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It specifies the pharmaceutical form and provides clinical particulars covering therapeutic indications for adults and paediatric patients, posology and method of administration, dose adjustment criteria, recommended treatment durations, dosing schedules for DVT/PE and recurrent prevention, and guidance on missed doses and switching between anticoagulant therapies.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/apixaban-grindeks-5-mg-film-coated-tablets-summary-of-product-characteristics/347644/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/apixaban-grindeks-5-mg-film-coated-tablets-summary-of-product-characteristics/347644.png","ImageObject",300,407,{"name":92,"@type":93},"Emma Wilson","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-27","2026-09-22",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is the recommended dose of apixaban for NVAF in adults?","Question",{"text":112,"@type":113},"The recommended dose is 5 mg taken orally twice daily. In patients with NVAF and at least two risk characteristics, the dose is reduced to 2.5 mg twice daily.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How is apixaban dosed for acute DVT or PE in adults?",{"text":117,"@type":113},"For the first 7 days, the dose is 10 mg orally twice daily, followed by 5 mg orally twice daily. Treatment duration should be based on transient risk factors such as recent surgery, trauma, or immobilisation.",{"name":119,"@type":110,"acceptedAnswer":120},"What guidance is given for missed doses and switching anticoagulant therapy?",{"text":121,"@type":113},"A missed morning dose should be taken immediately when noticed and may be taken with the evening dose; a missed evening dose can only be taken during the same evening. Switching from parenteral anticoagulants to apixaban can be done at the next scheduled dose, without simultaneous administration.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},347644,1790617990,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145},3848291630094,"https://eur-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","Health Products Regulatory Authority  \nSummary of Product Characteristics  \n1 NAME OF THE MEDICINAL PRODUCT  \nApixaban Grindeks 5 mg film-coated tablets  \n2 QUALITATIVE AND QUANTITATIVE COMPOSITION  \nEach film-coated tablet contains 5 mg apixaban.  \nExcipient with known effect  \nEach film-coated tablet contains 102.9 mg lactose.  \nFor the full list of excipients, see section 6.1.  \n3 PHARMACEUTICAL FORM  \nFilm-coated tablet (tablet)  \nPink, biconvex, oblong (approximately 10 mm x 5 mm), film-coated tablet, debossed with \"5\" on one side and \"  \" on the other side.  \n4 CLINICAL PARTICULARS  \n4.1 Therapeutic indications  \nAdults  \nPrevention 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) .  \nTreatment 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) .  \nPaediatric population  \nTreatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.  \n4.2 Posology and method of administration  \nPosology  \nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF)  \nThe recommended dose of apixaban is 5 mg taken orally twice daily.  \nDose reduction  \nThe 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) .  \nTherapy should be continued long-term.  \nTreatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) in adults  \nThe 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) .  \n26 May 2026 CRN00H679 Page 1 of 26  \nHealth Products Regulatory Authority  \nThe recommended dose of apixaban for the prevention of recurrent DVT and PE is 2.5 mg taken orally twice daily. When prevention of recurrent DVT and PE is indicated, the 2.5 mg twice daily dose should be initiated following completion of 6 months of treatment with apixaban 5 mg twice daily or with another anticoagulant, as indicated in Table 1 below (see also section 5. 1) .  \n\n|  | Dosing schedule | Maximum daily dose |\n| --- | --- | --- |\n| Treatment of DVT or PE | 10 mg twice daily for the first 7 days | 20 mg |\n|  | followed by 5 mg twice daily | 10 mg |\n| Prevention of recurrent DVT and/or PE following completion of 6 months of treatment for DVT or PE | 2.5 mg twice daily | 5 mg |\n\nTable 1: Dose recommendation (VTEt)  \nThe duration of overall therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4) .  \nTreatment of VTE and prevention of recurrent VTE in paediatric patients  \nApixaban treatment for paediatric patients from 28 days to less than 18 years of age should be initiated following at least 5 days of initial parenteral anticoagulation therapy (see section 5.1) .  \nTreatment with apixaban in paediatric patients is based on weight-tiered dosing. The recommended dose of apixaban in paediatric patients weighing ≥ 35 kg is shown in Table 2.  \nTable 2: Dose recommendation for treatment of VTE and prevention of recurrent VTE in paediatric patients weighing ≥ 35 kg (after initial parenteral anticoagulation)  \n\n|  | Days 1 – 7 |  | Day 8 and beyond |  |\n| --- | --- | --- | --- | --- |\n| Body weight (kg) | Dosing schedule | Maximum daily dose | Dosing schedule | Maximum d","cbCaik9YlxAKm3OJ","https://ap.wps.com/l/cbCaik9YlxAKm3OJ","pdf",440917,26,"English","# Name of the medicinal product\n## Qualitative and quantitative composition\n## Pharmaceutical form\n## Clinical particulars\n### Therapeutic indications\n### Posology and method of administration\n## Table 1: Dose recommendation (VTEt)\n## Table 2: Dose recommendation for paediatric patients ≥ 35 kg","[{\"question\":\"What is the recommended dose of apixaban for NVAF in adults?\",\"answer\":\"The recommended dose is 5 mg taken orally twice daily. In patients with NVAF and at least two risk characteristics, the dose is reduced to 2.5 mg twice daily.\"},{\"question\":\"How is apixaban dosed for acute DVT or PE in adults?\",\"answer\":\"For the first 7 days, the dose is 10 mg orally twice daily, followed by 5 mg orally twice daily. Treatment duration should be based on transient risk factors such as recent surgery, trauma, or immobilisation.\"},{\"question\":\"What guidance is given for missed doses and switching anticoagulant therapy?\",\"answer\":\"A missed morning dose should be taken immediately when noticed and may be taken with the evening dose; a missed evening dose can only be taken during the same evening. Switching from parenteral anticoagulants to apixaban can be done at the next scheduled dose, without simultaneous administration.\"}]","Apixaban Grindeks 5 mg film-coated tablets - Summary of Product Characteristics | PDF",1790068314,66]