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

johnson & johnson medical pty ltd t/a depuy synthes - 48090 - press-fit shoulder humeral stem prosthesis - the global ap ball taper assembly is made from cocr and is impacted onto the humeral stem. the selected head is then placed onto the impacted ball taper assembly. the ball taper assembly allows for variable geometry of the humeral head (+15? inclination and version) for optimal patient anatomical match. the global ap ball taper assembly is one component of the global ap shoulder system which is intended for total or hemi shoulder arthroplasty. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head. 3. rotator cuff tear arthropathy.

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

johnson & johnson medical pty ltd t/a depuy synthes - 39702 - coated shoulder humeral stem prosthesis - the global advantage porocoat humeral stem is made of titanium and is coated with porocoat. porocoat coated humeral stem prostheses are indicated for cemented or cementless use with fixation provided by biological tissue ingrowth into the porous coating. the global advantage porocoat stem is designed to provide fixation within the proximal humerus and a site of attachment for a humeral head prosthesis. the global advantage porocoat humeral stem is the humeral stem component of total or hemi shoulder joint replacement. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head. 3. rotator cuff tear arthropathy.

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

johnson & johnson medical pty ltd t/a depuy synthes - 33710 - partial shoulder prosthesis - the global cap head duofix ha pc is made from cocr with its underside coated in duofix (combination of sintered titanium metal beads and hydroxyapatite) for cementless fixation. the global cap head duofix re-surfaces the humeral head and articulates with either an implanted glenoid component or without a glenoid (hemiarthroplasty). the global cap head duofix ha pc resurfaces the humeral head during total or hemi-shoulder arthroplasty and is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). 4. ununited humeral head fractures. 5. avascular necrosis of the humeral head. 6. rotator cuff tear arthropathy where the rotator cuff is either intact or repairable. 7. deformity and/or limited motion.

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

johnson & johnson medical pty ltd t/a depuy synthes - 39702 - coated shoulder humeral stem prosthesis - the global unite reverse fracture epiphyseal body is manufactured from titanium alloy. the device includes porocoat along the proximal circumference and is designed to achieve biological fixation to bone without the use of bone cement on the epiphyseal component, however the device is designed to be affixed to bone with or without bone cement. the global unite reverse fracture epipyseal body is used in conjunction with the global unite shoulder system or the delta xtend reverse shoulder system the global unite reverse fracture epiphyseal body is one component of the global unite shoulder system used in total, hemi, and reverse shoulder arthroplasty. the global unite reverse fracture epiphyseal body in conjunction with existing shoulder systems is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. the device is intended for reverse shoulder arthroplasty in treatment of the following: - fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory - irreducible 3- and 4- part fractures of the proximal humerus - ununited humeral head fractures

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

johnson & johnson medical pty ltd t/a depuy synthes - 35670 - prosthesis, internal, joint, shoulder, total - the global unite suture collar is made from titanium and facilitates anatomic reconstruction of the tuberosities. the suture collar is impacted onto the neck of the proximal body. sutures are passed through the suture collar for reattachment to the tuberosities. when all the sutures have been passed through the suture collar and implant, the humeral head can be impacted in the impaction stand or later when the stem has been implanted. the global unite suture collar is one component of the global unite shoulder system which is intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component) hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures 2. avascular necrosis of the humeral head 3. deformity and/or limited motion

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

johnson & johnson medical pty ltd t/a depuy synthes - 58950 - humeral metaphyseal anchor - the global icon anchor plate is manufactured from ti-6ai-4v, is circular, and includes four ribbed peripheral legs. the peripheral legs as well as the underside of the anchor plate component are plasma-sprayed with a thin coating of hydroxyapatite (ha) for cementless fixation. the anchor plate also includes a central female taper that mates to the male taper of the humeral head component. the global icon anchor plate is a component of the global icon stemless shoulder system intended to be used in total shoulder arthroplasty and indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. the stemless humeral components are intended for press-fit fixation without the use of bone cement.

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

johnson & johnson medical pty ltd t/a depuy synthes - 58951 - metaphyseal anchor-fixed humeral head prosthesis - the global icon humeral head component is made of cocrmo alloy and has a highly polished articular surface. the humeral heads are designed to be compatible with the global icon anchor plates and articulate with a global glenoid. the humeral head also includes a male taper that mates to the female taper of the anchor plate component. the global icon humeral head is a component of the global icon stemless shoulder system intended to be used in total shoulder arthroplasty and indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. the stemless humeral components are intended for press-fit fixation without the use of bone cement.

United Kingdom - English - VMD (Veterinary Medicines Directorate)

global vet health s.l. - amoxicillin trihydrate - powder for use in drinking water - antimicrobial - chickens, duck, pigs, turkeys

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

global medical solutions australia pty limited t/a radpharm scientific - aggregated albumin, quantity: 2.5 mg; stannous chloride dihydrate, quantity: 0.1 mg; sodium chloride, quantity: 1.2 mg; albumin, quantity: 5 mg - powder - excipient ingredients: nitrogen; water for injections - technetium tc 99m albumin aggregated injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and paediatric patients. technetium tc 99m albumin aggregated injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (leveen) shunt patency.

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

s & i cameron t/a trans global industries - evening primrose oil, quantity: 1 g (equivalent: gamma-linolenic acid, qty 100 mg) - capsule, soft - excipient ingredients: d-alpha-tocopherol; soya oil; gelatin; glycerol