Неоваскулген®

General characteristics. Structure:

Active ingredient: 1,2 mg of dezoksiribonukleinovay acid of the plasmid supertwisted pCMV-VEGF 165.

Excipients: Dextrosums monohydrate, sodium hydrophosphate dodecahydrate, sodium dihydrophosphate dihydrate.

Pharmacological properties:

Pharmacodynamics. The drug Neovaskulgen® represents the high cleaning supertwisted form of a plasmid pCMV-VEGF165 coding an endothelial growth factor of vessels (Vascular endothelial, growth factor, VEGF) under promoter control (the managing site of DNA). Recombinant plasmid DNA consists of the following components: a fragment of the regulatory site (22 nucleotide couples) which defines a transcription of a gene, a mini-gene of VEGF at which expression the VEGF isoform consisting of 165 amino acids, a signal of splicing, a signal of polyadenylation and a transcription terminator of SV40, the providing synthesis of mature RNA of a gene and the auxiliary areas necessary for effective biosynthesis of plasmid DNA in E.coli strain producer cells is synthesized. At penetration of molecules of this plasmid in cells of mammals there is VEGF development, stimulating endothelium cells that leads to growth of blood vessels (vascularization) in the area at introduction. Endothelial cells participate in such various processes as vasoconstriction and a vazodilatation, the presentation of antigens, and also serve as very important elements of all circulatory vessels - both capillaries, and veins or arteries.

Thus, stimulating endothelial cells, VEGF plays the central role in the course of an angiogenesis. There are two different, but structurally close receptors of VEGF located on a surface of endothelial cells of vessels. These receptors known as a receptor of VEGF1 of type (Flt-1) and a receptor of VEGF 2 types (KDR/Flk-1) represent receptor tyrosinekinases which after linkng with a ligand of VEGF are exposed to phosphorylation. Activation of these receptors leads to turning on of the numerous intracellular post-receptor alarm cascades starting an angiogenesis. Penetration of a plasmid in cells is spontaneous process, and plasmid DNA cannot breed in cells of mammals. The molecular mass of a plasmid is-2817091,85 g/mol. The size - 4559 couples of the bases.

Feature of the supertwisted ring DNA is sensitivity to a rupture of one of 9116 phosphodiester chemical bonds. Molecule DNA with the only broken link, loses supertorsion, passing into a relaksirovanny ring form (related connection). Stimulated proliferation of cells of an endothelium of the person in an experiment of Neovaskulgen®, it is comparable with a recombinant growth factor of an endothelium of vessels, and also Neovaskulgen® considerably stimulated growth of blood vessels of a mouse. Drug is created as remedy for decrease in frequency of amputation and mortality in population of patients with chronic ischemia of an extremity, in particular at patients to whom standard revascularization concerning occlusive damage of peripheral arteries cannot be carried out.

Indications to use:

In complex therapy for revascularization at ischemia of the lower extremities of atherosclerotic genesis (degree IIA-III according to A. V. Pokrovsky-Fontaine).

Route of administration and doses:

The drug is administered intramusculary twice, in a dose of 1,2 mg at an interval of 14 days, whenever possible to the place the closest to the ischemic site. The drug divorced according to the instruction after standard processing of skin, following rules of an asepsis, enter fractionally having stuck through several so that all array, muscles of the struck segment, a bull инфильтрирован solution.

Features of use:

Before use add water for injections in number of 3-5 ml to contents of a bottle. To wait for full dissolution of drug (within 5-10 minutes). Before introduction to the patient solution has to be room temperature.

Treatment by drug has to be carried out under observation of doctors-surgeons in out-patient or stationary conditions.

Influence on ability to manage vehicles and mechanisms. It is necessary to be careful. As there are no data on influence of drug on ability to manage vehicles, mechanisms.

Side effects:

Allergic reactions are possible.

Interaction with other medicines:

There are no data.

Contraindications:

Hypersensitivity to drug components. Children's age up to 18 years. Pregnancy and lactation.

Overdose:

There are no data.

Storage conditions:

In the place protected from light at a temperature from 2 °C to 8 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of solution for intramuscular introduction on 1,2mg. Packaging: bottles (1) - packs cardboard or bottles (2) - packs cardboard.