XARELTO

Maa: Indonesia

Kieli: indonesia

Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiivinen ainesosa:

RIVAROXABAN (MICRONIZED)

Saatavilla:

BAYER INDONESIA - Indonesia

INN (Kansainvälinen yleisnimi):

RIVAROXABAN (MICRONIZED)

Annos:

20 MG

Lääkemuoto:

TABLET SALUT SELAPUT

Kpl paketissa:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Valmistaja:

BAYER AG - GERMANY

Valtuutus päivämäärä:

2018-03-22

Valmisteyhteenveto

ID/Xarelto/Rivaroxaban 10, 15 & 20 mg - Film Coated Tablet/Einstein
Choice KOMNAS approval & BPOM deficiency letter
(EMA reference)
1
XARELTO
®
FILM-COATED TABLET
Important information, please read carefully!
COMPOSITION
XARELTO 10 MG
1 film-coated tablet contains 10 mg rivaroxaban.
XARELTO 15 MG
1 film-coated tablet contains 15 mg rivaroxaban.
_ _
XARELTO 20 MG
1 film-coated tablet contains 20 mg rivaroxaban.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
XARELTO 10 MG
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.
XARELTO 15 MG
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.
XARELTO 20 MG
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK
OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA
A. PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF
THROMBOTIC EVENTS
PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING
XARELTO, INCREASES THE RISK OF THROMBOTIC EVENTS. IF ANTICOAGULATION
WITH
XARELTO IS DISCONTINUED FOR A REASON OTHER THAN PATHOLOGICAL BLEEDING
OR COMPLETION OF A COURSE OF THERAPY, CONSIDER COVERAGE WITH ANOTHER
ANTICOAGULANT _[POSOLOGY AND METHOD OF ADMINISTRATION, SPECIAL
WARNINGS AND PRECAUTIONS FOR USE, AND CLINICAL EFFICACY AND SAFETY]_.
B. SPINAL/EPIDURAL HEMATOMA
EPIDURAL OR SPINAL HEMATOMAS HAVE OCCURRED IN PATIENTS TREATED WITH
XARELTO WHO ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL
PUNCTURE. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT
PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL
PROCEDURES. FACTORS THAT CAN INCREASE THE RISK OF DEVELOPING EPIDURAL
OR SPINAL HEMATOMAS IN THESE PATIENTS INCLUDE:
•
USE OF INDWELLING EPIDURAL CATHETERS
•
CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HEMOSTASIS, SUCH AS
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), PLATELET INHIBITORS,
OTHER
ANTICOAGULANTS
•
A H