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

bayer australia ltd - oxymetazoline hydrochloride, quantity: 0.5 mg/ml - spray, nasal - excipient ingredients: povidone; purified water; glycerol; macrogol 1450; dispersible cellulose; dibasic sodium phosphate; benzalkonium chloride; monobasic sodium phosphate monohydrate; benzyl alcohol; disodium edetate; flavour - symptomatic relief of nasal and nasopharyngeal congestion associated with the common cold and flu, hayfever and sinusitis, and to facilitate visual intranasal examination. by decreasing congestion around the eustachian tube ostia, drixine nasal may be useful in the adjunctive treatment of congestion associated with middle ear conditions.

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

life systems medical pty ltd - 35855 - catheter, cardiac, ablation - the device is prepared by inserting endoscope into catheter, then placed into left atrium via std transeptal puncture & guided to the pv orifice using a sheath. balloon is inflated & endoscope within allows physician to visualise & perfect balloon/tissue contact. lesion generator within the catheter, used with laser, delivers arc shaped patterns of light energy into atrial or ostial wall under endoscopic guidance. ir laser energy raises tissue temp. resulting in thermal ablation of target tissue the easac catheter is a single use disposable device for the isolation of pulmonary veins to be used in the treatment of af. it is introduced percutaneously in the setting of an electrophysiology or cathererization laboratory. the easac catheter is a component of the easac system which is intended to be used to direct light energy in the antrum of the pulmonary veins to create conduction block as a treatment for atrial fibrillation in patients aged 18 or older.

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

orbusneich medical pty ltd - 17184 - catheter, angioplasty, balloon dilatation - the scoreflex is a semi-compliant balloon that utilizes a two-wire dilatation mechanism. during a gradually controlled balloon dilatation, controlled force is applied to facilitate plaque fractures at low and gradually-increasing inflation pressures. the scoreflex offers a wide range of balloon sizes to accommodate various vascular anatomies. it has also a potentially broad application including small vessel disease, ostial lesions, bifurcation lesions, as well as in-stent restenosis. balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischaemia for the purpose of improving myocardial perfusion.

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 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. the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, or 28 mm) with a reference vessel diameter of ? 2.5 mm and ? 4.25 mm.

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), 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. the treated lesion length should be less than the nominal stent length (33 mm or 38 mm) with a reference vessel diameter of ? 2.5 mm and ? 4.25 mm.

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), 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. the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, or 28 mm) with a reference vessel diameter of ? 2.25 mm and ? 2.5 mm.

Singapore - English - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - loratadine; pseudoephedrine sulphate - syrup - 5 mg/5 ml - loratadine 5 mg/5 ml; pseudoephedrine sulphate 60 mg/5 ml

Singapore - English - HSA (Health Sciences Authority)

teva pharmaceutical investments singapore pte. ltd. - pseudoephedrine hcl; triprolidine hcl - syrup - 30 mg/5 ml - pseudoephedrine hcl 30 mg/5 ml; triprolidine hcl 1.25 mg/5 ml

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

point of care diagnostics australia pty ltd - ct872 - coagulation calibrator/control ivds - ivds that are intended to be used in testing to establish known points of reference and/or verify the performance of coagulation assays.

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

point of care diagnostics australia pty ltd - ct871 - general coagulation ivds - measuring prothrombin time (pt) / international normalised ratio (inr) in human blood samples.