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

gm pharma international pty ltd - amitriptyline hydrochloride, quantity: 50 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; croscarmellose sodium; colloidal anhydrous silica; purified talc; magnesium stearate; macrogol 6000; hypromellose; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - for the treatment of major depression. entrip 50mg tablets are indicated only for the maintenance treatment of major depression (see precautions). nocturnal enuresis where organic pathology has been excluded.

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

gm pharma international pty ltd - amitriptyline hydrochloride, quantity: 25 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; croscarmellose sodium; colloidal anhydrous silica; purified talc; magnesium stearate; macrogol 6000; hypromellose; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - for the treatment of major depression. nocturnal enuresis where organic pathology has been excluded.

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

gm pharma international pty ltd - amitriptyline hydrochloride, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; croscarmellose sodium; colloidal anhydrous silica; purified talc; magnesium stearate; macrogol 6000; hypromellose; titanium dioxide; brilliant blue fcf aluminium lake; polyvinyl alcohol; macrogol 3350 - for the treatment of major depression. nocturnal enuresis where organic pathology has been excluded.

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

gm pharma international pty ltd - hydroxychloroquine sulfate, quantity: 200 mg - tablet - excipient ingredients: colloidal anhydrous silica; pregelatinised maize starch; magnesium stearate; hypromellose; polysorbate 80; calcium hydrogen phosphate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.

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

gm pharma international pty ltd - metoclopramide hydrochloride, quantity: 10 mg - tablet, film coated - excipient ingredients: purified talc; stearic acid; macrogol 6000; pregelatinised maize starch; hypromellose; titanium dioxide; colloidal anhydrous silica; maize starch; microcrystalline cellulose - in adults (20 years and over): as an adjunct to x-ray examination of the stomach and duodenum. to assist in intestinal intubation. to control nausea and vomiting associated with the following conditions: intolerance to essential drugs possessing emetic properties; uraemia; radiation sickness; malignant disease; postoperative vomiting; labour; infectious diseases. there is no clear benefit in motion sickness or other labyrinth disturbances. metoclopramide hydrochloride has been found useful in the management of gastric retention after gastric surgery. metoclopramide hydrochloride may be useful in the treatment of diabetic gastroparesis of mild to moderate severity. once control of diabetes has been established by diet and/or insulin, metoclopramide hydrochloride should be discontinued.,young adults: the use of metoclopramide hydrochloride in patients under 20 years should be restricted to the following situations: severe intractable vomiting of known cause. vomiting associated with radiotherapy and intolerance to cytotoxic drugs. as an aid to gastrointestinal intubation

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

gm pharma international pty ltd - metoclopramide hydrochloride, quantity: 5 mg - tablet, film coated - excipient ingredients: maize starch; pregelatinised maize starch; titanium dioxide; microcrystalline cellulose; macrogol 6000; purified talc; hypromellose; stearic acid; colloidal anhydrous silica - in adults (20 years and over): as an adjunct to x-ray examination of the stomach and duodenum. to assist in intestinal intubation. to control nausea and vomiting associated with the following conditions: intolerance to essential drugs possessing emetic properties; uraemia; radiation sickness; malignant disease; postoperative vomiting; labour; infectious diseases. there is no clear benefit in motion sickness or other labyrinth disturbances. metoclopramide hydrochloride has been found useful in the management of gastric retention after gastric surgery. metoclopramide hydrochloride may be useful in the treatment of diabetic gastroparesis of mild to moderate severity. once control of diabetes has been established by diet and/or insulin, metoclopramide hydrochloride should be discontinued.,young adults: the use of metoclopramide hydrochloride in patients under 20 years should be restricted to the following situations: severe intractable vomiting of known cause. vomiting associated with radiotherapy and intolerance to cytotoxic drugs. as an aid to gastrointestinal intubation

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

gm pharma international pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to 18 years),primary hypercholesterolaemia,ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,ezetimibe is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

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

gm pharma international pty ltd - irbesartan, quantity: 300 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; magnesium stearate; croscarmellose sodium; iron oxide yellow; iron oxide red; titanium dioxide; hypromellose; macrogol 4000 - for the treatment of hypertension. treatment should not be initiated with this fixed-dose combination.

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

gm pharma international pty ltd - irbesartan, quantity: 300 mg; hydrochlorothiazide, quantity: 25 mg - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; croscarmellose sodium; magnesium stearate; iron oxide yellow; iron oxide red; titanium dioxide; hypromellose; macrogol 4000; iron oxide black - for the treatment of hypertension. treatment should not be initiated with this fixed-dose combination.

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

gm pharma international pty ltd - irbesartan, quantity: 150 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; lactose monohydrate; croscarmellose sodium; iron oxide yellow; iron oxide red; titanium dioxide; hypromellose; macrogol 4000 - for the treatment of hypertension. treatment should not be initiated with this fixed-dose combination.