Deximune 100 mg soft capsules

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

CICLOSPORIN

Fáanlegur frá:

Dexcel Pharma GmbH Carl-Zeiss-Straße 2 63755 Alzenau, Germany

ATC númer:

L04AD01

INN (Alþjóðlegt nafn):

CICLOSPORIN 100 mg

Lyfjaform:

SOFT CAPSULE

Samsetning:

CICLOSPORIN 100 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

IMMUNOSUPPRESSANTS

Vörulýsing:

Licence number in the source country: NOT APPLICAPABLE

Leyfisstaða:

Authorised

Leyfisdagur:

2021-03-03

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_DEXIMUNE 100 MG SOFT CAPSULES _
ACTIVE SUBSTANCE: ciclosporin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are
the same as yours.
▪
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Deximune 100 mg is and what it is used for
2.
What you need to know before you take Deximune 100 mg
3.
How to take Deximune 100 mg
4.
Possible side effects
5.
How to store Deximune 100 mg
6.
Contents of the pack and other information
1.
WHAT DEXIMUNE 100 MG IS AND WHAT IT IS USED FOR
WHAT DEXIMUNE 100 MG IS
This medicine is called Deximune 100 mg soft capsules. It contains the
active substance ciclosporin. This active substance belongs
to a group of medicines known as immunosuppressive agents. These
medicines are used to reduce the body's immune reactions.
WHAT DEXIMUNE 100 MG IS USED FOR AND HOW IT WORKS
•
IF YOU HAVE HAD AN ORGAN TRANSPLANT, BONE MARROW OR STEM CELL
TRANSPLANT, the function of Deximune 100 mg is to control
your body’s immune system. Deximune 100 mg prevents rejection of
transplanted organs by blocking the development of
certain cells which would normally attack the transplanted tissue.
•
IF YOU HAVE AN AUTOIMMUNE DISEASE, in which your body’s immune
response attacks your body’s own cells, Deximune 100 mg
blocks this immune reaction. These autoimmune diseases include eye
problems that may endanger your vision (endogenous
uveitis including Behçet's disease), severe cases of certain skin
diseases (atopic dermatitis or atopic eczema and psoriasis),
severe rheumatoid arthritis as well as a kidney disease calle

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
DEXIMUNE
® 25 MG / 50 MG / 100 MG SOFT CAPSULES
1. NAME OF THE MEDICINAL PRODUCTS
Deximune 25 mg soft capsules
Deximune 50 mg soft capsules
Deximune 100 mg soft capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Deximune 25 mg soft capsules _
Each capsule_ _contains 25 mg ciclosporin.
_Excipients with known effect: _
83.00 mg ethyl lactate (corresponding to 32.87 mg ethanol), 21.00 mg
(3-sn-phosphatidyl)choline (soya) and 42.00 mg
macrogolglycerol hydroxystearate.
_Deximune 50 mg soft capsules _
Each capsule_ _contains 50 mg ciclosporin.
_Excipients with known effect: _
166.00 mg ethyl lactate (corresponding to 64.74 mg ethanol), 42.00 mg
(3-sn-phosphatidyl)choline (soya) and 84.00 mg
macrogolglycerol hydroxystearate.
_Deximune 100 mg soft capsules_
Each capsule contains 100 mg ciclosporin.
_Excipients with known effect: _
332.00 mg ethyl lactate (corresponding to 129.48 mg ethanol), 84.00 mg
(3-sn-phosphatidyl)choline (soya) and 168.00 mg
macrogolglycerol hydroxystearate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Soft capsules.
_Deximune 25 mg_ _soft capsules_
Grey gelatin capsules marked "DX 25 mg"
_ _
_Deximune 50 mg_ _soft capsules_
Grey gelatin capsules marked "DX 50 mg"
_ _
_Deximune 100 mg soft capsules_
Grey gelatin capsules marked "DX 100 mg"
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APPLICATION IN ASSOCIATION WITH TRANSPLANTATIONS
Organ transplantation
Prophylaxis of allogeneic transplant rejection after organ
transplantation.
Treatment of cellular transplant rejection in patients who have
previously received other immunosuppressants.
Bone marrow transplantation
Prophylaxis of transplant rejection after allogeneic bone marrow or
stem cell transplantation.
Prophylaxis or treatment of a graft-versus-host disease (GvHD).
SUMMARY OF PRODUCT CHARACTERISTICS
DEXIMUNE
® 25 MG / 50 MG / 100 MG SOFT CAPSULES
OTHER AREAS OF APPLICATION
Endogenous uveitis
Treatment of intermediate or posterior uveitis of non-infectious
etiology with r