SANDIMMUN NEORAL SOL 100 mg/ml

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Ciclosporin 100 mg/ml

Available from:

شركة مستودع الأدوية الأردني - The Jordan Drugstore Co

ATC code:

L04AA01

INN (International Name):

Ciclosporin 100 mg/ml

Dosage:

100 mg/ml

Units in package:

50ml

Manufactured by:

Delpharm Huningue S.A.S (فرنسا)

Product summary:

132.59 :سعر الجمهور + الضريبة

Patient Information leaflet

SANDIMMUN NEORAL
®
COMPOSITION
_Active substance: _Ciclosporin.
_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 gelatin capsules contain 11.8% v/v ethanol
(9.4% w/v).
Capsule shell: Iron oxide black (E 172) (25- and 100-mg capsules),
titanium dioxide (E 171),
glycerol 85%, propylene glycol, gelatin.
Imprint: carminic acid (E 120).
Oral solution
alpha–tocopherol, ethanol anhydrous, propylene glycol, corn
oil-mono–di–triglycerides,
macrogolglycerol hydroxystearate (Ph.Eur)/polyoxyl 40 hydrogenated
castor oil
(USP).Sandimmun Neoral oral solution contains 12% v/v ethanol (9.5%
w/v).
Information might differ in some countries.
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
_Capsules_ containing 10, 25, 50 or 100 mg.
_Oral solution_ containing 100 mg/ml.
_Sandimmun_ is also available as a concentrate for i.v. infusion. See
corresponding prescribing
information.
INDICATIONS/POTENTIAL USES
_Transplantation_
_Organ transplantation_
Prevention of rejection of kidney, liver, heart, combined heart-lung,
lung and pancreas allografts.
Treatment of transplant rejection in patients previously treated with
other immunosuppressive agents.
_Bone marrow transplantation_
Prevention of graft rejection following bone marrow transplantation.
Prevention and treatment of graft-versus-host disease (GVHD).
_Non-transplantation indications_
_Endogenous uveitis_
Active sight-threatening intermediate or posterior uveitis of
non-infectious aetiology in which
alternative therapy has proved ineffective or inappropriate.
Uveitis in Behçet’s disease, with recurrent inflammatory attacks
involving the retina, in patients with
normal renal function who are 7 to 70 years of age.
_Psoriasis_
Treatment of severe cases of psoriasis in which alternative therapies
are ineffective or inappropriate.
_Atopic dermatitis_
Treatment