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Distreptaza®

NSTRUCTIONS for medical use

1. NAME OF MEDICINAL PREPARATION
Tradename
DISTREPTAZA®
International Nonproprietary Name (INN)
Streptokinase + Streptodornase

DOSAGE FORM
Rectal suppositories.

QUALITATIVE AND QUANTITATIVE FORMULATION
Name of substance Number
in the dosing unit \
1 suppository
Functions of substances
Streptokinase
Streptodornase 15,000 IU ± 10%
1250 IU - 20000 IU Active substances
Liquid paraffin
(Paraffin oil) 0.16 g Excipient
Neutral fat
Witepsol H15 1.84 g Auxiliary

2. LIST OF EXCIPIENTS
For the manufacture of suppositories used candle base, consisting of excipients:
- neutral fat (Witepsol H15)
- liquid paraffin (paraffin oil).

3. GENERAL CHARACTERISTIC OF THE MEDICINE
Physicochemical properties
The shape of cones or "torpedoes" with a pointed tip; the surface is homogeneous without spots and bumps, air bubbles, cracks and mechanical damage; creamy color * white.

4. PHARMACOTHERAPY  GROUP
Combined enzyme preparation containing streptokinase, PBX code: В06АА55.

5. PHARMACOLOGICAL PROPERTIES OF THE MEDICINE
Pharmacodynamics
DISTREPTAZA® in the form of suppositories contains two active ingredients: Streptokinase and Streptodornase.
Streptokinase is an activator of plasminogen proenzyme contained in human blood, which, under the influence of streptokinase, is converted to plasmin, which has the property of dissolving human blood clots.
Streptodornase is an enzyme that exhibits the ability to dissolve sticky masses of nucleoproteins, dead cells or pus, without affecting living cells and their physiological functions.
DISTREPTAZA® suppositories are used as a stand-alone or as an adjunct medicine. The drug can improve access to the site of inflammation of antibiotics and other chemotherapeutic agents.

Pharmacokinetics
There is no data confirming the systemic absorption of the active ingredients of the medicine with rectal suppositories DISTREPTAZA®

6. INDICATIONS 
DISTREPTAZA® in the form of suppositories is used in adults as part of complex therapy in the following cases:
1. Chronic salpingoophoritis.
2. Postoperative infiltrative changes.
3. Endometritis.
4. Hemorrhoids with acute and chronic course.
5. Perirectal abscesses and fistulas with extensive inflammatory infiltrate.
6. Purulent caudal cysts.
The efficacy of DISTREPTAZA® in inflammatory diseases of the pelvic organs in women has not been demonstrated in placebo-controlled randomized trials. The use of the drug is based on the experience of clinical use.

7. DOSAGE AND ADMINISTRATIONS
The suppository, after removing the blister from the cell, must be inserted deep into the rectum.
The dosage depends on the type and degree of intensity of the inflammatory process.
Use as directed by the physician.
In severe course of the disease in adults:
1 suppository 3 times a day for the first 3 days;
1 suppository 2 times a day for the next 3 days;
1 suppository 1 time per day for the next 3 days.

With mild to moderate severity of the disease in adults:
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 to 18 suppositories are used per course of treatment.
The average duration of treatment is 7 to 10 days.
All residues of unused product or its waste must be disposed of in the manner prescribed by local regulations.

8.SIDE EFFECTS
Sometimes there may be allergic reactions, fever and a tendency to bleed.
In the event of any unusual reactions, please consult with your doctor about the possibility of continuing the use of the medicine!

9. CONTRAINDICATIONS FOR USING A MEDICINE
Hypersensitivity to any component of the medicine, hemorrhagic diathesis, early period after operations on the pelvic and rectal organs. The preparation should not come into contact with a fresh wound covered with a scab, as well as with a freshly laid suture, as this may cause relaxation of the stitches and, as a result, hemorrhage from the wound.

10. OVERDOSE
No overdose symptoms are known.

11. INFORMATION ABOUT THE ACTIONS OF THE PATIENT, IN CASE IF IF IT WAS MISSING THE NEXT RECEPTION OF THE MEDICINE
If the next drug intake has been missed, do not use a double dose.

12. PRECAUTIONS
Features of the use of the drug in certain categories of patients (children, pregnant or lactating women, the elderly, patients with certain types of pathologies)
DISTREPTAZA® in the form of suppositories can not be used by pregnant women, as well as during breastfeeding.
There is no data regarding the characteristics of use in persons with impaired liver and kidney function, as well as in elderly patients.
Data on the safety and efficacy of using the medicine in pediatric practice is limited, so its use in children under the age of 18 years is not recommended.

The effect of the drug on the ability to drive and work with dangerous machinery
DISTREPTAZA® does not affect the ability to drive and work with dangerous machinery.

13. INTERACTION WITH OTHER MEDICINES
DISTREPTAZA® should not be used with anticoagulants, as local bleeding may occur.
If you are taking other medicines, be sure to tell your doctor!

14. TERMS AND CONDITIONS
The storage place for the medicinal product must be inaccessible and invisible to children.
Store at 2 ° C - 8 ° C (in the refrigerator). Do not freeze.
Shelf life - 3 years.
Do not use after the expiration date printed on the package.

15. CONDITIONS FOR VACATION FROM DRUGSTORES
DISTREPTAZA® medicine is available on prescription.

16. PACKAGING
6 rectal suppositories in a blister, 1 blister pack of 6 each. PVC / PE blister in carton box.
5 rectal suppositories in a blister, 2 blisters of 5 each. PVC / PE blister in carton box.

17. PRODUCER INFORMATION
“BIOMED-LUBLIN” 
st. University 10, 20-029 Lublin, Poland

Exclusive representative:
Alpen Pharma AG
Bern, Switzerland

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