Instructions Proteflazid suppositories blister 3 g No. 10
Composition
active ingredient: 1 suppository contains Proteflazid flavonoids, obtained from a mixture (1:1) of the grass of the Sodden Pike (Herba Deschampsia caespitosa L.) and the grass of the Ground Warrior (Herba Calamagrostis epigeios L.), not less than 1.8 mg;
excipients: butylhydroxyanisole (E 320), polyethylene glycol-400, polyethylene glycol-1500, polyethylene glycol-4000, to obtain a mass of 3 g.
Dosage form
Suppositories.
Main physicochemical properties: suppositories of brown-green color, torpedo-shaped.
Pharmacotherapeutic group
Direct-acting antivirals. ATX code J05A X.
Other gynecological products. ATX code G02 C X.
Pharmacological properties
Pharmacodynamics
The active ingredient of the drug (flavonoids) inhibits the synthesis of DNA and RNA viruses in infected cells by suppressing the activity of virus-specific enzymes RNA, DNA polymerases, thymidine kinase and reverse transcriptase; it has immunotropic properties.
It has been established that the active substance promotes the synthesis of endogenous alpha and gamma interferons to a physiologically active level (without the occurrence of refractoriness), which increases local nonspecific resistance to viral and bacterial infections.
Clinical studies have proven that the drug PROTEFLAZID® (suppositories) restores the protective function of the vaginal mucosa and cervix by normalizing local immunity factors (sIgA, lysozyme and C3 complement component).
In vitro studies on experimental models of oncogenic human papillomaviruses have shown that the active substance of the drug has specific antiviral activity and inhibits the reproduction of human papillomavirus (HPV) by 2 lg ID50.
Cytological studies have shown that the active substance inhibits the proliferative and destructive effects of HPV on cells.
In the treatment of cervical epithelial dysplasia caused by papillomavirus infection, normalization of the cytological picture or transition of cervical intraepithelial neoplasia class CIN-II (moderate dysplasia) to class CIN-I (mild dysplasia) is noted.
In genital herpes, the drug prevents the formation of new elements of the rash, reduces the likelihood of dissemination and visceral complications, and accelerates the healing of lesions.
In case of vaginosis, vaginitis and inflammatory diseases of the cervix, the drug helps restore local immunity and more rapid and effective elimination of the pathogen.
The drug helps eliminate dysbiotic disorders of the microflora of the genital tract, restores the normal biotope of the vagina, accelerates the processes of restoration of the epithelium of the cervical mucosa; prevents recurrence of diseases.
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.
The drug is an apoptosis modulator, enhancing the effect of apoptosis-inducing substances and activating caspase 9, which contributes to the elimination of virus-infected cells and the primary prevention of the occurrence of chronic diseases against the background of latent viral infections.
Pharmacokinetics
When applied topically, the active substance practically does not enter the systemic circulation and does not exhibit systemic action. Experiments have shown that when applied vaginally, a therapeutic concentration of the drug is achieved locally.
Indication
Treatment of diseases of the female genital organs caused by:
- herpes simplex viruses (Herpes simplex) types I and II, cytomegalovirus and Epstein-Barr virus;
- human papillomaviruses (HPV), including oncogenic strains.
As part of the complex treatment of diseases of the female genital organs caused by:
- pathogens of inflammatory diseases of mixed etiology (viruses, bacteria, pathogenic fungi, chlamydia, mycoplasma, ureaplasma).
Contraindication
Individual hypersensitivity to the components of the drug.
Special safety measures.
Suppositories should not be used orally.
The drug does not require any special safety measures.
Interaction with other medicinal products and other types of interactions
PROTEFLAZID® (suppositories) can be combined with other antiviral drugs and antibiotics for the treatment of viral-bacterial and viral-fungal diseases of the pelvic organs. No negative manifestations due to interaction with other drugs have been identified.
If any reactions occur during the combined use of drugs, you should consult a doctor.
Application features
During treatment with suppositories, it is advisable to avoid sexual contact.
Etiopathogenetic
To achieve the desired therapeutic effect in the treatment of genital diseases caused by pathogens of viral, bacterial, fungal infections and their associations (chlamydia, mycoplasma, ureaplasma), simultaneous treatment of sexual partners is necessary. In this case, the drug PROTEFLAZID® (drops) should be used for the treatment of the partner according to the scheme and in the doses specified in the relevant instructions.
Use during pregnancy or breastfeeding
During preclinical studies of the active substance of the extract PROTEFLAZID®, no toxicological, teratogenic, mutagenic, embryotoxic, fetotoxic and carcinogenic effects were detected. Clinical experience with the use of the drug PROTEFLAZID® (drops) in the I-III trimesters of pregnancy and during breastfeeding did not reveal any negative effects.
It is necessary to follow the rules for prescribing medications during pregnancy or breastfeeding, assessing the benefit/risk ratio. Use is possible only as prescribed and under the supervision of a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
No negative impact on the ability to engage in potentially hazardous activities that require special attention and quick reactions was detected.
Method of administration and doses
Suppositories should be used vaginally.
Suppositories should be used after hygiene procedures. Before use, remove the protective plastic packaging from the suppository. Insert the suppository deep into the vagina. After inserting the suppository, it is advisable to lie down for at least 3 hours and not have sexual intercourse for at least 8 hours. It is recommended to start treatment immediately after menstruation. At the time of menstruation, a break in treatment should be taken.
For the treatment of genital diseases caused by herpes viruses of types 1 and 2, use 1 suppository once a day for 7-10 days or more until the symptoms of the disease disappear.
For the treatment of recurrent herpes infection, including in the presence of cytomegalovirus infection and Epstein-Barr infection, 1 suppository is used once a day for 10 days. The course of treatment is carried out for 3 months (10 days per month).
In case of papillomavirus infection and/or herpetic infections in combination with bacterial, fungal infections, use 1 suppository 2 times a day for 14 days. The course of treatment should be carried out for 3 months (14 days every month).
Children
The use of PROTEFLAZID® in suppository form in children has not been studied, therefore the drug should not be prescribed to children.
Overdose
Not described. In case of overdose, consult a doctor immediately for further treatment.
Adverse reactions
When using the drug, slight local itching or burning of the mucous membrane is possible, which disappear on their own and do not require discontinuation of the drug.
Hypersensitivity reactions, allergic reactions are possible.
In case of allergic or any other undesirable reactions, the use of suppositories should be suspended and a doctor should be consulted regarding further treatment tactics.
Expiration date
2 years.
Storage conditions
In the original packaging at a temperature not exceeding 25 ° C. Do not freeze!
Keep out of reach of children.
Packaging
5 suppositories in a blister, 1, or 2, or 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
1. Joint Ukrainian-Spanish enterprise in the form of LLC "Sperco Ukraine", Ukraine.
2. LLC "Pharmex Group", Ukraine.
Location of the manufacturer and its business address
1. Ukraine, 21027, Vinnytsia region, Leninsky district, Vinnytsia city, 600-richchia st., 25.
2. Ukraine, 08300, Kyiv region, Boryspil city, Shevchenko st., 100.
Applicant
LLC "NVC "Ecopharm", Ukraine.
Applicant's location
Ukraine, 04073, Kyiv, Stepana Bandera Ave., 9-V.
