Vessel Due F capsules

देश: आर्मेनिया

भाषा: अंग्रेज़ी

स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

सक्रिय संघटक:

sulodexide

थमां उपलब्ध:

Alfasigma S.p.A.

ए.टी.सी कोड:

B01AB11

INN (इंटरनेशनल नाम):

sulodexide

डोज़:

250LSU

फार्मास्यूटिकल फॉर्म:

capsules

पैकेज में यूनिट:

(50/2x25/) in blister

प्रिस्क्रिप्शन प्रकार:

Prescription

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2019-12-25

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL
PRODUCT VESSEL DUE F
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Soft capsules:
Sulodexide 250 LSU
Ampoules:
Sulodexide 600
LSU
3.
PHARMACEUTICAL FORM
Soft capsules
Solution for intravenous and intramuscular injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic venous ulcers.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Solution for intravenous and intramuscular
injections. Capsules.
Treatment begins with daily intramuscular injection of 1 ampoule of a
preparation or
intravenous bolus or drop infusion preliminary having dissolved in 150
– 200 ml
physiological solution. The course treatment is 15-20 days. Then,
within 30-40 days,
therapy should be continued with 1 capsule 2 times a day orally
between food intake.
The treatment complete course should be repeated at least 2 times a
year.
Depending on results of clinical and laboratory investigations the
treatment regime can
be changed upon physician’s decision.
_Paediatric population _
The safety and effectiveness of sulodexide in children and adolescents
under 18 years of
age have not yet been established.
4.3
CONTRA-INDICATIONS
Hypersensitivity to the active ingredient or any one of the excipients
listed in section 6.1
and to heparin and heparinoids.
Diathesis and haemorrhagic diseases.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
During sulodexide administration the haemocoagulative parameters
should be monitored
periodically. In the beginning and in end of the treatment the
following tests should be
done: activated partial thromboplastin time, antithrombin III,
bleeding time, clotting
time. Vessel Due F gives 1,5fold prolongation of the activated partial
thromboplastin
time.
VESSEL DUE F soft capsules 250 LSU_ _contains sodium ethyl
p-hydroxybenzoate and
sodium propyl p-hydroxybenzoate and therefore may cause allergic
reactions (possibly
delayed)._ _
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION Important interactions of Vessel Due F with other