Xarelto Film Coated Tablet 10 mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

RIVAROXABAN MICRONIZED

Διαθέσιμο από:

BAYER (SOUTH EAST ASIA) PTE LTD

Φαρμακολογική κατηγορία (ATC):

B01AF01

Δοσολογία:

10.00 mg

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED

Σύνθεση:

RIVAROXABAN MICRONIZED 10.00 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Bayer AG

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2008-11-05

Φύλλο οδηγιών χρήσης

 
1. 
NAME OF THE MEDICINAL PRODUCT 

Xarelto 10 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Xarelto 10 mg 
1 film-coated tablet contains 10 mg rivaroxaban. 
Each 10mg film-coated tablet contains 27.90mg lactose monohydrate (= 26.51mg lactose) per tablet. 

For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Film-coated, round, biconvex, light red immediate release tablets of 6 mm diameter and 9mm radius of 
curvature for oral use. 
BAYER-cross on the bottom side and "10" and a triangle on the top side. 

4. 
CLINICAL PARTICULARS 

4.1 
INDICATIONS 

Prevention of venous thromboembolism (VTE) in patients undergoing total hip replacement or total 
knee replacement surgery. 

4.2 
DOSAGE AND METHOD OF ADMINISTRATION 

The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken 
within 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 the 10mg Xarelto dose immediately and then continue on 
the following day with the once daily intake as before. 

Xarelto may be taken with or without food. 

For patients who are unable to swallow whole tablets, Xarelto tablet may be crushed and mixed with 
water or soft foods such as applesauce immediately prior to use and administered orally. 
The crushed Xarelto tablet�

Αρχείο Π.Χ.Π.

1
Xarelto 10mg_CCDS 14+17_ June 2023
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xarelto 10 mg
1 film-coated tablet contains 10 mg rivaroxaban.
Each 10mg film-coated tablet contains 27.90mg lactose monohydrate (=
26.51mg lactose) per tablet.
For a full list of excipients, see section ‘List of excipients’.
3.
PHARMACEUTICAL FORM
Film-coated, round, biconvex, light red immediate release tablets of 6
mm diameter and 9mm radius of
curvature for oral use.
BAYER-cross on the bottom side and "10" and a triangle on the top
side.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
Prevention of venous thromboembolism (VTE) in patients undergoing
total hip replacement or total
knee replacement surgery.
Xarelto is indicated for the treatment of Deep Vein Thrombosis (DVT)
and pulmonary embolism (PE),
and for the prevention of recurrent DVT, PE in adults. (See section
‘Special warnings and precautions
for use’ for haemodynamically unstable PE patients.)
4.2
DOSAGE AND METHOD OF ADMINISTRATION
_Prevention of VTE in patients undergoing total hip replacement or
total knee replacement surgery _
The recommended dose is 10 mg rivaroxaban taken orally once daily. The
initial dose should be taken
within 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 the 10mg Xarelto dose
immediately and then continue on
the following day with the once daily intake as before.
_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 by 20 m