Chlorophyllipt

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHLOROPHYLLIPT

Composition:

Active substance: 1 ml of solution contains 2.5 mg of chlorophyllipt extract, thick (10.76:1) (extractant ethanol 93%);

Excipient: ethanol (96%).

Pharmaceutical form. Concentrate for solution for injection, alcoholic.

Main physicochemical properties: clear green liquid.

Pharmacotherapeutic group. Antimicrobial agents for systemic use. ATC code J01X X.

Pharmacological properties.

Pharmacodynamics.

Chlorophyllipt has antibacterial (bactericidal and bacteriostatic) and etiotropic activity against antibiotic-resistant and antibiotic-dependent staphylococci. Chlorophyllipt is capable of eliminating plasmids of resistance of various bacterial infection causative agents to antibiotics, increases oxygen content in tissues, and exerts a pronounced detoxifying effect. Therefore, the drug should also be used in conditions of reduced natural body defense as a means to combat tissue hypoxia and to enhance the efficacy of concurrently administered antibacterial agents. Experimental studies of Chlorophyllipt have demonstrated its tropism toward lung tissue and the absence of any carcinogenic, mutagenic, teratogenic, or embryotoxic effects. Bactericidal blood concentration of Chlorophyllipt is achieved after a single intravenous administration of 8 mL of 0.25% solution; bacteriostatic concentration is achieved with 4 mL of 0.25% solution. Therapeutic concentration is maintained on average for 6 hours; optimal administration is four times daily.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications. Staphylococcal septic conditions (postpartum, postoperative, post-infectious), purulent-inflammatory and postoperative complications of staphylococcal etiology: in burn disease, staphylococcal endocarditis in patients after cardiac surgery, pneumonia; lung abscesses; pleuritis, peritonitis, osteomyelitis, parametritis and metroendometritis, post-abortion sepsis, as well as acute and subacute inflammatory diseases of internal genital organs unrelated to childbirth or abortion, purulent-destructive forms of pyelonephritis and urosepsis (as part of complex therapy). In diseases caused by non-staphylococcal antibiotic-resistant pathogens (particularly for the treatment of glanders, tuberculosis of any localization, listeriosis infection).

Contraindications. Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions. Enhances the effect of antiseptic agents.

Instructions for use.

This medicinal product contains 1484 mg/dose of ethanol (alcohol). Harmful for patients suffering from alcoholism. Caution should be exercised when administering to patients with liver diseases and to patients with epilepsy.

Use during pregnancy or breastfeeding. The efficacy and safety of the drug during pregnancy or breastfeeding have not been studied; therefore, the drug should not be used in these patient groups.

Ability to affect reaction speed when driving or operating machinery. Does not affect.

Method of Administration and Dosage

Intravenous (slow) administration of Chlorophyllipt is indicated for septic conditions, burn disease, and pneumonia. Dilute 2 ml of 0.25% alcoholic solution of the drug with 38 ml of sterile 0.9% sodium chloride solution (i.e., dilute 20-fold). The preparation must be made ex tempore. The solution should be clear and free of precipitates. Administer the prepared solution intravenously, 40 ml four times daily for 4–5 days.

For peritonitis and empyema of the pleura, administer Chlorophyllipt into the cavity daily through a drainage tube for 5–8 days (dilute the 0.25% alcoholic solution with 0.25% novocaine solution in a 1:20 ratio). Prepare the solution ex tempore.

Children. There is no experience with the use of the drug in children.

Overdose. May result in an increase in adverse reactions.

Treatment is symptomatic.

Side effects.

Hypersensitivity reactions are possible during the use of the drug, including skin rashes, itching, angioneurotic edema, hyperemia, and changes at the injection site.

Shelf life. 5 years.

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

Keep out of reach of children.

Incompatibility. Do not mix in the same container with other medicinal products.

Packaging. 2 ml in vials, 10 in a pack; 10 in a blister pack in a carton.

Prescription category. Prescription only.

Manufacturer.

Limited Liability Company "Research Plant "GNCLC".

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's location and address of business activity.

8 Vorobiova Street, Kharkiv, Kharkiv region, Ukraine.

(Limited Liability Company "Research Plant "GNCLC")

22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.

(LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA")