Xaboplax 10 mg, filmomhulde tabletten

Negara: Belanda

Bahasa: Belanda

Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Bahan aktif:

RIVAROXABAN 10 mg/stuk

INN (Nama Internasional):

RIVAROXABAN 10 mg/stuk

Bentuk farmasi:

Filmomhulde tablet

Komposisi:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLOXAMEER 188 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 188 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Rute administrasi :

Oraal gebruik

Tanggal Otorisasi:

1900-01-01

Selebaran informasi

Sandoz B.V.
Page 1/9
XABOPLAX 10 mg, filmomhulde
tabletten
RVG 127726
1313-V3
1.3.1.3 Bijsluiter
November 2023
PATIËNTENBIJSLUITER: INFORMATIE VOOR DE PATIËNT
XABOPLAX 10 MG, FILMOMHULDE TABLETTEN
rivaroxaban
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[
Nationally completed name] contains the active substance rivaroxaban
and is used in adults to
−
prevent blood clots in the
veins after a hip or knee replacement operation. Your doctor has
prescribed this medicine for you because after an operation you are at
an increased risk of
getting blood clots.
−
treat blood clots in the veins of your legs (deep vein thrombosis) and
in the blood vessels of
your lungs (pulmonary embolism), and to prevent blood clots from
re-occurring in the
blood vessels of your legs and/or lungs.
[Nationally completed name] belongs to a group of medicines called
antithrombotic agents. It
works by blocking a blood clotting factor (factor Xa) and thus
reducing the tendency of the blood
to form clots.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
-
if you are allergic to rivaroxaban or any of the other ingredients of

Karakteristik produk

Sandoz
Page 1/29
XABOPLAX 10 mg, filmomhulde tabletten
RVG 127726
1311-V3
1.3.1.1 Samenvatting van de Productkenmerken
November 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xaboplax 10 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban.
Excipient(s) with known effect
Each film-coated tablet contains 29 mg lactose, 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 of 8.6 mm diameter, debossed with
‘10’ on one side and plain 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.
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).
4.2
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 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 rivaroxaban immediately
and then continue the following day
with once daily intake as before.
Sandoz
Page 2/29
XABOPLAX 10 mg, filmomhulde tabletten
RVG 127726
1311-V3
1.3.1.1 Samenvatting van de Productkenmerken
November 2023
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE _
The recommended dose for the initial tre