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

b braun australia pty ltd - gentamicin sulfate, quantity: 1.39 mg/ml (equivalent: gentamicin, qty 1 mg/ml) - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections - for the treatment of infections due to one or more susceptible strains of bacteria, including pseudomonas aeruginosa, proteus species (indole positive and indole negative), escherichia coli, klebsiella, enterobacter and serratia species and staphylococcus (including strains resistant to other antibiotics). gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, septic abortion and burns complicated by sepsis. aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics. in suspected or documented gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. therapy may be instituted before obtaining results of susceptibility tests. the decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk toxicity. if anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin regimen should be considered.

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

b braun australia pty ltd - gentamicin sulfate, quantity: 4.17 mg/ml (equivalent: gentamicin, qty 3 mg/ml) - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections; disodium edetate - for the treatment of infections due to one or more susceptible strains of bacteria, including pseudomonas aeruginosa, proteus species (indole positive and indole negative), escherichia coli, klebsiella, enterobacter and serratia species and staphylococcus (including strains resistant to other antibiotics). gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, septic abortion and burns complicated by sepsis. aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics. in suspected or documented gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. therapy may be instituted before obtaining results of susceptibility tests. the decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk toxicity. if anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin regimen should be considered.

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

b braun australia pty ltd - gentamicin sulfate, quantity: 4.17 mg/ml (equivalent: gentamicin, qty 3 mg/ml) - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections; disodium edetate - for the treatment of infections due to one or more susceptible strains of bacteria, including pseudomonas aeruginosa, proteus species (indole positive and indole negative), escherichia coli, klebsiella, enterobacter and serratia species and staphylococcus (including strains resistant to other antibiotics). gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, septic abortion and burns complicated by sepsis. aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics. in suspected or documented gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. therapy may be instituted before obtaining results of susceptibility tests. the decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk toxicity. if anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin regimen should be considered.

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

pfizer australia pty ltd - gemcitabine hydrochloride, quantity: 1.139 g - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections - dbl gemcitabine injection is indicated: 1. for treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). 2. for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. for treatment of patients with fu refractory pancreatic cancer. 4. alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. in combination with paclitaxel, for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. 6. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

pfizer australia pty ltd - gemcitabine hydrochloride, quantity: 227.7 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - dbl gemcitabine injection is indicated: 1. for treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). 2. for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. for treatment of patients with fu refractory pancreatic cancer. 4. alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. in combination with paclitaxel, for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. 6. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

pfizer australia pty ltd - vancomycin, quantity: 1000 mg - injection, powder for - excipient ingredients: hydrochloric acid; sodium hydroxide - potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. 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. alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg strep. faecalis), effective only in combination with an aminoglycoside. diphtheroid endocarditis. in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia, and soft itssue 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 injections. should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c difficile). parenteral administration alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral adminsitration, the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudo-membranous colitis.

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

pfizer australia pty ltd - sodium thiosulfate pentahydrate, quantity: 2.5 g - injection, solution - excipient ingredients: sulfuric acid; sodium metabisulfite; dibasic sodium phosphate dodecahydrate; water for injections; sodium hydroxide - dbl sodium thiosulfate injection is indicated as an antidote in the treatment of cyanide poisoning. it is frequently used in conjunction with sodium nitrite. sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning.

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

cipla australia pty ltd - adalimumab, quantity: 80 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

cipla australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

cipla australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.