Distreptaza 6 Rectal Suppositories

1. Medicinal product name with International Nonproprietary Name, if the manufacturer (applicant) uses a name different from the International Nonproprietary Name, or if the medicinal product contains only one active ingredient. DISTREPTAZA® DISTREPTAZA® Streptokinase + Streptodornase Streptokinase + Streptodornase 2. Dosage of the medicinal product, if the medicinal product is available in several dosage forms and (or) dosage forms that differ in action (newborns, infants, adults), which is indicated next to the trade name of the medicinal product. distreptaza® (15,000 IU + 1250 IU) one suppository (2 g) contains Streptokinase (Streptokinasum) 15000 IU, Streptodornase (Streptodornasum) 1250 IU. 3. Name of the dosage form Rectal suppositories 4. Brief description of the finished dosage form, including physical and chemical properties (information must comply with the "Description" section of the manufacturer's quality control regulatory document). Physical and chemical properties: Cone or "torpedo" shape with a pointed tip. Whitish-cream color. During storage, suppositories retain their correct shape, smooth surface, and do not develop cracks or mechanical damage. Suppositories are a homogeneous and uniform mass, the surface of the longitudinal cut is uniform, without spots, conglomerates, and air bubbles. Suppositories are mechanically sufficiently stable, which protects them from deformation during packaging, transportation, and use. Suppositories are sufficiently solid, as confirmed by hardness tests. Suppositories meet the following requirements: • Uniformity of mass of individual suppositories - the average mass of a suppository is within ± 0.5% of the average mass. Only two out of 20 tested suppositories may exceed the maximum limit data, but not more than twice. • Time of complete deformation of the suppository - the deformation time of the suppository is not more than 30 minutes at a temperature of 37°C, and the time difference between different measurements should not exceed ± 10%. • Disintegration time - the disintegration time of the suppository is not more than 30 minutes at a temperature of 37°C. • Content of active substances: The content of streptokinase is within the following range: 15.000 ± 10% SK / 1 suppository, the content of streptodornase in one suppository is from 1250 IU to 20,000 IU SD. • Content of streptolysin O (SLO) contamination - 1 suppository should not contain more than 10 units of SLO, calculated per 1000 IU of SK. • Protein content is 1-2 mg per suppository. • 1 g contains no more than 103 colony-forming bacteria (CFU), no more than 102 colony-forming fungi, does not contain Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella, and also does not contain bacteria of the Enterobacteriaceae family and other Gram-negative rods. Active substances are evenly distributed in the lipophilic base of the suppository, consisting of neutral fats and liquid paraffin. 5. Composition of the medicinal product, indicating its active substances in the form of International Nonproprietary Names and their quantitative content in one dose or one package, list of excipients. Name of substance Quantity per dosage unit / 1 suppository Functions of substances Streptokinase + Streptodornase 15.000 IU ± 10% 1.250 IU – 20.000 IU Active substances Liquid paraffin (paraffin oil) 0.16 g Excipient Neutral fat Vitepsol N15 1.84 g Excipient 6. Information on which pharmacotherapeutic group the medicinal product belongs to or its pharmacological action in terminology understandable to the patient. Pharmacotherapeutic group: Streptokinase, complex drugs, ATC code B06AA55. 7. Information on the indications for the medicinal product with a list of diseases and conditions for which it is used. distreptaza® in the form of suppositories is used in adults for the treatment of the following diseases: 1. Chronic inflammation of the uterine adnexa. 2. Postoperative infiltrative lesions of the pelvic organs. 3. Inflammation of the uterine mucosa. 4. Hemorrhoids of acute and chronic course. 5. Perianal abscess and fistula with diffuse inflammatory infiltrate. 6. Purulent caudal cysts. distreptaza® in the form of suppositories contains two active substances: streptokinase and streptodornase. Streptokinase in the form of suppositories is an activator of proenzyme plasminogen, which is present in human blood. Plasminogen is converted to plasmin as a result of streptokinase action, which has the ability to dissolve human blood coagulants. Streptodornase is an enzyme that has the ability to dissolve sticky masses of nucleoproteins, necrotic cells, or pus. At the same time, it does not affect living cells and their physiological functions. distreptaza® in the form of suppositories is used as an independent or auxiliary medication, which by its action enhances the penetration of antibiotics or chemotherapeutic drugs into the focus of inflammation. The preparation reduces subjective sensations and significantly reduces the healing period. 8. Information on the correct use of the medicinal product, including contraindications, warnings, interactions with other medicinal products and other types of interactions (with tobacco, alcohol, food products) that may affect the action of the medicinal product, special instructions for the use of the medicinal product. After removal from the blister, the suppository should be inserted deep into the rectum. Unused product or its waste should be disposed of according to local regulations. Contraindications for use include allergy to components, hemorrhagic diathesis. The product is not allowed to come into contact with a wound covered with a crust or a wound with newly placed sutures, as contact may weaken the sutures and cause bleeding from the wound. Do not use with anticoagulants, as local bleeding may occur. The preparation enhances the penetration of antibiotics or chemotherapeutic drugs into the focus of inflammation. If you are using other medications, be sure to inform your doctor! During treatment with Distreptaza, do not take other medications, including over-the-counter ones, without consulting a doctor. Uncontrolled treatment can harm your health. 