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RIVAROXABAN GRINDEKS is a brand name for Rivaroxaban. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Prevention of stroke and systemic embolism in adults The recommended dose is 20 mg once daily, which is also the recommended maximum dose. 4). If a dose is missed the patient should take Rivaroxaban Grindeks immediately and continue on the following day with the once daily intake as recommended.
The dose should not be doubled within the same day to make up for a missed dose. Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE in adults The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE.
e. recent major surgery or trauma). Longer duration of therapy should be considered in patients with provoked DVT or PE not related to major transient risk factors, unprovoked DVT or PE, or a history of recurrent DVT or PE. When extended prevention of recurrent DVT and PE is indicated (following completion of at least 6 months therapy for DVT or PE), the recommended dose is 10 mg once daily.
In patients in whom the risk of recurrent DVT or PE is considered high, such as those with complicated comorbidities, or who have developed recurrent DVT or PE on extended prevention with Rivaroxaban Grindeks 10 mg once daily, a dose of Rivaroxaban Grindeks 20 mg once daily should be considered.
4). Time period Dosing schedule Total daily dose Treatment and prevention of Day 1-21 15 mg twice daily 30 mg recurrent DVT and PE Day 22 onwards 20 mg once daily 20 mg Prevention of recurrent DVT and PE Following completion of at least 6 months therapy for DVT or PE 10 mg once daily or 20 mg once daily 10 mg or 20 mg If a dose is missed during the 15 mg twice daily treatment phase (day 1 - 21), the patient should take Rivaroxaban Grindeks immediately to ensure intake of 30 mg Rivaroxaban Grindeks per day.
In this case two 15 mg tablets may be taken at once. The patient should continue with the regular 15 mg twice daily intake as recommended on the following day. If a dose is missed during the once daily treatment phase, the patient should take Rivaroxaban Grindeks immediately, and continue on the following day with the once daily intake as recommended.
The dose should not be doubled within the same day to make up for a missed dose. 1). The dose for children and adolescent is calculated based on body weight. - Body weight from 30 to 50 kg: a once daily dose of 15 mg rivaroxaban is recommended.
Summary of the safety profile The safety of rivaroxaban has been evaluated in thirteen pivotal phase III studies (see Table 1). Overall, 69,608 adult patients in nineteen phase III studies and 488 paediatric patients in two phase II and two phase III studies were exposed to rivaroxaban.
4 and ‘Description of selected adverse reactions’ below) (Table 2). 8 %). 74 per 100 patient years*** # * For all rivaroxaban studies all bleeding events are collected, reported and adjudicated. ** In the COMPASS study, there is a low anaemia incidence as a selective approach to adverse event collection was applied.
*** A selective approach to adverse event collection was applied. # From the VOYAGER PAD study. Tabulated list of adverse reactions The frequencies of adverse reactions reported with rivaroxaban in adult and paediatric patients are summarised in Table 3 below by system organ class (in MedDRA) and by frequency.
Frequencies are defined as: very common (≥ 1/10) common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) rare (≥ 1/10,000 to < 1/1,000) very rare (< 1/10,000) not known (cannot be estimated from the available data) Table 3: All adverse reactions reported in adult patients in phase III clinical studies or through post-marketing use* and in two phase II and two phase III studies in paediatric patients Common Uncommon Rare Very rare Not known Blood and lymphatic system disorders Anaemia (incl.
respective laboratory parameters) Thrombocytosis (incl. platelet count increased)A, thrombocytopenia Immune system disorders Common Uncommon Rare Very rare Not known Allergic reaction, dermatitis allergic, angioedema and allergic oedema Anaphylactic reactions including anaphylactic shock Nervous system disorders Dizziness, headache Cerebral and intracranial haemorrhage, syncope Eye disorders Eye haemorrhage (incl.
conjunctival haemorrhage) Cardiac disorders Tachycardia Vascular disorders Hypotension, haematoma Respiratory, thoracic and mediastinal disorders Epistaxis, haemoptysis Eosinophilic pneumonia Gastrointestinal disorders Gingival bleeding, gastrointestina l tract haemorrhage (incl.
4. 1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Light red, round, film-coated tablets, with slightly curved smooth surface and logo “15” on one side. Diameter of the tablet is approximately 7 mm. 1 Therapeutic indications Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. ) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.
2 Posology and method of administration Posology Prevention of stroke and systemic embolism in adults The recommended dose is 20 mg once daily, which is also the recommended maximum dose. 4). If a dose is missed the patient should take Rivaroxaban Grindeks immediately and continue on the following day with the once daily intake as recommended.
The dose should not be doubled within the same day to make up for a missed dose. Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE in adults The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE.
e. recent major surgery or trauma). Longer duration of therapy should be considered in patients with provoked DVT or PE not related to major transient risk factors, unprovoked DVT or PE, or a history of recurrent DVT or PE. When extended prevention of recurrent DVT and PE is indicated (following completion of at least 6 months therapy for DVT or PE), the recommended dose is 10 mg once daily.
