SANDIMMUN NEORAL CAPSULE 10 mg

Страна: Сингапур

Язык: английский

Источник: HSA (Health Sciences Authority)

Активный ингредиент:

CICLOSPORIN

Доступна с:

NOVARTIS (SINGAPORE) PTE LTD

код АТС:

L04AD01

дозировка:

10.0mg

Фармацевтическая форма:

CAPSULE, LIQUID FILLED

состав:

CICLOSPORIN 10.0mg

Администрация маршрут:

ORAL

Тип рецепта:

Prescription Only

Производитель:

Catalent Germany Eberbach GmbH

Статус Авторизация:

ACTIVE

Дата Авторизация:

1998-07-02

тонкая брошюра

SANDIMMUN NEORAL


Immunosuppressive agents, calcineurin inhibitors 

DESCRIPTION AND COMPOSITION  

PHARMACEUTICAL FORMS 
Sandimmun Neoral soft gelatin capsules.  
10 mg: yellow-white, oval gelatin capsules, soft, imprinted
“NVR 10” in red 
25 mg: blue-grey oval shaped gelatin capsule, soft,
imprinted with “NVR 25mg” in red 
50 mg: yellow-white oblong shaped gelatin capsule, soft,
imprinted with “NVR 50mg” in red 
100 mg: blue-grey oblong shaped gelatin capsule, soft,
imprinted with “NVR 100mg” in red 
Sandimmun  Neoral  oral  solution:  clear,  faintly  yellow  to  browning  yellow  solution  for  oral 
administration. The formulation of Sandimmun Neoral is
a microemulsion preconcentrate. 
ACTIVE SUBSTANCE 
Each capsule contains 10, 25, 50 or 100 mg of ciclosporin.  
The  oral  solution  contains  100  mg  of  ciclosporin  per  mL.  Each  bottle  of  50  mL  contains 
5000 mg of ciclosporin. 
Sandimmun Neoral is a pharmaceutical form of the active ingredient ciclosporin based on the 
microemulsion  principle,  which  reduces  the  variability  of  pharmacokinetic  parameters  and 
provides dose linearity of ciclosporin exposure with a more consistent absorption profile and 
less  influence  from  concomitant  food  intake.  The  Sandimmun  Neoral  formulation  is  a 
microemulsion  preconcentrate,  which  in  pharmacokinetic  and  clinical  studies  has 
demonstrated that the correlation between trough concentration and exposure to ciclosporin is 
much  stronger  when  ciclosporin  is  given  as  Sandimmun  Neoral  than  when  it  is  given  as 
Sandimmun. The formation of the microemulsion itself  takes place in the presence of water, 
either in the form of a beverage or in
the form of the gastric fluid.�

Характеристики продукта

Sandimmun Neoral Jul 2022.SIN
Page 1 of 25
SANDIMMUN NEORAL

Immunosuppressive agents, calcineurin inhibitors
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Sandimmun
®
Neoral
®
soft gelatin capsules.
10 mg: yellow-white, oval gelatin capsules, soft, imprinted “NVR
10” in red
25 mg: blue-grey oval shaped gelatin capsule, soft, imprinted with
“NVR 25mg” in red
50 mg: yellow-white oblong shaped gelatin capsule, soft, imprinted
with “NVR 50mg” in red
100 mg: blue-grey oblong shaped gelatin capsule, soft, imprinted with
“NVR 100mg” in red
Sandimmun
®
Neoral
®
oral solution: clear, faintly yellow to browning yellow solution for
oral administration. The formulation of Sandimmun Neoral is a
microemulsion
preconcentrate.
ACTIVE SUBSTANCE
Each capsule contains 10, 25, 50 or 100 mg of ciclosporin.
The oral solution contains 100 mg of ciclosporin per mL. Each bottle
of 50 mL contains
5000 mg of ciclosporin.
Sandimmun Neoral is a pharmaceutical form of the active ingredient
ciclosporin based on the
microemulsion principle, which reduces the variability of
pharmacokinetic parameters and
provides dose linearity of ciclosporin exposure with a more consistent
absorption profile and
less
influence
from concomitant
food
intake.
The
Sandimmun
Neoral
formulation
is
a
microemulsion preconcentrate, which in pharmacokinetic and clinical
studies has
demonstrated that the correlation between trough concentration and
exposure to ciclosporin is
much stronger when ciclosporin is given as Sandimmun Neoral than when
it is given as
Sandimmun. The formation of the microemulsion itself takes place in
the presence of water,
either in the form of a beverage or in the form of the gastric fluid.
Certain dosage strengths and dosage forms may not be available in all
countries.
EXCIPIENTS
SOFT GELATIN CAPSULES
Capsule content: alpha–tocopherol, ethanol anhydrous, propylene
glycol, corn oil–mono–di–
triglycerides, macrogolglycerol hydroxystearate (Ph.Eur)/ polyoxyl 40
hydrogenated castor
oil (NF). Sandimmun Neoral soft g