SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
Streptokinase + Streptodornaze
15 000 i.u. + 1250 i.u.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One suppository (2g) contains streptokinase (Streptokinasum)15 000 i.u. and streptodornase (Streptodornasum) 1250 i.u.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Rectal suppositories with mass of 2 g.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Distreptaza in suppositories is used in the following cases:
1. Chronic adnexitis
2. Infiltrative postoperative changes
3. Uterus mucous membrane inflammation
4. Acute and chronic haemorrhoids
5. Rectal abscesses and fistulas with excessive inflammatory intumenscences
6. Purulent cysts in the area coccygeal bone.
4.2 Posology and method of administration
Dosage depends on the type and extent of inflammation’s intensity.
The drug should be used according to doctor’s recommendation.
In serious states one uses:
3 x 1 suppository through first 3 days
2 x 1 suppository through next 3 days
1 x 1 suppository through next 3 days
in slighter states:
2 x 1 suppository through 3 days
1 x 1 suppository through next 4 days
2 x 1 suppository through 2 days
Average number of suppositories used in therapy is 8-18.
Average treatment lasts 7-10 days.
Method of administration
After extracting the suppository from blister’s mold one should put deeply into rectum.
Hypersensitivity to the active substances or to any of excipients listed in section 6.1.
The product should not be in contact with wound freshly covered with crust or fresh put in stitch, because it may cause looseness of stitches and secondary bleeding from the wound.
4.4 Special warnings and precautions for use
4.5 Interactions with other medicinal products and other form of interaction
Does not occur.
4.6 Fertility, pregnancy or lactation
Distreptaza can not be used by women in pregnant.
Distreptaza can not be used in the period of breast feeding.
4.7 Effects on ability to drive and use machines
Distreptaza has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Sometimes may occur: allergic reactions, higher body temperature and tendency to bleedings.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Pharmacovigilance Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, e mail: email@example.com.
Undesirable effects can also be reported to the marketing authorisation holder.
There are no known symptoms of overdose.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Streptokinase, combined drugs, code ATC: B06AA55
5.2 Pharmacokinetic properties
Distreptaza in suppositories contains two active substances : streptokinase and streptodornase. Streptokinase is an activator of proenzyme contained in human blood called plasminogen, which under the impact of streptokinase passes into plasmin which is characterized by ability to dissolve human blood clots.
Streptodornase is an enzyme indicating ability to dissolve viscid nukleoprotein masses, dead cells or pus not affecting living cells and their physiological functions.
Distreptaza in suppositories is used as an independent or supplementary drug, which thanks to its effect enables much better access of antibiotics and chemotherapeutics to inflammatory focus.
The product reduces subjective ailments and shortens eminently time of treatment.
5.3 Preclinical safety data
During the research on laboratory animals (guinea pigs and white mice), it is stated that Distreptaza product is not toxic.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Does not occur.
6.3 Shelf life
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C ). Do not freeze.
6.5 Nature and contents of container
6 items – 1 blister of 6 items
10 items – 2 blisters of 5 items
One blister of PCV in a cardboard box.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
“BIOMED-LUBLIN” Wytwórnia Surowic i Szczepionek Spółka Akcyjna
20-029 Lublin, ul. Uniwersytecka 10
tel 81 533 82 21
fax 81 533 80 60
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21 August 1967
Date of latest renewal: 09 May 2013
10. DATE OF REVISION OF THE TEXT