Giotrif New Zealand - English - Medsafe (Medicines Safety Authority)

giotrif

boehringer ingelheim (nz) ltd - afatinib dimaleate 44.34mg equivalent to afatinib 30 mg - film coated tablet - 30 mg - active: afatinib dimaleate 44.34mg equivalent to afatinib 30 mg excipient: colloidal silicon dioxide crospovidone hypromellose indigo carmine aluminium lake lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose polysorbate 80 purified talc titanium dioxide - giotrif is indicated as monotherapy for the treatment of patients with: locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have epidermal growth factor receptor (egfr) mutations. locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.

Giotrif New Zealand - English - Medsafe (Medicines Safety Authority)

giotrif

boehringer ingelheim (nz) ltd - afatinib dimaleate 59.12mg equivalent to afatinib 40 mg - film coated tablet - 40 mg - active: afatinib dimaleate 59.12mg equivalent to afatinib 40 mg excipient: colloidal silicon dioxide crospovidone hypromellose indigo carmine aluminium lake lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose polysorbate 80 purified talc titanium dioxide - giotrif is indicated as monotherapy for the treatment of patients with: locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have epidermal growth factor receptor (egfr) mutations. locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.

Giotrif New Zealand - English - Medsafe (Medicines Safety Authority)

giotrif

boehringer ingelheim (nz) ltd - afatinib dimaleate 73.9mg equivalent to afatinib 50 mg - film coated tablet - 50 mg - active: afatinib dimaleate 73.9mg equivalent to afatinib 50 mg excipient: colloidal silicon dioxide crospovidone hypromellose indigo carmine aluminium lake lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose polysorbate 80 purified talc titanium dioxide - giotrif is indicated as monotherapy for the treatment of patients with: locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have epidermal growth factor receptor (egfr) mutations. locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.

Ofev New Zealand - English - Medsafe (Medicines Safety Authority)

ofev

boehringer ingelheim (nz) ltd - nintedanib esilate 120.4mg equivalent to 100 mg nintedanib;   - liquid filled capsule - 100 mg - active: nintedanib esilate 120.4mg equivalent to 100 mg nintedanib   excipient: gelatin glycerol hard fat iron oxide red iron oxide yellow lecithin medium-chain triglycerides opacode black s-1-17823 purified water titanium dioxide - ofev is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (nsclc) of adenocarcinoma tumour histology after failure of first line chemotherapy.

Ofev New Zealand - English - Medsafe (Medicines Safety Authority)

ofev

boehringer ingelheim (nz) ltd - nintedanib esilate 180.6mg equivalent to 150 mg nintedanib;   - liquid filled capsule - 150 mg - active: nintedanib esilate 180.6mg equivalent to 150 mg nintedanib   excipient: gelatin glycerol hard fat iron oxide red iron oxide yellow lecithin medium-chain triglycerides opacode black s-1-17823 titanium dioxide - ofev is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (nsclc) of adenocarcinoma tumour histology after failure of first line chemotherapy.

Jardiance New Zealand - English - Medsafe (Medicines Safety Authority)

jardiance

boehringer ingelheim (nz) ltd - empagliflozin 10mg;  ;   - film coated tablet - 10 mg - active: empagliflozin 10mg     excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow 02b38190 - type 2 diabetes mellitus glycaemic control: jardiance is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above as: monotherapy - when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. add-on combination therapy - in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see further information in section 5.1).

Jardiance New Zealand - English - Medsafe (Medicines Safety Authority)

jardiance

boehringer ingelheim (nz) ltd - empagliflozin 25mg;  ;   - film coated tablet - 25 mg - active: empagliflozin 25mg     excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow 02b38190 - type 2 diabetes mellitus glycaemic control: jardiance is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above as: monotherapy - when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. add-on combination therapy - in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see further information in section 5.1).

Mobic New Zealand - English - Medsafe (Medicines Safety Authority)

mobic

boehringer ingelheim (nz) ltd - meloxicam 7.5mg - tablet - 7.5 mg - active: meloxicam 7.5mg excipient: colloidal silicon dioxide lactose monohydrate magnesium stearate microcrystalline cellulose povidone sodium citrate dihydrate - · symptomatic treatment of painful osteoarthritis (arthrosis, degenerative joint disease). · symptomatic treatment of rheumatoid arthritis. in patients for whom longer-term use may be required, treatment efficacy should be reviewed within the first month of treatment and mobic withdrawn if there is a lack of therapeutic benefit. patients on long-term treatment should be reviewed regularly, such as every three months with regards to efficacy, risk factors and the ongoing need for treatment. the decision to prescribe a selective cox-2 inhibitor should only be made after assessment of the individual patient's overall risk for developing severe adverse events e.g. history of cardiovascular, renal, or gastrointestinal disease, and after use of alternative therapies such as non-pharmacological interventions and simple analgesic therapy where these have been found to lack analgesic efficacy or to have unacceptable adverse effects.

Actilyse New Zealand - English - Medsafe (Medicines Safety Authority)

actilyse

boehringer ingelheim (nz) ltd - alteplase 10mg - injection with diluent - 10 mg - active: alteplase 10mg excipient: arginine nitrogen phosphoric acid polysorbate 80 water for injection - actilyse is indicated for fibrinolytic therapy in acute thrombotic artery occlusion to restore coronary artery patency, reduce infarct size, preserve ventricular function, prevent cardiac insufficiency and reduce mortality · 90 minutes (accelerated) dose regimen: for patients in whom treatment can be started within 6 h of symptom onset; · 3 hour dose regimen: for patients in whom treatment can be started between 6 - 12 hrs after symptom onset.

Actilyse New Zealand - English - Medsafe (Medicines Safety Authority)

actilyse

boehringer ingelheim (nz) ltd - alteplase 20mg - injection with diluent - 20 mg - active: alteplase 20mg excipient: arginine nitrogen phosphoric acid polysorbate 80 water for injection - actilyse is indicated for fibrinolytic therapy in acute thrombotic artery occlusion to restore coronary artery patency, reduce infarct size, preserve ventricular function, prevent cardiac insufficiency and reduce mortality · 90 minutes (accelerated) dose regimen: for patients in whom treatment can be started within 6 h of symptom onset; · 3 hour dose regimen: for patients in whom treatment can be started between 6 - 12 hrs after symptom onset.