DEXIMUNE 25

国家: 以色列

语言: 英文

来源: Ministry of Health

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资料单张 资料单张 (PIL)
01-09-2023
公众评估报告 公众评估报告 (PAR)
17-08-2016

有效成分:

CICLOSPORIN

可用日期:

DEXCEL LTD, ISRAEL

ATC代码:

L04AA01

药物剂型:

CAPSULES

组成:

CICLOSPORIN 25 MG

给药途径:

PER OS

处方类型:

Required

厂商:

DEXCEL LTD, ISRAEL

治疗组:

CYCLOSPORIN

治疗领域:

CYCLOSPORIN

疗效迹象:

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.

授权日期:

2021-12-31

资料单张

                                PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine can be sold with a physician’s prescription only
DEXIMUNE
® 25, 50, 100 MG, CAPSULES
Each capsule contains: Ciclosporin 25, 50 or 100 mg respectively.
Inactive ingredients and allergens in the medicine – see section 6
"Additional information" and in
section 2 "Important information about some of the ingredients of the
medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions, ask
the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
you think that their medical condition is the same as yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?

Prophylaxis of organ rejection in kidney, liver and heart
transplantation in combination with
corticosteroids.

Treatment during a bone marrow transplantation.

Treatment of eye inflammation called uveitis, which is not caused by
infection (Endogenous
uveitis).

Treatment of nephrotic syndrome (MCD, Minimal Change Disease type)
when conventional
therapy has failed.

Treatment of severe cases of rheumatoid arthritis, when standard
treatment is ineffective or
inappropriate.

Treatment of severe cases of psoriasis, in patients above 16 years of
age that do not respond to
other treatment.

Treatment of severe cases of atopic dermatitis in adults, for up to 8
weeks only, when
conventional therapy is ineffective or inappropriate.
THERAPEUTIC GROUP: Immunosuppressants.
If you have undergone an organ or bone marrow transplantation, the
function of DEXIMUNE is to
regulate your body’s immune system. DEXIMUNE prevents rejection of
transplanted organs by
blocking the development of special cells which would normally attack
the transplanted tissue.
If you suffer from a non-transplant disease, in which your body’s
immune response attacks the cells
in your body (autoimmune disease), DEXIMUNE sup
                                
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