Стенты коронарные: стент-система коронарная BioMime™ с лекарственным покрытием сиролимус (длина, мм: 8; 13; 16; 19; 24; 29; 32; 37; 40; 44; 48, диаметр, мм: 2; 2,25; 2,5; 2,75; 3; 3,5; 4; 4,5)

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Meril Life Sciences Pvt. Ltd., ИНДИЯ

класс:

изделия медицинского назначения

Производитель:

Meril Life Sciences Pvt. Ltd.

Дата Авторизация:

2020-09-03

Характеристики продукта

6.7
DRUG INTERACTION
While no specific clinical data are available, drugs, like Tacrolimus,
that
act through the same binding protein (FKBP) may interfere with the
efficacy of Sirolimus.
Drug interaction studies have not been performed. Sirolimus is
metabolized by CYP3A4. Strong inhibitors of CYP3A4 (e.g. ketoconazol)
might cause increased Sirolimus exposure to levels associated with
systemic effects, especially if multiple stents are deployed. Systemic
exposure of Sirolimus should also be taken into consideration if the
patient is treated concomitantly with systemic immunosuppressive
therapy.
7.
ADVERSE EFFECTS:
Undesirable effects/adverse events (in alphabetical order) that may be
associated with the implantation of a coronary stent in native
coronary
arteries include but are not limited to:
l
Abrupt stent closure
l
Acute myocardial infarction
l
Allergic reactions
l
Aneurysm
l
Angina
l
Arrhythmias, including ventricular fibrillation (VF) and ventricular
tachycardia (VT)
l
Arteriovenous fistula
l
Cardio tamponade
l
Coronary Artery Occlusion
l
Cardiogenic shock
l
Death
l
Dissection
l
Drug reactions to antiplatelet agents / anticoagulation agents /
contrast
media
l
Emboli, distal (air, tissue or thrombotic emboli)
l
Embolization, stent
l
Emergency Coronary Artery Bypass Graft Surgery (CABG)
l
Failure to deliver the stent at the intended site
l
Fever
l
Fistulization
l
Heart Failure
l
Hemotoma
l
Hemorrhage
l
Hypotension / Hypertension
l
Incomplete Stent Apposition
l
Infection, including infection and/or pain at the access site
l
Myocardial Infarction
l
Myocardial Ischemia
l
Perforation or rupture
l
Pericardial effusion
l
Prolong Angina
l
Pseudoaneurysm
l
Renal failure
l
Respiratory failure
l
Restenosis of stented segment
l
Rupture of native and bypass graft
l
Shock / Pulmonary edema
l
Spasm
l
Stent compression
l
Stent migration
l
Stroke / cerebrovascular accident / TIA
l
Stent thrombosis (acute, subacute, or late)/occlusion
l
Ventricular fibrillation
l
Vessel perforation
l
Vessel spasm
l
Vessel trauma requiring surg