1. Active clinically significant bleeding. Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
g. 5). 2). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This is the maximum daily dose. - Body weight of 50 kg or more: a once daily dose of 20 mg rivaroxaban is recommended. This is the maximum daily dose. - For patients with body weight less than 30 kg other pharmaceutical forms may be more appropriate for administration to this population.
The weight of a child should be monitored and the dose reviewed regularly. This is to ensure a therapeutic dose is maintained. Dose adjustments should be made based on changes in body weight only. Treatment should be continued for at least 3 months in children and adolescents.
Treatment can be extended up to 12 months when clinically necessary. There is no data available in children to support a dose reduction after 6 months treatment. The benefit-risk of continued therapy after 3 months should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential bleeding risk.
If a dose is missed, the missed dose should be taken as soon as possible after it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed. The patient should not take two doses to make up for a missed dose.
0. 5. When converting patients from VKAs to Rivaroxaban Grindeks, INR values will be falsely elevated after the intake of Rivaroxaban Grindeks. 5). Converting from Rivaroxaban Grindeks to Vitamin K antagonists (VKA) There is a potential for inadequate anticoagulation during the transition from Rivaroxaban Grindeks to VKA.
Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Rivaroxaban Grindeks can contribute to an elevated INR. 0. For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing, as guided by INR testing.
While patients are on both Rivaroxaban Grindeks and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of […]
rectal haemorrhage), gastrointestina l and abdominal pains, dyspepsia, nausea, constipationA, diarrhoea, vomitingA Dry mouth Hepatobiliary disorders Increase in transaminases Hepatic impairment, increased bilirubin, increased blood Jaundice, bilirubin conjugated increased (with or without Common Uncommon Rare Very rare Not known alkaline phosphataseA, increased GGTA concomitant increase of ALT), cholestasis, hepatitis (incl.
hepatocellular injury) Skin and subcutaneous tissue disorders Pruritus (incl. uncommon cases of generalised pruritus), rash, ecchymosis, cutaneous and subcutaneous haemorrhage Urticaria Stevens-Johns on syndrome/Tox ic Epidermal Necrolysis, DRESS syndrome Musculoskeletal and connective tissue disorders Pain in extremityA Haemarthrosis Muscle haemorrhage Compartment syndrome secondary to a bleeding Renal and urinary disorders Urogenital tract haemorrhage (incl.
haematuria and menorrhagiaB), renal impairment (incl. blood creatinine increased, blood urea increased) Renal failure/acute renal failure secondary to a bleeding sufficient to cause hypoperfusio n, Anticoagulan […]
In patients in whom the risk of recurrent DVT or PE is considered high, such as those with complicated comorbidities, or who have developed recurrent DVT or PE on extended prevention with Rivaroxaban Grindeks 10 mg once daily, a dose of Rivaroxaban Grindeks 20 mg once daily should be considered.
4). Time period Dosing schedule Total daily dose Treatment and prevention of Day 1-21 15 mg twice daily 30 mg recurrent DVT and PE Day 22 onwards 20 mg once daily 20 mg Prevention of recurrent DVT and PE Following completion of at least 6 months therapy for DVT or PE 10 mg once daily or 20 mg once daily 10 mg or 20 mg If a dose is missed during the 15 mg twice daily treatment phase (day 1 - 21), the patient should take Rivaroxaban Grindeks immediately to ensure intake of 30 mg Rivaroxaban Grindeks per day.
In this case two 15 mg tablets may be taken at once. The patient should continue with the regular 15 mg twice daily intake as recommended on the following day. If a dose is missed during the once daily treatment phase, the patient should take Rivaroxaban Grindeks immediately, and continue on the following day with the once daily intake as recommended.
The dose should not be doubled within the same day to make up for a missed dose. 1). The dose for children and adolescent is calculated based on body weight. - Body weight from 30 to 50 kg: a once daily dose of 15 mg rivaroxaban is recommended.
This is the maximum daily dose. - Body weight of 50 kg or more: a once daily dose of 20 mg rivaroxaban is recommended. This is the maximum daily dose. - For patients with body weight less than 30 kg other pharmaceutical forms may be more appropriate for administration to this population.
The weight of a child should be monitored and the dose reviewed regularly. This is to ensure a therapeutic dose is maintained. Dose adjustments should be made based on changes in body weight only. Treatment should be continued for at least 3 months in children and adolescents.
Treatment can be extended up to 12 months when clinically necessary. There is no data available in children to support a dose reduction after 6 months treatment. The benefit-risk of continued therapy after 3 months should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential bleeding risk.
If a dose is missed, the missed dose should be taken as soon as possible after it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed. The patient should not take two doses to make up for a missed dose.
0. 5. When converting […]