New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - isotretinoin 5mg;   - soft gelatin capsule - 5 mg - active: isotretinoin 5mg   excipient: ferrous oxide gelatin glycerol soya bean oil, partially hydrogenated ferrous oxide yellow e172 soya bean oil, hydrogenated soya oil titanium dioxide yellow beeswax - severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. isotretinoin actavis should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if isotretinoin actavis is used during pregnancy.

United Kingdom - Inggeris - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance pharmaceuticals ltd - isotretinoin - oral capsule - 5mg

United Kingdom - Inggeris - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - isotretinoin - oral capsule - 5mg

United Kingdom - Inggeris - MHRA (Medicines & Healthcare Products Regulatory Agency)

sun pharmaceutical industries europe b.v. - isotretinoin - oral capsule - 10mg

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin 10 mg - absorica and absorica ld are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, absorica and absorica ld are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of absorica/absorica ld therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)]. absorica/absorica ld is contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)]. absorica/absorica ld is contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphy

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

strides pharma science pty ltd - isotretinoin, quantity: 20 mg - capsule, soft - excipient ingredients: disodium edetate; purified water; yellow beeswax; indigo carmine; butylated hydroxyanisole; brilliant scarlet 4r; dl-alpha-tocopherol; gelatin; soya oil; partially hydrogenated soya oil; glycerol; sorbitol solution (70 per cent) (non-crystallising); titanium dioxide; hydrogenated vegetable oil - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects asssociated with its use. isotretinoin should be reversed for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

strides pharma science pty ltd - isotretinoin, quantity: 10 mg - capsule, soft - excipient ingredients: soya oil; dl-alpha-tocopherol; disodium edetate; butylated hydroxyanisole; partially hydrogenated soya oil; yellow beeswax; hydrogenated vegetable oil; gelatin; glycerol; sorbitol solution (70 per cent) (non-crystallising); brilliant scarlet 4r; iron oxide black; titanium dioxide; purified water - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

strides pharma science pty ltd - isotretinoin, quantity: 40 mg - capsule, soft - excipient ingredients: purified water; titanium dioxide; dl-alpha-tocopherol; sorbitol solution (70 per cent) (non-crystallising); yellow beeswax; butylated hydroxyanisole; soya oil; partially hydrogenated soya oil; sunset yellow fcf; glycerol; disodium edetate; hydrogenated soya oil; gelatin - dermatane is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cyctic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

strides pharma science pty ltd - isotretinoin, quantity: 5 mg - capsule, soft - excipient ingredients: gelatin; dl-alpha-tocopherol; soya oil; titanium dioxide; purified water; yellow beeswax; sorbitol solution (70 per cent) (non-crystallising); butylated hydroxyanisole; partially hydrogenated soya oil; hydrogenated vegetable oil; disodium edetate; glycerol - dermatane is indicated for the treatment of patients with severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

douglas pharmaceuticals australia pty ltd - isotretinoin, quantity: 5 mg - capsule, soft - excipient ingredients: sorbitol solution (70 per cent) (non-crystallising); glycerol; purified water; butylated hydroxyanisole; hydrogenated vegetable oil; titanium dioxide; disodium edetate; soya oil; dl-alpha-tocopherol; gelatin; yellow beeswax; partially hydrogenated soya oil - treatment of patients with severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.