Rovamycinum tab n / about 16 pieces 1500000me

$27.60

Rovamycinum tab n / about 16 pieces 1500000me

Quantity:

Description

Composition
Active substance:
1 tablet contains 1.5 million IU: spiramycin – 1.5 million ME.
1 tablet contains 3 million IU: spiramycin – 3 million ME..
Excipients:
1 tablet contains 1.5 million IU: colloidal silicon dioxide – 1.20 mg magnesium stearate – 4.00 mg pregelatinized corn starch – 16.00 mg, giproloza – 8.00 mg, croscarmellose sodium – 8.00 mg microcrystalline cellulose to 400 mg; sheath: titanium dioxide (E 171) – 1.694 mg of macrogol-6000 – 1,694 mg, hypromellose – 5.084 mg.
1 tablet contains 3 million IU: colloidal silicon dioxide – 2.40 mg magnesium stearate – 8.00 mg pregelatinized corn starch – 32.00 mg, giproloza – 16.00 mg Croscarmellose sodium – 16.00 mg Microcrystalline cellulose to 800 mg; sheath: titanium dioxide (E 171) – 2.96 mg macrogol 6000 – 2.96 mg hypromellose – 8.88 mg.
Description:
For 1.5 million IU dosages:. Biconcave, round tablets, film-coated, white or white to cream color. On one side there engraving «RPR 107″. View in cross section: white or white to cream color shade
For dosage 3 million IU:. Biconcave, round tablets, coated with a creamy white color. On one side there engraving «ROVA 3″. A view of the cross-section: white with cream color.
Product form:
Tablets, film-coated. . For 1.5 million IU dosages: By blister 8 tablets in PVC / aluminum foil. 2 blisters together with instructions for use in a cardboard box. . To 3 million IU dosages: 5 tablets in a blister made of PVC / aluminum foil. 2 blisters together with instructions for use in a cardboard box. 10 tablets in blister PVC / aluminum foil. 1 blister together with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to spiramycin and other ingredients. Lactation. Deficiency of the enzyme glucose-6-phosphate dehydrogenase deficiency (risk of acute hemolysis). Infancy (up to 6 years – to 1.5 million tablets ME, up to 18 years -. Pill 3 million ME.).
Carefully
The obstruction of the bile ducts. Liver failure.
Dosage
1.5 million U
Indications
Infectious diseases caused by susceptible microorganisms to the drug: acute and chronic pharyngitis caused by beta-hemolytic streptococcus A (alternatively treating beta-lactam antibiotics, especially in the case of contraindications for their use); acute sinusitis (considering the sensitivity of the most frequently cause this pathology microorganisms Rovamitsin® drug application shown in the case of contraindications to the use of beta-lactam antibiotics); acute and chronic tonsillitis, caused by susceptible microorganisms spiramycin; acute bronchitis caused by bacterial infection, viral developed after acute bronchitis; exacerbation of chronic bronchitis; community-acquired pneumonia in patients with no risk factors for adverse outcome, severe clinical symptoms and the clinical signs of pneumonia, pneumococcal etiology; pneumonia caused by atypical pathogens (such as Chlamydia pneumoniae and trachomatis, Mycoplasma pneumoniae, Legionella spp) or suspected it (irrespective of severity and presence or absence of an adverse outcome risk factors); infections of the skin and subcutaneous tissue, including impetigo impetiginizatsiyu, ecthyma, dermal-infectious hypodermal (especially face), secondary infected dermatoses, erythrasma; oral infections (stomatitis, glossitis etc…); non-gonococcal genital infections; toxoplasmosis, including pregnant women; infection of the musculoskeletal system and connective tissue, including periodontal.
Prevention of recurrence of rheumatic fever in patients with allergy to beta-lactam antibiotics;
Eradication of Neisseria meningitidis from the nasopharynx (with contraindications for receiving rifampicin) for the prevention (not the treatment) of meningococcal meningitis patients after treatment and before leaving the quarantine or in patients, who were within 10 days prior to admission into contact with persons allocated Neisseria meningitidis with the saliva into the environment.
Interaction with other drugs
