LIOLIV-BIOLIC

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIOLIV-BIOLIK (LIOLIV-BIOLIK)

Composition:

Active substances: 1 vial (bottle) contains lecithin-standard (calculated as lecithin) – 320 mg; anthral (calculated as anhydrous substance) – 4.2 mg;

Excipient: lactose monohydrate.

Pharmaceutical form. Lyophilisate for emulsion for injection.

Main physicochemical properties: amorphous mass of white or light-yellow color with a characteristic odor.

Pharmacotherapeutic group.

Drugs used in liver diseases, lipotropic agents.

ATC code A05BA.

Pharmacological properties.

Pharmacodynamics.

LIOLEV-BIOLIK belongs to the group of hepatoprotective agents. With course administration, the medicinal product exhibits pronounced detoxifying properties, reduces manifestations of cytolytic, mesenchymal-inflammatory, and cholestatic syndromes: normalizes proteinogram parameters, levels of bilirubin, cholesterol, transaminases, alkaline phosphatase, and prothrombin index in blood. Reduces the severity of asthenovegetative disorders and dyspeptic symptoms. Preclinical studies have shown that LIOLEV-BIOLIK helps alleviate the effects of hepatotoxins, activates reparative processes in hepatocytes, and promotes practical normalization of structural-functional liver parameters in adult, young, and immature animals. The drug inhibits lipid peroxidation processes in blood and tissues, supports the activity of the body's antioxidant systems, acts as a nonspecific detoxicant, and exerts membrane-protective and anti-inflammatory effects. LIOLEV-BIOLIK does not impair functional activity of organs and body systems, is nontoxic, and lacks cumulative properties.

Pharmacokinetics.

After intravenous administration, LIOLEV-BIOLIK, as a liposomal composition, circulates in the blood for up to 2 hours. Maximum accumulation of the drug occurs in the liver and spleen (up to 20%), reached within 5 minutes after administration and maintained for 180–300 minutes. The drug is excreted in urine and feces.

Clinical characteristics.

Indications.

Acute and chronic hepatitis of various etiologies (including viral), liver cirrhosis in adults and children aged 12 years and older.

Contraindications.

Individual hypersensitivity to components of the medicinal product.

History of allergic reactions to vaccines or proteins.

Impaired renal excretory function.

Interaction with other medicinal products and other types of interactions.

LIOLEV-BIOLIK does not affect the activity of steroid and cytostatic drugs when used concomitantly in patients with liver cirrhosis. LIOLEV-BIOLIK may be used in complex therapy with choleretic and vitamin agents.

Special precautions for use.

The efficacy of hepatoprotective therapy is increased when LIOLIV-BIOLIK is used together with the oral hepatoprotector anthral.

Should be prescribed with caution to patients with a history of drug abuse or predisposition to allergic reactions.

The preparation contains lactose; therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome should not take LIOLIV-BIOLIK.

Use during pregnancy or breastfeeding.

The efficacy and safety of the use of the drug during pregnancy or breastfeeding have not been established; therefore, LIOLIV-BIOLIK is not recommended for use in these patient groups.

Ability to influence reaction rate while driving or operating machinery.
Not studied.

Method of Administration and Dosage

For intravenous use only. The LIOLEV-BIOLIK emulsion must be prepared immediately before use by adding 50 ml of 0.9% sodium chloride injection or infusion solution to the vial (bottle). After that, shake the vial (bottle) for 2–3 minutes until a homogeneous emulsion of diluted milk color is formed.

The drug should be administered intravenously by slow drip infusion, 1–2 vials (bottles) 1–2 times daily. The treatment course is 5–15 days, depending on the severity and course of the disease.

Children. The use of the drug is not recommended in children under 12 years of age.

Overdose.

Cases of overdose have not been reported. Possible manifestations of increased sensitivity to the drug, which requires its discontinuation.

Treatment is symptomatic.

Side effects

The drug is well tolerated by patients when used at therapeutic doses.

Nervous system disorders: headache, dizziness.

Immune system disorders: allergic reactions, including angioneurotic edema.

Skin and subcutaneous tissue disorders: itching, redness, rash, urticaria.

Cardiac disorders: palpitations.

Vascular disorders: decrease in blood pressure.

Gastrointestinal disorders: with prolonged use, dyspeptic symptoms, nausea, vomiting, abdominal pain, diarrhea may occur.

General disorders and administration site reactions: increased body temperature, weakness, lower back pain, limb tremor, shooting pains in the chest and lower back.

In such cases, the drug should be discontinued and symptomatic treatment prescribed.

Shelf life: 1 year 6 months.

Storage conditions

Store in the freezer compartment at a temperature from minus 20 °C to minus 10 °C.

Keep out of reach of children.

Incompatibility: Do not use solvents not specified in the section "Administration and dosage". Do not mix in the same infusion container with other parenteral solutions.

Packaging: 1 vial (bottle) per carton.

Prescription status: Prescription only.

Manufacturer:

LLC "BIOLIK PHARMA"

Manufacturer's address and address of the place of business activity

Legal entity location:

70 Pomyrky, Kharkiv, Kharkiv region, 61070, Ukraine

Address of the place of business activity:

Pomyrky-70, building b/n, Kharkiv, Kharkiv region, 61070, Ukraine