DEXIMUNE 25

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CICLOSPORIN

Available from:

DEXCEL LTD, ISRAEL

ATC code:

L04AA01

Pharmaceutical form:

CAPSULES

Composition:

CICLOSPORIN 25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DEXCEL LTD, ISRAEL

Therapeutic group:

CYCLOSPORIN

Therapeutic area:

CYCLOSPORIN

Therapeutic indications:

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.

Authorization date:

2021-12-31

Patient Information leaflet

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