Xarelto 10mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rivaroxaban

Available from:

Bayer Pharma AG

ATC code:

B01AF01

INN (International Name):

rivaroxaban

Dosage:

10mg

Pharmaceutical form:

tablets film-coated

Units in package:

(10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-06-08

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban.
Excipient with known effect:
Each film-coated tablet contains 2
7
.
90
mg lactose (as monohydrate), see section 4.4.
For the full list of excipients, see section 6.1.
3.
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip or knee
replacement surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 10 mg rivaroxaban taken orally once daily. The
initial dose should be taken
6 to 10 hours after surgery, provided that haemostasis has been
established.
The duration of treatment depends on the individual risk of the
patient for venous thromboembolism
which is determined by the type of orthopaedic surgery.

For patients undergoing major hip surgery, a treatment duration of 5
weeks is recommended.

For patients undergoing major knee surgery, a treatment duration of 2
weeks is recommended.
If a dose is missed the patient should take Xarelto immediately and
then continue the following day
with once daily intake as before.
_Converting from Vitamin K Antagonists (VKA) to Xarelto _
When converting patients from VKAs to Xarelto, International
Normalized Ratio (INR) values will be
falsely elevated after the intake of Xarelto. The INR is not valid to
measure the anticoagulant activity
of Xarelto, and therefore should not be used (see section 4.5).
_Conv