Singapor - Ingliż - HSA (Health Sciences Authority)

transmedic pte ltd - hematology - the haemonetics cell saver 5+ system and its related accessory devices are intended to be used for recovery of blood shed during or after an operation, or as the result of trauma, processing the blood by a centrifugation and washing procedure and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. the cs5+ system should be considered for a procedure when it is anticipated that blood will be shed from a clean wound and retrieved at a rate permitting aspiration without undue hemolysis. the presence of any of the following criteria may be an indication for blood salvage: • anticipated blood loss is 15% or more of the patient’s estimated blood volume. • blood would ordinarily be crossmatched. • more than 10% of the patients undergoing the type of procedure require transfusion. • the mean transfusion rate for the type procedure exceeds one unit.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - brexucabtagene autoleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: albumin; dimethyl sulfoxide; sodium chloride - cellular therapies - tecartus is a genetically modified autologous immunocellular therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (mcl), who have received two or more lines of therapy, including a btk inhibitor, unless ineligible or intolerant to treatment with a btk inhibitor.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

specialised therapeutics alim pty ltd - tafasitamab, quantity: 200 mg - injection, powder for - excipient ingredients: polysorbate 20; citric acid monohydrate; trehalose dihydrate; sodium citrate dihydrate - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).,this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bortezomib, quantity: 3 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - - velcade, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. - velcade, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. - velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bortezomib, quantity: 1 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - - velcade, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. - velcade, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. - velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - - velcade, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. - velcade, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. - velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib-aft, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib-aft, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib-aft is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib-aft in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 1 mg - injection, powder for - excipient ingredients: mannitol - bortezomib, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol - bortezomib, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

interpharma pty ltd - bortezomib, quantity: 3.5 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol - bortezomib ever pharma, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib ever pharma, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib ever pharma is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib ever pharma in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.