Country: আর্মেনিয়া
ভাষা: ইংরেজি
সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
apixaban
Bristol-Myers Squibb S.R.L.
B01AF02
apixaban
5mg
tablets film-coated
(20/2x10/) blisters, (60/6x10/) blisters
Prescription
Registered
2015-07-16
27 1. NAME OF THE MEDICINAL PRODUCT Eliquis 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg apixaban. Excipients with known effect Each 5 mg film-coated tablet contains 102.86 mg lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Pink, oval tablets debossed with 894 on one side and 5 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) _ The recommended dose of apixaban is 5 mg taken orally twice daily. _Dose reduction_ The recommended dose of apixaban is 2.5 mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL (133 micromole/L). Therapy should be continued long-term. _Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt)_ The recommended dose of apixaban for the treatment of acute DVT and treatment of PE is 10 mg taken orally twice daily for the first 7 days followed by 5 mg taken orally twice daily. As per available medical guidelines, short duration of treatment (at least 3 months) should be based on transient risk factors (e.g., recent surgery, trauma, immobilisation). The recommended dose of apixaban for the prevention of recurrent DVT and PE is 2.5 mg taken orally twice daily. When prevention of re সম্পূর্ণ নথি পড়ুন