Nuclex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NUCLEX

Composition:

Active ingredient: ribonucleic acid;

1 capsule contains 250 mg of ribonucleic acid;

Excipients: mannitol (E 421), magnesium stearate;

Capsule shell composition: gelatin, titanium dioxide (E 171).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules No. 0 with white cap and body. The contents of the capsule are powder and granules ranging in color from light yellow to dark yellow. Presence of compacted columns or lumps which disintegrate upon pressure is permissible.

Pharmacotherapeutic group. Antiviral agents. ATC code J05.

Agents affecting the cardiovascular system. Cardiological preparations.

ATC code C01EB.

Pharmacological Properties

Pharmacodynamics

Has specific antiviral activity. The antiviral effect is based on mechanisms influencing the conformation of viral surface antigens and receptors. Inhibits hemagglutinating and neuraminidase activity of influenza and parainfluenza viruses, blocking viral entry into cells and their replication, thereby providing both prophylactic and therapeutic antiviral action. Suppresses the growth of concentrations of other viruses causing acute respiratory viral infections (ARVI).

Stimulates migration of stem cells in the bone marrow, restores differentiation and quantitative and qualitative composition of bone marrow and peripheral blood cells. Normalizes cellular immunity by enhancing migration and cooperation of T- and B-lymphocytes and phagocytic activity of macrophages, strengthening the activity of non-specific resistance factors. Possesses anti-inflammatory, immunomodulatory, antioxidant, organoprotective, anti-ischemic, and hematopoietic activities, and inhibits increased platelet aggregation.

The pharmacotherapeutic effects of the drug are based on the following mechanisms: stimulation of cellular metabolism, enhanced biosynthesis of endogenous nucleic acids, specific enzymes and proteins, increased mitotic activity of bone marrow cells, acceleration of regeneration processes, and improved cellular energy supply through stimulation of synthesis of macroergic compounds such as ATP.

Anti-inflammatory activity is mediated by regulation of the adenosine Ade1-receptor, normalization of NO-synthase activity, inhibition of oxidative processes in cellular membranes, stabilization of cell membranes, and optimization of tissue redox processes.

Specific antiviral activity is achieved by altering the conformation of neuraminidase and hemagglutinin receptors of influenza and parainfluenza viruses, while non-specific antiviral activity results from increased interferon production in vivo and stimulation of non-specific antiviral defense.

Specific cardioprotective action is provided by a positive effect on the dynamics of myocardial necrosis zone formation and reduction of the final necrosis zone mass, as well as increased left ventricular ejection fraction.

Regulation of the hormonal system involves activation of the pituitary-adrenal system with an increase in endogenous glucocorticoid levels. The drug optimizes adrenergic and cholinergic regulation of cardiac function and coronary and systemic circulation via sympathetic and parasympathetic nervous systems. NUCLEKS relaxes coronary vessels against the background of adrenaline-induced vasoconstriction and reduces arterial pressure.

Nephroprotective properties are achieved by increasing the global indicator of kidney function—glomerular filtration rate.

Antiviral efficacy.
In phase II clinical trials, patients received Nucleks throughout the entire treatment period following the onset of influenza or ARVI symptoms. Treatment clearly reduced the duration of clinically significant symptoms and objective manifestations by 1–3 days. Treatment efficacy in patients with confirmed diagnosis of influenza or ARVI who received NUCLEKS was nearly 30% higher than in the control group. Nucleks significantly reduced the incidence of complications of influenza and ARVI (bronchitis, pneumonia, sinusitis, otitis media) requiring antibiotic therapy. Data obtained during studies in patients with concomitant cardiovascular and/or respiratory diseases show that Nucleks intake was associated with clinically significant reduction in symptoms of the underlying condition.

In the study evaluating efficacy and safety of Nucleks for treatment of influenza and ARVI in patients with cardiovascular diseases, administration of Nucleks compared to the control group resulted in: reduction of clinical manifestations of influenza and ARVI 1–3 days earlier; stabilization of hemodynamic parameters 1.5 days earlier; significant improvement or normalization of echocardiography and ECG parameters. The drug NUCLEKS was well tolerated by patients.

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications.

As an antiviral agent for the prevention and treatment of acute respiratory viral infections (ARVI) and influenza. In the complex therapy of chronic viral hepatitis and urogenital herpes. As a cardioprotective agent in the complex therapy of ischemic heart disease, acute myocardial infarction, and ischemic cardiomyopathy.

Contraindications.

Individual hypersensitivity to the components of the drug, hemoblastoses (leukemias, malignant lymphomas). Gout.

Interaction with other medicinal products and other types of interactions.

When treating with antibiotics and vitamins, the use of the drug in complex therapy significantly enhances therapeutic efficacy. When used simultaneously with antiplatelet agents and anticoagulants, due to an increased risk of bleeding, blood coagulation parameters must be monitored. If necessary, in patients with a history of high uric acid levels, the drug is recommended to be used concomitantly with allopurinol.

Special precautions for use.

Treatment should be carried out under monitoring of immune status and uric acid levels.

Use during pregnancy or breastfeeding.

There is insufficient clinical data on the use of the drug during pregnancy or breastfeeding; therefore, the drug should not be administered to these patient groups.

Ability to affect reaction rate while driving or operating machinery.

Nuclex does not affect the reaction rate while driving or operating machinery.

Dosage and Administration.

As a cardioprotective agent, administer orally 500 mg 2–3 times daily after meals. Treatment duration is 10–15 days.
As an antiviral agent, administer orally to adults 500 mg 2–3 times daily, either before or after meals, for 5–7 days, followed by 250 mg twice daily for 7–14 days.
For prophylaxis, administer orally 250 mg either before or after meals during the period of respiratory viral infections and influenza epidemic.

Children.

Currently, there is insufficient experience with the use of Nuklex in children; therefore, the drug should not be prescribed to this age group of patients.

Overdose.

Symptoms of overdose have not been identified.

Side effects.

Gastrointestinal disorders: epigastric pain and dyspeptic symptoms may occur when taken orally on an empty stomach.

Metabolism and nutrition disorders: increased serum uric acid levels.

Immune system disorders: hypersensitivity reactions.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging. Capsules of 250 mg;

10 capsules in a blister pack, 2 or 4 blisters per carton.

Supply category. Over-the-counter (without prescription).

Manufacturer.

LLC "VALARTIN PHARMA".

Manufacturer's address and place of business.

Ukraine, 08135, Kyiv region, Kyiv-Sviatoshyn district, village Chayky, Hrushevskoho Street, bld. 60.

Marketing Authorization Holder.

Subsidiary company "BioCell" of the corporation "Baiesel Laboratories Corporation".

Address of the Marketing Authorization Holder and/or its representative.

Ukraine, 01021, Kyiv, Klovs'kyi uzviz, bld. 17, apt. 51.