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

lupin australia pty limited - pravastatin sodium, quantity: 20 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin-lupin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. pravastatin-lupin is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin-lupin is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin-lupin is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

lupin australia pty limited - pravastatin sodium, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin-lupin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. pravastatin-lupin is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin-lupin is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin-lupin is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

lupin australia pty limited - lurasidone hydrochloride, quantity: 20 mg - tablet, film coated - excipient ingredients: hypromellose; mannitol; magnesium stearate; croscarmellose sodium; titanium dioxide; macrogol 6000 - lurasidone lupin is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

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

lupin australia pty limited - lurasidone hydrochloride, quantity: 40 mg - tablet, film coated - excipient ingredients: hypromellose; croscarmellose sodium; magnesium stearate; mannitol; titanium dioxide; macrogol 6000 - lurasidone lupin is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

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

lupin australia pty limited - lurasidone hydrochloride, quantity: 80 mg - tablet, film coated - excipient ingredients: mannitol; hypromellose; magnesium stearate; croscarmellose sodium; titanium dioxide; iron oxide yellow; macrogol 6000; indigo carmine aluminium lake - lurasidone lupin is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

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

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 113.373 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; hyprolose; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lupin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,? monotherapy when metformin is considered inappropriate due to intolerance; or,? in combination with other antihyperglycaemic agents, including insulin.,(see section 5.1 pharmacodynamic properties - clinical trials and section 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.)

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

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 56.686 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; microcrystalline cellulose; hyprolose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lupin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,? monotherapy when metformin is considered inappropriate due to intolerance; or,? in combination with other antihyperglycaemic agents, including insulin.,(see section 5.1 pharmacodynamic properties - clinical trials and section 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.)

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

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 28.343 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: hyprolose; calcium hydrogen phosphate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lupin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,? monotherapy when metformin is considered inappropriate due to intolerance; or,? in combination with other antihyperglycaemic agents, including insulin,(see section 5.1 pharmacodynamic properties - clinical trials and section 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.)

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

lupin australia pty limited - ethambutol hydrochloride, quantity: 400 mg - tablet, film coated - excipient ingredients: ethylcellulose; magnesium stearate; titanium dioxide; polyethylene glycol monomethyl ether; povidone; purified talc; propylene glycol; hypromellose; maize starch; colloidal anhydrous silica - ethambutol lupin is indicated for the treatment of pulmonary tuberculosis, as shown by a large number of studies by investigators throughout the world. it has also been used successfully in cases of primary tuberculosis and extrapulmonary forms of tuberculosis, including miliary tuberculosis, tuberculous meningitis, tuberculosis of bones and joints, genitourinary tuberculosis, tuberculosis of the skin and tuberculous eye diseases. it should not be used as the sole antituberculosis drug, but should be used in conjunction with at least one other antituberculosis drug. selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in vitro susceptibility studies.,in patients who have not received previous antituberculosis therapy, i.e. initial treatment, the most frequently used regimens have included three of the following drugs ? ethambutol, isoniazid, rifampicin and streptomycin - for the first 2-4 months. for example:,? ethambutol plus isoniazid plus rifampicin; or ? ethambutol plus isoniazid plus streptomycin,then continuing with a two drug regimen such as,? ethambutol plus isoniazid; or ? ethambutol plus rifampicin.,in patients who have received previous antituberculosis therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. consequently, in such retreatment cases ethambutol lupin should be combined with at least one of the second-line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. antituberculosis drugs used with ethambutol have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. alternating drug regimens have also been utilised.

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

lupin australia pty limited - ethambutol hydrochloride, quantity: 400 mg - tablet, film coated - excipient ingredients: maize starch; propylene glycol; hypromellose; colloidal anhydrous silica; purified talc; povidone; magnesium stearate; titanium dioxide; ethylcellulose; polyethylene glycol monomethyl ether - ethambutol lupin is indicated for the treatment of pulmonary tuberculosis, as shown by a large number of studies by investigators throughout the world. it has also been used successfully in cases of primary tuberculosis and extrapulmonary forms of tuberculosis, including miliary tuberculosis, tuberculous meningitis, tuberculosis of bones and joints, genitourinary tuberculosis, tuberculosis of the skin and tuberculous eye diseases. it should not be used as the sole antituberculosis drug, but should be used in conjunction with at least one other antituberculosis drug. selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in vitro susceptibility studies.,in patients who have not received previous antituberculosis therapy, i.e. initial treatment, the most frequently used regimens have included three of the following drugs ? ethambutol, isoniazid, rifampicin and streptomycin - for the first 2-4 months. for example:,? ethambutol plus isoniazid plus rifampicin; or ? ethambutol plus isoniazid plus streptomycin,then continuing with a two drug regimen such as,? ethambutol plus isoniazid; or ? ethambutol plus rifampicin.,in patients who have received previous antituberculosis therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. consequently, in such retreatment cases ethambutol lupin should be combined with at least one of the second-line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. antituberculosis drugs used with ethambutol have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. alternating drug regimens have also been utilised.