欧盟 - 英文 - EMA (European Medicines Agency)

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - protein kinase inhibitors - imatinib medac is indicated for the treatment of:paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;paediatric patients with ph+cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase;adult and paediatric patients with ph+cml in blast crisis;adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy;adult patients with relapsed or refractory ph+all as monotherapy;adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement;adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp.the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited. except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

欧盟 - 英文 - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - pemetrexed - carcinoma, non-small-cell lung; mesothelioma - folic acid analogues, antineoplastic agents - malignant pleural mesothelioma pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer pemetrexed medac in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed medac is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,

欧盟 - 英文 - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 48091 - reverse shoulder prosthesis base plate - the glenoid baseplate is intended to be fixed on the glenoid bone by means of a central press-fit and with the help of glenoid polyaxial screws (locking or non-locking). the glenosphere is intended to be assembled with the glenoid baseplate by means of a taper morse connection and secured by the glenosphere screw. the ?22 and ?24.5 baseplates have 2 spherical holes for the glenoid polyaxial locking screws, while the ?27 has 4 spherical seats, and the central post is available in three lengths. 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.

澳大利亚 - 英文 - 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.

澳大利亚 - 英文 - 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.

澳大利亚 - 英文 - 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.

澳大利亚 - 英文 - 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.

澳大利亚 - 英文 - 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.

欧盟 - 英文 - EMA (European Medicines Agency)

meda ab - zaleplon - sleep initiation and maintenance disorders - psycholeptics - sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. it is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.