Нова Зеландия - английски - 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.

Нова Зеландия - английски - 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.

Канада - английски - 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

Канада - английски - Health Canada

hospira healthcare ulc - 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; n-acetyl-l-tyrosine; dextrose; sodium chloride; potassium chloride; magnesium chloride; sodium phosphate dibasic; l-isoleucine; l-leucine - solution - 368mg; 60mg; 104mg; 140mg; 70mg; 175mg; 348mg; 356mg; 245mg; 258mg; 175mg; 105mg; 252mg; 186mg; 94mg; 5g; 120mg; 97mg; 30mg; 49mg; 231mg; 350mg - l-lysine (l-lysine acetate) 368mg; methionine 60mg; l-phenylalanine 104mg; l-threonine 140mg; tryptophan 70mg; l-valine 175mg; l-alanine 348mg; l-arginine 356mg; l-aspartic acid 245mg; glutamic acid 258mg; glycine 175mg; histidine 105mg; l-proline 252mg; serine 186mg; n-acetyl-l-tyrosine 94mg; dextrose 5g; sodium chloride 120mg; potassium chloride 97mg; magnesium chloride 30mg; sodium phosphate dibasic 49mg; l-isoleucine 231mg; l-leucine 350mg - caloric agents

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

servier laboratories ltd - pixantrone dimaleate - powder for solution for infusion - 29mg

Белгия - английски - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - asparagine 3,4 mg/ml; glutamic acid 5,6 mg/ml; valine 7,3 mg/ml; arginine 11,3 mg/ml; leucine 7,9 mg/ml; serine 4,5 mg/ml; proline 6,8 mg/ml; alanine 16 mg/ml; lysine acetate 12,7 mg/ml - eq. lysine 9 mg/ml; histidine 6,8 mg/ml; threonine 5,6 mg/ml; tryptophan 1,9 mg/ml; glycyl-l-glutamine 30,27 mg/ml; glycyl-l-tyrosine 3,45 mg/ml; isoleucine 5,6 mg/ml; methionine 5,6 mg/ml; phenylalanine 5,85 mg/ml - solution for infusion - glycyl-l-glutamine 30.27 mg/ml; histidine 6.8 mg/ml; glutamic acid 5.6 mg/ml; glycyl-l-tyrosine 3.45 mg/ml; leucine 7.9 mg/ml; isoleucine 5.6 mg/ml; methionine 5.6 mg/ml; lysine acetate 12.7 mg/ml; phenylalanine 5.85 mg/ml; proline 6.8 mg/ml; serine 4.5 mg/ml; threonine 5.6 mg/ml; tryptophan 1.9 mg/ml; alanine 16 mg/ml; asparagine 3.4 mg/ml; arginine 11.3 mg/ml; valine 7.3 mg/ml - amino acids

Белгия - английски - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - calcium gluconate monohydrate 2,69 mg/ml; magnesium lactate dihydrate 0,95 mg/ml; zinc acetate dihydrate 6,72 µg/ml; copper sulfate pentahydrate 1,18 mg/l; selenium dioxide 70 mg/ml; manganese chloride tetrahydrate 0,36 mg/l; chromic chloride hexahydrate 0,1 mg/l; dipotassium hydrogen phosphate 1,39 g/l; ferric sulfate heptahydrate 2,49 mg/l; cobalt chloride hexahydrate 0,61 mg/l; ammonium molybdate tetrahydrate 0,09 mg/l; glycine 0,48 g/l; glutamic acid 1,63 g/l; valine 0,83 g/l; arginine 0,94 g/l; leucine 1,61 g/l; potassium chloride 0,67 mg/ml; sodium fluoride 1,11 mg/l; serine 0,87 g/l; proline 1,29 g/l; alanine 1,45 g/l; histidine 0,48 g/l; threonine 0,83 g/l; tryptophan 0,32 g/l; sodium chloride 1,75 g/l; taurine 0,07 g/l; lysine monohydrate 1,45 mg/ml - eq. lysine 1,29 g/l; aspartic acid 0,94 g/l; glucose monohydrate 165 mg/ml - eq. glucose anhydrous 150 g/l; tyrosine 0,11 g/l; isoleucine 0,71 g/l; methionine 0,3 g/l; phenylalanine 0,62 g/l; potassium iodide 0,07 mg/l; acetylcysteine 0,31 g/l - eq. cysteine 0,23 g/l - solution for infusion - alanine 1.45 g/l; arginine 0.94 g/l; aspartic acid 0.94 g/l; acetylcysteine 0.31 g/l; glutamic acid 1.63 g/l; glycine 0.48 g/l; histidine 0.48 g/l; isoleucine 0.71 g/l; leucine 1.61 g/l; lysine monohydrate 1.45 mg/ml; methionine 0.3 g/l; phenylalanine 0.62 g/l; proline 1.29 g/l; serine 0.87 g/l; taurine 0.07 g/l; threonine 0.83 g/l; tryptophan 0.32 g/l; tyrosine 0.11 g/l; valine 0.83 g/l; dipotassium phosphate 1.39 g/l; glucose monohydrate 165 mg/ml; calcium gluconate monohydrate 2.69 mg/ml; magnesium lactate dihydrate 0.95 mg/ml; sodium chloride 1.75 g/l; potassium chloride 0.67 mg/ml; zinc acetate dihydrate 6.72 µg/ml; copper sulfate pentahydrate 1.18 mg/l; sodium fluoride 1.11 mg/l; selenium dioxide 70 mg/ml; manganese chloride tetrahydrate 0.36 mg/l; potassium iodide 0.07 mg/l; chrome chloride hexahydrate 0.1 mg/l; ferric sulfate heptahydrate 2.49 mg/l; cobalt chloride hexahydrate 0.61 mg/l; ammonium molybdate tetrahydrate 0.09 mg/l - combinations

