tablets, film coated: a round biconvex form, color, white or white with a cream shade, on one party the engraving of "RPR 107" (a tablet on 1,5 million ME) or "ROVA 3" is put (tablets on 3 million ME); on cross section – color white or white with a cream shade (on 1,5 million international units (IU): on 8 pieces in the blister, in a cardboard pack 2 blisters; on 3 million ME: on 5 pieces in the blister, in a cardboard pack 2 blisters);
lyophilisate for preparation of solution for intravenous (in/in) introductions: weight with porous structure, from yellowish till white color (on 1,5 million ME in glass transparent bottles, in a cardboard pack 1 bottle).

Contains in 1 tablet:

active ingredient: Spheromycinum – 1,5 million ME (with an engraving of "RPR 107") and 3 million ME (with an engraving of "ROVA 3");
auxiliary components: starch corn prezhelatinizirovanny, silicon dioxide colloid, hypro rod, magnesium stearate, cellulose microcrystallic, croscarmellose sodium;
structure of a cover: gipromelloza, macrogoal 6000, titanium dioxide (E171).

Contains in 1 bottle:

active ingredient: Spheromycinum – 1,5 million ME;
auxiliary components: adipic acid.

Indications to use

Tablets, film coated
Use of Rovamycinum in the form of tablets is shown at the infectious and inflammatory diseases caused by microorganisms, sensitive to Spheromycinum:

acute form of chronic bronchitis;
chronic and acute forms of the pharyngitis caused by a beta and hemolitic streptococcus of A (alternative therapy beta лактамным to antibiotics, including at a contraindication to their use);
adenoid and acute diseases;
stomatitises, glossites and other infectious pathologies of an oral cavity;
acute sinusitis (at a contraindication to use beta лактамных antibiotics);
the acute bronchitis of a bacterial etiology which is a complication of acute viral bronchitis;
the atypical pneumonia caused by Chlamydia pneumoniae, Mycoplasma pneumoniae, Chlamydia trachomatis, Legionella spp. bacteria, or suspicion on it (at absence or existence of risk factors of a failure and at any form of weight);
community-acquired pneumonia in the absence of heavy clinical symptoms, risk factors of a failure, clinical signs of pneumonia of a pneumococcal etiology;
infectious dermogipodermit (including an ugly face), the secondary infected dermatosis, impetigo, impetiginization, an ecthyma, an erythrasma and other infections of skin and hypodermic cellulose;
infections of generative organs of not gonococcal etiology;
toxoplasmosis, including during pregnancy;
periodontium and other infections of connecting fabric and musculoskeletal system.

Besides, tablets appoint for prevention of a recurrence of rheumatism to patients with an allergy to a beta laktamnye antibiotics.

Rovamycinum is accepted for prevention (not for treatment) a spotted fever by Neisseria meningitidis eradikation from a nasopharynx at the patients (with contraindications to rifampicin) contacting before hospitalization (within 10 days) with the faces excreting with saliva to Neisseria meningitidis environment before an exit from a quarantine and after performing treatment.

Lyophilisate for preparation of solution for intravenous (in/in) introductions
Use of lyophilisate is shown to adult patients at treatment of infectious pathologies of the lower respiratory tracts:

acute pneumonia;
infectious and allergic bronchial asthma;
exacerbation of chronic bronchitis.

Contraindications

deficit glyukozo-6-fosfatdegidrogenazy (because of risk of emergence of acute hemolysis);
breastfeeding period;
hypersensitivity to drug components.

Age contraindications:

tablets: on 1,5 million ME at children under 6 years, on 3 million ME – up to 18 years;
lyophilisate: up to 18 years.

With care it is recommended to appoint Rovamycinum sick with a liver failure, obstruction of bilious channels.

Besides, it is impossible to apply lyophilisate at patients with the extended QT interval along with the medicines causing ventricular tachycardia like "pirouette": hydroquinidine, quinidine, Disopyramidum (antiarrhytmic means of an IA class), соталол, Amiodaronum, дофетилид, ибутилид (antiarrhytmic means of the III class), Chlorpromazinum, thioridazine, levomepromazinum, циамемазин, трифлуоперазин, Droperidolum, a haloperidol, пилюзид (fenotiazinovy neuroleptics), тиаприд, Sulpiridum, сультоприд, амисульприд (neuroleptics of group of benzamides), pentamidine, галофантрин, moxifloxacin, bepridit, difemanit, цизаприд, мизоластин, at in administration of erythromycin and Vincaminum.

With care it is necessary to appoint lyophilisate at the means influencing development of the bradycardia, the ergot alkaloids, drugs reducing potassium concentration in blood serum accompanying therapy.

Route of administration and dosage

Tablets, film coated
Pill is taken inside, swallowing entirely and washing down with a necessary amount of water.

