Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

amplitude australia pty ltd - 43168 - non-constrained polyethylene acetabular liner - the device is a modular, advanced bearing surface liner, composed of amplitude highly cross-linked polyethylene, that minimizes wear and increases durability. high tolerance machining and a stable liner locking mechanism provide ease in liner insertion and reduces the potential for wear and particulate debris generation at the cup-liner interface. the acetabular systems feature a cross-linked uhmwpe bearings with a 20? hooded and neutral options. a device intended for replacement of the total hip joint in order to reduce pain and restore hip function in comparison to the preoperative status and intended to be used in primary replacement for total hip arthroplasty. the device is indicated for use as a component of a total hip replacement for the relief of pain and significant disability in case of: - primitive and secondary hip osteoarthritis; - aseptic osteonecrosis; - rheumatoid arthritis/inflammatory diseases; - hip and acetabular fracture; - hip joint arthroplasty when other devices or treatments have failed.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 34179 - stent, vascular, coronary artery - a premounted l 605 cobalt chromium alloy stent. two radiopaque markers located underneath the balloon, which fluoroscopically mark the balloon and expanded stent length improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed interventional therapy of de nobo and restenotic native coronary artery lesions with diameters of 2.0 to 2.5 mm.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 34179 - stent, vascular, coronary artery - a pre-mounted l-605 cobalt chromium alloy stent. two radiopaque markeres, located underneath the balloon which fluoroscopically mark the working length of the balloon and the expanded stent. the coronary stent systems are indicated for improving coronary luminal diameter in patients with symptomatic ischaemic heart disease due to discrete de novo native coronary artery lesions (length < 26mm) with reference vessel diameters ranging from 2.75mm to 4.0mm and for restoring coronary flow in patients experiencing acute myocardial infarction who within 12 hours of symptom onset present with native coronary artery lesions of < 26mm in length and a reference vessel diameter of 3.0mm to 4.0mm.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

link orthopaedics australia pty ltd - 32831 - uncoated knee femur prosthesis - the total condylar replacement femoral component is manufactured from cocrmo alloy. three (3) sizes are available for the left and right side, in widths ranging from 60 mm to 75 mm. femoral components have a modular taper connection for connection with modular stems. hinge knee prosthesis is linked by an axis mechanism. the femoral and tibial components are linked by the special anti-luxation device of the plateau without reducing the motional and rotational sequences the link endo-model evo knee system is a non-active, surgically-invasive, implantable device which is intended for long-term replacement of a diseased and/ or defective knee joint in the human body. it can be used with full-grown, anesthetized patients of any ethnic origin and sex. the link endo-model evo knee system is implanted with or without cement related to the selected implant version. the femoral component is generally indicated for use in mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. these include primary and secondary osteoarthritis; rheumatoid arthritis; revision after primary or revision total knee replacement, bone necrosis, varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers; extreme cases of varus/valgus deformities or muscular deficiency; oncological and revision surgery in lower limb (in conjunction with the endo-model w/ endo-model evo-w and the megasystem-c).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

link orthopaedics australia pty ltd - 32831 - uncoated knee femur prosthesis - the total condylar replacement femoral component is manufactured from cocrmo alloy. three (3) sizes are available for the left and right side, in widths ranging from 60 mm to 75 mm. femoral components feature female tapers and have a modular taper connection for connection with modular stems. joint components are equipped with an anti-luxation device. the femoral and tibial components are linked by special anti-luxation device of the plateau without reducing motional and rotational sequences. the link endo-model evo knee system is a non-active, surgically-invasive, implantable device which is intended for long-term replacement of a diseased and/ or defective knee joint in the human body. it can be used with full-grown, anesthetized patients of any ethnic origin and sex. the link endo-model evo knee system is implanted with or without cement related to the selected implant version. the femoral component is generally indicated for use in mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. these include primary and secondary osteoarthritis; rheumatoid arthritis; revision after primary or revision total knee replacement, bone necrosis, varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers; oncological and revision surgery in lower limb (in conjunction with the endo-model w/ endo-model evo-w and the megasystem-c).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

link orthopaedics australia pty ltd - 38156 - ceramic femoral head prosthesis - the ceramic femoral prosthesis head replaces in combination with femoral stem and acetabular components the diseased hip joint. key functional elements: - ceramic material - 12/14 mm taper connection for modular femoral stems - different head diameters - different head neck length for optimal adjustment ceramic prosthesis head indicated for use in treatment of mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures ? primary and secondary coxarthrosis ? osteoarthritis ? necrosis of the femoral head ? femoral neck fractures ? revision after implant loosening

Nova Zelanda - anglès - Ministry for Primary Industries

innovative medical solutions limited - cross-linked polyacrylamide hydrogel 2.5% in water - cross-linked polyacrylamide hydrogel 2.5% in water 1,000 g/litre - musculoskeletal modifier

Austràlia - anglès - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ims vet pty ltd - cross-linked polyacrylamide hydrogel - parenteral liquid/solution/suspension - cross-linked polyacrylamide hydrogel solvent-water active 25.0 mg/ml - musculoskeletal system

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - colistimethate sodium -

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

link pharmaceuticals ltd - chloramphenicol sodium succinate 1.4 g equivalent to chloramphenicol 1 g - powder for injection - 1 g - active: chloramphenicol sodium succinate 1.4 g equivalent to chloramphenicol 1 g - chloramphenicol succinate is specifically indicated for bacterial meningitis, typhoid fever, rickettsial infections, intraocular infections and other serious infections where bacteriological evidence or clinical judgement indicates that chloramphenicol is an appropriate antibiotic.