SANDIMMUN ciclosporin 100mg capsules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciclosporin, Quantity: 100 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: corn oil PEG-6 esters; ethanol; Gelatin; glycerol; titanium dioxide; iron oxide red; Maize Oil; purified water; sorbitol; 1,4-sorbitan; mannitol; hydrogenated starch hydrosylate

Administration route:

Oral

Units in package:

50 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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 inapprpriate, and when renal function is unimpaired. Indications as at 11 February 1994 from Dr James McGinness. 1. As animmunosuppressive 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 occ

Product summary:

Visual Identification: Dusty rose oblong soft gelatin capsule, approx. 24.9mm in length, and approx. 8.7mm in diameter.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 42 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1991-08-21

Summary of Product characteristics

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