Australië - Engels - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - linezolid, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: hydrochloric acid; sodium citrate; citric acid; sodium hydroxide; water for injections; glucose monohydrate - linezolid is indicated for the treatment of suspected or proven infections due to gram-positive organisms resistant to multiple classes of antibiotics, including methicillin resistant staphylococcus species and vancomycin resistant enterococcus species.,linezolid is active against gram-positive bacteria only. linezolid has no clinical activity against gram-negative pathogens. specific gram-negative therapy is required if a concomitant gram-negative pathogen is documented or suspected.

Ierland - Engels - HPRA (Health Products Regulatory Authority)

vetoquinol ireland limited - cloprostenol sodium - solution for injection - 0.250 milligram(s)/millilitre - cloprostenol

Australië - Engels - Department of Health (Therapeutic Goods Administration)

b braun australia pty ltd - midazolam hydrochloride, quantity: 5.56 mg/ml (equivalent: midazolam, qty 5 mg/ml) - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium chloride - iv as an agent for conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with a narcotic; iv for induction of anaesthesia, preliminary to administration of other anaesthetic agents. with the use of a narcotic premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time; iv for sedation in intensive care units; intermittent administration or continuous infusion; im for preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

b braun australia pty ltd - midazolam hydrochloride, quantity: 1.112 mg/ml (equivalent: midazolam, qty 1 mg/ml) - injection, solution - excipient ingredients: hydrochloric acid; sodium chloride; water for injections - iv as an agent for conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with a narcotic; iv for induction of anaesthesia, preliminary to administration of other anaesthetic agents. with the use of a narcotic premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time; iv for sedation in intensive care units; intermittent administration or continuous infusion; im for preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

b braun australia pty ltd - midazolam hydrochloride, quantity: 5.56 mg/ml (equivalent: midazolam, qty 5 mg/ml) - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium chloride - iv as an agent for conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with a narcotic; iv for induction of anaesthesia, preliminary to administration of other anaesthetic agents. with the use of a narcotic premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time; iv for sedation in intensive care units; intermittent administration or continuous infusion; im for preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

b braun australia pty ltd - midazolam hydrochloride, quantity: 5.56 mg/ml (equivalent: midazolam, qty 5 mg/ml) - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid - iv as an agent for conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with a narcotic; iv for induction of anaesthesia, preliminary to administration of other anaesthetic agents. with the use of a narcotic premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time; iv for sedation in intensive care units; intermittent administration or continuous infusion; im for preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: calcobutrol sodium; trometamol; hydrochloric acid; water for injections - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: ? contrast enhancement in cranial and spinal magnetic resonance imaging (mri) ? contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system ? use in first?pass mri studies of cerebral perfusion (see precautions) ? contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) ? contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement

Australië - Engels - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - ixekizumab, quantity: 80 mg/ml - injection, solution - excipient ingredients: water for injections; citric acid; sodium citrate dihydrate; polysorbate 80; sodium chloride - plaque psoriasis,taltz is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,taltz is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately, or who are intolerant, to previous dmard therapy.,taltz may be used as monotherapy or in combination with a conventional dmard (e.g. methotrexate).,axial spondyloarthritis - ankylosing spondylitis (radiographic axial spondyloarthritis),taltz is indicated for the treatment of active ankylosing spondylitis in adult patients.,axial spondyloarthritis - non-radiographic axial spondyloarthritis,taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri evidence, who have responded inadequately to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).

Australië - Engels - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - follitropin beta, quantity: 833 iu/ml - injection, solution - excipient ingredients: sucrose; sodium citrate dihydrate; polysorbate 20; benzyl alcohol; methionine; hydrochloric acid; sodium hydroxide; water for injections - female: anovulatory infertility and; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in vitro fertilisation and related procedures). male: for the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - filgrastim, quantity: 600 microgram/ml - injection, solution - excipient ingredients: sodium hydroxide; polysorbate 80; water for injections; glutamic acid; sorbitol - indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. ,indicated for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. ,indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with non-myeloid malignancies. ,indicated for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation.,in patients receiving myeloablative chemotherapy, is indicated for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation.,indicated for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia.,indicated in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.