RIBONE 150

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

RISEDRONIC ACID AS SODIUM

Beschikbaar vanaf:

UNIPHARM LTD, ISRAEL

ATC-code:

M05BA07

farmaceutische vorm:

TABLETS

Samenstelling:

RISEDRONIC ACID AS SODIUM 150 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

UNIPHARM LTD, ISRAEL

Therapeutisch gebied:

RISEDRONIC ACID

therapeutische indicaties:

Treatment of postmenopausal osteoporosis.Prevention of postmenopausal osteoporosis.

Autorisatie datum:

2018-06-11

Bijsluiter

ىتح يقبتملا تقولاو ددحملا مويلا يف
صرقلا لوانت تيسن اذإ
زوجي لاف - مايأ 7 نم لقأ مداقلا يرهشلا
جلاعلا لوانت دعوم
يف صرقلا لوانتو راظتنلإا بجي لب اذه
يئاودلا رادقملا لوانت
.مداقلا يرهشلا جلاعلا دعومك ةيادبلا
ذنم هتددح يذلا مويلا
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
،بيبطلا ةراشتسإ نودب ءاودلاب جلاعلا
نع فقوتلا زوجي لا
.ةيحصلا كتلاح ىلع نسحت أرط ولو ىتح
.كضرم مقافتب كلذ ببستي دقف ،ءاودلا
لوانت نع تفقوت اذإ عباط صيخشت بجي !ةمتعلا يف ةيودأ لوانت
زوجي لا نيلوانتت ةرم لك يف يئاودلا رادقملا نم
دكأتلاو ءاودلا
.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا يعض
.ءاود اهيف ،ءاودلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل
ترفوت اذإ
.يلديصلا وأ بيبطلا يريشتسإ
ةيبناجلا ضارعلأا )4
ً
اضارعأ ببسي دق 150 نوبير لامعتسإ نإ
،ءاود لكب امك
ضارعلأا ةمئاق نم يشهدنت لا .نيلمعتسملا
ضعب ىدل ةيبناج
.اهنم
ً
ايأ نيناعت لاأ زئاجلا نم .ةيبناجلا
:ةريطخ ةيبناج ضارعأ
ً
اروف هجوتلاو رضحتسملا لامعتسإ نع
فقوتلا بجي
:ضارعلأا هذه ىدحإ نم نيساقت تنك اذإ
بيبطلا ىلإ
،جيهت لمشت نأ نكمملا نم لكاشملا هذه -
ءيرملا يف لكاشم
●
بنجت لجلأ .ءيرملا يف )فزني دق
ً
انايحأ( ةحرق وأ باهتلإ
."؟ءاودلا لامعتسإ ةيفيك" 3 ةرقفلا يرظنأ
ضارعلأا هذه
وأ ةبوعص ،مئاق ناقرح مقافت وأ روهظ
،ردصلا يف ملأ
●
.علبلا د

Productkenmerken

RIBONE 150
1.
Name of the Medicinal Product
RIBONE 150
2.
Qualitative and Quantitative Composition
RISEDRONATE 150mg tablets.
Excipients with known effect: each tablet contains 77.14mg lactose
monohydrate.
For full list of excipients see section 6.1.
3.
Pharmaceutical Form
Film-coated, oval, biconvex, pale-yellow tablet.
4.
Clinical Particulars
4.1.
Therapeutic Indications
• Treatment of postmenopausal osteoporosis
• Prevention of postmenopausal osteoporosis
4.2
Posology and method of Administration
RIBONE 150 tablets should be taken orally once a month. The tablet
should be taken
on the same date each month.
The absorption of risedronate sodium is affected by food and
polyvalent cations (see
section 4.6), thus to ensure adequate absorption patients should take
RIBONE 150
before breakfast: at least 30 minutes before the first food, other
medicinal product or
drink (other than plain water) of the day. Plain water is the only
drink that should be
taken with RIBONE 150 tablet. Please note that some mineral water may
have a
higher concentration of calcium and therefore should not be used (see
section 5.2).
Patients who miss a dose of RIBONE 150 should be instructed to take
one RIBONE
150 tablet the morning after the day it is remembered, unless the time
to the next
month’s scheduled doses is within 7 days.
If the next month’s scheduled doses of RIBONE 150 are within 7 days,
patients
should wait until their next month’s scheduled doses and then
continue taking
RIBONE 150 as originally scheduled.
The tablet must be swallowed whole and not sucked or chewed. To aid
delivery of
the tablet to the stomach RIBONE 150 is to be taken while in an
upright position with
a glass of plain water (>120 ml). Patients should not lie down for 30
minutes after
taking the tablet (see section 4.4).
Supplemental calcium and vitamin D should be considered if the dietary
intake is
inadequate.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been
established. The need for continued treatment should be re-eval