Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - rivaroxaban, quantity: 2.5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; macrogol 3350; titanium dioxide; propylene glycol; purified talc; iron oxide yellow; macrogol 6000 - xarelto is indicated for: ? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks) ? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke ? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe,xarelto, in combination with aspirin, is indicated for ? the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - regorafenib, quantity: 40 mg - tablet - excipient ingredients: polyvinyl alcohol; croscarmellose sodium; iron oxide red; microcrystalline cellulose; povidone; purified talc; magnesium stearate; titanium dioxide; macrogol 3350; colloidal anhydrous silica; iron oxide yellow; lecithin - stivarga is indicated for the treatment of patients with metastatic colorectal cancer (crc) who have been previously treated with fluoropyrimidine,- oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf therapy, and, if ras wild type, an anti-egfr therapy.,stivarga is indicated for the treatment of patients with unresectable or metastatic gastrointestinal stromal tumours (gist) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.,stivarga is indicated for the treatment of patients with hepatocellular carcinoma (hcc) who have been previously treated with sorafenib.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - sorafenib tosilate, quantity: 274 mg (equivalent: sorafenib, qty 200 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; titanium dioxide; hypromellose; microcrystalline cellulose; sodium lauryl sulfate; macrogol 3350; ferric oxide; magnesium stearate - hepatocellular carcinoma. nexavar is indicated for the treatment of patients with advanced hepatocellular carcinoma (hcc). renal cell carcinoma. nexavar is indicated for the treatment of patients with advanced renal cell carcinoma (rcc). differentiated thyroid carcinoma. nexavar is indicated for the treatment of patients with locally advanced or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - vardenafil hydrochloride trihydrate, quantity: 11.852 mg (equivalent: vardenafil, qty 10 mg) - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; macrogol 400; hypromellose; titanium dioxide; iron oxide yellow; iron oxide red - levitra is indicated for the treatment of erectile dysfunction in adult males (inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). levitra is not indicated for use by women.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - vardenafil hydrochloride trihydrate, quantity: 5.926 mg (equivalent: vardenafil, qty 5 mg) - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; macrogol 400; hypromellose; titanium dioxide; iron oxide yellow; iron oxide red - levitra is indicated for the treatment of erectile dysfunction in adult males (inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). levitra is not indicated for use by women.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - moxifloxacin, quantity: 400 mg (equivalent: moxifloxacin hydrochloride, qty 436.8 mg) - tablet, film coated - excipient ingredients: titanium dioxide; microcrystalline cellulose; hypromellose; ferric oxide; croscarmellose sodium; lactose monohydrate; magnesium stearate; macrogol 400 - avelox (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions. acute bacterial sinusitis, community acquired pneumonia, acute exacerbations of chronic bronchitis. avelox iv (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions. community acquired pneumonia (caused by susceptible organisms). acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics. avelox iv (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents. (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin may be initiated. in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - nimodipine, quantity: 30 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; maize starch; crospovidone; magnesium stearate; hypromellose; macrogol 4000; iron oxide yellow; titanium dioxide - prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm after subarachnoid haemorrhage following ruptured intracranial aneurysm, in patients who are in good neurological condition post-ictus (eg hunt and hess grades i-iii).

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - praziquantel, quantity: 600 mg - tablet, film coated - excipient ingredients: hypromellose; sodium lauryl sulfate; povidone; titanium dioxide; microcrystalline cellulose; macrogol 4000; magnesium stearate; maize starch - infections due to various types of blood fluke (eg, schistosoma haematobiium, s. japonicum, s. mekongi, s. mansoni)

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - larotrectinib sulfate, quantity: 30.7 mg - capsule, hard - excipient ingredients: gelatin; propylene glycol; dimethicone 12500; brilliant blue fcf aluminium lake; titanium dioxide; shellac; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - larotrectinib sulfate, quantity: 122.9 mg - capsule, hard - excipient ingredients: titanium dioxide; shellac; gelatin; dimethicone 12500; propylene glycol; brilliant blue fcf aluminium lake; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.