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

csl behring australia pty ltd - normal immunoglobulin, quantity: 10 g - injection, solution - excipient ingredients: water for injections; glycine - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 5 g - injection, solution - excipient ingredients: water for injections; glycine - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 2.5 g - injection, solution - excipient ingredients: glycine; water for injections - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

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

pfizer australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 500 mg - injection, concentrated - excipient ingredients: sorbitol; lactic acid; water for injections - irinotecan injection concentrate is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan injection concentrate is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

pfizer australia pty ltd - ciprofloxacin, quantity: 400 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; glucose monohydrate; lactic acid - ciprofloxacin injection for intravenous infusion is indicated for use in the following: 1. hospitalised adult patients in whom oral ciprofloxacin is indicated but cannot be administered or where the oral form is inappropriate. 2. for the treatment of serious or life-threatening infections due to sensitive organisms involving the following organ systems: - lower respiratory tract infections (gram-negative organisms). skin and skin structure. septicaemia. bone and joint. urinary tract. 3. inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note: because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram positive infections due to streptococcus pneumoniae. if anaerobic organisms are suspected of contributing to the infection, use of other suitable drugs should be considered. strains of neisseria gonorrhoea resistant to ciprofloxacin have been reported in australia. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both gram-negative and gram-positive aerobic bacteria. if anaerobic organisms are suspected as accompanying aetiologic agents, additional therapy should be considered.

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

pfizer australia pty ltd - ciprofloxacin, quantity: 200 mg - injection, solution - excipient ingredients: hydrochloric acid; lactic acid; water for injections; glucose monohydrate - ciprofloxacin injection for intravenous infusion is indicated for use in the following: 1. hospitalised adult patients in whom oral ciprofloxacin is indicated but cannot be administered or where the oral form is inappropriate. 2. for the treatment of serious or life-threatening infections due to sensitive organisms involving the following organ systems: - lower respiratory tract infections (gram-negative organisms). skin and skin structure. septicaemia. bone and joint. urinary tract. 3. inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note: because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram positive infections due to streptococcus pneumoniae. if anaerobic organisms are suspected of contributing to the infection, use of other suitable drugs should be considered. strains of neisseria gonorrhoea resistant to ciprofloxacin have been reported in australia. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both gram-negative and gram positive aerobic bacteria. if anaerobic organisms are suspected as accompanying aetiologic agents, additional therapy should be considered.

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

aspen pharmacare australia pty ltd - ceftazidime pentahydrate, quantity: 1.164 g (equivalent: ceftazidime, qty 1 g) - injection, powder for - excipient ingredients: sodium carbonate - fortum is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials , but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. indications include: severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, e.g., infected burns. respiratory tract infections: for example, pneumonia, bronchopneumonia, infected pleurisy, infected bronchiectasis and bronchitis. severe ear, nose and throat infections: for example, otitis media, mastoiditis. urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones. skin and soft tissue infections: for example, erys

Australia - engelsk - 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

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

pfizer australia pty ltd - vancomycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide; hydrochloric acid - indications as at 31 october 2003: vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg strep. faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

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

pfizer australia pty ltd - gentamicin sulfate, quantity: 16.13 mg/ml - injection, solution - excipient ingredients: disodium edetate; water for injections; sulfuric acid; sodium hydroxide - indications as at 31 october 2003: gentamicin injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: pseudomonas aeruginosa, proteus species (indole positive and indole negative), escherichia coli, klebsiella - enterobacter - serratia species, staphylococcus species (coagulase positive and coagulase negative). gentamicin injection should be considered for the treatment of the following conditions when caused by susceptible organisms: septicaemia, respiratory tract infections, infected wounds, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections (recurrent, complicated). gentamicin injection is not routinely indicated in the initial treatment of uncomplicated urinary tract infections unless the organism is resistant to other less toxic antibacterials. gentamicin injection may be considered as initial therapy in suspected or confirmed gram negative infections and ther