Sk-sd, streptokinase-streptodornase

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SK-SD, STREPTOKINASE-STREPTODORNASE (SK-SD, STREPTOKINASE-STREPTODORNASE)

Composition:

Active substances: streptokinase, streptodornase;

1 suppository contains streptokinase 15,000 IU, streptodornase 1,250 IU;

Excipients: mineral oil, hard fat.

Dosage form. Rectal suppositories.

Main physicochemical characteristics: cylindrical-conical suppositories of white to beige color. Presence of an air-porous core and a pit-like depression on the cross-section is permissible.

Pharmacotherapeutic group. Blood and blood-forming organs. Other hematological agents. Enzymes. Streptokinase, combinations.

ATC code B06A A55.

Pharmacological Properties.

Pharmacodynamics.

The medicinal product "SK-SD, streptokinase-streptodornase", suppositories, acts locally after rectal administration. Streptokinase acts as a fibrinolytic agent and dissolves fibrin and other clots. Streptodornase dissolves deoxyribonucleoproteins and deoxyribonucleic acids, thereby reducing the viscosity of purulent exudates and dissolving dead cells.

Pharmacokinetics.

Streptokinase and streptodornase act locally on blood clots, purulent and necrotic cellular and tissue components. The medicinal product is administered rectally and is not absorbed into the bloodstream.

The streptokinase-plasminogen complex is gradually converted into polypeptides. The degradation products together with other substrate fragments are mechanically removed. Streptodornase, after DNA depolymerization, is converted into a mixture of nucleotides and is mechanically removed along with fragments of dead cells.

Clinical characteristics.

Indications.

• Perianal abscesses and fistulas with extensive inflammatory infiltration.
• Hemorrhoids in acute and chronic inflammation.
• Infiltrative and postoperative changes.

Contraindications.

• Hypersensitivity to the active or excipient ingredients of the medicinal product;
• Presence of a fresh wound, surgical suture, or bleeding within 10 days (this may cause suture loosening and, as a consequence, wound bleeding);
• Concomitant use with anticoagulants, which may lead to local bleeding;
• Coagulation disorders;
• Concomitant use with medicinal products containing calcium salts;
• In acute connective tissue inflammation without signs of suppuration.

Interaction with other medicinal products and other forms of interaction.

The medicinal product "SK-SD, streptokinase-streptodornase" is contraindicated for concomitant use with anticoagulants, as bleeding may occur.

Special precautions.

The medicinal product may cause local irritation.

Use during pregnancy or breastfeeding.

The effect of the medicinal product "SK-SD, streptokinase-streptodornase" on fertility, course of pregnancy, as well as on breastfeeding has not been studied.

Ability to affect reaction rate while driving or operating machinery.

Does not affect reaction rate while driving or operating machinery.

Method of Administration and Dosage

Dosage

Treatment course: 4–18 suppositories. Duration of treatment: 2–9 days.

Dosage is determined by the physician according to the severity of the inflammatory process.

In severe and chronic disease course:

• 1 suppository 3 times daily for the first 3 days;
• 1 suppository 2 times daily for the next 3 days;
• 1 suppository 1 time daily for the following 3 days.

Treatment course: 18 suppositories over 9 days.

In moderate disease course:

• 1 suppository 2 times daily for the first 3 days;
• 1 suppository 1 time daily for the next 4 days.

Treatment course: 10 suppositories over 7 days.

In mild disease course:

• 1 suppository 2 times daily for 2 days.

Treatment course: 4 suppositories over 2 days.

If no improvement is observed or if a relapse occurs, the physician should determine the need for a repeated course of treatment.

Method of Administration

Rectally. Insert the suppository deeply into the rectum after removing it from the blister. Hands must be thoroughly washed before and after administration.

Children.

The medicinal product should not be used in children due to insufficient data on safety and efficacy in this age group.

Overdose.

Data regarding overdose with streptokinase and streptodornase are lacking.

Side effects

Local pain, swelling or slight bleeding, irritation, diarrhea, allergic reactions, and increased body temperature may occasionally occur.

Reporting of suspected adverse reactions

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

Shelf life

2 years.

Storage conditions

Store at 2–8 °C in the original packaging. Do not freeze.

Keep out of reach of children.

Packaging

6 suppositories per blister; 1, 2 or 3 blisters per cardboard box.

Prescription category: Prescription only.

Manufacturer:

Farmina Ltd.

Manufacturer's address and place of business activity:

Lipska St. 44, 30-721 Kraków, Poland