Since levodopa: carbidopa inhibition spiramycin suction with a reduction in the plasma concentration of levodopa. When concomitant administration of spiramycin necessary clinical monitoring and dose adjustment of levodopa.
With indirect anticoagulants: registered numerous cases increasing the activity of anticoagulants in patients receiving antibiotics. Type of infection or the severity of the inflammatory response, the age and general condition of the patient are predisposing risk factors. In such circumstances, it is difficult to determine the extent to which the infection itself or its treatment play a role in changing the international normalized ratio (INR). However, the application of certain groups of antibiotics, this effect is observed more frequently, in particular when using fluoroquinolones, macrolides, cyclins, sulfamethoxazole + trimetaprim and some cephalosporins.
Overdose
There are no known cases of overdose spiramycin.
Symptoms: The symptoms of a possible overdose may include: nausea, vomiting, diarrhea. Cases interval lengthening QT, passing to remove the drug, observed in neonates receiving high dose or spiramycin spiramycin after intravenous administration in patients who are predisposed to a lengthening of the interval QT. In overdose spiramycin recommended ECG monitoring with QT interval length determination, especially in the presence of risk factors (hypokalemia, congenital QT interval elongation, the simultaneous use of drugs, prolonging the duration of QT interval and causing the development of ventricular tachycardia type “pirouette”).
Treatment: There is no specific antidote. If you suspect an overdose, symptomatic therapy is recommended spiramycin.
pharmachologic effect
Pharmacological group:
Macrolide antibiotic.
Pharmacodynamics:
Spiramycin belongs to macrolide antibiotics. The mechanism of the antibacterial action due to inhibition of protein synthesis in the microbial cell by binding to the 508-subunit of the ribosome. Antibacterial spectrum spiramycin
Sensitive organisms: minimum inhibitory concentration (MIC)
Gram-positive aerobes: Bacillus cereus; Corynebacterium diphtheria; Enterococcus spp, Rhodococcus equi; Staphylococcus meti-S (methicillin-susceptible staphylococci); Staphylococcus meti-R (resistant staphylococci metitsillin-); Streptococcus B; neklassitsirovanny streptococcus; Streptococcus pneumoniae; Streptococcus pyogenes
Gram-negative aerobes: Bordetella pertussis; Branhamella catarrhalis; Campylobacter spp; Legionella spp; Moraxella spp.
Anaerobes: Actinomyces spp; Bacteroides spp; Eubacterium sp; Mobiluncus spp; Peptostreptococcus spp; Porphyromonas spp; Prevotella spp; Propionibacterium acnes.
Miscellaneous: Borrelia burgdorferi; Chlamydia spp; Coxiella spp; Leptospires spp; Mycoplasma pneumoniae; Treponema pallidum; Toxoplasma gondii.
Moderately sensitive microorganisms: antibiotic moderately active in vitro at concentrations of antibiotic in the inflammation> 1 mg / l, but
Gram-negative aerobes: Neisseria gonorrhoeae.
Anaerobes: Clostridium perfringens.
Miscellaneous: Ureaplasma urealyticum.
Resistant microorganisms (MIC> 4 mg / l): at least 50% of the strains are resistant.
Gram-positive aerobes: Corynebacterium jeikeium; Nocardia asteroides
Gram-negative aerobes: Acinetobacter spp; Enterobacteria spp; Haemophilus spp; Pseudomonas spp.
Anaerobes: Fusobacterium spp.
Miscellaneous: Mycoplasma hominis
Spiramycin have not revealed teratogenic effects, so it is safe to take it to pregnant women. A decrease in the risk of transmission of toxoplasmosis fetus during pregnancy from 25% to 8%, when used in I trimester, from 54% to 19% – when used in P and from 65% to 44% – using a W trimester.
Pharmacokinetics:
Absorption: the absorption of spiramycin is fast, but not fully, with great variability (from 10 to 60%). Food intake does not affect absorption. After ingestion 6 million. ME spiramycin maximum plasma concentration of about 3.3 ug / ml.
