Flavozid
Producer: LLC NPK Ekofarm Ukraine
Code of automatic telephone exchange: J05AX
Release form: Liquid dosage forms. Syrup.
General characteristics. Structure:
Active ingredients: 100 ml of syrup contain Proteflazid® – the liquid extract (1:1) received from mix of a grass of Shchuchki turfy (Herba Deschampsia caespitosa L.) and herbs of the Smallreed land (Herba Calamagrostisepigeios L.), which contains not less than 0,32 mg of flavonoids in terms of Rutinum and not less than 0,3 mg of the sum of carboxylic acids in terms of malic acid;
excipients: propylene glycol, ethanol of 96%, sorbite (Е 420), methylparaben (Е 218), propylparaben (Е 216), sodium sulfite (Е 221), the water purified.
Main physical and chemical properties:
transparent sweet liquid of flavovirent color with a slight specific smell.
Pharmacological properties:
The flavonoids which are a part of drug have ability to suppress DNA replication and RNA of the kakin vitro viruses, and in vivo. When performing preclinical and clinical trials the inhibiting activity of drug concerning viruses of a herpes simplex of I and II types (HSV-1, HSV-2), a virus Epstein-Burra, the Varicella zoster virus and a cytomegalovirus is revealed.
When performing preclinical and clinical trials the inhibiting activity of drug concerning a human papillomavirus infection is defined.
The mechanism of antiviral action consists in inhibition of virusospetsifichesky enzymes of a DNA polymerase, thymidinekinase and the return transcriptase.
The mechanism of direct anti-influenzal effect of drug consists in inhibition of a neyraminidaznoyaktivnost, induction of synthesis of endogenous interferon, RNA synthesis inhibition.
Drug protects mucous membranes of upper respiratory tracts, normalizing indicators of local immunity of mucous upper respiratory tracts due to increase in level of lactoferrin and sIgA.
During the researches it is established that drug promotes synthesis endogenous α-and γ-interferon дозозависимо, to physiologically active level that increases nonspecific resistance of an organism to a viral and bacterial infection. By clinical trials it is established that on condition of long-term everyday use of drug there is no refrakternost of immune system: oppression of activity alpha and gamma интерферонов is not observed thanks to what the immune status of the person is normalized. It gives the chance to use drug throughout a long time for treatment of recurrent persistent infections.
Single oral administration leads to active synthesis of interferon up to 6 days with the peak of concentration on second day.
Drug has antioxidant activity as interferes with accumulation of products of peroxide oxidation of lipids, inhibits the course of free radical processes, thereby strengthening the antioxidant status of cells that reduces intoxication, promoting recovery of an organism after the postponed infection and adaptation to unfavorable environmental conditions.
Drug is the apoptosis modulator, strengthening effect of apoptozindutsiruyushchy substances that promotes more bystry elimination of the cells affected with a virus and prevention of developing of chronic diseases against the background of latent viral infections.
Pharmacokinetics. It was not studied.
Indications to use:
- Treatment of the infections caused by Herpes simplex І and ІІ types and also at neonatal herpes;
- treatment of the surrounding herpes of the 3rd type (Herpes zoster);
- treatment of the infectious mononucleosis caused by a virus of herpes of the 4th type (Epstein-Burra's virus), an acute and chronic active form;
- treatment of the infections caused by a virus of herpes of the 5th type (cytomegalovirus);
- treatment of chicken pox;
- as a part of complex treatment of a viral hepatitis In, With;
- treatment and prevention of flu A, B, including pandemic strain and SARS;
- as a part of complex treatment of HIV infection and AIDS.
Route of administration and doses:
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Age
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Dose
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Children since the birth till 1 year
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on 0,5 ml 2 times a day
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Children from 1 to 2 years
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on 1 ml 2 times a day
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Children from 2 to 4 years
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from 1st to the 3rd day – on 1,5 ml 2 times a day;
from the 4th day – on 3 ml 2 times a day.
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Children from 4 to 6 years
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from 1st to the 3rd day – on 3 ml 2 times a day;
from the 4th day – on 4 ml 2 times a day.
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Children from 6 to 9 years
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from 1st to the 3rd day – on 4 ml 2 times a day;
from the 4th day – on 5 ml 2 times a day.
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Children from 9 to 12 years
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from 1st to the 3rd day – on 5 ml 2 times a day;
from the 4th day – on 6 ml 2 times a day.
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Children age are more senior than 12 years and adults
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from 1st to the 3rd day – on 5 ml 2 times a day;
from the 4th day – on 8 ml 2 times a day.
