SANDIMMUN ciclosporin 250mg/5mL injection ampoule

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

ciclosporin, Quantity: 50 mg/mL

Доступно од:

Novartis Pharmaceuticals Australia Pty Ltd

Фармацеутски облик:

Injection, concentrated

Састав:

Excipient Ingredients: PEG-35 castor oil; ethanol

Пут администрације:

Intravenous

Јединице у пакету:

10 x 5mL

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

This product is accepted for registration as 'currently supplied' at the time of commencement of the Act. New indications were approved as specified in the letter of 16 June 1992 from Dr L. Hunt. Indications: as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. Extended indications as at 15 October 1993: For induction and/or maintenance of remission in the nephrotic syndrome. Cyclosporin is not a first-line agent. Its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired . Indications as at 11 February 1994 from Dr J McGinness: 1. As an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. 2. For induction and/or maintenance of remission in the nephrotic syndrome. Cyclosporin is not a first-line agent. Its use should be restricted to occasi

Резиме производа:

Visual Identification: Clear brown-yellow, oily solution; Container Type: Ampoule; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

1993-12-06

Информативни летак

SANDIMMUN
®
_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.NOVARTIS.COM.AU.
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 is used for people who
have had a kidney, heart or liver
transplant, to prevent the body from
rejecting the new organ. It does this
by blocking the development of
special cells which would normally
attack the transplanted tissue.
Sandimmun is also used to treat
several other conditions which are
thought to be caused by a problem
with the immune system:
•
a kidney disease, called nephrotic
syndrome
•
severe cases of rheumatoid
arthritis (a disease, affecting the
joints with pain and swelling)
•
severe cases of :
-
psoriasis (a skin disease with
thickened patches of red skin,
often with silvery scales)
-
atopic dermatitis (skin allergies)
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.
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.
Sandimmun i

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION – SANDIMMUN (CICLOSPORIN)
1
NAME OF THE MEDICINE
ciclosporin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPSULES
Each Sandimmun 25 mg capsule contains 25 mg ciclosporin
Each Sandimmun 50 mg capsule contains 50 mg ciclosporin
Each Sandimmun 100 mg capsule contains 100 mg ciclosporin
CONCENTRATE FOR INTRAVENOUS INFUSION
Sandimmun concentrate for intravenous infusion contains 250 mg/5 mL or
50 mg/1 mL of
ciclosporin
EXCIPIENTS WITH KNOWN EFFECT:
Alcohol (as ethanol 34% v/v in the concentrates for intravenous
infusion and ethanol 12.8% v/v in
the capsules)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CAPSULES
25 mg:
Pink oval soft gelatin capsule, approx. 11.3 mm (length) and 7.4 mm
(diameter)
50 mg:
Corn yellow, oblong, soft, gelatin capsule, approx 19.9 mm (length)
and 7.5mm
(diameter)
100 mg:
Dusty rose oblong soft gelatin capsule, approx. 24.9 mm (length) and
8.7 mm
(diameter)
CONCENTRATE FOR INTRAVENOUS INFUSION
250 mg/5 mL: Clear brown-yellow, oily solution
50 mg/1 mL:
Clear brown-yellow, oily solution
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Sandimmun is indicated:
•
As an immunosuppressive agent for the prevention of graft rejection
following kidney, liver and
heart allogeneic transplantation.
•
For induction and/or maintenance of remission in the nephrotic
syndrome. Ciclosporin is not a
first-line agent. Its use should be restricted to occasions when
steroids and cytostatic drugs have
failed,
or
are
not
tolerated, or
are
considered
inappropriate,
and
when
renal
function
is
unimpaired (see Section 4.4 Special Warnings and Precautions for Use).
•
For the treatment of severe, active rheumatoid arthritis in patients
for whom classical slow-acting
antirheumatic agents (including methotrexate) are inappropriate or
ineffective.
•
In patients with severe psoriasis in whom conventional therapy is
ineffective or inappropriate and
the disease has caused a significant interference with quality of
life.
•
For
the
treat