Distribution: Spiramycin does not penetrate into the cerebrospinal fluid. Spiramycin is excreted into breast milk. Communication with plasma proteins – low (approximately 10%). Crosses the placental barrier (concentration in blood of the fetus is about 50% of the concentration in maternal serum). Concentrations in the placental tissue is 5 times higher than corresponding concentrations in blood serum. The volume of distribution – about 383 liters. The drug penetrates well into the saliva and tissues (concentration in lung – from 20 to 60 g / g, tonsils – 20 to 80 ug / g of infected sinuses – from 75 to 110 micrograms / g, bones – from 5 to 100 mg / g ). Ten days after the treatment the concentration of drug substance in the spleen, liver and kidneys from 5 to 7 g / g. Spiramycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrophages). In humans, the drug concentration inside the phagocytes are sufficiently high. These properties explain the effects of spiramycin on intracellular bacteria.
Metabolism: spiramycin metabolized in the liver with the formation of active metabolites with unknown chemical structure.
Excretion: half-life from the blood plasma is about 8 hours. Excreted mainly in the bile (concentrations in bile in 15-40 times higher than in serum). Renal excretion is about 10% of the administered dose. The amount of drug excreted through the intestines (faeces), very slightly.
Pregnancy and breast-feeding
Pregnancy: Rovamitsin® may be administered, if necessary, during pregnancy. Large experience of spiramycin during pregnancy has not revealed it to be teratogenic or foetotoxic properties
Lactation: the appointment during lactation should stop breastfeeding because of possible penetration of spiramycin in breast milk.
Conditions of supply of pharmacies
On prescription.
side effects
The following classification is to indicate the frequency of occurrence of undesirable effects: very common (> 10%), common (> 1%
special instructions
During drug treatment in patients with liver disease need to periodically monitor its function. Tablets 3 million. ME in children are not applied due to difficulties swallowing their children because of the large diameter of the tablets and the risk of airway obstruction. If at the beginning of treatment the patient any generalized pustules and erythema, accompanied by high body temperature, it should be assumed acute generalized exanthematous pustuloz (see “Side effect”.); If such a reaction occurs, the treatment should be stopped and further the use of spiramycin as monotherapy, or in combination, is contraindicated
Effects on ability to drive and engage in other potentially hazardous activities There are no data on the negative impact of the drug on the ability to drive and engage in other potentially hazardous activities. However, one should take into account the severity of the patient’s condition, which can affect attention and speed of psychomotor reactions. Therefore, a decision on the possibility of driving or busy with other potentially hazardous activities in a particular patient should be made by a physician.
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Tablets are inside, squeezed with sufficient water.
Patients with normal renal function
Adults: daily dose is 2-3 tablets of 3 million or 4-6 ME 1.5 million tablets of the ME (i.e. 6-9 million ME.), Which is divided into 2 or 3 doses… The maximum daily dose is 9 million. ME.
Children: children from 6 to 18 years of age should only be used tablets to 1.5 million IU.. For children over 6 years of daily dosage of 150-300 thousand. ME per kg body weight, which is divided into 2 or 3 doses up to 6-9 million. ME. The maximum daily dose for children is 300 thousand. ME per kg of body weight, but in case the child’s body weight over 30 kg, it must not exceed 9 Mill. ME.
Prevention of meningococcal meningitis
Adults: 3 million ME twice a day for 5 days.
Children:. 75 thousand twice a day for 5 days ME per kg body weight.
Patients with impaired renal function
In connection with the minuteness of renal excretion of the drug dose adjustment is required.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

SANOFI RUSSIA

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