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Age
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Medical dose
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Preventive dose
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Children since the birth till 1 year
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on 0,5 ml 2 times a day
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on 0,5 ml once a day
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Children from 1 to 2 years
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on 1 ml 2 times a day
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on 1 ml once a day
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Children from 2 to 4 years
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from 1st to the 3rd day – on 1,5 ml 2 times a day.
from the 4th day – on 3 ml 2 times a day
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from 1st to the 3rd day – on 1,5 ml once a day;
from the 4th day – on 3 ml once a day
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|
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Children from 4 to 6 years
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from 1st to the 3rd day – on 3 ml 2 times a day
from the 4th day – on 4 ml 2 times a day
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from 1st to the 3rd day – on 3 ml once a day;
from the 4th day – on 4 ml once a day
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Children from 6 to 9 years
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from 1st to the 3rd day – on 4 ml 2 times a day;
from the 4th day – on 5 ml 2 times a day
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from 1st to the 3rd day – on 4 ml once a day;
from the 4th day – on 5 ml once a day
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|
|
Children from 9 to 12 years
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from 1st to the 3rd day – on 5 ml 2 times a day;
from the 4th day – on 6 ml 2 times a day.
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from 1st to the 3rd day – on 5 ml once a day;
from the 4th day – on 6 ml once a day
|
|
|
Children are more senior than 12 years and adults
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from 1st to the 3rd day – on 5 ml 2 times a day;
from the 4th day – on 8 ml 2 times a day
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from 1st to the 3rd day – on 5 ml of 1 times
in day;
from the 4th day – on 8 ml once a day.
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Features of use:
At treatment of a viral hepatitis at 10-15% of patients with the expressed cytolytic syndrome in 3-4 weeks after an initiation of treatment increase in activity of aminotransferases is observed, is more rare – the bilirubin level which lasts 2-4 weeks and does not demand drug withdrawal.
Patients with a chronic gastroduodenit in case of an aggravation have a gastroduodenita, at emergence of a gastroesophageal reflux it is necessary to accept drug in 1,5 - 2 hours after food.
At tranzitorny fervescence to 38 °C it is necessary temporarily, to reduce for 2-3 days a dose of Flavozida® twice.
Ability to influence speed of response at control of motor transport or other mechanisms.
The negative impact on carrying out potentially dangerous types of activity requiring special attention and bystry reaction is not revealed.
Side effects:
Drug use, as a rule, does not cause side effect. Isolated cases of gastrointestinal frustration – pains in epigastric area, nausea, vomiting, diarrhea (in the presence of these symptoms it is necessary to accept drug in 1,5-2 hours after food) were observed. Perhaps tranzitorny fervescence to 38 °C for the 3-10th day of therapy by drug.
At treatment of a viral hepatitis at 10-15% of patients with the expressed cytolytic syndrome increase in activity of aminotransferases is observed (more rare – bilirubin level).
At patients with a chronic gastroduodenit the aggravation of a gastroduodenit, a vozniknoveniyegastroezofagealny reflux is possible (reflux esophagitis).
Allergic reactions develop seldom, mainly in the form of erythematic rashes. In isolated cases the headache is possible.
Interaction with other medicines:
During a clinical use an opportunity and expediency of a combination of Flavozida® with antibiotics and antifungal drugs for treatment virus and bacterial and virus fungus diseases are established. Negative manifestations owing to interaction with other medicines it is not established.
Contraindications:
Hypersensitivity to drug components. A peptic ulcer of a stomach or duodenum in aggravation stages, autoimmune diseases.
Overdose:
Cases of overdose are unknown, but development of side effects is possible, especially from digestive tract.
Use during pregnancy or feeding by a breast.
When carrying out preclinical trials of teratogenic, mutagen, cancerogenic and embriotoksichesky action it is not revealed. Clinical experience of use of drug in II and III trimesters of pregnancy and during feeding by a breast of a negative impact did not find (clinical data on use of drug in the I trimester of pregnancy are absent). However it is necessary to follow rules of prescription of medicines during pregnancy or feeding by a breast.
Children. Use of Flavozida® to children is possible since the birth.
Storage conditions:
Period of validity - 2 years. Not to apply after the termination of the period of validity specified on packaging. To store in protected from light and the place, unavailable to children, at a temperature not over 25 ˚С. Not to freeze!
After the first opening of a bottle to store it closed in the place protected from light no more than 30 days.
Issue conditions:
According to the recipe
Packaging:
On 60 ml, 100 ml, 200 ml in bottles from dark glass or plastic. The dosing capacity invests in packaging.
