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

life healthcare pty ltd - 61561 - body femoral/tibial extension stem, uncoated - composed of tial6v4 with silver anti-infective coating. consists of two parts: the mutars connecting part distal & mutars connecting part proximal. the two parts are connected to each other with the mutars screw for connecting part. utilizes the mutars cylindrical fit & serration connection design for attachment to the distal femur or modular proximal tibia component and a femoral or tibial stem. the connecting part has 1 retention ring for securing a pet mesh soft tissue attachment tube. a component of the mutars system intended to be sued as an extraosseous length adjustment in the area of the distal femur or proximal tibia for the bridging of bone defects. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis. the silver coated surface builds a long term prophylaxis against the colonisation of human pathogenic bacteria such as staphylococcus aureus and epidermis, exclusive enterobacteriae and should not be considered as acute treatment.

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

life healthcare pty ltd - 33692 - rotating hinged total knee prosthesis - composed of tial6v4 with silver anti-infective coating. to be combined with the mutars modular proximal tibia to bridges bone defects in the area of the proximal tibia. design has a retention ring for securing a pet mesh soft tissue attachment tube. the connecting part is attached to the modular proximal tibia component by the means of two screws. the distal end of the connecting part provides a cylindrical fit connection for connecting with a tibial stem and/or extension piece(s). a component of the mutars system intended to be used as a component of a replacement for the proximal section of the tibia as part of a total knee replacement or revision. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis. the silver coated surface builds a long term prophylaxis against the colonisation of human pathogenic bacteria such as staphylococcus aureus and epidermis, exclusive enterobacteriae and should not be considered as acute treatment.

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

life healthcare pty ltd - 58084 - diaphysis prosthesis - composed of cocrmo alloy. the surface is sandblasted and provides a silver coating which is applied circumferentially on the extra osseous part of the component. it is to be combined with the mutars connecting part for diaphyseal implant. the two parts are attached to each other by the means of the mutars screws for diaphyseal implant and can be combined with femoral stems & extension pieces depending on the size & position of the resection required. a component of the mutars system intended to bridge diaphyseal bone defects of the femoral bone. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis. the silver coated surface builds a long term prophylaxis against the colonisation of human pathogenic bacteria such as staphylococcus aureus and epidermis, exclusive enterobacteriae and should not be considered as acute treatment.

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

life healthcare pty ltd - 58084 - diaphysis prosthesis - composed of tial6v4 with silver anti-infective coating. a component of the mutars (modular universal tumor and revision) system. connects between the mutars diaphyseal implant and an extension piece or directly to a femoral stem. a connecting part for a diaphyseal implant to bridge diaphyseal bone defects of the femoral bone with a silver coating to prevent infection and colonisation of the implant. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis. the silver coated surface builds a long term prophylaxis against the colonisation of human pathogenic bacteria such as staphylococcus aureus and epidermis, exclusive enterobacteriae and should not be considered as acute treatment.

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

life healthcare pty ltd - 58085 - knee arthrodesis prosthesis - composed of tial6v4 coated with silver to prevent infection. a part of the mutars (modular universal tumor and revision) system. connects with a mutars femoral stem and tibial stem for complete replacement of the knee joint with a rigid connection. may also interconnect with mutars extension piece/s and connecting part depending on the size of the resection. a fused (non-articulating) replacement for the knee joint intended to be implanted after failed primary knee arthroplasty and which functions as a bridge between the resected metaphyses of the femur and tibia. arthrodesis implants are indicated, in the case of - massive bone loss with insufficient skin and soft tissue coverage because of tumors, revisions, fractures or morbus gorham. - a deficit extensor mechanism. the silver coated surface builds a long term prophylaxis against the colonisation of human pathogenic bacteria such as staphylococcus aureus and epidermis, exclusive enterobacteriae and should not be considered as acute treatment.

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

heraeus medical australia pty ltd - 46059 - orthopaedic cement, medicated - palacos fast r+g is a very fast-curing x-ray positive bone cement based on polymethylmethacrylate. it contains the aminoglycoside antibiotic gentamicin to protect the cured cement and surrounding tissue from colonisation with gentamicin-sensitive germs. contains zirconium dioxide as an x-ray contrast agent. the bone cement is produced immediately prior to use by mixing the polymer powder component and the liquid monomer component. this creates a plastic paste which cures within a few minutes. palacos fast r+g is indicated for - stable anchoring of total or partial joint endoprostheses in the bone, especially acetabula and for total or partial endoprostheses of small joints - filling and stabilisation of bone defects as part of osteosynthetic treatment or in the case of endoprosthetic replacement operations palacos fast r+g may not be used to anchor the femoral component of hip joint endoprostheses.

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

qiagen pty ltd - ct921 - enterococcus ivds - ivd's intended for the qualitative detection of nucleic acids encoding vana and vanb vancomycin resistance genes from patients at risk for vancomycin resistant enterococcus (vre) colonisation.

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

heraeus medical australia pty ltd - 35217 - cement, orthopaedic, bone - palacos r+g pro is the fast-curing radiopaque poly(methyl methacrylate) based palacos r+g bone cement, packed in a closed mixing and application system ready-to-mix. contains the antibiotic gentamicin for protection of the cured cement and contiguous tissue against colonisation by microorganisms sensitive to gentamicin. the cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. this forms a ductile dough, which sets within a few minutes. palacos r+g pro is indicated for; ;? stable attachment of total or partial joint endoprostheses in bone ? filling and stabilising bone defects within the scope of internal fixation treatment or for endoprosthesis exchange surgery ? primary and secondary coverage of skull bone defects

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

phebra pty ltd - colistimethate sodium, quantity: 1 million iu - inhalation - excipient ingredients: - colistimixin phebra powder for nebuliser solution is indicated for the treatment of colonisation and infections of the lung due to susceptible pseudomonas aeruginosa in patients with cystic fibrosis. consideration should be given to official guidance on the appropriate use of antibacterial agents.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

morningside healthcare ltd - clarithromycin - modified-release tablet - 500mg