Dexiclo

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Ciclosporin 25mg

Saatavilla:

Douglas Pharmaceuticals Limited

INN (Kansainvälinen yleisnimi):

Ciclosporin 25 mg

Annos:

25 mg

Lääkemuoto:

Soft gelatin capsule

Koostumus:

Active: Ciclosporin 25mg Excipient: Ethyl lactate Gelatin Glycerol Iron oxide black Lecithin Medium-chain triglycerides PEG-40 castor oil Polysorbate 20 Purified water Sorbitan oleate Titanium dioxide

Prescription tyyppi:

Prescription

Valmistaja:

Teva Czech Industries s.r.o.

Käyttöaiheet:

Solid organ transplantation: - Prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas allergenic transplantations. - Treatment of transplant rejection in patients previously receiving other immunosuppressive agents.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Blister pack, Alu/Alu - 50 capsules - 24 months from date of manufacture stored at or below 25°C protect from light

Valtuutus päivämäärä:

2013-01-07

Pakkausseloste

CONSUMER MEDICINE INFORMATION
DEXICLO
_ _
_25 mg, 50 mg, 100 mg capsules _
_ciclosporin _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Dexiclo.
It does not contain all the available information
.
It does not take the place of talking to your
doctor or pharmacist.
You should ensure that you speak to your pharmacist or doctor to
obtain the most up-to-date
information on the medicine.
You can also download the most up-to-date leaflet from
www.medsafe.govt.nz.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking Dexiclo
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DEXICLO IS USED FOR
Dexiclo contains the active ingredient, ciclosporin. It belongs to a
group of medicines called
immunosuppressive agents. These medicines help to control your body's
immune system.
Dexiclo is used for people who have received a graft transplant of a
kidney, heart, lung,
pancreas, or liver. Dexiclo is also used in bone marrow
transplantation.
Dexiclo prevents the rejection of the transplanted organ by blocking
the development of
special cells, which would normally attack the transplanted tissue.
Dexiclo is also used to treat several other non-transplant conditions,
known as autoimmune
diseases, which are thought to be caused by a problem with your
body’s immune system:
• nephrotic syndrome (a kidney disease)
• severe cases of rheumatoid arthritis (joint disease with pain and
swelling)
• severe cases of:
-
Psoriasis (skin disease involving thickened patches of red skin, often
with silvery scales)
-
skin allergies
• endogenous uveitis (inflammation anywhere in the pigmented inside
lining of the eye).
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason. Dexiclo is only
available with a
doctor's prescription. It i

Valmisteyhteenveto

DATA SHEET
DEXICLO
SOFT GELATIN CAPSULES
_ciclosporin 25 mg, 50 mg and 100mg _
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexiclo soft gelatin capsules containing 25 mg, 50 mg and 100 mg
ciclosporin.
For a full list of excipients see List of excipients.
PHARMACEUTICAL FORM
Dexiclo soft gelatin capsules for oral administration.
DEXICLO 25 MG CAPSULES
Grey soft gelatin capsules, imprinted with “DX 25 mg.
DEXICLO 50 MG CAPSULES:
Grey soft gelatin capsules, imprinted with “DX 50 mg.
DEXICLO 100 MG CAPSULES
Grey soft gelatin capsules, imprinted with “DX 100 mg.
Ciclosporin is a pharmaceutical form of the active ingredient
ciclosporin based on the
microemulsion principle, which reduces the variability of
pharmacokinetic parameters
and provides dose linearity of ciclosporin exposure with a more
consistent absorption
profile
and
less
influence
from
concomitant
food
intake.
The
formulation
is
a
microemulsion
preconcentrate.
Pharmacokinetic
and
clinical
studies
have
demonstrated
a
correlation
between
trough
concentration
and
exposure
to
ciclosporin. The formation of the microemulsion itself takes place in
the presence of
water, either in the form of a beverage or in the form of the gastric
fluid.
CLINICAL PARTICULARS
_ _
_THERAPEUTIC INDICATIONS _
TRANSPLANTATION INDICATIONS
SOLID ORGAN TRANSPLANTATION
Prevention of graft rejection following kidney, liver, heart, combined
heart-lung, lung
or pancreas allergenic transplantations.
Treatment
of
transplant
rejection
in
patients
previously
receiving
other
immunosuppressive agents.
CONVERSION BETWEEN ORAL CICLOSPORIN FORMULATIONS
Switching from one oral ciclosporin formulation to another should be
made with
caution and under physician supervision. The introduction of the new
formulation
must be made with monitoring of blood levels of ciclosporin to ensure
that pre-
conversion levels are attained.
BONE MARROW TRANSPLANTATION
Prevention of graft rejection following bone marrow transplantation.
Prevention or treatment of graft-versus-host disease (GVHD).
NON-TRANSPLANTATION IND