New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - linezolid 20 mg/ml - granules for oral suspension - 20 mg/ml - active: linezolid 20 mg/ml excipient: ammonium glycyrrhizinate aspartame citric acid monohydrate colloidal silicon dioxide dispersible cellulose sweet-am powder #918.005 nor-cap natural & artificial orange cream mannitol orange flavour (cream) 884.010 orange flavour 884.114 peppermint flavour sd f93125 sodium benzoate sodium chloride sodium citrate dihydrate sucrose sweet flavour (am) 918.005 vanilla flavour 712729 (mc008927) xanthan gum - zyvox is indicated for the treatment of infections when known or suspected to be caused by susceptible organisms including those associated with concurrent bacteraemia such as: · pneumonia - community acquired and nosocomial pneumonia · skin and soft tissue infections · enterococcal infections. linezolid is active against gram-positive bacteria only. linezolid has no clinical activity against gram-negative pathogens. specific gram-negative therapy is required if a concomitant gram-negative pathogen is documented or suspected. consideration should be given to official guidance on the appropriate use of antibacterial agents.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - linezolid 2 mg/ml - solution for infusion - 2 mg/ml - active: linezolid 2 mg/ml excipient: citric acid glucose monohydrate hydrochloric acid sodium citrate dihydrate sodium hydroxide - zyvox is indicated for the treatment of infections when known or suspected to be caused by susceptible organisms including those associated with concurrent bacteraemia such as: · pneumonia - community acquired and nosocomial pneumonia · skin and soft tissue infections · enterococcal infections. linezolid is active against gram-positive bacteria only. linezolid has no clinical activity against gram-negative pathogens. specific gram-negative therapy is required if a concomitant gram-negative pathogen is documented or suspected. consideration should be given to official guidance on the appropriate use of antibacterial agents.

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi limited - cysteine; tryptophan; glutamic acid; tyrosine; histidine; alanine; phenylalanine; leucine; aspartic acid; lysine; arginine; threonine; serine; taurine; valine; proline; methionine; glycine; isoleucine - solution for infusion - 100 millilitre(s) - solutions for parenteral nutrition; amino acids

Malta - English - Medicines Authority

baxter healthcare limited - phenylalanine; histidine; arginine; aspartic acid; olive oil; alanine; threonine; tyrosine; valine; glucose monohydrate; glutamic acid; glycine; methionine; isoleucine; l-tryptophan; lysine; serine; leucine; proline; soybean oil - emulsion for infusion - phenylalanine; histidine; arginine; aspartic acid; olive oil; alanine; threonine; tyrosine; valine; glucose monohydrate; glutamic acid; glycine; methionine; isoleucine; l-tryptophan; lysine; serine; leucine; proline; soybean oil - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

baxter healthcare limited - phenylalanine; histidine; arginine; aspartic acid; olive oil; alanine; threonine; tyrosine; valine; glucose monohydrate; glutamic acid; glycine; methionine; isoleucine; l-tryptophan; lysine; serine; leucine; proline; soybean oil - emulsion for infusion - phenylalanine; histidine; arginine; aspartic acid; olive oil; alanine; threonine; tyrosine; valine; glucose monohydrate 250 g; glutamic acid; glycine; methionine; isoleucine; l-tryptophan; lysine; serine; leucine; proline; soybean oil - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

fresenius kabi limited - phenylalanine; arginine; aspartic acid; alanine; threonine; valine; glutamic acid; glycine; isoleucine; l-lysine; l-methionine; l-tryptophan; l-tyrosine; serine; l-cysteine; leucine; l-histidine; proline - solution for infusion - phenylalanine 7.9 g/l; arginine 11.3 g/l; aspartic acid 3.4 g/l; alanine 16 g/l; threonine 5.6 g/l; valine 7.3 g/l; glutamic acid 5.6 g/l; glycine 7.9 g/l; isoleucine 5.6 g/l; l-lysine 9 g/l; l-methionine 5.6 g/l; l-tryptophan 1.9 g/l; l-tyrosine 230 mg/l; serine 4.5 g/l; l-cysteine 560 mg/g; leucine 7.9 g/l; l-histidine 6.8 g/l; proline 6.8 g/l - blood substitutes and perfusion solutions

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - alirocumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: alirocumab 150 mg/ml   excipient: histidine polysorbate 20 sucrose water for injection - primary hypercholesterolaemia praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - alirocumab 75 mg/ml;   - solution for injection - 75 mg/ml - active: alirocumab 75 mg/ml   excipient: histidine polysorbate 20 sucrose water for injection - primary hypercholesterolaemia praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

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

takeda pharmaceuticals australia pty ltd - ponatinib hydrochloride, quantity: 16 mg (equivalent: ponatinib, qty 15 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - iclusig is indicated for the treatment of adult patients with:,chronic phase (cp), accelerated phase (ap), or blast phase (bp) chronic myeloid ieukaemia (cml) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a t315i mutation.,philadelphia chromosome positive acute lymphoblastic ieukaemia (ph+ all) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a t315i mutation.,therapy with iclusig should be initiated and monitored by a haematologist with expertise in managing adult ieukaemias.

Canada - English - Health Canada

hospira healthcare ulc - l-isoleucine; l-leucine; l-lysine (l-lysine acetate); methionine; l-phenylalanine; l-threonine; tryptophan; l-valine; l-alanine; l-arginine; l-aspartic acid; glutamic acid; glycine; histidine; l-proline; serine; magnesium chloride; sodium phosphate dibasic; n-acetyl-l-tyrosine; dextrose; sodium chloride; potassium chloride - solution - 280mg; 425mg; 446mg; 73mg; 126mg; 170mg; 85mg; 212mg; 422mg; 432mg; 298mg; 314mg; 212mg; 128mg; 307mg; 225mg; 30mg; 49mg; 115mg; 10g; 120mg; 97mg - l-isoleucine 280mg; l-leucine 425mg; l-lysine (l-lysine acetate) 446mg; methionine 73mg; l-phenylalanine 126mg; l-threonine 170mg; tryptophan 85mg; l-valine 212mg; l-alanine 422mg; l-arginine 432mg; l-aspartic acid 298mg; glutamic acid 314mg; glycine 212mg; histidine 128mg; l-proline 307mg; serine 225mg; magnesium chloride 30mg; sodium phosphate dibasic 49mg; n-acetyl-l-tyrosine 115mg; dextrose 10g; sodium chloride 120mg; potassium chloride 97mg - caloric agents