NEORAL ciclosporin 100mg/mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciclosporin, Quantity: 100 mg/mL

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: dl-alpha-tocopherol; ethanol; corn glycerides; propylene glycol; PEG-40 hydrogenated castor oil

Administration route:

Oral

Units in package:

50ml

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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. Cyclosporin is not a first-line agent. Its use should be restricted to occasions when steroids and cystostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see WARNINGS). 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. ADDITIONAL INDICATION FROM 11 JUNE 1997: For the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.

Product summary:

Visual Identification: Clear, faintly yellow to faintly brownish-yellow liquid; Container Type: Bottle; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1995-08-28

Patient Information leaflet

NEORAL
®
_cyclosporin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Neoral.
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 Neoral 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 NEORAL IS USED
FOR
Neoral 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.
Neoral 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)
Neoral 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.
Neoral is only available with a
do

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – NEORAL (CICLOSPORIN)
CAPSULES AND ORAL LIQUID
1
NAME OF THE MEDICINE
Ciclosporin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NEORAL CICLOSPORIN CAPSULES
Each Neoral 10 mg capsule contains 10 mg ciclosporin.
Each Neoral 25 mg capsule contains 25 mg ciclosporin.
Each Neoral 50 mg capsule contains 50 mg ciclosporin.
Each Neoral 100 mg capsule contains 100 mg ciclosporin.
NEORAL CICLOSPORIN ORAL SOLUTION
Neoral oral solution contains 100 mg/mL of ciclosporin
Excipients with known effect:
Alcohol (as ethanol 11.8% v/v in the capsules and ethanol 12% v/v in
the oral solution).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NEORAL CICLOSPORIN CAPSULES
10 mg:
yellow-white oblong soft gelatin capsules, imprinted in red with "NVR
10mg"
25 mg:
blue-grey oval soft gelatin capsules imprinted in red with "NVR 25 mg"
50 mg:
yellow-white oblong soft gelatin capsules imprinted in red with "NVR
50 mg"
100 mg:
blue-grey oblong soft gelatin capsules imprinted in red with "NVR 100
mg"
NEORAL CICLOSPORIN ORAL SOLUTION
100 mg/mL:
clear, faintly yellow to faintly brownish-yellow liquid
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Neoral is indicated:
2
•
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 significa