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

link orthopaedics australia pty ltd - 43167 - acetabular shell - metal acetabular shell component of an acetabular replacement system used for cement fixation in the acetabulum in hip arthroplasty; made from biocompatible and resilient cocrmo material with a mirror polished on the inner surface to minimize wear with satin finish metal acetabular shell cemented component of the link bimobile cup dual mobility system for the 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 ? acetabular dysplasia

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

link orthopaedics australia pty ltd - 43167 - acetabular shell - metal acetabular shell component of an acetabular replacement system used for cementless fixation in the acetabulum in hip arthroplasty; made from biocompatible and resilient cocrmo material with a mirror polished on the inner surface to minimize wear; double coated with highly porous surface to achieve primary fixation and an osteoconductive calcium phosphate coating, to ensure optimal primary and secondary implant stability. metal acetabular shell cementless component of the link bimobile cup dual mobility system for the 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 ? acetabular dysplasia

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

adler ortho australia pty ltd - 35661 - acetabulum prosthesis - the cross-linked pe/pe insert is fitted into the acetabular cup (acetabular shell) and is blocked inside the cup through a locking system present of the acetabular cup in the same group size with which the insert is coupled (i.e. equatorial teeth). it is available in different internal diameters and it articulates with the ceramic femoral head or the co-cr femoral head of the same internal diameter of the insert, permitting to restore the physiological motion of the hip joint. the cross-linked pe/pe insert is designed to be used in total hip arthroplasty (tha), as an articulating surface, and to interface with a ceramic femoral head or a co-cr femoral head, after insertion into an acetabulum prosthesis shell (acetabular cup).

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

perios pty ltd - 43167 - acetabular shell - a cross-linked polyethylene insert designed to reduce ware and as a result retard the onset of osteolysis. the device should be used only with an alumina head or a cocr metal head but not with a stainless steel head. the insert a component of the atlas system is intended for primary, dysplasic or protruding coxarthrosis; rheumatoid coxitis; coxarthrosis with necrosis of the femoral head; revision surgery in a septic or aseptic environment; congenital dislocation; traumatic injuries; femoral neck fracture and osteonecrosis of the femoral head.

New Zealand - English - Medsafe (Medicines Safety Authority)

link pharmaceuticals ltd - colistimethate sodium 384.6 mg/ml - powder for injection - 150 mg/2ml - active: colistimethate sodium 384.6 mg/ml - the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli; particularly when the infection is caused by sensitive strains of pseudomonas aeruginosa, and the following gram-negative organisms; aerobacter aerogenes, escherichia coli, klebsiella pneumoniae. pending results of appropriate bacteriologic cultures and sensitivity tests, colistimethate sodium may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms.

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

link medical products pty ltd t/a link pharmaceuticals - colistimethate sodium (equivalent: colistin, qty iu) - injection, powder for - excipient ingredients: - colistin link parental is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. it is particularly indicated when the infection is caused by sensitve strains of pseudomonas aeruginosa. this antibiotic is not indicated for infections due to proteus and neisseria. colistin link parental has proven clinically effective in treatment of infections due to the following gram-negative organisms: enterobacter aerogenes, escherichia coli, klebsiella pneumoniae and pseudomonas aeruginosa. pending results of appropriate bacterialogic cultures and sensitvity tests, colistin link parental may be used to initiate therapy in serious infections that are suspected due to gram-negative organisms.

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

link medical products pty ltd t/a link pharmaceuticals - erythromycin lactobionate, quantity: 1.4882 g/g (equivalent: erythromycin, qty 1 g) - injection, powder for - excipient ingredients: - oral erythromycin is not considered to be the antibiotic of choice in severely ill patients.,erythromycin-link (sterile erythromycin lactobionate) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. intravenous therapy should be replaced by oral administration at the appropriate time.,? upper respiratory tract infections caused by streptococcus pyogenes (group a beta-haemolytic streptococci); streptococcus pneumoniae (diplococcus pneumoniae); haemophilus influenzae (many strains of h. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved).,? lower respiratory tract infections caused by streptococcus pyogenes (group a beta-haemolytic streptococci); streptococcus pneumoniae (diplococcus pneumoniae).,? respiratory tract infections due to mycoplasma pneumoniae.,? skin and s

Singapore - English - HSA (Health Sciences Authority)

medicell pharmaceutical (s) pte. ltd. - general & plastic surgery - it is a cross-linked hyaluronic acid gel that is indicated for the treatment of facial rhytides and lipoatrophy by injection into the skin.

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

link orthopaedics australia pty ltd - 33692 - rotating hinged total knee prosthesis - the tibial component of the hinge version is manufactured from cocrmo alloy. three (3) sizes are available in widths ranging from 60 mm to 75 mm. the tibial components have also a modular taper connection for connection with modular stems. the hinge knee prosthesis is linked by an axis mechanism. 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 tibial 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).

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

link orthopaedics australia pty ltd - 55833 - press-fit hip femur prosthesis, modular - a porous coated modular cementless femoral stem made from tilastan titanium alloy is designed for the revision of failed hip stems in case of extensive proximal bone loss provides distal fixation without impending bone remodelling in proximal femur. tapered fluted stems offer less stiffness. modular stem component of the mp reconstruction prosthesis is indicated for use in treatment of mobility-limiting diseases, fractures or defects of the hip joint and the proximal femur which cannot be treated by conservative or osteosynthetic procedures ? revision arthroplasty due to juxta-articular bone defects ? revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone ? revision of loosened femoral prosthesis components by peri-/ subprosthetic fracture ? deformed proximal femur due to fractures or osteotomies ? correction of bone deficiencies, e.g. due to tumors ? large post-revision and post-trauma segmental bone defects