Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

boehringer ingelheim animal health australia pty. ltd. - leptospira icterohaemorrhagiae antigen; canine coronavirus vaccine - antigen - misc. vaccines or anti sera - leptospira icterohaemorrhagiae antigen vaccine-antigen active 1.0 rp; canine coronavirus vaccine - antigen vaccine-viral active 1.62 rp - immunotherapy - dog - over 6 weeks old - canine adenovirus - type 1 | canine adenovirus - type 2 | canine coronavirus | canine distemper | canine parainfluenza | canine parvovirus | leptospira icterohaemorrhagiae | parvovirus

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

abbott vascular division of abbott medical australia pty ltd - 53616 - bare-metal coronary artery stent - stent graft is made using sandwich technique with ultra thin layer of ptfe placed between two ss stents and pre-mounted on rapid exchange delivery system, with balloon and stent graft at distal end of catheter. proximal end provides inflation of balloon with contrast. the central distal lumen permits guidewire insertion. shaft of catheter, tip and taper of balloon are coated with hydrophilic coating. two radiopaque markers mark working length of balloon and aid stent positioning. the graftmaster rx is a balloon-expandable pre-mounted coronary stent graft for intraluminal chronic placement in coronary arteries or aorto-coronary bypass grafts for the treatment of coronary artery aneurysm; coronary bypass-vein graft aneurysm;acute coronary artery perforation and acute coronary artery rupture.

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

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - stenting system for coronary arteries, supplied pre-loaded onto an angioplasty balloon catheter. the xience prime is intended to deliver and deploy a balloon-expandable, drug coated metal stent in the de novo and restenotic native coronary arteries. five different stent diameters in six different lengths are available. drug dose (micrograms)varies with stent size. the xience prime? everolimus eluting coronary stent system is indicated for improving coronary artery luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. ? for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a s

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

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - stenting system for coronary arteries, supplied pre-loaded onto an angioplasty balloon catheter. the xience prime ll is intended to deliver and deploy a balloon-expandable, drug coated metal stent in the de novo and restenotic native coronary arteries. five different stent diameters in two different lengths are available. drug dose (micrograms) varies with stent size. indicated for improving coronary luminal diameter in the following: patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions; for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset; for the treatment of patients with concomitant diabetes, acute coronary syndrome, due vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels (rvd equal to or < 2.77 mm), and in lesions where treatment results in the jailing of side branches (lesion with a side branch < 2 mm in diameter or equal

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

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - stenting system for coronary arteries, supplied pre-loaded onto an angioplasty balloon catheter. the xience prime sv is intended to deliver and deploy a balloon expandable, drug coated metal stent in the de novo and restenotic native coronary arteries. six different lengths of 2.25mm diameter stent are available. drug dose (micrograms) varies with stent length. the xience prime sv everolimus eluting coronary stent system is indicated for improving coronary luminal diameter in the following: " patients with symptomatic ischemic heart disease due to discrete de novo native coronary ; artery lesions. " for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. " for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel ; lesions (two lesions in two different epicardial vessels), lesions residing within small coronary ; vessels; lesions where treatment results in the jailing of side branches (lesi

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

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - a balloon expandable, drug coated stent pre-mounted on rapid exchange delivery system. stent acts as scaffold to open the blockage in artery; polymers coated over stent provide a drug reservoir and control release profile of the anti-proliferative drug. two radiopaque markers underneath balloon mark working length of balloon and expanded stent length. two proximal delivery system shaft markers indicate relative position of delivery system to the brachial or femoral guiding catheter. the xience xpedition everolimus eluting coronary stent system ise indicated for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. ? for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions res

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

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - a balloon expandable, drug coated stent pre-mounted on rapid exchange delivery system. stent acts as scaffold to open the blockage in artery; polymers coated over stent provide a drug reservoir and control release profile of the antiproliferative drug. two radiopaque markers underneath balloon mark working length of balloon and expanded stent length. two proximal delivery system shaft markers indicate relative position of delivery system to the brachial or femoral guiding catheter. the xience xpedition everolimus ll eluting coronary stent system ise indicated for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. ? for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesion

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

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - a balloon expandable, drug coated stent pre-mounted on rapid exchange delivery system. stent acts as scaffold to open the blockage in artery; polymers coated over stent provide a drug reservoir and control release profile of the antiproliferative drug. two radiopaque markers underneath balloon mark working length of balloon and expanded stent length. two proximal delivery system shaft markers indicate relative position of delivery system to the brachial or femoral guiding catheter. the xience xpedition everolimus sv eluting coronary stent system ise indicated for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. ? for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesion

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

device technologies australia pty ltd - 57788 - mesh-sleeve coronary artery stent - the begraft coronary stent graft system consists of: - a balloon-expandable cobalt-chromium (l605) stent, covered with an eptfe graft material, which is - pre-mounted on the balloon of a rapid exchange (rx)stent delivery system. the delivery system is compatible with 0.014? guide wires and is available in usable lengths of 143 cm and 153 cm. the begraft coronary stent graft system is indicated for transluminal implantation in coronary arteries or aorto-coronary bypass grafts for the treatment of: 1. acute perforation or rupture of coronary arteries. 2. aneurysm of coronary arteries or coronary bypass-vein graft.

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

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - xience alpine is a pre-mounted l-605 cobalt chromium (cocr) alloy stent with a coating that consists of a blend of the anti-proliferative drug everolimus and polymers. two radiopaque markers, located underneath the balloon, fluoroscopically mark the working length of the balloon and the expanded stent length. two proximal delivery system shaft markers indicate relative position of delivery system to the end of the brachial or femoral guiding catheter. the xience alpine? everolimus eluting coronary stent system is indicated for improving coronary artery luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. ? for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of elderly patients (age ? 65), and for treatment of both men and women. ? for treatment of patients with high bleeding risk (hbr) under dual antiplatelet therapy (dapt) as short as 28 days. for the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (defined as coronary artery lesions with timi flow 0 and lasting longer than 3 months); and coronary artery bifurcation lesions. in all cases, the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter of ? 2.00 mm and ? 4.25 mm.