Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
ciclosporin, Quantity: 50 mg
Novartis Pharmaceuticals Australia Pty Ltd
ciclosporin
Capsule, soft
Excipient Ingredients: propylene glycol; ethanol; glycerol; titanium dioxide; PEG-40 hydrogenated castor oil; Gelatin; corn glycerides; dl-alpha-tocopherol; hypromellose; purified water; isopropyl alcohol; cochineal; aluminium chloride; sodium hydroxide
Oral
30 capsules, 50 capsules, 60 capsules
(S4) Prescription Only Medicine
Cyclosporin Sandoz 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. 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 (see Precautions). 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 the quality of life. For the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate. Careful monitoring of all cyclosporin-treated patients is mandatory. Cyclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see "Precautions").
Visual Identification: yellow-white oblong soft gelatin capsules imprinted in red with "NVR 50mg".; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2012-06-14
CYCLOSPORIN SANDOZ ® _ciclosporin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cyclosporin Sandoz. 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 Cyclosporin Sandoz 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 CYCLOSPORIN SANDOZ IS USED FOR Cyclosporin Sandoz 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. Cyclosporin Sandoz 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). Cyclosporin Sandoz 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 d Lees het volledige document
Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION CYCLOSPORIN SANDOZ CAPSULES (CICLOSPORIN) 1 NAME OF THE MEDICINE Ciclosporin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ciclosporin is poorly soluble in water (0.004% w/w) and n-hexane, but is very soluble in other organic solvents and in lipids. Each Cyclosporin Sandoz 25 mg capsule contains 25 mg ciclosporin. Each Cyclosporin Sandoz 50 mg capsule contains 50 mg ciclosporin. Each Cyclosporin Sandoz 100 mg capsule contains 100 mg ciclosporin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 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". 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Cyclosporin Sandoz 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 treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate. _CAREFUL MONITORING OF ALL CICLOSPORIN-TREATED PATIENTS IS MANDATORY. CICLOSPORIN SHOULD ONLY _ _BE USED BY MEDICAL PRACTITIONERS WHO ARE EXPERIENCED IN THE USE OF IMMUNOSUPPR Lees het volledige document