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

arrotex pharmaceuticals pty ltd - potassium clavulanate, quantity: 151.917 mg; amoxicillin trihydrate, quantity: 573.892 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; dichloromethane; isopropyl alcohol; sodium starch glycollate; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose - amclavox duo 500/125 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 (complicated and uncomplicated),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 amoxicillin and clavulanic acid 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 amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

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

teva pharma australia pty ltd - quetiapine fumarate, quantity: 460 mg - tablet, modified release - excipient ingredients: hypromellose; microcrystalline cellulose; sodium citrate; magnesium stearate; titanium dioxide; macrogol 400; polysorbate 80 - quetiapine modified release 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 ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets.,schizophrenia treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy,major depressive disorder treatment of recurrent major depressive disorder (mdd) in patients who are intolerant of, or who have an inadequate response to alternative therapies,generalised anxiety disorder treatment of generalised anxiety disorder (gad)

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

teva pharma australia pty ltd - quetiapine fumarate, quantity: 345 mg - tablet, modified release - excipient ingredients: hypromellose; microcrystalline cellulose; sodium citrate; magnesium stearate; titanium dioxide; macrogol 400; iron oxide yellow; iron oxide red; iron oxide black; polysorbate 80 - quetiapine modified release 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 ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets.,schizophrenia treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy,major depressive disorder treatment of recurrent major depressive disorder (mdd) in patients who are intolerant of, or who have an inadequate response to alternative therapies,generalised anxiety disorder treatment of generalised anxiety disorder (gad)

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

teva pharma australia pty ltd - quetiapine fumarate, quantity: 230 mg - tablet, modified release - excipient ingredients: hypromellose; microcrystalline cellulose; sodium citrate; magnesium stearate; titanium dioxide; macrogol 400; iron oxide yellow; iron oxide red; polysorbate 80 - quetiapine modified release 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 ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets.,schizophrenia treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy,major depressive disorder treatment of recurrent major depressive disorder (mdd) in patients who are intolerant of, or who have an inadequate response to alternative therapies,generalised anxiety disorder treatment of generalised anxiety disorder (gad)

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

teva pharma australia pty ltd - quetiapine fumarate, quantity: 172.5 mg - tablet, modified release - excipient ingredients: hypromellose; microcrystalline cellulose; sodium citrate; magnesium stearate; titanium dioxide; macrogol 400; polysorbate 80 - quetiapine modified release 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 ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets.,schizophrenia treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy,major depressive disorder treatment of recurrent major depressive disorder (mdd) in patients who are intolerant of, or who have an inadequate response to alternative therapies,generalised anxiety disorder treatment of generalised anxiety disorder (gad)

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

teva pharma australia pty ltd - quetiapine fumarate, quantity: 57.5 mg - tablet, modified release - excipient ingredients: hypromellose; microcrystalline cellulose; sodium citrate; magnesium stearate; titanium dioxide; macrogol 400; iron oxide yellow; iron oxide red; iron oxide black; polysorbate 80 - quetiapine modified release 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 ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets.,schizophrenia treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy,major depressive disorder treatment of recurrent major depressive disorder (mdd) in patients who are intolerant of, or who have an inadequate response to alternative therapies,generalised anxiety disorder treatment of generalised anxiety disorder (gad)

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 80 mg; naloxone hydrochloride dihydrate, quantity: 43.6 mg (equivalent: naloxone hydrochloride?, qty 40 mg) - tablet, modified release - excipient ingredients: ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; povidone; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - targin modified release tablet 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.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is not indicated as an as-needed (prn) analgesia,the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 60 mg; naloxone hydrochloride dihydrate, quantity: 32.7 mg (equivalent: naloxone hydrochloride?, qty 30 mg) - tablet, modified release - excipient ingredients: ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; povidone; titanium dioxide; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - targin modified release tablet 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.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is not indicated as an as-needed (prn) analgesia,the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

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

sandoz pty ltd - amoxicillin trihydrate, quantity: 1005 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; silicon dioxide; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose; sodium lauryl sulfate; cetyl alcohol - short-term treatment of bacterial infections at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms: skin and skin structure infections. urinary tract infections (complicated and uncomplicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxycillin/clavulanic acid tablet preparations. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptible studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections cause by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxycillin/clavulanic acid tablet preparations should not require the addition of another antibiotic due to the amoxycillin content of these products.

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

sandoz pty ltd - amoxicillin trihydrate, quantity: 574 mg (equivalent: amoxicillin, qty 500 mg); potassium clavulanate, quantity: 149 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose; sodium lauryl sulfate; cetyl alcohol - short-term treatment of bacterial infections at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms: skin and skin structure infections. urinary tract infections (complicated and uncomplicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxycillin/clavulanic acid tablet preparations. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptible studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections cause by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxycillin/clavulanic acid tablet preparations should not require the addition of another antibiotic due to the amoxycillin content of these products.