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

medacta australia pty ltd - 48094 - shoulder prosthesis screw - device manufactured from titanium alloy and enhanced with type-ii anodization. they are designed to aid fixation of the glenoid baseplate to bone. device intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. the humeral components are for cemented and cementless use.

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

medacta australia pty ltd - 48093 - reverse shoulder prosthesis head - the glenosphere is attached to the glenoid baseplate and secured by a taper connection and a fastening screw. the centre of the glenosphere is located at 4 or 9mm lateral to the deepest point of the reamed glenoid vault, while the inferior eccentricity is fixed at 2mm throughout the whole glenosphere range. the inferior offset reduces the risk of scapular notching, while the two options of lateralization allow the surgeon to select the desired level of rom and joint tension. device indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement. the patient?s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. the glenoid baseplate is intended for cementless application with the addition of screws for fixation.

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

medacta australia pty ltd - 39702 - coated shoulder humeral stem prosthesis - the device is manufactured from titianium. the shape of the humeral diaphysis devices was developed to be anatomical and provide a stable positioning in the canal, especially in the calcar region. fixation is achieved without the use of cement; stability is fostered by a titanium plasma spray and hydroxyapatite coating in the metaphyseal region. the devices can be used in anatomic and reverse configurations using either the anatomic metaphysis or the reverse metaphysis. device intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint.

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

medacta australia pty ltd - 48092 - reverse shoulder prosthesis cup - the humeral reverse hc liner has a 5? wedged shape and can be coupled with the humeral reverse metaphysis in two orientations: depending on the joint?s stability of the single patient, the surgeon can intraoperatively decide between an inclination of 145?, which allows for a wider range of motion at the cost of a reduced stability in total adduction, or 155?, which is associated to a higher stability and reduced range of motion. device indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement. the patient?s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. the glenoid baseplate is intended for cementless application with the addition of screws for fixation.

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

medacta australia pty ltd - 60511 - reverse shoulder prosthesis body - the device is manufactured from titanium is used with the humeral diaphysis cementless implant. it is designed as an inset adapter to prevent excessive distalisation of the humerus and over-tensioning of the deltoid, and to reduce the lever arm during shoulder abduction. the device is fixed to the humeral diaphysis cementless implant with a locking screw. device indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement. the patient?s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

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

meda pharmaceuticals ltd - nefopam hydrochloride - oral tablet - 30mg

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

meda pharmaceuticals pty ltd - pimecrolimus -

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - leflunomide - arthritis, rheumatoid - selective immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard).recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - zoledronic acid monohydrate - fractures, bone; cancer - drugs for treatment of bone diseases - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.treatment of adult patients with tumour-induced hypercalcaemia (tih).

United States - English - NLM (National Library of Medicine)

meda pharmaceuticals inc. - olsalazine sodium (unii: y7jew0xg7i) (olsalazine - unii:uls5i8j03o) - olsalazine sodium 250 mg - dipentum is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine. dipentum is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the excipients in dipentum.