Instructions Proteflazid 10 ml
Composition
1 ml of drops contains 1 ml of liquid extract Proteflazid (flavonoid content of at least 0.32 mg/ml in terms of rutin, carboxylic acid content of at least 0.30 mg/ml in terms of malic acid) from the grass of Sodden Pike (Herba Deschampsia caespitosa L.) and the grass of Ground Warbler (Herba Calamagrostis epigeios L.) (1:1).
Extraction solvent: ethanol 96%.
Dosage form
Drops.
Main physicochemical properties: dark green liquid with a specific odor.
Pharmacotherapeutic group
Direct-acting antivirals. ATX code J05A X.
Pharmacological properties
Pharmacodynamics
Flavonoids, which are part of the drug, inhibit the replication of DNA and RNA viruses both in vitro and in vivo. Preclinical and clinical studies have revealed and proven the antiviral effect of the drug against herpes viruses, hepatitis, papillomaviruses, HIV infection, influenza and acute respiratory infections.
It has been proven that the mechanism of direct antiviral action consists in the inhibition of virus-specific enzymes - DNA and RNA polymerases, thymidine kinase, reverse transcriptase, ZSL protease and neuraminidase.
Proteflazid inhibits the activity of the 3CL protease of the SARS-CoV2 coronavirus, which was confirmed by molecular docking and when using an assay kit containing 3CL protease labeled with MBP (maltose-binding protein of the SARS-CoV2 coronavirus).
The method of dual analysis of the Renilla luciferase reporter gene (reproducing the replication of the seasonal coronavirus CoV-229E) showed that the drug blocks it.
In preclinical in vitro studies on monkey (Vero E6) and human (A549/ACE2) cell cultures, the antiviral activity of the drug against the pandemic human coronavirus SARS-CoV-2 was demonstrated - with significant inhibition of virus replication.
The drug has immunotropic properties. It protects mucous membranes, normalizing local immunity indicators (lactoferrin, secretory immunoglobulin A, lysozyme and S3 component of complement).
It has been established that the drug is an inducer of the synthesis of endogenous α- and γ-interferons to a physiologically active level, which increases the body's nonspecific resistance to viral and bacterial infections.
Clinical studies have shown that, when taken daily, according to age-appropriate doses and application regimens, the drug does not have an immunotoxic effect and does not cause refractoriness (hyporeactivity) of the immune system: there is no inhibition of the synthesis of alpha and gamma interferons, which makes it possible, if necessary, to use the drug for a long time.
The drug has antioxidant activity, inhibits the course of free radical processes, thereby preventing the accumulation of lipid peroxidation products, enhancing the antioxidant status of cells, reduces intoxication, and promotes the recovery of the body after an infection and adaptation to adverse environmental conditions.
The drug is an apoptosis modulator, enhances the effect of apoptosis-inducing substances and activates caspase 9, thereby contributing to the elimination of virus-infected cells and primary prevention of the occurrence of chronic diseases against the background of latent viral infections.
The drug prevents disease relapses and prolongs the period of remission.
Pharmacokinetics
The active ingredients of the drug are rapidly absorbed from the gastrointestinal tract into the blood, reaching maximum concentrations 20 minutes after administration (in vivo studies). According to the available dynamics, the half-life from blood plasma is about 2.3 hours. Bioavailability after oral administration is 80%. Elimination from the body is slow. The level of accumulation of active ingredients by blood cells is significantly higher than that of blood plasma. Appropriate concentrations of active ingredients in the blood ensure the prolongation of the drug's action in the body and its accumulation in organs and tissues due to the release of blood cells from them. Such available pharmacokinetic dynamics of accumulation and release of active ingredients by blood cells necessitates the need for twice-daily administration of the drug to achieve effective concentrations.
Indication
Treatment of diseases and prevention of relapses caused by:
herpes simplex viruses (Herpes simplex) types 1 and 2;
herpes zoster and chickenpox viruses (Herpes Zoster, type 3);
herpes viruses type 4 (Epstein-Barr virus), acute and chronic active forms;
herpes viruses type 5 (cytomegalovirus).
Treatment and prevention of influenza and other acute respiratory viral infections (including pandemic influenza strains).
As part of the complex treatment:
hepatitis B and C;
viral, bacterial, fungal infections, their associations (chlamydia, mycoplasma, ureaplasma, etc.);
HIV infection and AIDS.
Etiotropic therapy of mild and moderate forms of cervical dysplasia (CIN1 and CIN2) caused by papillomavirus infection, including oncogenic strains.
As part of complex therapy for other forms of diseases caused by papillomavirus infection, including oncogenic strains.
Contraindication
Hypersensitivity to the components of the drug. Gastric or duodenal ulcer.
Interaction with other medicinal products and other types of interactions
During clinical use, the possibility and feasibility of combining Proteflazid® with antibiotics and antifungal drugs for the treatment of viral-bacterial and viral-fungal diseases have been established. No negative manifestations due to interaction with other drugs have been identified.
Application features
During the treatment of viral hepatitis, 10-15% of patients with severe cytolytic syndrome may experience an increase in aminotransferase activity 2-4 weeks after the start of treatment, less often in bilirubin levels, which lasts for 2-4 weeks and does not require discontinuation of the drug.
Patients with gastrointestinal disorders and chronic gastroduodenitis in case of exacerbation of gastroduodenitis or the occurrence of gastroesophageal reflux should take the drug 1.5-2 hours after meals.
A transient increase in body temperature to 38 °C does not require discontinuation of the drug. In case of an increase in body temperature, it is necessary to consult a doctor to exclude other possible causes of its occurrence.
When using the drug topically, if a burning sensation, itching, or dryness occurs, it is necessary to reduce the concentration of the drug in the application solution.
To prevent urogenital reinfection, simultaneous treatment of the sexual partner is recommended.
