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XARELTO 10mg Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Xarelto 10 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg rivaroxaban. Excipient with known effect: Each film-coated tablet contains 26.51 mg lactose (as monohydrate), see section 4.4. For the full list of excipients, see ...

Pharmaceutical form

Film-coated tablet (tablet). Light red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and 10 and a triangle on the other side.

Therapeutic indications

Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of ...

Posology and method of administration

Posology Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken 6 to ...

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 5, 10, 14, 28, 30 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 1, 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/1/08/472/001-010 EU/1/08/472/022 EU/1/08/472/042-045

Date of first authorization / renewal of the authorization

Date of first authorisation: 30 September 2008 Date of latest renewal: 22 May 2018

Πηγαίο έγγραφο

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