The recommended daily dosing has age restrictions:

adults: treatment – 6-9 million ME (4-6 tablets on 1,5 million ME or 2-3 tablets on 3 million ME) divided into 2-3 receptions; prevention of a spotted fever – on 3 million ME 2 times a day, a course – 5 days;
children are more senior than 6 years: treatment – from calculation for 150-300 thousand ME on 1 kg of body weight, a dose is divided into 2-3 receptions a day; prevention of a spotted fever – on 75 thousand ME on 1 kg of weight of the child 2 times a day, a course – 5 days.

Patients up to 18 years should appoint only tablets on 1,5 million ME.

The most admissible daily dose: adults and children weighing over 30 kg – 9 million ME, children – on 300 thousand ME on 1 kg.

Patients with functional disturbances of kidneys do not need dose adjustment.

Lyophilisate for preparation of solution for in/in introductions
Lyophilisate is applied by slow in/in drop by introductions.

For preparation of infusion solution contents of a bottle are dissolved in 4 ml of water for injections, then the received solution mix 5% of a dextrose (glucose) then ready solution is entered within 1 hour and more from 100 ml. At the room temperature solution of Rovamycinum keeps stability within 12 hours.

The dose and the period of treatment are appointed by the doctor taking into account sensitivity of microflora, weight and clinical features of a course of infectious process.

The recommended dosing: 4,5 million ME a day, on 1,5 million ME each 8 hours. At treatment of heavy infections the dose can be doubled.

As soon as the condition of the patient allows to accept drug inside, in/in introduction cancel.

Side effects

immune system: skin itch, rash, small tortoiseshell; very seldom – an acute anaphylaxis, a Quincke's disease; in some cases – Shenleyna-Genokh's purpura, a vasculitis;
digestive tract: nausea, diarrhea vomiting; very seldom – pseudomembranous colitis;
gepatobiliarny system: very seldom – the mixed or cholestatic hepatitis, disturbance of functional trials of a liver;
cardiovascular system: very seldom – lengthening of an interval of QT on the electrocardiogram (ECG);
nervous system: very seldom – passing paresthesia;
system of a hemopoiesis: very seldom – acute hemolysis;
dermatological reactions: very seldom – acute generalized exanthematous пустулез.

Besides, reception of tablets can cause disturbances from digestive tract in the form of an ulcer esophagitis, acute colitis, patients with AIDS have an acute injury of a mucous membrane of intestines against the background of high doses of Spheromycinum.

At treatment moderate painful sensitivity at administration of solution arises lyophilisate in rare instances on the course of a vein.

Special instructions

Treatment of patients with pathologies of a liver needs to be accompanied with periodic control of its function.

At emergence at the beginning of the use of Rovamycinum of a generalized erythema and pustules which are followed by the increased body temperature it is necessary to cancel drug as this state can specify on acute generalized exanthematous пустулез (in this case use of Spheromycinum to the patient contraindicated).

Use for children of tablets on 3 million ME is not recommended because of risk of the obstruction of respiratory tracts caused by a proglatyvaniye of tablets of big diameter.

At emergence of signs of allergic reaction administration of solution should be stopped immediately.

At infusion control of concentration of glucose in blood is required from patients with a diabetes mellitus (because of use of 5% of a dextrose).

The decision on a possibility of the patient to manage the vehicle and to carry out other potentially dangerous types of activity is accepted by the attending physician, considering weight of a condition of the patient.

Rovamycinum does not exert impact on ability to control of vehicles and mechanisms.

Medicinal interaction

At simultaneous use of Rovamycinum:

the levodopa – reduces the concentration in a blood plasma (correction of its dose and clinical control is required);
ftorkhinolona, some cephalosporins, tsiklina, macroleads, a combination of sulfamethoxazole and Trimethoprimum, other groups of antibiotics – increase activity of indirect anticoagulants. The type of an infection, expressiveness of inflammatory reaction, the general condition and age of the patient belongs to the risk factors contributing change of an indicator of system of a blood coagulation.

At the accompanying therapy of Rovamycinum in the form of lyophilisate with blockers of slow calcium channels, diltiazem, verapamil, beta adrenoblockers, a clonidine, guanfatsiny, foxglove glycosides, cholinesterase inhibitors (ривастигмин, donepezil, такрин, Galantaminum, неостигмин, an ambenoniya chloride, pyridostigmine) and the medicines reducing potassium concentration in blood (kaliyvyvodyashchy diuretics, in/in introduction of Amphotericinum of B, laxative the stimulating character, glucocorticosteroids, тетракозактид, mineralokortikosteroida) the risk of development of ventricular arrhythmias increases (it is recommended to eliminate a hypopotassemia prior to use of Spheromycinum, and during treatment to carry out control of level of electrolytes to blood, an ECG).