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

juno pharmaceuticals pty ltd - pemetrexed disodium hemipentahydrate, quantity: 604.05 mg (equivalent: pemetrexed, qty 500 mg) - injection, powder for - excipient ingredients: mannitol; hydrochloric acid; nitrogen; sodium hydroxide - pemetrexed juno, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. non-small cell lung cancer pemetrexed juno in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed juno as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

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

juno pharmaceuticals pty ltd - pemetrexed disodium hemipentahydrate, quantity: 120.81 mg (equivalent: pemetrexed, qty 100 mg) - injection, powder for - excipient ingredients: sodium hydroxide; nitrogen; mannitol; hydrochloric acid - pemetrexed juno, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. non-small cell lung cancer pemetrexed juno in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed juno as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

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

juno pharmaceuticals pty ltd - amoxicillin sodium, quantity: 530.1 mg; potassium clavulanate, quantity: 119.13 mg - injection, powder for - excipient ingredients: - amoxiclav juno is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed gram negative and gram positive infections, and situations where microbial confirmation has not yet been obtained. infections caused by amoxicillin susceptible organisms are amenable to amoxiclav juno treatment due to its amoxicillin content. infections caused by ?-lactamase producing amoxicillin resistant organisms are also amenable to amoxiclav juno due to its clavulanic acid content. susceptibility to amoxiclav juno will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. amoxiclav juno is indicated for the short term treatment of serious bacterial infections such as: ? ? upper respiratory tract infections (including ent): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms ? lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia ? genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, , female genital infections ? gastrointestinal infections ? e.g. intra-abdominal sepsis, peritonitis. ? skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess ? other infections e.g. septic abortion, puerperal sepsis, post-surgical infections. ? ? amoxiclav juno is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastronitestinal surgery.

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

juno pharmaceuticals pty ltd - amoxicillin sodium, quantity: 1060.2 mg (equivalent: amoxicillin, qty 1000 mg); potassium clavulanate, quantity: 238.25 mg (equivalent: clavulanic acid, qty 200 mg) - injection, powder for - excipient ingredients: - amoxiclav juno is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed gram negative and gram positive infections, and situations where microbial confirmation has not yet been obtained. infections caused by amoxicillin susceptible organisms are amenable to amoxiclav juno treatment due to its amoxicillin content. infections caused by ?-lactamase producing amoxicillin resistant organisms are also amenable to amoxiclav juno due to its clavulanic acid content. susceptibility to amoxiclav juno will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. amoxiclav juno is indicated for the short term treatment of serious bacterial infections such as: ? upper respiratory tract infections (including ent): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms ? lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia ? genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, , female genital infections ? gastrointestinal infections ? e.g. intra-abdominal sepsis, peritonitis. ? skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess ? other infections e.g. septic abortion, puerperal sepsis, post-surgical infections. ? amoxiclav juno is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastronitestinal surgery.

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

juno pharmaceuticals pty ltd - amoxicillin sodium, quantity: 2120.4 mg; potassium clavulanate, quantity: 238.25 mg - injection, powder for - excipient ingredients: - amoxiclav juno is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed gram negative and gram positive infections, and situations where microbial confirmation has not yet been obtained. infections caused by amoxicillin susceptible organisms are amenable to amoxiclav juno treatment due to its amoxicillin content. infections caused by ?-lactamase producing amoxicillin resistant organisms are also amenable to amoxiclav juno due to its clavulanic acid content. susceptibility to amoxiclav juno will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. amoxiclav juno is indicated for the short term treatment of serious bacterial infections such as: ? upper respiratory tract infections (including ent): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms ? lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia ? genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, , female genital infections ? gastrointestinal infections ? e.g. intra-abdominal sepsis, peritonitis. ? skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess ? other infections e.g. septic abortion, puerperal sepsis, post-surgical infections. ? amoxiclav juno is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastronitestinal surgery.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: silicified microcrystalline cellulose; macrogol 4000; sodium chloride; iron oxide red; purified talc; titanium dioxide; hyprolose; crospovidone; polacrilin potassium; magnesium stearate; colloidal anhydrous silica; polyvinyl alcohol - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; purified talc; polyvinyl alcohol; hyprolose; polacrilin potassium; macrogol 4000; sodium chloride; titanium dioxide; iron oxide red; silicified microcrystalline cellulose; colloidal anhydrous silica; iron oxide yellow - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - sodium valproate, quantity: 400 mg - injection, solution - excipient ingredients: water for injections - sodium valproate juno is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

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

juno pharmaceuticals pty ltd - esmolol hydrochloride, quantity: 10 mg/ml - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide; sodium chloride; glacial acetic acid; sodium acetate trihydrate - supraventricular tachycardia,esmolol juno is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol juno is also indicated in non compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. esmolol juno is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.

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

juno pharmaceuticals pty ltd - ertapenem sodium, quantity: 1.046 g (equivalent: ertapenem, qty 1 g) - injection, powder for - excipient ingredients: sodium bicarbonate; sodium hydroxide; nitrogen - treatment,ertapenem juno is indicated for the treatment of patients, aged 3 months or more, with moderate to severe infections (except meningitis, see precautions) caused by susceptible strains of microorganisms which are suspected or proven to be resistant to all other antibiotics, or for patients unable to tolerate other antibiotics.,ertapenem juno is also indicated for initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including post-partum endomyometritis, septic abortion and post-surgical gynaecological infections.,ertapenem juno is also indicated for the treatment of diabetic foot infections, which require parenteral antibiotic therapy and are caused by susceptible bacterial pathogens which are suspected or proven to be resistant to all other registered antibiotics, or for patients unable to tolerate other antibiotics. ,appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. therapy with ertapenem juno may be initiated empirically before the results of these tests are known; once these results become available, antimicrobial therapy,should be adjusted accordingly.