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medicalmeds.eu Medicines Antiviral drugs of direct action. Protfenolozid

Protfenolozid

Препарат Протфенолозид. ООО «НПК «Экофарм» Украина


Producer: LLC NPK Ekofarm Ukraine

Code of automatic telephone exchange: J05AX

Release form: Liquid dosage forms. Drops for oral administration.

Indications to use: Radiation therapy. Virus of papilloma of the person (Papillomavirusnaya infektsiiya). Herpes infection (Herpes). Viral hepatitis of C. Viral hepatitis of B. HIV infection.


General characteristics. Structure:

Active ingredients: 1 ml contains the liquid extract (1:1) received from mix of a grass of Shchuchki turfy (HerbaDeschampsiacaespitosaL.) and herbs of the Smallreed land (HerbaCalamagrostisepigeiosL.), 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: ethanol of 96%.




Pharmacological properties:

Pharmacodynamics. Protfenolozid's action on tumoral growth.
The drug Protfenolozid® affects cells of tumors cytostatically. Researches on the intertwined models of tumors and in experiences of invitroustanovleno that drug slows down tumoral growth. Brake action is caused by strengthening of function of a thymus gland, normalization of quantitative structure of T lymphocytes in peripheral blood and strengthening of cytotoxic activity of natural killers.
In experiences of invivona of experimental model growth inhibition of a melanoma of B16 at mice due to activation of immune system, function of a thymus gland and synthesis of interferon is shown.
 
Immunotropny action.
Протфенолозид® induces synthesis of endogenous interferon (IFN) in immunocompetent cells. For the 1st days activity the IFN-alpha increased to 23 pieces/ml. From 2 to 9 days change of activity of IFN towards IFN-gamma was observed, the maximum caption was defined for the 3rd day of treatment. The research of activity of IFN in 6 months of continuous administration of drug revealed preservation of moderate increase in level the IFN-alpha. At daily reception (6 months) activity suppression an alpha and gamma IFN was not revealed that testifies to lack of a refrakternost of immunotropny cells to Protfenolozidom® interferon induction.
 
Antioxidant action.
Drug дозозависимо brakes intensity of the induced free radical processes, increasing resistance of cells to a free radical stress. invivo is proved that drug more than twice brakes intensity of the free radical processes induced by hydrogen peroxide.
By researches at the cellular level it is established that drug slows down superoksidradikala-anion generation practically to zero in 24 hours from the moment of use of Protfenolozida®, i.e. supports the antioxidant status of cells.
 
Antiviral action.
Drug has direct antiviral effect in a wide range (affects DNA - and RNA viruses), including on oncogenous viruses: virus of papilloma of the person, viruses of herpes of all types, hepatitises B and C, HIV infection.
Протфенолозид® suppresses activity of the catalytic centers of virusospetsifichesky enzymes of synthesis (DNA and RNA viruses). In the researches invitroi invivodokazana antiviral activity both at prevention, and at treatment of viruses of herpes of all types, a virus of papilloma, hepatitises B and C, HIV.
Протфенолозид® in the researches invitro, invivoprivodit to full suppression of a reproduction of a virus of papilloma of the person also normalizes mitotic activity and level of abnormal mitoses.
 
Blocks a neuraminidase of influenza viruses And yes In, including a pandemic strain - enzyme is necessary for release of again formed virus particles from the infected cell and further distribution.
 
Apoptozobrazuyushchy action.
Drug is the apoptosis modulator, strengthens effect of apoptozindutsiruyushchy substances, promotes more bystry elimination of atypical cells. Протфенолозид® in the researches invitro, invivouvelichivayet the level of the spontaneous and induced apoptosis, reducing activity of proliferative processes in a tumor. The Apoptozmoduliruyushchy effect does not extend to thymocytes and splenocytes.
 
Influence on detoksikatsionny function of kidneys and liver.
In the researches invivov conditions of a chronic experiment detoksikatsionny action of Protfenolozida® was studied. The analysis гемограмм, a functional condition of a liver, kidneys in the conditions of long administration of exotoxins showed that Protfenolozid® improves indicators of detoksikatsionny function of a liver and kidneys, promotes adaptation of an organism to unfavorable conditions of its functioning, the caused effects of chemotherapy and radiation therapy. Thanks to it drug weakens negative effects of radiation therapy and chemotherapy. Improves blood indicators.

Pharmacokinetics. It was not studied.


Indications to use:

Drug is shown:
-    for treatment of postoperative infections and virus and bacterial complications at oncological patients;
-    for treatment of the viral infections and virus and bacterial complications caused by the immunodeficiencies developing in time and after carrying out himio-and radiation therapy;
-    in complex therapy for treatment of the diseases caused by oncogenous viruses of papilloma, viruses of herpes of all types, hepatitises B and C, opportunistic infections at HIV.


Route of administration and doses:


Drug is dosed by means of a dropper. The necessary amount of drug to drop in water (1-2 tablespoons), to accept in 10-15 minutes prior to food, and at treatment of a viral hepatitis - in 1,5-2 hours after food.
The dose and duration of treatment depends on character of indications and age of the patient.
Adults:
Treatment of postoperative infections and virus and bacterial complications at oncological patients: 1 - week - on 7 drops 2 times a day;
The 2-3rd week - on 12 drops 2 times a day;
The 4th week - the 8th week - on 15 drops 2 times a day.
Course of treatment - 2 months.
 
