Instructions Flavovir syrup glass bottle 50 ml
Composition
1 ml of syrup contains:
0.02 ml of liquid extract Proteflazid, obtained from a mixture of herbs (1:1) of Sodden Pike (Herba Deschampsia caespitosa L.) and Ground Warbler (Herba Calamagrostis epigeios L.) (extraction solvent – ethanol 96%), which is equivalent to at least 0.0035 mg of flavonoids in terms of rutin;
excipients: propylene glycol, ethanol 96%, sorbitol (E 420), methylparaben (E 218), propylparaben (E 216), sodium sulfite (E 221), purified water.
Dosage form
Syrup.
Main physicochemical properties: transparent sweet liquid of yellow-green color with a faint specific odor.
Pharmacotherapeutic group
Direct-acting antivirals. ATX code J05A X.
Immunostimulants. ATX code L03A X.
Pharmacological properties
Pharmacodynamics.
Flavonoids, which are part of the drug, have the ability to inhibit the replication of DNA and RNA viruses both in vitro and in vivo. Preclinical and clinical studies have revealed inhibitory activity of the drug against influenza viruses and acute respiratory infections, herpes viruses.
It has been proven that the mechanism of direct antiviral action consists in inhibiting the synthesis of virus-specific enzymes - DNA and RNA polymerases, thymidine kinase, reverse transcriptase, 3CL protease, neuraminidase and induction of endogenous interferon synthesis.
Flavonoids in the syrup inhibit the activity of the 3CL protease of the SARS-CoV2 coronavirus, which was confirmed by molecular docking and 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) shows its blocking.
In preclinical in vitro studies on Vero E6 and A549/ACE2 cell cultures, antiviral activity against the pandemic human coronavirus SARS-CoV-2 was demonstrated with significant inhibition of virus replication.
The drug protects the mucous membranes of the upper respiratory tract, normalizing local immunity indicators (lactoferrin, sIgA and lysozyme).
During the studies, it was found that the drug normalizes 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 with daily administration of the drug in accordance with age-appropriate doses and regimens, there is no immune system refractoriness: there is no inhibition of the synthesis of α- and γ-interferons. This property of Flavovir® syrup helps maintain the level of interferons sufficient for an adequate immune response of the body to an infectious agent. In turn, this 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: it enhances the effect of apoptosis-inducing factors by activating caspase 9, which contributes to faster elimination of virus-infected cells and primary prevention of the occurrence of chronic diseases against the background of latent viral infections.
Pharmacokinetics.
The active substances of the drug are rapidly absorbed from the digestive 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 substances by blood cells is significantly higher compared to blood plasma. Appropriate concentrations of active substances 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 the accumulation and release of active substances by blood cells necessitates the need for twice-daily administration of the drug to achieve effective concentrations.
Indication
Etiotropic treatment and prevention of acute respiratory viral infections;
Etiotropic treatment and prevention of influenza, including those caused by pandemic strain viruses.
Contraindication
Hypersensitivity to the components of the drug. Gastric or duodenal ulcer in the acute stage. Autoimmune diseases.
Interaction with other medicinal products and other types of interactions
During clinical use, it has been established that Flavovir® syrup can be combined with antibiotics and antifungal drugs for the treatment of viral-bacterial and viral-fungal diseases. No negative manifestations due to interaction with other drugs have been identified.
Application features
This medicinal product contains 3.85 vol. % ethanol (alcohol), i.e. from 15.4 mg/dose (for children from birth to one year) and up to 277.2 mg/dose (for children from 12 years of age and adults), which is equivalent to from 0.4 ml beer, 0.2 ml wine (for children from birth to one year) to 6.9 ml beer, 2.9 ml wine (for children from 12 years of age and adults) per dose.
Harmful for patients with alcoholism. Caution should be exercised when used in pregnant and breastfeeding women, children, and patients with liver disease and epilepsy.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product as it contains sorbitol.
Methylparaben and propylparaben may cause allergic reactions (possibly delayed).
Sodium sulfite may rarely cause hypersensitivity reactions and bronchospasm.
Use during pregnancy or breastfeeding
In preclinical studies, no teratogenic, mutagenic, embryotoxic, fetotoxic and carcinogenic effects were detected. Clinical experience with the use of the drug in the I-III trimesters of pregnancy and during breastfeeding has not revealed any negative effects. However, it is necessary to follow the rules for prescribing drugs during pregnancy or breastfeeding, assessing the benefit/risk ratio and consulting 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
The bottle with syrup must be shaken before use.
The syrup should be dosed using a dosing container and taken orally 20–30 minutes before meals. To achieve a greater therapeutic effect when exposed to respiratory viruses, it is advisable to hold the syrup in the mouth for 20–30 seconds, rinsing the throat before swallowing.
Doses and duration of treatment depend on the nature of the disease and the age of the patient.
Dosage of the drug
| Patient age | Dosage |
| From birth to 1 year | 0.5 ml 2 times a day |
| From 1 to 2 years | 1 ml 2 times a day |
| From 2 to 4 years | 3 ml 2 times a day |
| From 4 to 6 years | 4 ml 2 times a day |
| From 6 to 9 years old | 5 ml 2 times a day |
| From 9 to 12 years old | 6 ml 2 times a day |
| From 12 years old, including adults | 9 ml 2 times a day |
For the treatment of influenza and acute respiratory viral infections (with uncomplicated course of the disease), the syrup should be used for 5 days. To achieve the greatest effectiveness of therapy, the use of the syrup should be started at the first signs of the disease or after contact with patients. Depending on the course of the disease, the course of treatment can be extended to 2 weeks.
To prevent flu and SARS, use the syrup for 1 to 4 weeks in a dose that is half the therapeutic dose.
During an epidemic of pandemic strains, the duration of use of the syrup in a prophylactic dose can be extended to 6 weeks.
In case of bacterial complications of influenza and other acute respiratory viral infections, the syrup can be used for 4 weeks or longer to normalize the immune system.
Children
Flavovir® should be used in children from birth.
Overdose
Cases of overdose are unknown. In case of an overdose of syrup, you should consult a doctor.
Adverse reactions
Allergic reactions: Hypersensitivity reactions may occur in susceptible individuals. Allergic reactions may occur, including rash, itching, skin swelling, urticaria, and skin hyperemia.
On the part of the digestive system: there are cases of gastrointestinal disorders - pain in the epigastric region, nausea, vomiting, diarrhea (if these symptoms are present, the syrup should be taken 1.5–2 hours after a meal). In patients with chronic gastroduodenitis, exacerbation of gastroduodenitis and the occurrence of gastroesophageal reflux (reflux esophagitis) are possible.
General disorders: possible transient increase in body temperature to 38 °C on the 3rd–10th day of drug therapy, headache.
In case of any adverse reactions, you should consult a doctor.
Expiration date
2 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging out of the reach of children at a temperature not exceeding 25 ° C. Do not freeze.
After first opening the bottle, keep it closed in the original packaging for no more than 30 days.
Packaging
30 ml or 50 ml or 60 ml in dark glass or plastic bottles, sealed with plastic caps for bottles with first-opening control or plastic caps for bottles with first-opening control and child protection. A dosing container is placed in a cardboard pack.
Vacation category
Without a prescription.
Producer
LLC "NVC "Ecopharm", Ukraine.
Ukraine, 30070, Khmelnytskyi region, Shepetivskyi district, Ulashanivka village, Shevchenko st., 116
Applicant
LLC "NVC "Ecopharm".
Applicant's location
Ukraine, 03045, Kyiv, Naberezhno-Korchuvatska St., Building 136-B.