Белгия - английски - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - calcium gluconate monohydrate 2,69 mg/ml; magnesium lactate dihydrate 0,95 mg/ml; zinc acetate dihydrate 6,72 µg/ml; copper sulfate pentahydrate 1,18 mg/l; selenium dioxide 70 mg/ml; manganese chloride tetrahydrate 0,36 mg/l; chromic chloride hexahydrate 0,1 mg/l; dipotassium hydrogen phosphate 1,39 g/l; ferric sulfate heptahydrate 2,49 mg/l; cobalt chloride hexahydrate 0,61 mg/l; ammonium molybdate tetrahydrate 0,09 mg/l; glycine 0,64 g/l; glutamic acid 2,17 g/l; valine 1,1 g/l; arginine 1,26 g/l; leucine 2,14 g/l; potassium chloride 0,67 mg/ml; sodium fluoride 1,11 mg/l; serine 1,16 g/l; proline 1,72 g/l; alanine 1,93 g/l; histidine 0,64 g/l; threonine 1,1 g/l; tryptophan 0,43 g/l; sodium chloride 1,75 g/l; taurine 0,09 g/l; lysine monohydrate 1,93 mg/ml - eq. lysine 1,72 g/l; aspartic acid 1,26 g/l; glucose monohydrate 220 mg/ml - eq. glucose anhydrous 200 g/l; tyrosine 0,15 g/l; isoleucine 0,95 g/l; methionine 0,4 g/l; phenylalanine 0,83 g/l; potassium iodide 0,07 mg/l; acetylcysteine 0,42 g/l - eq. cysteine 0,31 g/l - solution for infusion - alanine 1.93 g/l; arginine 1.26 g/l; aspartic acid 1.26 g/l; acetylcysteine 0.42 g/l; glutamic acid 2.17 g/l; glycine 0.64 g/l; histidine 0.64 g/l; isoleucine 0.95 g/l; leucine 2.14 g/l; lysine monohydrate 1.93 mg/ml; methionine 0.4 g/l; phenylalanine 0.83 g/l; proline 1.72 g/l; serine 1.16 g/l; taurine 0.09 g/l; threonine 1.1 g/l; tryptophan 0.43 g/l; tyrosine 0.15 g/l; valine 1.1 g/l; dipotassium phosphate 1.39 g/l; glucose monohydrate 220 mg/ml; calcium gluconate monohydrate 2.69 mg/ml; magnesium lactate dihydrate 0.95 mg/ml; sodium chloride 1.75 g/l; potassium chloride 0.67 mg/ml; zinc acetate dihydrate 6.72 µg/ml; copper sulfate pentahydrate 1.18 mg/l; sodium fluoride 1.11 mg/l; selenium dioxide 70 mg/ml; manganese chloride tetrahydrate 0.36 mg/l; potassium iodide 0.07 mg/l; chrome chloride hexahydrate 0.1 mg/l; ferric sulfate heptahydrate 2.49 mg/l; cobalt chloride hexahydrate 0.61 mg/l; ammonium molybdate tetrahydrate 0.09 mg/l - combinations

