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

sandoz pty ltd - pravastatin sodium, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; dibasic sodium phosphate; lactose monohydrate; croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; sodium lauryl sulfate; povidone; iron oxide red - as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/l) serum cholesterol levels. patients with unstable angina pectoris (see clinical trials). 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)

sandoz pty ltd - pravastatin sodium, quantity: 40 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; iron oxide red; povidone; sodium lauryl sulfate; croscarmellose sodium; colloidal anhydrous silica; dibasic sodium phosphate; magnesium stearate - as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/l) serum cholesterol levels. patients with unstable angina pectoris (see clinical trials). 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)

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 64 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; indigo carmine aluminium lake; macrogol 400; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

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

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 32 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; iron oxide yellow; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; macrogol 400; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

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

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 16 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; iron oxide yellow; macrogol 400; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

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

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 8 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; iron oxide red; macrogol 400; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

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

generic health pty ltd - pravastatin sodium, quantity: 80 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 generichealth, 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 generichealth is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin generichealth is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin generichealth 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: 80 mg - tablet, film coated - excipient ingredients: crospovidone; sodium bicarbonate; lactose monohydrate; magnesium stearate; colloidal anhydrous silica; 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: 40 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: 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).