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XARELTO 15mg/20mg Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Xarelto 15 mg film-coated tablets. Xarelto 20 mg film-coated tablets.

Qualitative and quantitative composition

Each 15 mg film-coated tablet contains 15 mg rivaroxaban. Each 20 mg film-coated tablet contains 20 mg rivaroxaban. Excipient with known effect: Each 15 mg film-coated tablet contains 24.13 mg lactose ...

Pharmaceutical form

Film-coated tablet (tablet). 15 mg film-coated 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

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.)

Posology and method of administration

Posology Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed ...

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

Treatment initiation pack for the first 4 weeks of treatment: PP/Aluminium foil blisters in a wallet containing 49 film-coated tablets: 42 film-coated tablets Xarelto 15 mg and 7 film-coated tablets Xarelto ...

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/1/08/472/040

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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