy

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