XARELTO 15mg Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Xarelto 15 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 15 mg rivaroxaban. Excipient with known effect: Each film-coated tablet contains 24.13 mg lactose (as monohydrate), see section 4.4. For the full list of excipients, see ...
Pharmaceutical form
Film-coated tablet (tablet). Red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and 15 and a triangle on the other side.
Therapeutic indications
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 ...
Posology and method of administration
Posology Prevention of stroke and systemic embolism The recommended dose is 20 mg once daily, which is also the recommended maximum dose. Therapy with Xarelto should be continued long term provided the ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active clinically significant bleeding. Lesion or condition, if considered to be a significant risk for major ...
Special warnings and precautions for use
Clinical surveillance in line with anticoagulation practice is recommended throughout the treatment period. Haemorrhagic risk As with other anticoagulants, patients taking Xarelto are to be carefully observed ...
Interaction with other medicinal products and other forms of interaction
CYP3A4 and P-gp inhibitors Co-administration of rivaroxaban with ketoconazole (400 mg once a day) or ritonavir (600 mg twice a day) led to a 2.6 fold/2.5 fold increase in mean rivaroxaban AUC and a 1.7 ...
Fertility, pregnancy and lactation
Pregnancy Safety and efficacy of Xarelto have not been established in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Due to the potential reproductive toxicity, ...
Effects on ability to drive and use machines
Xarelto has minor influence on the ability to drive and use machines. Adverse reactions like syncope (frequency: uncommon) and dizziness (frequency: common) have been reported (see section 4.8). Patients ...
Undesirable effects
Summary of the safety profile The safety of rivaroxaban has been evaluated in thirteen phase III studies including 53,103 patients exposed to rivaroxaban (see Table 1). Table 1. Number of patients studied, ...
Overdose
Rare cases of overdose up to 600 mg have been reported without bleeding complications or other adverse reactions. Due to limited absorption a ceiling effect with no further increase in average plasma exposure ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors ATC code: B01AF01 Mechanism of action Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability. ...
Pharmacokinetic properties
Absorption Rivaroxaban is rapidly absorbed with maximum concentrations (C<sub>max</sub>) appearing 2-4 hours after tablet intake. Oral absorption of rivaroxaban is almost complete and oral bioavailability ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, phototoxicity, genotoxicity, carcinogenic potential and juvenile toxicity. ...
List of excipients
Tablet core: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Hypromellose 2910 Sodium laurilsulphate Magnesium stearate Film-coat: Macrogol 3350 Hypromellose 2910 Titanium dioxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PP/Aluminium foil blisters in cartons of 10, 14, 28, 42 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 1, or 100 1 or in multipacks containing 100 (10 packs of 10 1) film-coated ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Bayer AG, 51368 Leverkusen, Germany
Marketing authorization number(s)
EU/1/08/472/011-016 EU/1/08/472/023 EU/1/08/472/036 EU/1/08/472/038 EU/1/08/472/048
Date of first authorization / renewal of the authorization
Date of first authorisation: 30 September 2008 Date of latest renewal: 22 May 2018
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