Белгия - английски - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - calcium gluconate monohydrate 3,59 mg/ml; magnesium lactate dihydrate 1,43 mg/ml; zinc acetate dihydrate 13,43 µg/ml; copper sulfate pentahydrate 2,36 mg/l; selenium dioxide 140 mg/ml; manganese chloride tetrahydrate 0,72 mg/l; chromic chloride hexahydrate 0,21 mg/l; dipotassium hydrogen phosphate 1,74 g/l; ferric sulfate heptahydrate 4,98 mg/l; cobalt chloride hexahydrate 1,21 mg/l; ammonium molybdate tetrahydrate 0,18 mg/l; glycine 0,8 g/l; glutamic acid 2,72 g/l; valine 1,74 g/l; arginine 1,57 g/l; leucine 2,68 g/l; potassium chloride 1,49 mg/ml; sodium fluoride 2,21 mg/l; serine 1,45 g/l; proline 2,14 g/l; alanine 2,41 g/l; histidine 0,8 g/l; threonine 1,38 g/l; tryptophan 0,54 g/l; sodium chloride 2,34 g/l; taurine 0,11 g/l; lysine monohydrate 2,4 mg/ml - eq. lysine 2,14 g/l; aspartic acid 1,57 g/l; glucose monohydrate 275 mg/ml - eq. glucose anhydrous 250 g/l; tyrosine 0,19 g/l; isoleucine 1,19 g/l; methionine 0,5 g/l; phenylalanine 1,03 g/l; potassium iodide 0,13 mg/l; acetylcysteine 0,51 g/l - eq. cysteine 0,38 g/l - solution for infusion - alanine 2.41 g/l; arginine 1.57 g/l; aspartic acid 1.57 g/l; acetylcysteine 0.51 g/l; glutamic acid 2.72 g/l; glycine 0.8 g/l; histidine 0.8 g/l; isoleucine 1.19 g/l; leucine 2.68 g/l; lysine monohydrate 2.4 mg/ml; methionine 0.5 g/l; phenylalanine 1.03 g/l; proline 2.14 g/l; serine 1.45 g/l; taurine 0.11 g/l; threonine 1.38 g/l; tryptophan 0.54 g/l; tyrosine 0.19 g/l; valine 1.74 g/l; dipotassium phosphate 1.74 g/l; glucose monohydrate 275 mg/ml; calcium gluconate monohydrate 3.59 mg/ml; magnesium lactate dihydrate 1.43 mg/ml; sodium chloride 2.34 g/l; potassium chloride 1.49 mg/ml; zinc acetate dihydrate 13.43 µg/ml; copper sulfate pentahydrate 2.36 mg/l; sodium fluoride 2.21 mg/l; selenium dioxide 140 mg/ml; manganese chloride tetrahydrate 0.72 mg/l; potassium iodide 0.13 mg/l; chrome chloride hexahydrate 0.21 mg/l; ferric sulfate heptahydrate 4.98 mg/l; cobalt chloride hexahydrate 1.21 mg/l; ammonium molybdate tetrahydrate 0.18 mg/l - combinations

Белгия - английски - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxter sa-nv - glycine 0,51 mg/ml; valine 1,39 mg/ml; arginine 1,07 mg/ml; leucine 1,02 mg/ml; magnesium chloride hexahydrate 0,05 mg/ml; serine 0,51 mg/ml; proline 0,59 mg/ml; alanine 0,91 mg/ml; histidine 0,71 mg/ml; threonine 0,64 mg/ml; tryptophan 0,27 mg/ml; sodium chloride 5,38 mg/ml; sodium lactate 4,48 mg/ml; calcium chloride dihydrate 0,184 g/l; tyrosine 0,3 mg/ml; isoleucine 0,85 mg/ml; methionine 0,85 mg/ml; phenylalanine 0,57 mg/ml; lysine 0,95 mg/ml - solution for peritoneal dialysis - histidine 0.71 mg/ml; glycine 0.51 mg/ml; leucine 1.02 mg/ml; lysine 0.95 mg/ml; magnesium chloride hexahydrate 0.05 mg/ml; methionine 0.85 mg/ml; isoleucine 0.85 mg/ml; proline 0.59 mg/ml; phenylalanine 0.57 mg/ml; tyrosine 0.3 mg/ml; tryptophan 0.27 mg/ml; sodium chloride 5.38 mg/ml; threonine 0.64 mg/ml; serine 0.51 mg/ml; sodium lactate 4.48 mg/ml; arginine 1.07 mg/ml; alanine 0.91 mg/ml; calcium chloride dihydrate; valine 1.39 mg/ml - hypertonic solutions