SANDIMMUN NEORAL 50 MG CAPSULES

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

CICLOSPORIN

제공처:

NOVARTIS ISRAEL LTD

ATC 코드:

L04AA01

약제 형태:

CAPSULES

구성:

CICLOSPORIN 50 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

CATALENT GERMANY EBERBACH GMBH, GERMANY

치료 그룹:

CYCLOSPORIN

치료 영역:

CYCLOSPORIN

치료 징후:

Prophylaxis of organ rejection in kidney liver heart allogenic transplants in conjunction with corticosteroids. May also be used in the treatment of chronic rejection in patients previously treated with other immuno-suppressive agents. Bone marrow transplantation. Endogenous uveitis. Severe psoriasis above age 16 that did not respond to other treatment. Atopic dermatitis in adults only up to 8 weeks for severe cases in which conventional therapy is ineffective or inappropriate. Rheumatoid arthritis: Severe cases in which standard treatments are ineffective or inappropriate. Nephrotic syndrom type MCD (minimal change disease) in cases where conventional therapy has failed.

승인 날짜:

2015-02-28

환자 정보 전단

لاروئين نوميدناس لوانت ةيفيك
.نيتلصفنم نيتعرجب
ً
امئاد ىطعي نأ بجي يمويلا يئاودلا
رادقملا
بجي .ةحيوللا ةوبع نم ةلوسبكلا جارخإ
بجي :تلاوسبك لاروئين نوميدناس
.ءاملا نم سأك عم لماكلا اهلكشب
تلاوسبكلا علب
:برشلل لولحم لاروئين نوميدناس
:برشلل لولحم لاروئين نوميدناس ـل
يلولأا لامعتسلإا
.ةيندعملا قلاغلإا ةقلح زكرمب دوجوملا
ءاطغلا عفر بجي
.1
.
ً
امامت قلاغلإا ةقلح ةلازإ بجي
.2
.اهيمرو ،ةيدامرلا ةدادسلا جارخإ بجي
.3
لخادل ةوقب ءاضيبلا ةدادسلا عم بوبنلأا
ةدحو عفد بجي .4
.ةنينقلا قنع
يئاودلا رادقملا سايق
لبق نم فصو يذلا مجحلا مئلاي امب ةنقحم
رايتخإ بجي .5
بجي ،للم 1 ـل لداعملا وأ للم 1 نم رغصأ
مجحل .بيبطلا
بجي ،للم 1 نم ربكأ ماجحلأ .للم 1 تاذ
ةنقحم لامعتسإ
ةنقحملا فرط لاخدإ بجي .للم 4 تاذ ةنقحم
لامعتسإ
.ءاضيبلا ةدادسلا لخادل
فصو يذلا لولحملا مجح بحس ىتح سبكملا
بحس بجي
.6
لباقم سبكملا نم لفسلأا مسقلا عضو بجي(
بيبطلا لبق نم
.)بيبطلا لبق نم فصو يذلا مجحلل ةبسانملا
ةملاعلا
سبكملا بحسو عفد ةطساوب ةريبكلا
تاعاقفلا جارخإ بجي
.7
يوتحت يهو ،ةنينقلا نم ةنقحملا جارخإ
لبق كلذو ،تارم ةدع
تاعاقفلا نم ليلقلا دوجو نإ .فوصوملا
يئاودلا رادقملا ىلع
يأب يئاودلا رادقملا ىلع رثؤي لاو ةيمهأ
هل سيل ةريغصلا
.لكش
،ةنقحملا يف ءاودلا نم ةحيحصلا ةيمكلا
دوجو نم دكأتل

제품 특성 요약

SAN NEO API Oct23 V5
REF UK SmPC 15Sep23
1
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SANDIMMUN
®
NEORAL
®
25mg Capsules
SANDIMMUN
®
NEORAL
®
50mg Capsules
SANDIMMUN
®
NEORAL
®
100mg Capsules
SANDIMMUN
®
NEORAL
®
100mg/ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SANDIMMUN NEORAL 25mg Capsules
Each capsule contains 25 mg ciclosporin.
Excipients with known effect:
Ethanol: Sandimmun Neoral Capsules 25mg contain 11.8% v/v ethanol
(9.4% m/v).
Propylene glycol: 46.42 mg/capsule.
Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil:
101.25 mg/capsule.
SANDIMMUN NEORAL 50mg Capsules
Each capsule contains 50 mg ciclosporin.
Excipients with known effect:
Ethanol: Sandimmun Neoral Capsules 50mg contain 11.8% v/v ethanol
(9.4% m/v).
Propylene glycol: 90.36 mg/capsule.
Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil:
202.5 mg/capsule.
SANDIMMUN NEORAL 100mg Capsules
Each capsule contains 100 mg ciclosporin.
Excipients with known effect:
Ethanol: Sandimmun Neoral Capsules 100mg contain 11.8% v/v ethanol
(9.4% m/v).
Propylene glycol: 148.31 mg/capsule.
Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil:
405.0 mg/capsule.
SANDIMMUN NEORAL 100mg/ml Oral Solution
The oral solution contains 100 mg of ciclosporin per ml. Each bottle
of 50 ml contains 5000 mg of
ciclosporin.
Excipients with known effect:
Ethanol: 94.70 mg/ml. Neoral Oral Solution contains 12% v/v ethanol
(9.5% m/v).
Propylene glycol: 94.70 mg/ml.
Macrogolglycerol hydroxystearate / polyoxyl 40 hydrogenated castor
oil: 383.70 mg/ml.
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Sandimmun Neoral soft-gelatin capsules:
25 mg: blue-grey, oval soft gelatin capsules, imprinted with “NVR
25mg” in red.
50 mg: yellow-white oblong soft gelatin capsules, imprinted with "NVR
50 mg" in red.
100 mg: blue-grey oblong soft gelatin capsules, imprinted with "NVR
100 mg" in red.
Sandimmun Neoral oral solution:
Clear, yellow to faintly yellow resp. brownish