Use during pregnancy or breastfeeding
In preclinical studies, no embryotoxic, teratogenic, fetotoxic, mutagenic and carcinogenic effects were detected. Special studies on such effects of the drug on the human fetus have not been conducted, but clinical experience with the use of the drug in the I-III trimesters of pregnancy and during breastfeeding has not revealed any negative effects. The decision on the advisability of using the drug during pregnancy or breastfeeding is made by a doctor.
The ability to influence the reaction speed when driving or working with other mechanisms
When used in recommended doses, no negative effects on the ability to perform work requiring special attention and quick reactions were detected.
Method of administration and doses
The bottle must be shaken before use.
The drug is dosed using a dropper. The required amount of the drug should be dripped into water (volume - 1-2 tablespoons), taken 10-15 minutes before meals.
Proteflazid® drops dosage regimen, depending on age
| Age (years) | Dose (drops) and frequency reception per day |
| from birth to 1 year | 1 drop per day |
| 1 - 2 years | 1 drop 2 times a day |
| 2 - 4 years | 2 drops 2 times a day |
| 4 - 6 years | 4 drops 2 times a day |
| 6 - 9 years old | 9 drops 2 times a day |
| 9 - 12 years old | 10 drops 2 times a day |
| Children aged 12 and over and adults | 12-15 drops 2 times a day |
The duration of use of Proteflazid® depends on the indications and course of the disease.
For the treatment and prevention of recurrences of herpetic gingivostomatitis, pharyngotonsillitis, chickenpox; for the complex treatment of viral, bacterial, fungal infections and their associations; for the prevention of viral and bacterial infections that occur in patients with insufficient immune system function, it is recommended to take the drug for 1 month.
For the treatment of herpetic eczema and herpetic vesicular dermatitis (in combination with topical application of the solution); herpetic meningitis and encephalitis; herpetic eye lesions; genital herpes; for the treatment of herpes zoster (Herpes zoster); acute and chronic active forms of Epstein-Barr virus infection; cytomegalovirus disease; papillomavirus infection (in combination with topical application of the solution) it is recommended to take the drug for 3 months without a break.
In case of recurrent infections, treatment courses with the drug are carried out 1-2 times a year on the recommendation of a doctor.
The duration of treatment in pediatric practice is similar to that in adults. Doses are prescribed according to the patient's age, depending on the course of the disease. Treatment is carried out under the supervision of a physician.
In the complex treatment of viral hepatitis B and C, HIV infection, and AIDS, it is recommended to take the drug for 6-12 months without a break.
Treatment of hepatitis in HIV-infected and AIDS patients is carried out before or after antiretroviral therapy.
For the treatment of influenza and other acute respiratory viral infections, the drug is used for 5 to 14 days, depending on the course of the disease. For preventive purposes, the drug is taken for 2-4 weeks in a dose that is half the therapeutic dose. During an epidemic, the drug can be taken for up to 6 weeks.
Topical use in combination with oral administration of the drug:
For the treatment of herpes simplex infections of the skin and mucous membranes, acute forms of herpes zoster, skin papillomatosis, applications with a solution of the drug should be applied to the affected area up to 3-5 times a day. The exposure time of applications is 10-15 minutes. To prepare the solution, 1.5 ml (36-38 drops) should be diluted in 10 ml of physiological sodium chloride solution.
In case of primary and recurrent genital herpes, papillomavirus and viral-bacterial infections of the female genital organs, vaginal tampons with a solution of the drug are used. To prepare the solution, 3.0 ml (72-75 drops) of the drug must be diluted in 20 ml of physiological sodium chloride solution. The exposure time of vaginal tampons is 30-40 minutes, the procedures must be carried out 2 times a day.
The duration of local use of vaginal tampons for genital herpes is 10 days, for papillomavirus and viral-bacterial infections of the female genital organs – 14 days.
Children
The drug Proteflazid® is used for children from birth.
Overdose
Cases of overdose are unknown, but side effects may develop, especially from the gastrointestinal tract. Treatment is symptomatic.
In case of an overdose of Proteflazid®, you should immediately consult a doctor.
Side effects
Allergic reactions: Hypersensitivity reactions may occur in susceptible individuals. Rarely, allergic reactions may occur, including erythematous rashes and itching.
On the part of the digestive system: isolated cases of gastrointestinal disorders are observed - pain in the epigastric region, nausea, vomiting, diarrhea. In patients with chronic gastroduodenitis, exacerbation of gastroduodenitis and the occurrence of gastroesophageal reflux (reflux esophagitis) are possible.
General disorders: in rare cases, headache, general weakness, transient increase in body temperature up to 38 °C on the 3rd-10th day of drug therapy are possible.
Laboratory indicators: during the treatment of viral hepatitis, 10-15% of patients with severe cytolytic syndrome experience an increase in aminotransferase activity (less often, bilirubin levels).
Local reactions: with local application, a burning sensation, itching, and dryness may occur.
In case of any adverse reactions, you should consult a doctor.
Expiration date
3 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze! The formation of a gel-like structure is permissible, which collapses when shaken. Keep out of the reach of children.
Packaging
Light-resistant glass vials of 10 ml or 30 ml or 50 ml, closed with caps for vials with dropper stoppers with first-open control or caps for vials with dropper stoppers with first-open control and child protection, in a cardboard pack.
Vacation category
According to the recipe.
Producer
LLC "NVC "Ecopharm".
Location of the manufacturer and its business address.
Ukraine, 30070, Khmelnytskyi region, Shepetivskyi district, Ulashanivka village, Shevchenko st., 116.
Applicant
LLC "NVC "Ecopharm".
Location of the applicant.
Ukraine, 03045, Kyiv, Naberezhno-Korchuvatska St., Building 136-B
