Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib-aft, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib-aft, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib-aft is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib-aft in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

emcure pharmaceuticals pty ltd - teriflunomide, quantity: 14 mg - tablet, film coated - excipient ingredients: hyprolose; maize starch; microcrystalline cellulose; sodium starch glycollate type a; silicon dioxide; lactose monohydrate; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc; indigo carmine aluminium lake - teriflunomide is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; triethyl citrate; microcrystalline cellulose; croscarmellose sodium; propyl gallate; methacrylic acid - ethyl acrylate copolymer (1:1); xylitol; sodium stearylfumarate; hyprolose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - posaconazole juno is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.,? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole juno is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - pregabalin, quantity: 20 mg/ml - oral liquid, solution - excipient ingredients: sucralose; monobasic sodium phosphate monohydrate; purified water; methyl hydroxybenzoate; dibasic sodium phosphate; flavour - pregabalin-aft is indicated for the treatment of neuropathic pain in adults.,pregabalin-aft is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - meropenem trihydrate, quantity: 570 mg - injection, powder for - excipient ingredients: sodium carbonate - meropenem juno is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:,,? community acquired lower respiratory tract infection ,,? hospital acquired lower respiratory tract infection,,? complicated urinary tract infection,,? febrile neutropaenia,,? intra-abdominal and gynaecological (poly microbial) infections,,? complicated skin and skin structure infections,,? meningitis,,? septicaemia

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - meropenem trihydrate, quantity: 1140 mg - injection, powder for - excipient ingredients: sodium carbonate - meropenem juno is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:,,? community acquired lower respiratory tract infection ,,? hospital acquired lower respiratory tract infection,,? complicated urinary tract infection,,? febrile neutropaenia,,? intra-abdominal and gynaecological (poly microbial) infections,,? complicated skin and skin structure infections,,? meningitis,,? septicaemia

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml); timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml) - eye drops, solution - excipient ingredients: sodium hydroxide; hyetellose; mannitol; water for injections; sodium citrate - vizo-pf dorzolatim is indicated in the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); bimatoprost, quantity: 300 microgram/ml - eye drops, solution - excipient ingredients: sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; citric acid monohydrate; hydrochloric acid; sodium hydroxide - vizo-pf bimatotim 0.3/5 eye drops are indicated for the reduction of intraocular pressure (iop) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - nimodipine, quantity: 10 mg - injection, intravenous infusion - excipient ingredients: citric acid; sodium citrate dihydrate; water for injections; ethanol; macrogol 400 - 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, e.g., hunt and hess grades i-iii (see section 5.1 pharmacodynamic properties).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - icatibant acetate, quantity: 31.38 mg (equivalent: icatibant, qty 30 mg) - injection, solution - excipient ingredients: glacial acetic acid; sodium chloride; water for injections; sodium hydroxide - fyzant is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older with c1-esterase-inhibitor deficiency.