Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
ciclosporin, Quantity: 50 mg
Arrotex Pharmaceuticals Pty Ltd
Capsule, soft
Excipient Ingredients: Gelatin; titanium dioxide; tricaprin; sorbitan oleate; lecithin; purified water; ethyl lactate; polysorbate 20; iron oxide black; PEG-40 hydrogenated castor oil; glycerol
Oral
50, 60, 30
(S4) Prescription Only Medicine
Ciclosporin 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 immunosuppressive therapy (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
Visual Identification: Grey oblong soft gelatin capsules; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2021-02-09
APO-CICLOSPORIN 1 APO-CICLOSPORIN CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING APO-CICLOSPORIN? APO-CICLOSPORIN contains the active ingredient ciclosporin. APO-CICLOSPORIN is used for people who have had a kidney, heart or liver transplant, to prevent the body from rejecting the new organ. APO-CICLOSPORIN is also used to treat several other conditions which are thought to be caused by a problem with the immune system: kidney disease (nephrotic syndrome), severe case of rheumatoid arthritis, severe case of psoriasis or atopic dermatitis. For more information, see Section 1. Why am I using APO-CICLOSPORIN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE APO-CICLOSPORIN? Do not use if you have ever had an allergic reaction to ciclosporin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use APO-CICLOSPORIN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with APO-CICLOSPORIN and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE APO-CICLOSPORIN? • Follow all directions given to you by your doctor and pharmacist carefully. • The dose of APO-CICLOSPORIN is worked out for each person. It will depend on how much you weigh, what condition is being treated, how well APO-CICLOSPORIN works for you, and whether you have any side effects from this medicine. • Swallow the capsules whole with a full glass of water. Do not chew the capsules. More instructions can be found in Section 4. How do I use APO-CICLOSPORIN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING APO-CICLOSPORIN? THINGS YOU SHOULD DO • Remind any doctor, dentist or Đọc toàn bộ tài liệu
1 AUSTRALIAN PRODUCT INFORMATION APO-CICLOSPORIN (Ciclosporin) CAPSULES 1 NAME OF THE MEDICINE Ciclosporin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION APO-CICLOSPORIN capsules are intended for oral administration. Each capsule contains either 25mg, 50mg or 100mg ciclosporin as the active ingredient. Ciclosporin is poorly soluble in water (0.004% w/w) and n-hexane but is very soluble in other organic solvents and in lipids. APO-CICLOSPORIN is a microemulsion pre-concentrate formulation of ciclosporin. When mixed with water (either in the form of gastric fluid or a beverage), APO-CICLOSPORIN immediately forms a microemulsion which facilitates the gastrointestinal absorption of ciclosporin Each tablet contains sulfites and soya bean products. EXCIPIENTS WITH KNOWN EFFECT: Ethyl lactate (28.0% w/w). Ethyl lactate rapidly metabolises to ethanol and lactic acid. An oral dosage that provides 100mg of ciclosporin would thus result in concomitant oral administration of 129mg of ethanol. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM APO-CICLOSPORIN CAPSULES 25 mg: Grey soft gelatin capsules filled with an oily liquid solution with imprinting “DX 25mg” 50 mg: Grey soft gelatin capsules filled with an oily liquid solution with imprinting “DX 50mg” 100 mg: Grey soft gelatin capsules filled with an oily liquid solution with imprinting “DX 100mg” 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS APO-CICLOSPORIN is indicated: • 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. 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 Đọc toàn bộ tài liệu