Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

2%) solution for injection vials (hameln pharma ltd - lidocaine hydrochloride - solution for injection - 20mg/1ml

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

base) 3.3mg/1ml solution for injection ampoules (hameln pharma ltd - dexamethasone sodium phosphate - solution for injection - 3.3mg/1ml

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

sun pharma anz pty ltd - ganirelix acetate, quantity: 0.269 mg (equivalent: ganirelix, qty 0.25 mg) - injection, solution - excipient ingredients: glacial acetic acid; sodium hydroxide; mannitol; water for injections - for the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques.

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

theramex australia pty ltd - ganirelix, quantity: 0.25 mg - injection, solution - excipient ingredients: glacial acetic acid; water for injections; mannitol; sodium hydroxide - for the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 2 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 1 g - injection, solution - excipient ingredients: water for injections; proline; polysorbate 80 - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

interpharma pty ltd - apomorphine hydrochloride hemihydrate, quantity: 5 mg/ml - injection, solution - excipient ingredients: sodium metabisulfite; sodium chloride; hydrochloric acid; water for injections - indicated to reduce the number and severity of ?off? phases in patients with parkinson?s disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. conventional therapy should be continued during ?on? phases.

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

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; arginine; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; water for injections - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards.,actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx.,in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.,actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate.,giant cell arteritis (sc formulations only),actemra is indicated for the treatment of giant cell arteritis (gca) in adult patients.,polyarticular juvenile idiopathic arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations),intravenous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.,subcutaneous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.,actemra iv and sc can be given alone or in combination with methotrexate (mtx).

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

teva pharma australia pty ltd - lipegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 20; sorbitol; sodium hydroxide; water for injections - lonquex? is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

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

juno pharmaceuticals pty ltd - morphine hydrochloride trihydrate, quantity: 10 mg/ml - injection, solution - excipient ingredients: water for injections; dilute hydrochloric acid - - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. - symptomatic relief of severe and intractable pains in terminal cancer patients. - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.