PURI-NETHOL TABLETS 50 MG

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

MERCAPTOPURINE

제공처:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC 코드:

L01BB02

약제 형태:

TABLETS

구성:

MERCAPTOPURINE 50 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

ASPEN PHARMA TRADING LTD, IRELAND

치료 그룹:

MERCAPTOPURINE

치료 영역:

MERCAPTOPURINE

치료 징후:

For the treatment of acute Leukemia and also in cases of chronic myelogenous Leukemia.

승인 날짜:

2020-09-30

환자 정보 전단

ةعرجلا ديدحت متيس .طقف بيبطلا لبق نم
ناددحت جلاعلا ةقيرطو ةيئاودلا ةعرجلا
مهملا نم .ضيرملل ىطع
ُ
ت يتلا ىرخلأا تاجلاعلا ىلع
ً
ادامتعإو يدرف لكشب ةيئاودلا
.ةمظتنم تاقوأ يف ءاودلا لوانت ىلع
صرحلا
.بيلحلا برش وأ لكلأا دعب تاعاس 3 وأ لبق
لقلأا ىلع ةعاس ءاودلا لوانت بجي
●
.ءاملا نم بوك عم هلماكب ءاودلا علب بجي
●
،رطشب ىصوي لا .صرقلا رطشل صصخم ريغ
صرقلا ىلع دوجوملا رطشلا طخ
●
.صارقلأا غضم وأ قحس
ايلاخلل ماس رضحتسملا
.ةروسكم صارقأ كب صاخلا جلاعملا وأ تنأ
تسملا اذإ
ً
لااح نيديلا لسغ بجي
ةعباتملاو تاصوحفلا
اذهو .ةينيتور مد تاصوحف بيبطلا يرجي
فوس لوتن-يروپ ـب جلاعلا ةرتف للاخ
ءارجإب بيبطلا موقي نأ لمتحملا نم
.دبكلا فئاظوو كمد يف ايلاخلا دادعت
صحفل
نكمي يذلا )لوبلا ضمح( كيرويلا ضمح ةبسن
ةعباتمل ىرخأ لوبو مد تاصوحف
جلاعلا للاخ ةيئاودلا ةعرجلا بيبطلا
ريغي دق .لوتن-يروﭙ ـب جلاعلا ءانثأ
عفتري نأ
:تاصوحفلا جئاتنل
ً
اقفو
فئاظو جئاتنل
ً
اقفو ةيئاودلا ةعرجلا ضفخ زئاجلا نم –
نيغلابلا ىضرملا ىدل
●
.دبكلاو ىلكلا
.ةيئاودلا ةعرجلا ضفخ زئاجلا نم – دبكلا
وأ ىلكلا يف لكاشم عم ىضرملا ىدل
●
.ةيئاودلا ةعرجلا ضفخ زئاجلا نم –
TPMT
ميزنإ يف صقن كيدل ناك اذإ
●
.اهب ىصوملا ةيئاودلا ةعرجلا زواجت زوجي
لا
ربكأ ةيئاود ةعرج أطخلاب تلوانت اذإ
تلوانت اذإ .لاهس�

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Puri-Nethol Tablets 50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mercaptopurine.
Each tablet contains 50 mg of the active substance mercaptopurine.
Excipients with known effect:
Lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
A pale yellow, round, biconvex tablet, marked PT above the score line
and 50 below the score line on one side and plain
on the other.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
For the treatment of acute leukaemia and also in cases of chronic
myelogenous leukemia.
4.2
Posology and Method of Administration
Posology
Mercaptopurine should be administered at least 1 hour before or 3
hours after food or milk (see sections 5.2
Pharmacokinetic properties: Absorption).
Populations
•
Adults and children
For adults and children the usual dose is 2.5 mg/kg bodyweight per
day, or 50 to 75 mg/m
2
body surface area per day,
but the dose and duration of administration depend on the nature and
dosage of other cytotoxic agents given in
conjunction with mercaptopurine.
The dosage should be carefully adjusted to suit the individual
patient.
Mercaptopurine has been used in various combination therapy schedules
for acute leukaemia and the literature should be
consulted for details.
Studies carried out in children with acute lymphoblastic leukaemia
suggested that administration of mercaptopurine in
the evening lowered the risk of relapse compared with morning
administration.
Children considered to be overweight may require doses at the higher
end of the dose range and therefore close
monitoring of response to treatment is recommended (see section 5.2
Pharmacokinetic properties: Special patient
populations; Overweight children).
2
•
Elderly
It is advisable to monitor renal and hepatic function in these
patients, and if there is any impairment, consideration
should be given to reducing the mercaptopurine dosage.
•
Renal impairment