אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 100 mg - capsule, soft - excipient ingredients: gelatin; iron oxide black; ethyl lactate; lecithin; polysorbate 20; glycerol; sorbitan oleate; purified water; tricaprin; peg-40 hydrogenated castor oil; titanium dioxide - 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).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 46221 - pacing lead cap - bk sealing caps are intended for use as components of systems designed to treat cardiac fibrillations or arrhythmias. such systems may include pacemaker/pulse generator units, implantable cardioverter/defibrillators (icds), pacemaker or icd leads, and various lead adapters. bk sealing caps provide a permanent insulative barrier of medical-grade silicone between the electrical conductive elements of the implantable therapeutic device lead(s) or adapter(s) and the physiological environment.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - ct758 - bk virus ivds - the panther fusion? bkv quant assay is a fully automated real-time pcr (rt-pcr) in vitro nucleic acid amplification test for the quantitation of human bk virus (bkv) dna in human plasma and urine samples. the panther fusion bkv quant assay is intended for use to aid in the diagnosis and to aid in the management of solid-organ transplant patients and in hematopoietic stem cell transplant patients. this assay is designed for use on the panther fusion system.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - everolimus -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - mycophenolate sodium -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - cyclosporin -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - cyclosporin -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

haleon australia pty ltd - isopropyl alcohol, quantity: 634 mg/ml; glacial acetic acid, quantity: 17.3 mg/ml - ear drops, solution - excipient ingredients: purified water - helps prevent and helps treat swimmer's ear the painful ear infection that often occurs when water is trapped in the ear canal after swimming, bathing, surfing or diving. aquaear dries up moisture and retards the growth of bacteria. aquaear also helps relieve the painful inflammation caused by swimmer's ear.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - mycophenolate mofetil, quantity: 500 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; hyprolose; povidone; purified talc; magnesium stearate; titanium dioxide; hypromellose; iron oxide red; iron oxide black; macrogol 400; indigo carmine aluminium lake - prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. prophylaxis of organ rejection in paediatric patients (with a body surface area > 1.5 m2) receiving allogeneic renal transplants.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - tofacitinib citrate, quantity: 8.078 mg (equivalent: tofacitinib, qty 5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; triacetin; macrogol 3350 - rheumatoid arthritis (ra),xeljanz is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. xeljanz can be used alone or in combination with conventional synthetic disease-modifying antirheumatic drugs (dmards), including methotrexate. psoriatic arthritis (psa),xeljanz in combination with conventional synthetic dmards is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response to a prior dmard therapy. ulcerative colitis (uc),xeljanz is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.,ankylosing spondylitis (as),xeljanz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.,juvenile idiopathic arthritis (jia),xeljanz is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis, extended oligoarthritis and systemic juvenile arthritis without systemic features for six months) and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with dmards.