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

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 11.2 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 pharmacodynamic properties, clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of genvoya. genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

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

boucher & muir pty ltd - flecainide acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; maize starch - 1. supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes. b) due to dual av nodal pathways in patients with debilitating symptoms. c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms.,although flecainide may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs.,flecainide sandoz tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.,prescribers should also consult the "precautions" section of this product information.

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

boucher & muir pty ltd - flecainide acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: pregelatinised maize starch; maize starch; microcrystalline cellulose; croscarmellose sodium; magnesium stearate - 1. supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes. b) due to dual av nodal pathways in patients with debilitating symptoms. c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms.,although flecainide may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs.,flecainide sandoz tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.,prescribers should also consult the "precautions" section of this product information.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 80 mg - tablet, modified release - excipient ingredients: polyethylene oxide; magnesium stearate; hypromellose; indigo carmine; hyprolose; polysorbate 80; iron oxide yellow; macrogol 400 - novacodone 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. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 40 mg - tablet, modified release - excipient ingredients: magnesium stearate; polyethylene oxide; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400 - novacodone 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. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 20 mg - tablet, modified release - excipient ingredients: polyethylene oxide; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - novacodone 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. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 10 mg - tablet, modified release - excipient ingredients: magnesium stearate; polyethylene oxide; titanium dioxide; hypromellose; hyprolose; macrogol 400 - novacodone 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. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.

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

pharmacor pty ltd - amoxicillin trihydrate, quantity: 1012.617 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149.774 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; isopropyl alcohol; dichloromethane; sodium starch glycollate type a; colloidal anhydrous silica; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose - alkem-amoxiclav tablets are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to microbiology):,urinary tract infections (uncomplicated and complicated), lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis, upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis.skin and skin structure infection.,appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to alkem-amoxiclav tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. once these results are known, therapy should be adjusted if appropriate.,the treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to alkem-amoxiclav tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

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

pharmacor pty ltd - amoxicillin trihydrate, quantity: 1012.617 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149.774 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type a; dichloromethane; magnesium stearate; isopropyl alcohol; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose - alkem-amoxiclav tablets are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to microbiology):,urinary tract infections (uncomplicated and complicated), lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis, upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis.skin and skin structure infection.,appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to alkem-amoxiclav tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. once these results are known, therapy should be adjusted if appropriate.,the treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to alkem-amoxiclav tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

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

sun pharma anz pty ltd - quetiapine fumarate, quantity: 230.284 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; sodium starch glycollate type a; magnesium stearate; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; macrogol 400 - quetiapine rbx tablets are indicated for: bipolar disorder = maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes = treatment of depressive episodes associated with bipolar disorder (see dosage and administration) = treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate schizophrenia = treatment of schizophrenia