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

solasta life pty ltd -

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

solasta life pty ltd -

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

solasta life pty ltd -

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

auscan medbio pty limited - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - rapid tests intended for use at the point-of-care to detect the presence of, or exposure to, sars-cov-2 in relevant specimen samples.

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

amicus therapeutics pty ltd - migalastat hydrochloride, quantity: 150 mg - capsule, hard - excipient ingredients: magnesium stearate; pregelatinised maize starch; indigo carmine; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; gelatin; sodium lauryl sulfate - galafold is indicated for long-term treatment of adult and adolescent patients 12 years and older with a confirmed diagnosis of fabry disease (alpha-galactosidase a deficiency) and who have an amenable mutation (see the table in section 5.1 pharmacodynamic properties, mechanism of action).

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

amgen australia pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections - for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

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

sandoz pty ltd - zoledronic acid monohydrate, quantity: 5.33 mg (equivalent: zoledronic acid, qty 5 mg) - injection, solution - excipient ingredients: mannitol; sodium citrate dihydrate; water for injections - - treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures. - treatment of osteoporosis in patients over 50 years of age with a history of at least one low trauma hip fracture, to reduce the incidence of further fractures. - to increase bone mineral density in men with osteoporosis. - to increase bone mineral density in patients with osteoporosis associated with long term glucocorticoid use. - to prevent glucocorticiod-induced bone mineral density loss. - treatment of paget's disease of bone.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - cilastatin sodium 530.7mg equivalent to 500 mg cilastatin; imipenem monohydrate 530.1mg equivalent to 500 mg imipenem - powder for injection - 500mg/500mg - active: cilastatin sodium 530.7mg equivalent to 500 mg cilastatin imipenem monohydrate 530.1mg equivalent to 500 mg imipenem excipient: sodium bicarbonate - indicated for the treatment of the following infections due to susceptible organisms: · intra-abdominal infections · lower respiratory tract infections · gynaecological infections · septicaemia · genitourinary tract infections · bone and joint infections · skin and soft tissue infections · endocarditis indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. the majority of these mixed infections are associated with contamination by faecal flora or flora originating from the vagina, skin and mouth. in these mixed infections, bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, ephalosporins and penicillins. however, bacteroides fragilis is usually susceptible to imipenem and cilastatin combination. imipenem and cilastatin combination has demonstrated efficacy against many infections caused by aerobic and anaerobic gram-positive and gram-negative bacteria resistant to the cephalosporins, including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime, moxalactam, cefamandole, ceftazidime and ceftriaxone. similarly, many infections caused by organisms resistant to aminoglycosides (gentamicin, amikacin, tobramycin) and/or penicillins (ampicillin, carbenicillin, penicillin-g, ticarcillin, piperacillin, azlocillin, mezlocillin) responded to treatment imipenem and cilastatin. imipenem+cilastatin rbx is not indicated for the treatment of meningitis.

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

actavis uk ltd - cilastatin sodium; imipenem monohydrate - powder for solution for infusion - 500mg ; 500mg

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

merck sharp & dohme (australia) pty ltd - imipenem, quantity: 500 mg; cilastatin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium bicarbonate - primaxin is indicated for the treatment of serious infections caused by susceptible strains of micro-organisms in the diseases listed below: 1. lower respiratory tract infections. 2 intra-abdominal infections. 3. gynaecological infections. 4. bacterial septicaemia. 5. bone and joint infections. 6. skin and skin structure infections. 7. endocarditis. 8. polymicrobial infections. primaxin is indicated for polymicrobial infections including those in which s. pneumoniae (pneumonia, septicaemia), group a beta-haemolytic streptococcus (skin and skin structure), or non-penicillinase-producing s. aureus is one of the causative organisms. however monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin g. efficacy against polymicrobial infection in the immunocompromised host has not yet been established. although clinical improvement has been observed in patients with cystic fibrosis, chronic pulmonary disease, and lower respiratory tract infections cau