XIFAXAN Film-coated Tablet 550mg

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

Rifaximin

متاح من:

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

ATC رمز:

A07AA11

الشكل الصيدلاني:

TABLET, FILM COATED

تركيب:

Rifaximin 550mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

Alfasigma S.p.A.

الوضع إذن:

ACTIVE

تاريخ الترخيص:

2015-03-23

خصائص المنتج

XIFAXAN 550 MG FILM-COATED TABLETS
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
XIFAXAN 550 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 550 mg rifaximin.
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval biconvex 10 mm x 19 mm film-coated tablets embossed with
“RX” on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
XIFAXAN is indicated for the reduction in recurrence of episodes of
overt hepatic encephalopathy in
patients ≥ 18 years of age (see section 5.1).
In the pivotal study, 91% of the patients were using concomitant
lactulose.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose: 550 mg twice a day. The clinical benefit was
established from a controlled study in
which subjects were treated for 6 months. Treatment beyond 6 months
should take into consideration
the individual balance between benefits and risks, including those
associated with the progression of
hepatic dysfunction (see sections 4.4, 5.1 and 5.2).
XIFAXAN can be administered with or without food.
_Paediatric population _
The safety and efficacy of XIFAXAN in paediatric patients (aged less
than 18 years) have not been
established.
_Elderly _
No dosage adjustment is necessary as the safety and efficacy data of
XIFAXAN showed no differences
between the elderly and the younger patients.
_Hepatic impairment _
No dosage adjustment is necessary for patients with hepatic
insufficiency (see section 4.4).
_Renal impairment _
Although dosing change is not anticipated, caution should be used in
patients with impaired renal function
(see section 5.2).
Method of administration
Orally with a glass of water.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to rifaximin, rifamycin-derivatives or to any of the
excipients listed in section 6.1.
•
Cases of intestinal obstruction.
4.4 SPECIAL W