União Europeia - tcheco - EMA (European Medicines Agency)

alfasigma s.p.a. - methylthioniniumchloridu - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

República Tcheca - tcheco - SUKL (Státní ústav pro kontrolu léčiv)

as kalceks, riga array - 3406 natrium-oxybÁt - perorální roztok - 500mg/ml - natrium-oxybÁt

União Europeia - alemão - EMA (European Medicines Agency)

alfasigma s.p.a. - methylthioniniumchlorid - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 48088 - humeral head prosthesis - comprehensive shoulder system standard taper adaptor. made from titanium alloy. the adaptor has two male tapers (one mates with the head, one mates with the stem), which are offset from each other. this allows the head to have variable offset. use with biomet comprehensive shoulder system. taper adaptor for use as a component of the comprehensive shoulder system. indications include: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. revision where other devices or treatments have failed. correction of functional deformity. fractures of the proximal humerus, where other methods of treatment are deemed inadequate. difficult clinical management problems, including cuff arthropathy, where other methods of treatment are deemed inadequate.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 48093 - reverse shoulder prosthesis head - comprehensive r versa-dial glenosphere (40mm diameter) is used in conjunction with humeral bearing and humeral tray component. it attaches to glenosphere baseplate through use of standard or mini baseplate taper adapter that inserts into rear of glenosphere. features variable offsets which allow their use with the versa-dial taper adapter to allow surgeon to ?dial in? an offset in order to adjust the center of rotation of the implant. composed of cobalt-chrome alloy (contains nickel). the comprehensive reverse versa dial glenosphere is a component of the comprehensive reverse shoulder system which is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. the patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. the comprehensive reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 39702 - coated shoulder humeral stem prosthesis - this stem is made of cobalt chrome alloy with titanium alloy porous plasma spray coating at the proximal end, and smooth distal end for cement fixation. two lateral fins with three suture holes and a single medial fin with one suture hole aid tuberosity fixation. comprehensive fracture stems are intended for use with the bio-modular humeral heads and glenoid components and versa-dial humeral heads. stems are 122mm long; available in 2 mm diameter increments comprehensive fracture stem with plasma porous spray as component for use in a total, reverse or partial shoulder replacements. indications for use: 1. non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. rheumatoid arthritis. 3. revision where other devices or treatments have failed. 4. correction of functional deformity. 5. fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. indicated for either cemented or uncemented biological fixation applications.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 48091 - reverse shoulder prosthesis base plate - titanium alloy mini baseplate with hydroxyapatite coating over porous plasma spray for uncemented biologic fixation; baseplate has 4 identical peripheral locking screw holes for additional fixation; central boss for enhanced fixation and resistance to shear forces. use with biomet comprehensive reverse shoulder system and reverse mini instrumentation. packaged with ti alloy mini taper adaptor. mini baseplate and taper adaptor for the comprehensive reverse shoulder system. indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. the patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 39702 - coated shoulder humeral stem prosthesis - intramedullary humeral stem with for fixation into the remaining humeral bone. made from ti-al-4v alloy. the terminal portion is porous coated for biological fixation in shoulder applications and cement adherence in both proximal humeral and elbow applications. the distal portion is grit blasted. the stems, proximal bodies, intercalary segments and distal bodies connect to each other via a taper junction and locking screws. the ti-6al-4v modular stem is part of the comprehensive segmental revision system. it is designed to create a proximal, distal and total humeral replacement and can be used in total or partial shoulder replacements when used with components from the comprehensive total shoulder system and bio-modular shoulder system. indications for use include: non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. revision where other devices or treatments have failed. correction of functional deformity. oncology applications including bone loss due to tumor resection.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 39702 - coated shoulder humeral stem prosthesis - intramedullary humeral stem for fixation into the remaining humeral bone. made from co-cr-mo. the terminal portion has a porous ti-al-4v alloy coating for biological fixation in shoulder applications and cement adherence in both proximal humeral and elbow applications. the distal portion is grit blasted. the stems, proximal bodies, intercalary segments and distal bodies connect to each other via a taper junction and locking screws. the cocr modular stem is part of the comprehensive segmental revision system. it is designed to create a proximal, distal and total humeral re placement and can be used in total or partial shoulder replacements when used with components from the comprehensive total shoulder system and bio-modular shoulder system. indications for use include: non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. revision where other devices or treatments have failed. correction of functional deformity. oncology applications including bone loss due to tumor resection.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 60511 - reverse shoulder prosthesis body - titanium humeral tray component, reverse shoulder joint replacement prosthesis. an expanding ring locks around the humeral bearing. six suture slots provide attachment points. compatible with all humeral bearings and glenospheres. the humeral tray is made from ti-6al-4v alloy and the locking ring is made from cp titanium. comprehensive reverse shoulder titanium humeral tray is intended for use as a component of a shoulder replacement prosthesis. indications include patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. the patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.