Expiration date: 10/2024

Neovir - the official instructions for use

MANUAL

for medical use of the drug

Registration number:

R N003311/01

Commercial name: Neovir®

Chemical name: 2-(9-oxo-9,10-dihydrouridine-10-yl) sodium acetate

INN or grouping name: Oxidehydrogenation sodium

Dosage form:

the solution for intramuscular introduction

Composition:

1 ml of solution contains: 

Active component: Assodigitale-ylacetic sodium (Neovir®) — 125 mg 

Auxiliary substances: sodium citrate 2.5 mg; citric acid monohydrate and 0.5–1.5 mg (up to pH 7,5–8,3); water for injections up to 1 ml.

Description: transparent liquid greenish-yellow

Pharmacotherapeutic group:

immunostimulatory agent

ATX code: L03A

PHARMACOLOGICAL PROPERTIES 

Pharmacodynamics: 

The drug has antiviral activity against DNA and RNA-genomic viruses. Has expressed antihlamidiinam action. 

Neovir® causes a rapid increase in titers of endogenous interferons a, p, y, especially interferon. Introduction 250 mg Neovir® intramuscularly detectable serum concentrations of interferon equivalent to the introduction of the 6-9 million ME of recombinant interferon-a. The peak activity of interferon in the blood observed after 1.5–2 hours and lasts for 16-20 hours after injection of Neovir®. As a result, the body is induced by a cascade of immune reactions aimed at the destruction and elimination of pathogens and affected cells. Cells producing interferon acquire the ability to formulate interferon in response to re-induction, caused by the pathological agent. This property is stored for a long time after discontinuation of the drug. 

Immunomodulatory effects due to the ability of Neovir® activate hematopoietic stem cells, normalize the balance of subpopulations 

T-lymphocytes, to stimulate the effector parts of the immune system. Neovir® has a strong stimulating effect on functional activity of macrophages and polymorphonuclear leukocytes, increasing their migration and phagocytic activity. 

Neovir® corrects tissue growth-activates NK cells, enhances all forms of cytotoxicity, a positive effect on the recovery of adhesiveness of cells, inhibits their proliferative and metastatic activity. 

Pharmacokinetics: 

Intramuscular administration the bioavailability of Neovir® is over 90 %. After the introduction of 100-500 mg Neovir®, the maximum plasma concentration is achieved after 15-30 minutes and is 8.3 µg/ml. after 5 hours are determined by only a small number of Neovir®, after 6 hours Neovir® in plasma is not detected. 

Neovir® excreted unchanged by the kidneys without metabolism, with a halflife of 1 hour. 

Through 15-30 minutes after administration of Neovir® in plasma begin to increase the titers of endogenous interferon, in particular interferon early. Peak 2 identified in the content of interferon in plasma: 70 IU/ml after 1.5–2 hours and 110 IU/ml after 8-10 hours, after which the contents of interferon and begins to decline. After 24 hours the concentration of endogenous interferons remains high enough to the original values returned via 46-48 hours after administration.

INDICATIONS FOR USE 

As monotherapy or part of combination therapy: 

— influenza and other acute respiratory viral diseases, including on the background of immunodeficiency States; 

infections caused by Herpes simplex virus, Varicella zoster, Herpes simplex genitalis, including in individuals with immune system disorders; 

— cytomegalovirus infection in patients with immunodeficiency; 

— radiation immunodeficiency; 

— HIV infection; 

— encephalitis and encephalomyelitis viral etiology; 

— acute and chronic hepatitis b and C; 

— urethritis, epididymitis, prostatitis, cervicitis and salpingitis chlamydial etiology; 

 venereal lymphogranuloma; 

— oncological diseases; 

— multiple sclerosis; 

— candidal lesions of the skin and mucous membranes; 

— human papillomavirus infection. 

Prevention of influenza and other acute respiratory viral diseases.

USE DURING PREGNANCY AND BREASTFEEDING 

Safety of Neovir® during pregnancy and lactation has not been studied, therefore the drug is contraindicated during pregnancy and breastfeeding.

CONTRAINDICATIONS 

Individual intolerance of the drug. Marked insufficiency of kidney function (creatinine clearance less than 30 ml/min). Autoimmune diseases. Pregnancy and lactation, children up to age 18 years.

WITH CAUTION 

Apply elderly patients.

METHOD OF APPLICATION AND DOSES 

The solution for injection is administered intramuscularly, single therapeutic dose is 250 mg (1 ampoule) or 4-6 mg / kg of body weight of the patient. If necessary, a single dose of the drug Neovir® may be increased to 500 mg. 

The course of treatment, unless otherwise specified, consists of 5-7 intramuscular injection of Neovir® at a dose of 250 mg every 48 hours, course dose depends on the clinical picture. The duration of the course of 8-12 days. A single prophylactic dose is 250 mg (1 ampoule) or 4-6 mg / kg of body weight. With prolonged use the recommended interval between administration of Neovir® 3-7 days. 

In HIV infection the solution of Neovir® for injection is used in combination with specific antiviral drugs. The course of treatment consists of 10 injections of 250 mg with the interval between injections 48 hours. After the course take a break for 2 months. Perhaps the use of repeated courses indicated.

SIDE EFFECTS 

In rare cases, may cause allergic reactions such as rashes on the skin. Possible low-grade fever, local quickly passing pain at the injection site. When poor tolerability or pain at the injection site it is recommended to enter Neovir®, together with a solution of local anesthetic (2 ml of 0.25–0.5 % solution of procaine).

OVERDOSE 

Overdoses of Neovir® not described.

AIMOGASTA WITH OTHER DRUGS 

Physico-chemical incompatibilities and other unwanted interactions have been identified.

SPECIAL INSTRUCTIONS 

Information about the possibility of negative influence of the drug on performance of potentially hazardous activities that require special attention and fast reactions (driving and other vehicles, work with moving machinery, work Manager and operator, etc.).

RELEASE FORM 

Solution for intramuscular injection 250 mg/2 ml in ampoules of glass lighting 2 ml, 3, 5 ampoules in a blister made of polyvinylchloride film; 1 a contour acheikova packing with instruction on medical application in the cardboard pack.

SHELF LIFE 

3 years. 

Do not use after the expiry date printed on the package.

STORAGE CONDITIONS 

In a dry, protected from light place at temperature from 15 to 25 °C. Keep out of reach of children. 

The turbidity of Neovir® and milky-white evidence of the violation of storage conditions and unsuitability for use.

CONDITIONS OF SUPPLY OF PHARMACIES 

According to the recipe.

THE MANUFACTURER 

FGU "Russian cardiological scientific-production complex" Minzdravsotsrazvitija Russia Pilot production of biomedical drugs. 

Russia, 121552, Moscow, street 3-I Cherepkovskaya, D. 15.

Neovir
(Oxidehydrogenation
sodium)