Proteflazid

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROTEFLAZID® (Proteflazidum®)

Composition:

Active substance: 1 suppository contains not less than 1.8 mg of flavonoids from Proteflazid, obtained from a mixture (1:1) of Deschampsia meadow grass (Herba Deschampsia caespitosa L.) and Calamagrostis grass (Herba Calamagrostis epigeios L.);

Excipients: butylhydroxyanisole (E 320), polyethylene glycol-400, polyethylene glycol-1500, polyethylene glycol-4000, to make up the total mass of 3 g.

Pharmaceutical form. Suppositories.

Main physicochemical properties: brown-green colored, torpedo-shaped suppositories.

Pharmacotherapeutic group.

Direct-acting antiviral agents. ATC code J05A X.

Other gynecological preparations. ATC code G02C X.

Pharmacological Properties.

Pharmacodynamics.

The active ingredient of the drug (flavonoids) inhibits DNA and RNA virus synthesis in infected cells by suppressing the activity of virus-specific enzymes such as RNA- and DNA-polymerases, thymidine kinase, and reverse transcriptase; it also possesses immunotropic properties.

It has been established that the active ingredient promotes the synthesis of endogenous alpha- and gamma-interferons to a physiologically active level (without inducing refractoriness), thereby enhancing local nonspecific resistance to viral and bacterial infections.

Clinical studies have demonstrated that PROTEF LAZID® (suppositories) restores the protective function of the vaginal and cervical mucosa by normalizing local immune factors (sIgA, lysozyme, and complement component C3).

In experimental models of oncogenic human papillomavirus in vitro, the active substance of the medicinal product has shown specific antiviral activity and inhibits human papillomavirus (HPV) replication by 2 lg ID50.

Cytological studies have confirmed that the active ingredient suppresses the proliferative and destructive effects of HPV on cells.

In the treatment of cervical epithelial dysplasia caused by papillomavirus infection, normalization of cytological findings or regression of cervical intraepithelial neoplasia from CIN-II class (moderate dysplasia) to CIN-I class (mild dysplasia) is observed.

In genital herpes, the drug prevents the formation of new skin lesions, reduces the risk of dissemination and visceral complications, and accelerates lesion healing.

In vaginosis, vaginitis, and inflammatory diseases of the cervix, the drug promotes recovery of local immunity and more rapid and effective elimination of the causative agent.

The drug helps correct dysbiotic disturbances in the genital microbiota, restores the normal vaginal biotope, accelerates epithelial regeneration of the cervical mucosa, and prevents disease recurrences.

The drug exhibits antioxidant activity, inhibits free-radical processes, thereby preventing the accumulation of lipid peroxidation products and enhancing the cellular antioxidant status.

The drug acts as a modulator of apoptosis, enhancing the effects of apoptosis-inducing agents and activating caspase-9, thus promoting the elimination of virus-infected cells and providing primary prevention of chronic diseases associated with latent viral infections.

Pharmacokinetics.

When administered locally, the active ingredient practically does not enter the systemic circulation and does not produce systemic effects. Studies have shown that vaginal administration achieves therapeutic drug concentrations locally.

Clinical characteristics.

Indications.

Treatment of diseases of female genital organs caused by:

• herpes simplex virus (Herpes simplex) types 1 and 2, cytomegalovirus, and Epstein-Barr virus;
• human papillomaviruses (HPV), including oncogenic strains.

As part of complex treatment of diseases of female genital organs caused by:

• pathogens of inflammatory diseases of mixed etiology (viruses, bacteria, pathogenic fungi, chlamydia, mycoplasmas, ureaplasmas).

Contraindications.

Individual hypersensitivity to components of the drug.

Special safety measures.

Suppositories must not be used orally.

The drug does not require 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 pelvic organ diseases. No negative effects due to interaction with other medicinal products have been established.

If any adverse reactions occur during combined use of drugs, consult a physician.

Special precautions.

During treatment with suppositories, it is advisable to avoid sexual intercourse.

Etiopathogenetic therapy of diseases listed in the section "Indications", in addition to local treatment with PROTEFRAZID® (suppositories), should be supplemented with oral administration of PROTEFRAZID® (drops) according to the regimen and doses specified in the relevant instruction.

To achieve the desired therapeutic effect in the treatment of genital diseases caused by viral, bacterial, fungal infections and their associations (chlamydia, mycoplasma, ureaplasma), simultaneous treatment of sexual partners is required. In such cases, the partner should be treated with PROTEFRAZID® (drops) according to the regimen and doses specified in the relevant instruction.

The product contains butylated hydroxyanisole (E 320), which may cause local skin reactions (e.g. contact dermatitis) or irritation of mucous membranes.

Use during pregnancy or breastfeeding.

Preclinical studies of the active substance of PROTEFRAZID® did not reveal any toxicological, teratogenic, mutagenic, embryotoxic, fetotoxic, or carcinogenic effects. Clinical experience with the use of PROTEFRAZID® (drops) during the I–III trimesters of pregnancy and during breastfeeding has not revealed any negative effects.

Prescribing medications during pregnancy or breastfeeding requires adherence to general principles, carefully evaluating the benefit-risk ratio. Use is possible only under medical prescription and supervision.

Ability to influence reaction rate when driving or operating machinery.

No negative effect on the ability to perform potentially hazardous activities requiring high attention and rapid reactions has been observed.

Method of Administration and Dosage.

The suppositories are intended for vaginal use.

The suppositories should be used after hygiene procedures. Before use, remove the protective plastic packaging from the suppository. Insert the suppository deeply into the vagina. After insertion, it is recommended to remain in a lying position for at least 3 hours and to abstain from sexual intercourse for at least 8 hours. Treatment should begin immediately after menstruation. Treatment should be paused during menstruation.

For the treatment of genital diseases caused by herpes simplex virus types 1 and 2, administer 1 suppository once daily for 7–10 days or longer, until symptoms of the disease have resolved.

For the treatment of recurrent herpes infection, including in the presence of cytomegalovirus infection and Epstein-Barr virus infection, administer 1 suppository once daily for 10 days. The treatment course should be repeated monthly for 3 months (10 days each month).

In case of human papillomavirus infection and/or herpes infections combined with bacterial or fungal infections, administer 1 suppository twice daily for 14 days. The treatment course should be repeated monthly for 3 months (14 days each month).

Children.

The use of PROTEF LAZID® suppositories in children has not been studied; therefore, the drug should not be prescribed to children.

Overdose.

Not reported. In case of suspected overdose, immediate consultation with a physician is required for further management.

Side effects

When using the drug, slight local itching or burning of the mucous membrane may occur, which disappear spontaneously and do not require discontinuation of the drug.

Hypersensitivity reactions, allergic reactions are possible.

If allergic or any other adverse reactions occur, the use of suppositories should be discontinued and a doctor should be consulted regarding further treatment strategy.

Shelf life.

2 years.

Storage conditions.

Store 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 pack, 1, 2, or 3 blisters per carton.

Prescription status.

Prescription only.

Manufacturer.

LLC "NVC "Ecopharm", Ukraine.

Manufacturer's address and place of business.

Ulashanivka village, Shepetivka district, Khmelnytskyi region, 30070, Ukraine, Shevchenko St., 116.

Marketing Authorization Holder.

LLC "NVC "Ecopharm", Ukraine.

Address of the Marketing Authorization Holder.

136-B Naberezhno-Korchuvatska St., Kyiv, 03045, Ukraine