Rivaroxaban AET 10 mg, filmomhulde tabletten

国家: 荷兰

语言: 荷兰文

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

有效成分:

RIVAROXABAN 10 mg/stuk

可用日期:

Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)

ATC代码:

B01AF01

INN（国际名称）:

RIVAROXABAN 10 mg/stuk

药物剂型:

Filmomhulde tablet

组成:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110),

给药途径:

Oraal gebruik

治疗领域:

Rivaroxaban

產品總結:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);

授权日期:

2017-11-23

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR
THE USER
RIVAROXABAN AET 10 MG FILM-COATED TABLETS
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
RIVAROXABAN AET
is and what it is used for?
2.
What you need to know before you take
RIVAROXABAN AET?
3.
How to take
RIVAROXABAN AET?
4.
Possible side effects
5.
How to store
RIVAROXABAN AET?
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN AET IS AND WHAT IT IS USED FOR?
RIVAROXABAN AET 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.
RIVAROXABAN AET 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
RIVAROXABAN AET
DO NOT TAKE RIVAROXABAN AET
-
if you are allergic to rivaroxaban or any of the other ingredients of
this medicine
(listed in section 6)
-
if you are bleeding excessively
-
if you have a disease or condition in an organ of the body that
increases the risk of
serious bleeding (e.g. stomach ulcer, injury or bleeding in th

产品特点

1
1.
NAME OF THE MEDICINAL PRODUCT
RIVAROXABAN AET 10 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban.
Excipients with known effect:
Each film-coated tablet contains 46.050 mg lactose (as monohydrate),
see section 4.4.
Each film-coated tablet contains 0.081 mg sunset yellow FCF aluminium
lake (E 110), see
section 4.4.
Each film-coated tablet contains 0.2947 mg sodium, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Peach coloured, round, biconvex film coated tablets marked with
‘10’ on one side, with a
diameter of 6 mm.
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.
2
_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 mg once daily for the