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

hospira australia pty ltd - pentamidine isetionate -

Canada - English - Health Canada

swiss herbal remedies ltd. - choline bitartrate; inositol; dl-methionine - tablet - 333mg; 333mg; 333mg - choline bitartrate 333mg; inositol 333mg; dl-methionine 333mg - lipotropic agents

Canada - English - Health Canada

baxter corporation - histidine; tryptophan; sodium acetate trihydrate; alanine; soybean oil; dextrose; sodium glycerophosphate; magnesium chloride; calcium chloride; potassium chloride; olive oil; methionine; glycine; glutamic acid; l-tyrosine; l-proline; l-arginine; l-valine; l-aspartic acid; l-threonine; l-phenylalanine; l-leucine; l-isoleucine; lysine (l-lysine acetate); serine - emulsion - 1.96g; 0.55g; 1.50g; 4.76g; 8g; 126.5g; 3.67g; 0.81g; 0.52g; 2.24g; 32g; 1.64g; 2.28g; 1.64g; 0.08g; 1.96g; 3.22g; 2.1g; 0.95g; - histidine 1.96g; tryptophan 0.55g; sodium acetate trihydrate 1.50g; alanine 4.76g; soybean oil 8g; dextrose 126.5g; sodium glycerophosphate 3.67g; magnesium chloride 0.81g; calcium chloride 0.52g; potassium chloride 2.24g; olive oil 32g; methionine 1.64g; glycine 2.28g; glutamic acid 1.64g; l-tyrosine 0.08g; l-proline 1.96g; l-arginine 3.22g; l-valine 2.1g; l-aspartic acid 0.95g; l-threonine 1.64g; l-phenylalanine 2.28g; l-leucine 2.28g; l-isoleucine 1.64g; lysine (l-lysine acetate) 2.59g; serine 1.30g - replacement preparations

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

fresenius kabi australia pty ltd - alanine, quantity: 14 g/l; arginine, quantity: 12 g/l; glycine, quantity: 11 g/l; histidine, quantity: 3 g/l; isoleucine, quantity: 5 g/l; leucine, quantity: 7.4 g/l; lysine acetate, quantity: 9.31 g/l (equivalent: lysine, qty 6.6 g/l); methionine, quantity: 4.3 g/l; phenylalanine, quantity: 5.1 g/l; proline, quantity: 11.2 g/l; serine, quantity: 6.5 g/l; taurine, quantity: 1 g/l; threonine, quantity: 4.4 g/l; tryptophan, quantity: 2 g/l; tyrosine, quantity: 400 mg/l; valine, quantity: 6.2 g/l - injection, solution - excipient ingredients: glacial acetic acid; water for injections - to supply amino acids as part of a composite admixture of total parenteral nutrition.

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

fresenius kabi australia pty ltd - alanine, quantity: 14 g/l; arginine, quantity: 12 g/l; glycine, quantity: 11 g/l; histidine, quantity: 3 g/l; isoleucine, quantity: 5 g/l; leucine, quantity: 7.4 g/l; lysine acetate, quantity: 9.31 g/l (equivalent: lysine, qty 6.6 g/l); methionine, quantity: 4.3 g/l; phenylalanine, quantity: 5.1 g/l; proline, quantity: 11.2 g/l; serine, quantity: 6.5 g/l; taurine, quantity: 1 g/l; threonine, quantity: 4.4 g/l; tryptophan, quantity: 2 g/l; tyrosine, quantity: 400 mg/l; valine, quantity: 6.2 g/l - injection, solution - excipient ingredients: glacial acetic acid; water for injections - to supply amino acids as part of a composite admixture of total parenteral nutrition.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

farmalinx pty ltd - salts of isethionate - unknown - salts of isethionate active 0.0 - active constituent

United States - English - NLM (National Library of Medicine)

seton pharmaceuticals - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - pentamidine isethionate is indicated for the prevention of pneumocystis jiroveci pneumonia (pjp) in high-risk, hiv-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of pjp ii. a peripheral cd4+ (t4 helper/inducer) lymphocyte count less than or equal to 200/mm3. these indications are based on the results of an 18-month randomized, dose-response trial in high risk hiv-infected patients and on existing epidemiological data from natural history studies. the patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of pjp. the remaining patients without a history of pjp included 55 patients with kaposi’s sarcoma and 116 patients with other aids diagnoses, arc or asymptomatic hiv infection. patients were randomly assigned to receive pentamidine isethionate via the respirgard® ii nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). the results of the trial demonstrated a significant protective effect (p<0.01) against pjp with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. the 300 mg dose regimen reduced the risk of developing pjp by 50 to 70% compared to the 30 mg regimen. a total of 293 patients (72% of all patients) also received zidovudine at some time during the trial. the analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine. the results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of pentamidine isethionate prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks. no dose-response was observed for reduction in overall mortality; however, mortality from pjp was low in all three dosage groups. pentamidine isethionate is contraindicated in patients with a history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.

Malta - English - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - phenylalanine, arginine, aspartic acid, threonine, valine, glutamic acid, glycine, isoleucine, lysine, methionine, tryptophan, tyrosine, serine, cysteine, histidine, proline - solution for infusion - 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 proline 6.8 g/l l-cysteine 560 mg/g phenylalanine 7.9 g/l arginine 11.3 g/l leucine 7.9 g/l serine 4.5 g/l l-methionine 5.6 g/l aspartic acid 3.4 g/l l-tryptophan 1.9 g/l l-histidine 6.8 g/l alanine 16 g/l l-tyrosine 230 mg/l - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, dihydrate, phenylalanine, potassium chloride, histidine, arginine, aspartic acid, olive oil, threonine, tryptophan, tyrosine, valine, glucose monohydrate, glutamic acid, glycine, methionine, isoleucine, lysine, magnesium chloride, hexahydrate, serine, proline, sodium acetate, trihydrate, sodium glycerophosphate, soybean oil - emulsion for infusion - tryptophan tyrosine valine glucose monohydrate glutamic acid glycine methionine isoleucine lysine magnesium chloride hexahydrate serine proline sodium acetate trihydrate sodium glycerophosphate soybean oil calcium chloride dihydrate phenylalanine potassium chloride histidine arginine aspartic acid olive oil alanine threonine - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - phenylalanine, histidine, arginine, aspartic acid, olive oil, threonine, tyrosine, valine, glucose monohydrate, glutamic acid, glycine, methionine, isoleucine, tryptophan, lysine, serine, 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