Vessel Due F

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

sulodexide

Inapatikana kutoka:

Alfa Wassermann S.p.A.

INN (Jina la Kimataifa):

sulodexide

Kipimo:

250LSU

Dawa fomu:

capsules

Dawa ya aina:

Prescription

Tabia za bidhaa

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
Injectable solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Angiopathy with high risk of thrombosis including thrombosis after
acute myocardial
infarction;
Stroke (acute ischemic stroke and at early rehabilitation phase after
stroke); discirculatory
encephalopathy caused by atherosclerosis, diabetes mellitus, arterial
hypertension;
vascular dementia
Peripheral arterial obstructive disease (of atherosclerotic and
diabetic origin)
Venous disease and deep vein thrombosis
Microangiopathy (nephropathy, retinopathy, neuropathy) and
macroangiopathy in
diabetes mellitus (diabetic foot, encephalopathy, cardiopathy)
Thrombophilia, antiphospholipid syndrome (sulodexide is administered
in combination
with acetylsalicylic acid after the treatment with low molecular
weight heparin)
Heparin-induced thrombotic thrombocytopenia (as sulodexide does not
induce and
aggravate it).
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.
4.3
CONTRA-INDICATIONS
- Hypersensitivity;
- Hemorrhagic diathesis and the diseases accompanied by lowered
coagulability of blood;
- Pregnancy in I trimester.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
During sulodexide administration the haemocoagulative parameters
should be