Bondronat Tablet 50mg

ประเทศ: สิงคโปร์

ภาษา: อังกฤษ

แหล่งที่มา: HSA (Health Sciences Authority)

สารออกฤทธิ์:

Ibandronic acid ( as monosodium monohydrate 56.25mg)

มีจำหน่ายจาก:

DKSH SINGAPORE PTE. LTD.

รหัส ATC:

M05BA06

ปริมาณ:

50mg

แบบฟอร์มเภสัชกรรม:

TABLET, FILM COATED

องค์ประกอบ:

Ibandronic acid ( as monosodium monohydrate 56.25mg) 50mg

เส้นทางการบริหาร:

ORAL

ประเภทใบสั่งยา:

Prescription Only

Manufactured by:

Penn Pharmaceutical Services Ltd

สถานะการอนุญาต:

ACTIVE

วันที่อนุญาต:

2008-03-10

แผ่นพับข้อมูลผู้ป่วย

BONDRONAT
®

Ibandronic acid 
______________________________________________________________________________ 
1. 
P
HARMACEUTICAL 
F
ORM

TABLETS 50MG 
Film-coated tablets of oblong shape and white
to off-white in colour, engraved L2/IT. 

2. 
Q
UALITATIVE AND 
Q
UANTITATIVE 
C
OMPOSITION

Ibandronic acid, monosodium salt, monohydrate. 

TABLETS 50MG 
One film-coated tablet contains 56.25 mg of ibandronic acid, monosodium salt, monohydrate 
corresponding to 50 mg ibandronic acid. 

3. 
C
LINICAL 
P
ARTICULARS

3.1 
THERAPEUTIC INDICATIONS 
Bondronat is indicated for the prevention of skeletal events associated with metastatic
bone 
disease due to breast cancer. 

3.2 
DOSAGE AND METHOD OF ADMINISTRATION 
The recommended dose is one 50 mg film-coated tablet daily.  

Bondronat should be taken after an
overnight fast and before the first food or drink of the day. 
Medications and supplements (including calcium) should
similarly be avoided prior to taking 
Bondronat tablets. Fasting should be
continued for at least 60 minutes after taking the tablet. 
Plain water may be taken at any time during the course
of Bondronat treatment.  

- 
The tablets should be swallowed whole
with a full glass of plain water (180 to 240 ml) 
while the patient is standing or sitting in an
upright position. 

- 
Patients should not chew or suck the tablet because of a
potential for oropharyngeal 
ulceration.  

- 
Plain water is the only drink that should be
taken with Bondronat. Please note that some 
mineral waters may have a
higher concentration of calcium and therefore should not be 
used. 

-  Patients should not lie down for 60
minutes after taking Bondronat. 
_ _
_Patients with hepatic impairment _
No dosage adjustment is expected to be necessary (see
4.2.5 Pharmacokinetics in 

สรุปลักษณะสินค้า

1
BONDRONAT
®
Ibandronic acid
1.
P
HARMACEUTICAL
F
ORM
TABLETS 50MG
Film-coated tablets of oblong shape and white to off-white in colour,
engraved L2/IT.
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Ibandronic acid, monosodium salt, monohydrate.
TABLETS 50MG
One film-coated tablet contains 56.25 mg of ibandronic acid,
monosodium
salt, monohydrate corresponding to 50 mg ibandronic acid.
3.
C
LINICAL
P
ARTICULARS
3.1
THERAPEUTIC INDICATIONS
Bondronat is indicated for the prevention of skeletal events
associated with
metastatic bone disease due to breast cancer.
3.2
DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose is one 50 mg film-coated tablet daily.
Bondronat should be taken after an overnight fast and before the first
food
or drink of the day. Medications and supplements (including calcium)
should similarly be avoided prior to taking Bondronat tablets. Fasting
should be continued for at least 60 minutes after taking the tablet.
Plain
water may be taken at any time during the course of Bondronat
treatment.
-
The tablets should be swallowed whole with a full glass of plain water
(180 to 240 ml) while the patient is standing or sitting in an upright
position.
-
Patients should not chew or suck the tablet because of a potential for
oropharyngeal ulceration.
-
Plain water is the only drink that should be taken with Bondronat.
Please
note that some mineral waters may have a higher concentration of
calcium and therefore should not be used.
-
Patients should not lie down for 60 minutes after taking Bondronat.
_ _
_Patients with hepatic impairment _
No
dosage
adjustment
is
expected
to
be
necessary
(see
4.2.5
Pharmacokinetics in Special Populations).
_Patients with renal impairment _
For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no
dosage
adjustment
is
necessary.
For
patients
with
moderate
renal
impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50
mg
film-coated tablet every second day is recommended. For patients with
severe renal impairment (CLcr <30 mL/min) the recommend