New Zealand - English - Medsafe (Medicines Safety Authority)

psm healthcare ltd trading as api consumer brands - cycloserine 250mg - tablet - 250 mg - active: cycloserine 250mg

United States - English - NLM (National Library of Medicine)

abbvie inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 50 mg - gengraf® capsules (cyclosporine capsules, usp [modified ]) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. cyclosporine (modified ) has been used in combination with azathioprine and corticosteroids. gengraf® capsules (cyclosporine capsules, usp [modified ]) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. gengraf® can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. gengraf® capsules (cyclosporine capsules, usp [modified ]) is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., puva, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated. while rebound rarely occurs, most patients will experience relapse with gengraf® as with other therapies upon cessation of treatment. gengraf® capsules (cyclosporine capsules, usp [modified ]) is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive gengraf® capsules (cyclosporine capsules, usp [modified ]). psoriasis patients who are treated with gengraf® capsules (cyclosporine capsules, usp [modified ]) should not receive concomitant puva or uvb therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive gengraf® .

United States - English - NLM (National Library of Medicine)

ax pharmaceutical corp - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 247.5 g in 250 g

United States - English - NLM (National Library of Medicine)

ax pharmaceutical corp - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 99 g in 100 g

United States - English - NLM (National Library of Medicine)

ax pharmaceutical corp - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 495 g in 500 g

United States - English - NLM (National Library of Medicine)

allergan, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 0.5 mg in 1 ml - restasis ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. restasis ® is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. risk summary clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see clinical pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see  data ]. data animal data at maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (usp) was teratogenic as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. these doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcl) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. no evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. these doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose. an oral dose of 45 mg/kg/day cyclosporine administered to rats from day 15 of pregnancy until day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. this dose is 7,000 times greater than the daily recommended human dose. no adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose). risk summary cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. although blood concentrations are undetectable following topical administration of restasis ® ophthalmic emulsion [see clinical pharmacology ( 12.3 )] , caution should be exercised when restasis ® is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for restasis ®   and any potential adverse effects on the breast-fed child from cyclosporine. safety and efficacy have not been established in pediatric patients below the age of 16. no overall difference in safety or effectiveness has been observed between elderly and younger patients.

United States - English - NLM (National Library of Medicine)

a-s medication solutions - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 0.5 mg in 1 ml - restasis ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. restasis ® is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. risk summary clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see clinical pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see  data ]. data animal data at maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (usp) was teratogenic as indicated by i

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 100 mg - capsule, soft - excipient ingredients: propylene glycol; iron oxide black; titanium dioxide; corn glycerides; dl-alpha-tocopherol; glycerol; gelatin; ethanol; peg-40 hydrogenated castor oil; hypromellose; purified water; isopropyl alcohol; cochineal; aluminium chloride; sodium hydroxide - 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").

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 50 mg - 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 - 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").

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: titanium dioxide; peg-40 hydrogenated castor oil; propylene glycol; glycerol; corn glycerides; iron oxide black; dl-alpha-tocopherol; gelatin; ethanol; hypromellose; purified water; isopropyl alcohol; cochineal; aluminium chloride; sodium hydroxide - 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").