Sandimmun

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Ciclosporin 50 mg/mL

Mevcut itibaren:

Novartis New Zealand Ltd

INN (International Adı):

Ciclosporin 50 mg/mL

Doz:

250 mg/5mL

Farmasötik formu:

Solution for infusion

Kompozisyon:

Active: Ciclosporin 50 mg/mL Excipient: Ethanol Polyoxyl 35 castor oil

Paketteki üniteler:

Ampoule, 10x5ml, 50 mL

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Novartis Ringaskiddy Ltd

Terapötik endikasyonlar:

Solid organ transplantation Prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas allogeneic transplantations. Treatment of transplant rejection in patients previously receiving other immunosuppressive agents. Bone marrow transplantation Prevention of graft rejection following bone marrow transplantation. Prevention or treatment of graft-versus-host disease (GVHD).

Ürün özeti:

Package - Contents - Shelf Life: Ampoule, 5ml - 10 dose units - 48 months from date of manufacture stored at or below 30°C

Yetkilendirme tarihi:

1983-12-15

Bilgilendirme broşürü

__________________________________________________________________________________________________
Sandimmun

1
SANDIMMUN

_50mg / mL concentrate for solution for intravenous infusion _
_cyclosporin_
_____________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
_________________
WHAT IS IN THIS LEAFLET
_________________________________
This leaflet answers some common
questions about Sandimmun.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
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
.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Sandimmun
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 SANDIMMUN IS
USED FOR
________________________
Sandimmun contains the active
ingredient, cyclosporin. It belongs to
a group of medicines called immuno-
suppressive agents. These medicines
help to control your body's immune
system.
Sandimmun is used for people who
have had a bone marrow, kidney,
heart, combined heart-lung, liver or
pancreas transplant.
Sandimmun control your body’s
immune system and prevents the
body from rejecting the new organ. It
does this by blocking the
development of special cells which
would normally attack the
transplanted tissue.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have presc

Ürün özellikleri

NEW ZEALAND DATA SHEET
Page 1 of 17
1 PRODUCT NAME
SANDIMMUN
®
50 mg/mL concentrate for solution for infusion
_(ciclosporin)_
2 QUALITY AND QUANTITATIVE COMPOSITION
Sandimmun
®
concentrate for solution for infusion containing 50 mg ciclosporin per
mL. Each ampoule
of 1 mL contains 50 mg of ciclosporin. Each ampoule of 5 mL contains
250 mg ciclosporin.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Sandimmun concentrate for solution for infusion is a clear,
brown-yellow, oleaginous concentrate to be
diluted before parenteral administration.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solid organ transplantation
Prevention of graft rejection following kidney, liver, heart, combined
heart-lung, lung or pancreas
allogeneic transplantations.
Treatment of transplant rejection in patients previously receiving
other immunosuppressive agents.
Bone marrow transplantation
Prevention of graft rejection following bone marrow transplantation.
Prevention or treatment of graft-versus-host disease (GVHD).
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage
The daily doses of Sandimmun oral formulations should always be given
in 2 divided doses. The dose
ranges given are intended to serve as guidelines only. The recommended
dose of Sandimmun
concentrate for solution for infusion is approximately one third of
the appropriate oral dose.
Because of considerable inter- and intra-individual variations in
absorption and elimination and the
possibility of pharmacokinetic drug interactions (see Section 4.5
Interaction with other medicines and
other forms of interaction), doses should be titrated individually
according to clinical response and
tolerability.
In transplant patients, routine monitoring of ciclosporin blood levels
is required to avoid adverse effects
due to high levels and to prevent organ rejection due to low levels
(see Section 4.4 Special warnings
and precautions for use); this can be carried out by means of a
radioimmunoassay (RIA) method based
on monoclonal antibodies. The results obtained will ser