9. Information on the peculiarities of the use of the medicinal product in different categories of patients (children, pregnant or lactating women, elderly patients, patients with various pathologies). distreptaza® in the form of suppositories is not used in pregnant women, as well as during breastfeeding. 10. Information on the effect of the drug on human behavior, ability to drive a car or operate machinery (if necessary). distreptaza® does not cause a decrease in mental abilities, does not affect the ability to operate mechanical devices and service mechanical equipment. 11. Information on excipients that are important for the safety and efficacy of the medicinal product. The following substances are used to prepare the suppositories: - Neutral fat (Vitepsol N15), - Liquid paraffin (paraffin oil). Vitepsol N15 (neutral fat, Adept neutralis, Adept solidus) is a neutral fat that forms the lipophilic base of the suppository. Chemically, it is a mixture of mono-, di-, and triglycerides of saturated, higher fatty acids, obtained by hydrolysis of natural glycerides present in vegetable oils - coconut and palm oil. Vitepsol N15 is a white, solid, brittle mass, fatty and solid to the touch, which does not become rancid when unsaturated fatty acids are removed. It hardens quickly at room temperature. It is characterized by contraction (volume change when mixing with mutually soluble liquid substances). Vitepsol N15 is used as a base for suppository mass because it melts easily at temperatures above 33.5 – 35.5°C. This parameter meets the limit indicated in the "European Pharmacopoeia" (according to the "European Pharmacopoeia", the melting temperature of neutral fat is in the range of 30 – 45°C). Active substances can be easily weighed into liquid Vitepsol and easily brought to a homogeneous state by mixing. At room and lower temperatures, Vitepsol solidifies, which is why it is used for the preparation of suppositories. Vitepsol N15 does not irritate mucous membranes, melts at human body temperature and easily releases active substances. Liquid paraffin (paraffin oil, Paraffinum liquidum) is a high-quality refined mineral oil obtained synthetically. Liquid paraffin is a colorless, fatty, transparent, odorless liquid that is practically insoluble in water and ethanol. CAS No.: 8042-47-5/8012-95-1 In suppositories, liquid paraffin is used as a lubricant. 12. Information on the correct administration of the drug, including dosage, route and method of administration, frequency of use and, if necessary, the time of administration of the drug, dependence on food intake, as well as, if necessary, depending on the properties of the drug, the duration of use without medical supervision, if it is limited. After removal from the blister, the suppository is inserted deep into the rectum. Dosage depends on the type and severity of the inflammatory process. Used as recommended by a doctor. For adults with severe disease course: 1 suppository 3 times a day for the first 3 days; 1 suppository 2 times a day for the next 3 days; 1 suppository once a day for the next 3 days. For adults with moderate and mild disease: 1 suppository 2 times a day for 3 days; 1 suppository once a day for the next 4 days; or 1 suppository 2 times a day for 2 days. On average, 8 - 18 suppositories are prescribed during the course of treatment. The average duration of the treatment course is 7 - 10 days. 13. Information on cases of overdose of the medicinal product and measures to be taken in such cases (emergency medical care measures and symptomatic therapy). Symptoms of overdose are unknown. 14. Information on the patient's actions in case of missing a scheduled dose of the medicinal product, with an indication of the risk of developing the effect of stopping the drug (if necessary). If a dose of the medicinal product is missed, do not take a double dose. 15. Side reactions observed when using the medicinal product at therapeutic or prophylactic doses, a necessary indication in the instructions about the need to consult a doctor when side effects are detected. Sometimes allergic reactions, increased body temperature, and a tendency to bleeding are expected. If atypical reactions occur, be sure to consult a doctor about the possibility of continuing the use of the drug! 16. Information on special storage conditions, including indication of the exact temperature regime (parameters) under which the medicinal product retains its pharmacological properties, warning about visual control of the medicinal product (if necessary), shelf life of the medicinal product, warning about the inadmissibility of using the medicinal product after its expiration date, the need to store the medicinal product out of reach of children. The preparation should be stored out of reach of children. Store at a temperature of 2°C – 8°C (in the refrigerator). Do not freeze. Shelf life - 3 years. Use of the preparation after the expiration date indicated on the packaging is not allowed. 17. Information on the dispensing category of the medicinal product: prescription or over-the-counter. Pharmaceutical product group II, dispensing form №3 by prescription. 18. Information on the number of doses in the package and the type of packaging of the medicinal product. 6 rectal suppositories in a blister, 1 blister with 6 suppositories. PVC/PE blister in a cardboard box. 5 rectal suppositories in a blister, 2 blisters of 5 suppositories each. PVC/PE blister in a cardboard box. 19. Information about the manufacturer (applicant), its address, as well as data about the representative of the manufacturer's (applicant's) interests, its address, telephone number and other information. "BIOMED-LUBLIN" Wytwórnia Surowic i Szczepionek Spółka Akcyjna ul. Wieniawska 10, 20-029 Lublin, Poland Exclusive representative Alpen Pharma AG Bern, Switzerland