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

southern cross pharma pty ltd - nebivolol hydrochloride, quantity: 5.45 mg (equivalent: nebivolol, qty 5 mg) - tablet - excipient ingredients: lactose monohydrate; maize starch; croscarmellose sodium; hypromellose; polysorbate 80; microcrystalline cellulose; silicon dioxide; magnesium stearate - nebivolol is indicated: - to treat essential hypertension; - to treat stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older.

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

southern cross pharma pty ltd - prasugrel, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; microcrystalline cellulose; croscarmellose sodium; sucrose stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red - prasugrel, co-administered with aspirin, is indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (ua), non st-segment elevation myocardial infarction (nstemi) or st-segment elevation myocardial infarction (stemi)) who are to undergo percutaneous coronary intervention (pci).

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

southern cross pharma pty ltd - prasugrel, quantity: 5 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; crospovidone; microcrystalline cellulose; lactose monohydrate; sucrose stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow - prasugrel, co-administered with aspirin, is indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (ua), non st-segment elevation myocardial infarction (nstemi) or st-segment elevation myocardial infarction (stemi)) who are to undergo percutaneous coronary intervention (pci).

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

southern cross pharma pty ltd - isotretinoin, quantity: 20 mg - capsule, soft - excipient ingredients: soya oil; yellow beeswax; hydrogenated soya oil; partially hydrogenated soya oil; gelatin; glycerol; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; brilliant blue fcf; ethanol; purified water; shellac; strong ammonia solution - 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 - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - isotretinoin, quantity: 10 mg - capsule, soft - excipient ingredients: soya oil; yellow beeswax; hydrogenated soya oil; partially hydrogenated soya oil; gelatin; glycerol; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; brilliant blue fcf; ethanol; purified water; shellac; strong ammonia solution - 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 - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - pregabalin, quantity: 300 mg - capsule, hard - excipient ingredients: lactose monohydrate; pregelatinised maize starch; titanium dioxide; iron oxide yellow; purified talc; gelatin; iron oxide red; iron oxide black; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; potassium hydroxide - pregabalin apotex is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation pregabalin apotex is indicated for the treatment of neuropathic pain in adults.

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

southern cross pharma pty ltd - pregabalin, quantity: 150 mg - capsule, hard - excipient ingredients: lactose monohydrate; pregelatinised maize starch; titanium dioxide; iron oxide black; purified talc; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; potassium hydroxide - pregabalin apotex is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation pregabalin apotex is indicated for the treatment of neuropathic pain in adults.

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

southern cross pharma pty ltd - pregabalin, quantity: 75 mg - capsule, hard - excipient ingredients: lactose monohydrate; pregelatinised maize starch; titanium dioxide; iron oxide red; purified talc; gelatin; iron oxide yellow; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; iron oxide black; potassium hydroxide - pregabalin apotex is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation pregabalin apotex is indicated for the treatment of neuropathic pain in adults.

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

southern cross pharma pty ltd - pregabalin, quantity: 25 mg - capsule, hard - excipient ingredients: lactose monohydrate; pregelatinised maize starch; titanium dioxide; iron oxide black; purified talc; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; potassium hydroxide - pregabalin apotex is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation pregabalin apotex is indicated for the treatment of neuropathic pain in adults.

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

southern cross pharma pty ltd - pregabalin -