Treatment of the viral infections and virus and bacterial complications caused by the immunodeficiencies developing in time and after carrying out himio-and radiation therapy:
The 1st    week - on 7 drops 2 times a day;
The 2-3rd week - on 12 drops 2 times a day;
Since the 4th week and for 12 months - on 15 drops 2 times a day. A course of treatment - 12 months.
 
In complex therapy for the purpose of treatment of the diseases caused by oncogenous viruses of papilloma:
1 - week - on 7 drops 2 times a day;
The 2-3rd weeks - on 15 drops 2 times a day;
The 4th week - on 12 drops 2 times a day.
Duration of treatment of a human papillomavirus infection makes 3 months without interruption.
 
In complex therapy for the purpose of treatment of diseases of all types and opportunistic infections caused by viruses of herpes at HIV:
Adults and children are more senior than 12 years:
• on 7 drops 2 times a day during the next 3 days;
• on 10 drops 2 times a day during the next 3 days;
•  till 12-15 drops 2 times a day.
Course of treatment - 3 months.
 
In complex therapy for the purpose of treatment of hepatitises B and C:
For adults and children 12 years are more senior such scheme of dosing is recommended:
from 1st to the 3rd day - on 4 drops 2 times a day;
from the 4th to the 6th day - on 7 drops 2 times a day;
from the 7th day - on 15 drops 2 times a day.
For treatment of a viral hepatitis In and With at children to 12 years use a children's dosage form - Flavozid® syrup. Treatment duration - not less than 6-12 months.
Children:
The dosage of drug is carried out according to age doses of the basic scheme of treatment (see tab. 1).
Due to the existence in drug not less than 85% of ethanol children up to 6 years should part the dosed quantity of Protfenolozida® with sugar in 50 ml of the boiled water cooled to room temperature.
Table 1. Age doses of the drug Protfenolozid® for children:

Age:
Dose:
Children till 1 year
on 1 drop a day
Children from 1 to 2 years
on 1 drop 2 times a day
Children from 2 to 4 years
The 1st week - on 1 drop 2 times a day; since the 2nd week - on 2 drops 2 times a day
Children from 4 to 6 years
The 1st week - on 3 drops 2 times a day; since the 2nd week - on 4 drops 2 times a day
 
Children from 6 to 9 years
The 1st week - on 5 drops 2 times a day; since the 2nd week - on 9 drops 2 times a day
Children from 9 to 12 years
The 1st week - on 6 drops 2 times a day; since the 2nd week - on 10 drops 2 times a day
Treatment duration in pediatric practice same as well as at adults.
External use:
for treatment of skin at virus and virus and bacterial complications (infections of a herpes simplex of skin, acute forms of the surrounding herpes, a skin papillomatosis) drug should be applied in the form of application for 30-40 minutes directly from a bottle on an affected area or solution of drug to 3-5 times a day. If the mucous membrane of an oral cavity is affected use drug solution (for preparation of solution it is necessary to part 1,5 ml (36-38 drops) of drug in 10 ml of normal saline solution of sodium chloride), which is held in a mouth of 5-10 minutes. To repeat the procedure to 3-5 times a day.
External use should be carried out before disappearance of signs of damage of skin and mucous membranes.
At primary and recurrent genital herpes, and also at a human papillomavirus infection apply vaginal tampons with drug solution.
For preparation of solution it is necessary to part 72-75 drops of drug in 20 ml of normal saline solution of sodium chloride. The term of exposure of vaginal tampons - 30-40 minutes. To carry out the procedure 2 times a day.
At emergence of a burning sensation in a vagina it is necessary to increase amount of solvent.
External use should be carried out before disappearance of signs of damage of skin and mucous membranes.

Features of use:

Use е period of pregnancy or feeding by a breast.
When carrying out preclinical trials of teratogenic, mutagen, embriotoksichesky and cancerogenic 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 Itrimestre of pregnancy are absent). However it is necessary to follow rules of prescription of medicines during pregnancy and feeding by a breast.

Children.
Use of Protfenolozida® to children is possible from the birth.
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 proceeds for 2-4 weeks and does not demand drug withdrawal.

At patients with a chronic gastroduodenit in case of an aggravation of a gastroduodenit 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 Protfenolozida® twice.

Ability to influence speed of response at control of motor transport or work with other mechanisms.
Negative influence 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 effects. Isolated cases of gastrointestinal frustration - pain 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.
Allergic reactions develop seldom, mainly in the form of erythematic rashes. The headache, the general weakness are in rare instances possible. At patients with 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, emergence of a gastroesophageal reflux is possible (reflux esophagitis). At topical administration of Protfenolozida® emergence of burning sensation, an itch, a xeroderma is possible.


Interaction with other medicines:

During a clinical use an opportunity and expediency of a combination of Protfenolozida® with antibiotics and antifungal drugs for treatment virus and bacterial and virus fungus diseases is established. Negative manifestations owing to interaction with other medicines it is not established.
Studying of interaction with other cytokines and immunomodulators was not carried out.


Contraindications:

Hypersensitivity to drug components. Stomach ulcer or duodenum. Autoimmune diseases.


Overdose:

Cases of overdose are unknown, but development of side effects is possible, especially from digestive tract.


Storage conditions:

To store in protected from light and the place, unavailable to children, at a temperature not above 25 °C.
Not to freeze!
Formation of gel structure which collapses when stirring is admissible.


Issue conditions:

According to the recipe


Packaging:

Glass bottles of dark color on 50 ml in cardboard packaging.



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