Instructions for Lioliv-Biolic lyophilized powder for preparation of solution for injection, vial No. 1
Composition
active ingredients: 1 vial (bottle) contains lecithin standard (calculated as lecithin) – 320 mg; antral (calculated as anhydrous substance) – 4.2 mg;
excipient: lactose monohydrate.
Dosage 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 substances. ATX code A05B A.
Pharmacological properties
Pharmacodynamics
LIOLIV-BIOLIK® belongs to the group of hepatoprotective drugs. When used in courses, the drug exhibits pronounced detoxification properties, reduces the manifestations of cytolytic, mesenchymal-inflammatory and cholestatic syndromes: normalizes the proteinogram, bilirubin, cholesterol, transaminases and alkaline phosphatase in the blood, prothrombin index. Reduces the intensity of asthenovegetative disorders and dyspeptic manifestations. According to the results of preclinical studies, it was found that LIOLIV-BIOLIK® contributes to the weakening of the effects of hepatotoxins, activation of reparative processes in hepatocytes and practical normalization of indicators of the structural and functional state of the liver in adults, young and immature animals. The drug inhibits the processes of lipid peroxidation in the blood and tissues, supports the activity of the body's antioxidant systems, performs the function of a non-specific detoxifier, exhibits a membrane-protective and anti-inflammatory effect. LIOLIV-BIOLIK® does not disrupt the functional activity of organs and body systems, is non-toxic, and has no cumulative properties.
Pharmacokinetics
After intravenous administration, LIOLIV-BIOLIK® as a liposomal composition circulates in the blood for up to 2 hours. The maximum accumulation of the drug is noted in the liver and spleen (up to 20%), which is achieved 5 minutes after administration and persists for 180-300 minutes. The drug is excreted in the urine and feces.
Indication
Acute and chronic hepatitis of various etiologies (including viral), benign hyperbilirubinemia and liver cirrhosis in adults and children over 12 years of age.
Contraindication
Individual hypersensitivity to the components of the drug. History of allergic reactions to vaccines or protein. Impaired renal excretory function.
Interaction with other medicinal products and other types of interactions
LIOLIV-BIOLIK® does not affect the activity of steroid and cytostatic drugs when used simultaneously in patients with liver cirrhosis. LIOLIV-BIOLIK® can be used in complex therapy with choleretic and vitamin drugs.
Application features
The effectiveness of hepatoprotective therapy increases when using LIOLIV-BIOLIK® together with the oral hepatoprotector Antral.
It should be prescribed with caution to patients with a history of drug abuse, a tendency to allergic reactions.
The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug LIOLIV-BIOLIK®.
Ability to influence reaction speed when driving vehicles or other mechanisms
Not studied.
Use during pregnancy or breastfeeding
The efficacy and safety of the drug for use in pregnant women or during breastfeeding have not been established, therefore LIOLIV-BIOLIK® is not recommended for use in this category of patients.
Method of administration and doses
Administer intravenously. LIOLIV-BIOLIK® emulsion must be prepared immediately before use by adding 50 ml of 0.9% sodium chloride solution for injection or infusion to the vial (bottle). After that, shake the vial (bottle) for 2-3 minutes until a homogeneous emulsion of the color of diluted milk is formed.
The drug is administered intravenously drip, slowly, 1-2 vials (bottles) 1-2 times a day. The course of treatment is 5-15 days, depending on the severity and course of the disease.
Children
It is not recommended for children under 12 years of age.
Overdose
Cases of overdose have not been described. There may be manifestations of hypersensitivity to the drug, which requires its withdrawal.
Treatment is symptomatic.
Adverse reactions
The drug in therapeutic doses is well tolerated by patients.
From the side of the central and peripheral nervous system: headache, dizziness, weakness, vertigo.
Immune system disorders: allergic reactions, including angioedema.
Skin and subcutaneous tissue disorders: itching, redness, rash, urticaria.
From the cardiovascular system: decreased blood pressure, palpitations.
Others: fever, weakness, pain in the lumbar spine, tremor of the limbs, shooting pains in the thoracic and lumbar spine.
In these cases, the drug should be discontinued and symptomatic treatment should be prescribed.
Expiration date
1 year 6 months.
Storage conditions
Store in the freezer at a temperature of minus 20°C to minus 10°C.
Keep out of reach of children.
Packaging
1 vial (bottle) per pack.
Vacation category
According to the recipe.
Producer
JSC "BIOLIK", Ukraine.
Location of the manufacturer and its business address
Kharkiv region, Kharkiv city, Pomirky.
