Capsorin 50mg capsules

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Ciclosporin

Հասանելի է:

Morningside Healthcare Ltd

ATC կոդը:

L04AD01

INN (Միջազգային անվանումը):

Ciclosporin

Դոզան:

50mg

Դեղագործական ձեւ:

Oral capsule

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Caution - AMP level prescribing advised

Ապրանքի ամփոփագիր:

BNF: 08020200; GTIN: 5055132707117

Տեղեկատվական թերթիկ

before

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Capsorin 50 mg soft capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg of ciclosporin.
Excipients with known effect:
Ethanol: 50 mg/capsule
Macrogolglycerol hydroxystearate: 190 mg/capsule
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Soft capsule.
White gelatin capsule
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Transplantation indications
_Solid organ transplantation _
Prevention of graft rejection following solid organ transplantation.
Treatment of
transplant cellular rejection in patients previously receiving other
immunosuppressive
agents.
_Bone marrow transplantation _
Prevention of graft rejection following allogeneic bone marrow and
stem cell
transplantation.
Prevention or treatment of graft-versus-host disease (GVHD).
Non-transplantation indications
_Endogenous uveitis _
Treatment of sight-threatening intermediate or posterior uveitis of
non-infectious
aetiology in patients in whom conventional therapy has failed or
caused unacceptable
side effects.
Treatment of Behçet uveitis with repeated inflammatory attacks
involving the retina
in patients without neurological manifestations.
_Nephrotic syndrome_
Steroid-dependent and steroid-resistant nephrotic syndrome, due to
primary
glomerular diseases such as minimal change nephropathy, focal and
segmental
glomerulosclerosis, or membranous glomerulonephritis.
Capsorin can be used to induce and maintain remissions. It can also be
used to
maintain steroid-induced remission, allowing withdrawal of steroids.
_ _
_Rheumatoid arthritis_
Treatment of severe, active rheumatoid arthritis.
_Psoriasis_
Treatment of severe psoriasis in patients in whom conventional therapy
is
inappropriate or ineffective.
_Atopic dermatitis_
Capsorin is indicated in patients with severe atopic dermatitis when
systemic therapy
is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose ranges given for oral administration are intended to serve as
guide