אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - amoxicillin trihydrate, quantity: 574 mg (equivalent: amoxicillin, qty 500 mg); potassium clavulanate, quantity: 149 mg (equivalent: amoxicillin, qty 500 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 - short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. skin and skin structure infections. urinary tract infections (uncomplicated and complicated). 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 tablets. 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 susceptibility studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections caused

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

apotex nz ltd - paroxetine hydrochloride 22.2mg equivalent to to 20 mg paroxetine base - film coated tablet - 20 mg - active: paroxetine hydrochloride 22.2mg equivalent to to 20 mg paroxetine base excipient: hyprolose hypromellose lactose macrogol 8000 magnesium stearate purified water sodium starch glycolate titanium dioxide - -depression of all types, including reactive and severe depression and depression accompanied by anxiety, and the prevention of relapse and recurrence of further depressive episodes - obsessive compulsive disorder (ocd) and for the prevention of relapse of ocd - panic disorder and for the prevention of relapse of panic disorder -social anxiety disorder or social phobia - generalised anxiety disorder - post-traumatic stress disorder.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

apotex nz ltd - capecitabine 150mg - film coated tablet - 150 mg - active: capecitabine 150mg excipient: colloidal silicon dioxide croscarmellose sodium hyprolose hypromellose iron oxide red iron oxide yellow lactose macrogol 8000 magnesium stearate methylcellulose titanium dioxide - breast cancer capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated. capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. colon cancer capecitabine is indicated for the adjuvant treatment of patients with dukes' stage c and high risk stage b colon cancer, either as monotherapy or in combination with oxaliplatin. colorectal cancer capecitabine is indicated for first-line treatment of patients with metastatic colorectal cancer. oesophagogastric cancer capecitabine is indicated for the first line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

apotex nz ltd - capecitabine 500mg - film coated tablet - 500 mg - active: capecitabine 500mg excipient: colloidal silicon dioxide croscarmellose sodium hyprolose hypromellose iron oxide red iron oxide yellow lactose macrogol 8000 magnesium stearate methylcellulose titanium dioxide - breast cancer capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated. capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. colon cancer capecitabine is indicated for the adjuvant treatment of patients with dukes' stage c and high risk stage b colon cancer, either as monotherapy or in combination with oxaliplatin. colorectal cancer capecitabine is indicated for first-line treatment of patients with metastatic colorectal cancer. oesophagogastric cancer capecitabine is indicated for the first line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

apotex nz ltd - imatinib mesilate 119.5mg equivalent to imatinib 100 mg - film coated tablet - 100 mg - active: imatinib mesilate 119.5mg equivalent to imatinib 100 mg excipient: colloidal silicon dioxide crospovidone hyprolose hypromellose iron oxide red iron oxide yellow macrogol 8000 magnesium stearate - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

apotex nz ltd - imatinib mesilate 478mg equivalent to imatinib 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib 400 mg excipient: colloidal silicon dioxide crospovidone hyprolose hypromellose iron oxide red iron oxide yellow macrogol 8000 magnesium stearate - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

apotex nz ltd - candesartan cilexetil 16mg;   - tablet - 16 mg - active: candesartan cilexetil 16mg   excipient: carmellose calcium hyprolose iron oxide red lactose monohydrate magnesium stearate maize starch purified water triacetin - treatment of hypertension.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

apotex nz ltd - candesartan cilexetil 32mg;   - tablet - 32 mg - active: candesartan cilexetil 32mg   excipient: carmellose calcium hyprolose iron oxide red lactose monohydrate magnesium stearate maize starch purified water triacetin - treatment of hypertension.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

apotex nz ltd - candesartan cilexetil 4mg;   - tablet - 4 mg - active: candesartan cilexetil 4mg   excipient: carmellose calcium hyprolose lactose monohydrate magnesium stearate maize starch purified water triacetin - treatment of hypertension.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

apotex nz ltd - candesartan cilexetil 8mg;   - tablet - 8 mg - active: candesartan cilexetil 8mg   excipient: carmellose calcium hyprolose iron oxide red lactose monohydrate magnesium stearate maize starch purified water triacetin - treatment of hypertension.