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

medis pharma pty ltd - oxymetazoline hydrochloride, quantity: 0.5 mg/ml - spray, nasal - excipient ingredients: dibasic sodium phosphate heptahydrate; purified water; hydrochloric acid; sodium hydroxide; disodium edetate; citric acid monohydrate; sodium chloride; benzalkonium chloride - symptomatic relief of nasal and nasopharyngeal congestion associated with common cold, hay fever and sinusitis, and to facilitate visual intranasal examination. by decreasing congestion around the eustachian tube ostia, at-eze nasal spray may be useful in the adjunctive treatment of congestion with middle ear conditions.

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

medis pharma pty ltd - oxymetazoline hydrochloride, quantity: 0.25 mg/ml - spray, nasal - excipient ingredients: benzalkonium chloride; disodium edetate; dibasic sodium phosphate heptahydrate; sodium chloride; sodium hydroxide; hydrochloric acid; citric acid monohydrate; purified water - symptomatic relief of nasal and nasopharyngeal congestion associated with common cold, hay fever and sinusitis, and to facilitate visual intranasal examination. by decreasing congestion around the eustachian tube ostia, at-eze nasal spray may be useful in the adjunctive treatment of congestion with middle ear conditions.

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 sierra 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 the delivery system to the end of the brachial or femoral guiding catheter. the xience sierra 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.

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

boston scientific pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - the synergy megatron everolimus-eluting platinum chromium coronary stent system is mounted on a balloon expandable delivery catheter, is inserted percutaneously and advanced through the vasculature to the site of the lesion. the balloon is then inflated to expand the stent to the appropriate diameter. finally, the balloon is deflated and the balloon catheter removed, leaving the stent in position. the synergy megatron stent system is intended to improve luminal diameter due to discrete, de novo native coronary artery stenosis in patients with symptomatic ischemic heart disease; including those with acute coronary syndromes (acute myocardial infarction and unstable angina), diabetes mellitus, renal failure or who are at a high risk of bleeding. the synergy megatron stent system is also indicated for use in the following coronary lesion types: ? bifurcation ? ostial ? unprotected left main ? total occlusion ? in-stent restenosis ? saphenous vein graft ? multi-vessel disease the treated lesion length should be less than the nominal stent length with a reference vessel diameter of 3.50 mm - 5.00 mm.

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

compliance management solutions - 64402 - intranasal splint, non-bioabsorbable, animal-derived - the chitogel endoscopic sinus surgery kit is a post-operative nasal hydrogel dressing that can be applied to sinuses after ess. the gel is made by combining chitosan succinimide (cs), dextran aldehyde (da), and a sodium phosphate buffer solution (bs). all components are provided sterile and are for single use only. the da is mixed with the bs until dissolved, then mixed with the cs to form the gel. the gel is applied using the malleable cannula provided into the patient?s nasal cavity. the chitogel endoscopic sinus surgery kit is indicated for use in patients undergoing nasal sinus surgery as a space occupying packing to: ? separate tissue or structures compromised by surgical trauma; ? separate and prevent adhesions between mucosal surfaces in the nasal cavity and minimize ostial stenosis following endoscopic sinus surgery; ? control minimal bleeding following surgery or trauma by tarnponade effect, blood absorption and platelet aggregation; ? act as an adjunct to aid in the natural healing process. the chitogel endoscopic sinus surgery kit is indicated for use as a nasal packing to treat epistaxis.

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 skypoint is a medical device that will deliver and deploy a balloon-expandable, drug-coated 605 stent in de novo and restenotic native arteries to improve coronary artery luminal diameter.the mode of action is mechanical opening of stenosed vessels. the radiopaque balloon markers are used to position the stent in the target lesion. the balloon is then inflated to deploy the stent, followed by withdrawal of the delivery system once stent position and full deployment have been confirmed. the xience skypoint 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 anti-platelet 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. additional indication applicable for xience skypoint ((2.0 ? 4.0 mm, 8.0 - 38 mm) and (4.5 - 5.0 mm, 12 ? 33mm)): ? for the treatment of patients presenting with left main coronary artery lesions. in all cases for ? xience skypoint ((2.0 ? 4.0 mm, 8.0 - 38 mm) and (4.5 - 5.0 mm, 12 ? 33mm)): 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 ? 5.25 mm. ? xience skypoint (2.5 ? 4.0 mm, 48 mm): the treated lesion length should be less than the nominal stent length (48 mm) with a reference vessel diameter of ? 2.50 mm and ? 4.25 mm.

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

medtronic australasia pty ltd - 61370 - drug-eluting nasal sinus stent - the propel contour sinus implant is intended for use in patients ? 18 years of age with chronic rhinosinusitis following sinus surgery to maintain patency of the frontal sinus ostia and to locally deliver mometasone furoate to the sinus mucosa. the propel contour sinus implant separates/dilates mucosal tissues, prevents obstruction by adhesions/scarring, and reduces edema. the implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

p .t . mustika ratu, indonesia - herbal tea in bag - theae folium, extract mixture