Composition, form of production and packaging
Solution for injection as a clear liquid from light yellow to brown, with a characteristic odor.
1 amp.
placental hydrolyzate, 112 mg
Excipients: water d / injection, sodium hydroxide or hydrochloric acid (for pH correction).
2 ml - ampoules of dark glass (10) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Immunomodulating and hepatoprotective drug.
The drug exhibits immunomodulatory properties due to its ability to stimulate humoral immunity and to increase the functional activity of phagocytes and natural killers. Increases the bactericidal activity of peripheral blood leukocytes, manifested in their ability to destroy the captured pathogen. Cytokines, which are part of the drug, activate the metabolic and surveillance functions of skin cells.
Biologically active substances contained in the hydrolyzate stimulate the regeneration (proliferation) of hepatocytes, show detoxification properties, reduce the deposition of lipids and cholesterol in the liver cells, increase the activity of tissue respiration, activate the metabolism in the liver, and decrease the intensity of the development of connective tissue in the liver.
PHARMACOKINETICS
Data on pharmacokinetics are not available.
INDICATIONS
- chronic recurrent herpes (as part of complex therapy);
- Atopic dermatitis of moderate and severe severity, incl. complicated (as part of complex therapy);
- chronic liver diseases: steatohepatitis (alcohol, metabolic and mixed etiology) - in the form of monotherapy.
DOSING MODE
With chronic recurrent herpes and atopic dermatitis, the drug is injected intravenously: 10 ml (560 mg of placental hydrolyzate) of the drug (5 ampoules) is dissolved in 250-500 ml of a 5% solution of dextrose or saline and injected through the ulnar vein for 1.5-2 h. Injections are carried out 3 times a week with an interval of 2 days. The course of treatment is 10 injections.
For chronic liver diseases (steatohepatitis / alcohol, metabolic and mixed etiology), the drug is administered in / m 2 ml / day (112 mg placental hydrolyzate).Depending on the severity of the disease, the frequency of injections can be increased up to 2-3 times (6 ml) / day. The drug can be injected intravenously: 10 ml (560 mg of placental hydrolyzate) of the drug (5 ampoules) are dissolved in 250-500 ml of a 5% solution of dextrose or saline and injected through the ulnar vein for 1.5-2 hours. Injections are performed 2 times in Week. The course of treatment is 2-3 weeks.
SIDE EFFECT
Side effects are observed in 3.7% of patients.
Clinically significant adverse reactions: allergic reactions are possible.
Other adverse events: pain at the injection site (2.56%), allergic reactions (redness, itchy skin) (0.37%), numbness at the injection site (0.37%), gynecomastia (0.37%) - causal connection with drug administration not established .
CONTRAINDICATIONS
- childhood;
- Pregnancy;
- lactation period;
- Hypersensitivity to the drug.
Caution should be used in patients with a polyvalent allergy to medicines, in the elderly.
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during breastfeeding is contraindicated.
APPLICATION FOR CHILDREN
Studies on the safety of the use of Laennec in newborns (including premature infants) and minor children were not conducted. Use in children is not recommended.
APPLICATION IN ELDERLY PATIENTS
Caution should be used in elderly patients.
SPECIAL INSTRUCTIONS
According to the currently available data, the drug can be prescribed to the elderly. However, given that the physiological functions of the elderly are deteriorating, the drug should be administered under close supervision.
Use in Pediatrics
Studies on the safety of the use of Laennec in newborns (including premature infants) and minor children were not conducted. Use in children is not recommended.
Impact on the ability to drive vehicles and manage mechanisms
The effect on the ability to drive vehicles and mechanisms is not established.
OVERDOSE
At present, no cases of an overdose of the drug Laennek have been reported.
DRUG INTERACTION
Pharmaceutical interaction
When mixing a solution of Laennec with other drugs that are strong bases (pH above 8.5), the activity of the drug is reduced.
To date, no other clinically significant drug interaction has been identified.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light, inaccessible to children at a temperature of 18 В° to 25 В° C. Shelf life - 3 years.
