New Zealand - English - Medsafe (Medicines Safety Authority)

juno pharmaceuticals nz limited - bortezomib 1mg (as mannitol boronic ester) - powder for injection - 1 mg - active: bortezomib 1mg (as mannitol boronic ester) excipient: mannitol - - in combination with melphalan and prednisone, indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. - as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

juno pharmaceuticals nz limited - bortezomib 3.5mg (as mannitol boronic ester) - powder for injection - 3.5 mg - active: bortezomib 3.5mg (as mannitol boronic ester) excipient: mannitol - - in combination with melphalan and prednisone, indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. - as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

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.

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

juno pharmaceuticals pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; triethyl citrate; microcrystalline cellulose; croscarmellose sodium; propyl gallate; methacrylic acid - ethyl acrylate copolymer (1:1); xylitol; sodium stearylfumarate; hyprolose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - posaconazole juno is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.,? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole juno is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

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

juno pharmaceuticals pty ltd - vancomycin hydrochloride, quantity: 952 mg (equivalent: vancomycin, qty 1000000 iu) - injection, powder for - excipient ingredients: sodium hydroxide; hydrochloric acid - vancomycin juno is indicated in potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins.,vancomycin juno is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who 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 juno is effective alone or in combination with an aminoglycoside for endocarditis caused by s. viridans or s. bovis. for endocarditis caused by enterococci (e.g. e. faecalis), vancomycin juno is effective only in combination with an aminoglycoside. vancomycin juno is effective for the treatment of diphtheroid endocarditis. vancomycin juno is used in combination with rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by s. epidermidis or diphtheroids.,the effectiveness of vancomycin juno has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia, and soft tissue infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures.,specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin juno.,vancomycin juno should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis produced by c. difficile. parenteral administration of vancomycin juno 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 - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - vancomycin hydrochloride, quantity: 476 mg (equivalent: vancomycin, qty 500000 iu) - injection, powder for - excipient ingredients: hydrochloric acid; sodium hydroxide - vancomycin juno is indicated in potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins.,vancomycin juno is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who 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 juno is effective alone or in combination with an aminoglycoside for endocarditis caused by s. viridans or s. bovis. for endocarditis caused by enterococci (e.g. e. faecalis), vancomycin juno is effective only in combination with an aminoglycoside. vancomycin juno is effective for the treatment of diphtheroid endocarditis. vancomycin juno is used in combination with rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by s. epidermidis or diphtheroids.,the effectiveness of vancomycin juno has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia, and soft tissue infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures.,specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin juno.,vancomycin juno should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis produced by c. difficile. parenteral administration of vancomycin juno 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 - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - tigecycline, quantity: 50 mg - injection, powder for - excipient ingredients: arginine; hydrochloric acid; sodium hydroxide - tigecycline juno is indicated for the treatment of the following infections in adults:,? complicated skin and skin structure infections, including those with methicillin resistant staphylococcus aureus (mrsa), where there is suspected or proven resistance to, intolerance of, or there are co- morbidities preventing the use of, other available agents.,? complicated intra-abdominal infections, where there is suspected or proven resistance to, intolerance of, or there are co-morbidities preventing the use of, other available agents.

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

juno pharmaceuticals pty ltd - valganciclovir hydrochloride -

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

juno pharmaceuticals pty ltd - capecitabine -