Брамитоб

General characteristics. Structure:

Active agent: Tobramycinum of 75 mg

Excipients: sodium chloride, sodium hydroxide, sulphuric acid, water for injections.

Pharmacological properties:

Tobramycinum - the aminoglikozidny antibiotic produced by mikroorgayonizm of the sort Streptomyces tenebrarius. The main mechanism of its action - disturbance of synthesis of protein that leads to change of permeability of a kletochyony membrane, the accruing damage of a cellular cover and posleyoduyushchy death of a cell. Tobramycinum possesses bactericidal action in the concentration equal or a little exceeding overwhelming concentration.
Tobramycinum shows activity, mainly, concerning gram-negative aerobic microorganisms, having low activity concerning anaerobic microorganisms and the majority of gram-positive bacteria.
Tobramycinum is more active, than gentamycin, concerning Pseudomonas aeruginosa and some strains a protea; about 50% of strains of Pseudomonas aeruginosa steady against gentamycin are sensitive to Tobramycinum.
At inhalation introduction the minimum overwhelming concentration (MOC) of Tobramycinum in a phlegm of patients with a mucoviscidosis is significantly higher, than at parenteral administration.

Pharmacokinetics. After inhalation of 300 mg of BRAMITOBA by patients with a mucoviscidosis че­рез 30 minutes in a phlegm the maximum concentration equal to about 1289 mkg/g while in plasma the maximum concentration equal of 758 ng/ml, is reached approximately in 1,5 hours is reached. The period of a poluvyveyodeniye makes 4,5 hours.
Removal of the drug which is soaked up in blood happens through kidneys by glomerular filtering.

Indications to use:

Treatment of the respiratory infections caused by Pseudomonas aeruginosa in patients with a mucoviscidosis.

Route of administration and doses:

It is inhalation, with use of the nebulizer. Adults and children are more senior than 6 years:
- on one ampoule (300 mg) two times a day (in the morning and in the evening) within 28 days. The interval between inhalations has to make about 12 hours, but not less than 6 hours.
After use of BRAMITOBA within 28 days, it is necessary to take a break for 28 days then, to continue therapy during the next 28 days.
The mode of dosing does not consider body weight. All patients should appoint on one ampoule of Bramitoba (300 mg of Tobramycinum) two times a day.

Instructions to the correct use.

To bend the separated ampoule from a strip in both directions.
To separate an ampoule from a strip, in the beginning an upper part, then average.
To open an ampoule, having turned its upper part concerning the case in the direction specified by an arrow.
Moderately pressing walls, to pour out medicine in a glass neck of the nebulizer.

The contents of one ampoule (300 mg) poured in the nebulizer are entered by inhalation in 10-15 minutes by means of the reusable PARI LC PLUS nebulizer with compressors which at connection to the PARI LC Plus nebulizer, provide delivery of 4-6 l/min and/or the return davleyony, equal 110-217 kPa.
Inhalations of Bramitoba are carried out in position of the patient sitting or standing, at usual breath through a nebulizer mouthpiece. The nasal clip can help the patient to breathe through the mouth.
Instructions on cleaning and disinfection of the nebulizer.
After the end of a procedure of inhalation it is necessary to disassemble the nebulizer, its separate parts (except for a tube) to wash out carefully hot water and liquid detergent, to rinse and to wipe dry the pure dry rag which is not leaving fibers. For regular disinfection of the nebulizer it is recommended to lower its separate parts (except a tube) cleared according to instructed above, in the solution consisting of one part of 9% of acetic acid and three parts of hot water for one hour, then to wash out hot water and to wipe dry a pure rag.
After completion of disinfection the used solution should be poured out at once.
As an alternative disinfection can be carried out by boiling within 10 minutes.

Features of use:

The doctor having experience of maintaining patients with a mucoviscidosis has to appoint treatment of BRAMITOBOM. Duration of course treatment opredeyolyatsya by the doctor, proceeding from a clinical picture of a disease. In case of podyotverzhdenny deterioration in pulmonary functions it is necessary to appoint additional antibacterial therapy.
At inhalation use of BRAMITOBA the bronchospasm can develop. The first dose of BRAMITOBA should be entered under observation of the doctor, having appointed bronchodilator before inhalation if it is already included into the used scheme of treatment of the patient. Before and after the procedure it is necessary to measure OFV1 (volume of the forced exhalation). At emergence of signs of an iatrogenic bronchospasm in the patient who is not receiving bronchodilator, use of drug needs to be repeated separately, with bronchodilator use. Emergence of a bronchospasm against the background of use of bronchodilator can indicate allergic reaction. At suspicion on allergic reaction use of BRAMITOBA should be stopped. For stopping of a bronchospasm it is necessary to carry out the corresponding patoyogenetichesky therapy.
During treatment of BRAMITOBOM the patient should continue standard physical therapy of a thorax. Use of bronchodilators has to continue according to clinical indications. When using several methods of treatment of respiratory disturbances the sleyoduyushchy order is recommended: bronchodilator, respiratory physical therapy, other inyogalyatsionny medicines and at the end - Bramitob.
Брамитоб it is not necessary to mix with other inhalation lekarstyovenny means.
BRAMITOB should be applied carefully at patients with parkinsonism or other states which are characterized by muscular weakness including myasthenia gravis as aminoglycosides can increase muscular weakness because of possible kurarepodobny action on neuromuscular conductivity.
Drug should be used with care at patients with the proved or suspected renal failure, on condition of monitoring of concentration of Tobramycinum in blood serum.
It is necessary to estimate periodically indicators of function of kidneys (level of urea and creatinine not less once during 6 courses of therapy of BRAMITOBOM). At emergence of signs of nephrotoxicity, treatment by Tobramycinum should be interrupted before decrease in the minimum concentration of drug in serum less than 2 mkg/ml. Then treatment of BRAMITOBOM can be resumed on medical indications. The patients who are at the same time receiving parenteral therapy by other aminoglycosides should be observed carefully because of a possibility of development of cumulative toxicity.
When using aminoglycosides ototoxicity development (a gipoakuziya, a rotatory and not rotatory vertigo, an ataxy) is possible.
The doctor has to consider a possibility that aminoglycosides can have vestibular and cochlear toxicity and during therapy of BRAMITOBOM has to estimate hearing function. Passing of audiometric tests prior to therapy of BRAMITOBOM is recommended to the patients accepting earlier aminoglycosides for a long time. At treatment of dizziness it is necessary to take into account that it is ototoxicity manifestation. When developing dizziness or decrease in hearing during therapy of BRAMITOBOM, carrying out audiological inspection is necessary.
At inhalation emergence of a tussive reflex is possible. Use of inhalation Tobramycinum for patients with an acute pneumorrhagia has to be carried out only if the advantage of treatment exceeds risk of provocation of further bleeding.
At some patients receiving Tobramycinum increase in MPK of aminoglycosides concerning the studied allocated strains of P. aeruginosa is noted. Development of resistance of strains of P. aeruginosa, to intravenously entered Tobramycinum is possible.

