Fibrinase-10

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FIBRINAZA-10, FIBRINAZA-20 (FIBRINAZA-10, FIBRINAZA-20)

Composition:

Active substance: serratiopeptidase;

1 tablet contains serratiopeptidase in the form of granules 10 mg or 20 mg (equivalent to enzymatic activity of 20,000 IU or 40,000 IU);

Excipients: microcrystalline cellulose, povidone, magnesium stearate, talc, sodium starch glycolate (type A), sodium croscarmellose, hypromellose, titanium dioxide (E 171), Eudragit L 100, iron oxide red (E 172), castor oil, diethyl phthalate, polyethylene glycol (PEG 6000).

Pharmaceutical form. Enteric-coated tablets.

Main physico-chemical properties: enteric-coated, pink-colored, round, biconvex tablets with a coating.

Pharmacotherapeutic group. Agents used in disorders of the musculoskeletal system. Enzymes. ATC code M09AB.

Pharmacological properties.

Pharmacodynamics.

The active substance of the medicinal product, serratiopeptidase, is a proteolytic enzyme isolated from the non-pathogenic intestinal bacterium Serratia E15. It exerts fibrinolytic, anti-inflammatory, and anti-edematous effects and reduces pain by blocking the release of pain mediators (painful amines) from inflamed tissues.

Serratiopeptidase directly reduces capillary dilation (expansion) and controls their permeability by hydrolyzing bradykinin, histamine, and serotonin. The drug also blocks plasmin inhibitors, thereby promoting plasmin's fibrinolytic activity. In chronic inflammatory foci, serratiopeptidase reduces levels of polypeptide mediators of inflammation (bradykinin), as well as fibrin, but has no significant effect on proteins of the living organism such as albumin, α- and γ-globulins.

Enzymatic activity of serratiopeptidase is 10 times higher than that of α-chymotrypsin. The drug effectively penetrates into sites of inflammation, lyses necrotic tissues and their degradation products, reduces hyperemia, and enhances penetration and activity of antibiotics.

Due to proteolysis of structural proteins in sputum, the enzyme improves rheological properties of sputum and promotes its expectoration.

Serratiopeptidase also reduces viscosity of saliva and nasal secretions, thus facilitating their removal.

Pharmacokinetics.

After oral administration, the drug is absorbed from the intestine in unchanged form. It is not inactivated by gastric juice and enters the bloodstream in enzymatically active form. Maximum plasma concentration is reached within 1 hour. The enzyme binds to blood α-2-macroglobulin in a 1:1 ratio; this complex masks the antigenicity of the enzyme while preserving its enzymatic activity. The drug is not metabolized in the body. It is excreted in active form via bile and, in insignificant amounts, by the kidneys.

Clinical characteristics.

Indications.

• Surgical conditions: ligament sprains and ruptures, fractures and dislocations, edema caused by plastic surgery.
• Respiratory tract diseases: reduction of sputum viscosity and facilitation of its expectoration from the respiratory tract.
• Otorhinolaryngological diseases: facilitation of secretion drainage from the paranasal sinuses.
• Skin diseases: acute inflammatory dermatoses.
• Gynecological and mammary gland disorders: hematomas, mammary gland congestion.

Contraindications.

• Hypersensitivity to the active substance or to other components of the medicinal product.
• Coagulation disorders.

Interaction with other medicinal products and other forms of interaction.

The drug enhances penetration of antibiotics and nonsteroidal anti-inflammatory agents into inflamed tissues.

When used concomitantly, the drug potentiates the effect of anticoagulants; such combination should be used with caution and under medical supervision.

Special precautions for use.

Due to its effect on the blood coagulation system, the drug should be used with caution in patients:

• at risk of bleeding;
• when used concomitantly with anticoagulants;
• in case of coagulation time disorders;
• in severe liver diseases;
• in severe kidney diseases.

Use during pregnancy or breastfeeding.

Due to the lack of clinical data, the drug is not recommended for use during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

The drug does not affect the reaction rate when driving or operating machinery.

Dosage and Administration.

The drug should be administered orally to adults in a dose of 10–20 mg after meals. The maximum daily dose is 30 mg. Tablets should be swallowed whole without chewing and taken with one glass of water.

The dosage and duration of treatment depend on the nature and progression of the pathological process and are determined individually by a physician in each case.

Children.

Due to the lack of clinical data, the medicinal product should not be used in pediatric practice.

Overdose.

Symptoms: nausea, vomiting, anorexia, epigastric discomfort, in some cases bleeding and blood streaks in sputum.

Treatment: symptomatic therapy.

Adverse reactions.

Respiratory system, thoracic organs and mediastinum: nasal bleeding, blood-tinged sputum, acute eosinophilic pneumonia.

Gastrointestinal system: abdominal pain, nausea, vomiting, diarrhoea, epigastric discomfort, anorexia.

Immune system, skin and subcutaneous tissue: hypersensitivity reactions, including rash, pruritus, hyperaemia.

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua

Shelf life. 2 years.

Storage conditions.

Keep out of reach and sight of children. Store at a temperature not exceeding 25 °C.

Packaging.

10 tablets in a blister; 1, 3 or 10 blisters in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

Evertogen Life Sciences Limited.

Manufacturer's address and place of business.

Plot No: S-8, S-9, S-13/P & S-14/P TSIIC, Pharma SEZ, Green Industrial Park, Polepally (V), Jadcherla (M), Mahabubnagar, Telangana, IN-509 301, India