Side effects:

Very seldom	Seldom	Not often
<1/10000	1/10000-1/1000	1/1000-1/100

From a musculoskeletal system
very seldom: dorsodynias.

From blood and lymphatic system:
very seldom: limfoadenopatiya;

From sense bodys:
seldom: a ring in ears, a hearing loss;
very seldom: vestibular and labyrinth disturbances, ear pains.

From the central and peripheral nervous system:
seldom: headache, dizziness;
very seldom: drowsiness.

From digestive tract:
seldom: nausea, stomacace, vomiting, taste change;
very seldom: diarrhea.

From a respiratory organs:
infrequently: change of a voice, asthma, strengthening of cough, pharyngitis;
seldom: bronchospasm, strengthening of formation of a phlegm, pneumorrhagia, deterioration in functions of lungs, laryngitis, nasal bleeding, rhinitis.
very seldom: hyperventilation, hypoxia, sinusitis.

Local reactions:
very seldom: fungal infections, oral cavity candidiasis.

Others:
seldom: skin rash, anorexia, thorax pains, adynamy, fever.
very seldom: pain and discomfort in a stomach.

Interaction with other medicines:

Significant medicinal interaction of BRAMITOBA at combined use with Mucolyticums, β 2 adrenomimetikam, inhalation corticosteroids and other peroral and parenteralyyony antibiotics with antipsevdomonadny activity is not revealed.
It is necessary to avoid simultaneous or consecutive use of inhalation Tobramycinum and others potentially nefro-or ototoksichny medicines. Some diuretics can increase toxicity of aminoglycosides, changing concentration of an antibiotic in serum and fabrics. It is odnoyovremenno not necessary to appoint inhalation Tobramycinum with Acidum etacrynicum, furosemide, urea or Mannitolum.
Toxicity of aminoglycosides can increase at parenteral administration of the following drugs: Amphotericinum In, cefalotin, cyclosporine, a takrolimus, polymyxins (risk of strengthening of nephrotoxicity), platinum drugs (risk of strengthening of nephrotoxicity and ototoxicity) and also inhibitors of cholinesterase and botulotoxin (neuromuscular effects).

Contraindications:

- hypersensitivity to drug;
- children's age up to 6 years;

With care.
Coronary heart disease, chronic heart failure in decompensation stages, a diabetes mellitus, pregnancy. A renal failure, a hearing disorder, dysfunction of a vestibular mechanism or neuromuscular pathology, such as parkinsonism or other states which are characterized by muscular weakness, including myasthenia gravis, an acute pneumorrhagia.

Pregnancy and lactation.
Use of drug during pregnancy is possible, only if the expected advantage for mother exceeds possible risk for a fruit.
In need of use of drug in the period of a lactation, it is necessary to stop breastfeeding.

Overdose:

The expressed voice osiplost can be a symptom of overdose.
At accidental hit of BRAMITOBA inside toxic action is improbable as Tobramycinum is badly soaked up from digestive tract.
At accidental intravenous administration of BRAMITOBA symptoms and signs of overdose of Tobramycinum, such as dizziness, hearing loss, ring in ears, вертиго, a respiratory distress syndrome, blockade of neuromuscular conductivity and a renal failure can develop.
In case of manifestation of signs of overdose of BRAMITOB it is necessary to cancel and conduct a research of indicators of function of kidneys immediately. For control of overdose there can be useful a definition of concentration of Tobramycinum in blood serum.

Storage conditions:

At a temperature + 2-8 °C, in original packaging for protection against a sveyot, far from heating devices. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Solution for inhalations of 300 mg / 4 ml.
On 4 ml in hermetically soldered plastic ampoule. The strip on 4 ampoules is located in an aluminum strip. On 4, 7 or 14 strips with an instyoruktion on use place in a cardboard pack.