Belgium - English - 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

Belgium - English - 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

Belgium - English - 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

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

nrc nutrition pty ltd - calcium citrate,calcium phosphate,colecalciferol,glycine,magnesium citrate,menaquinone 7 -

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

the better health company (australia) pty - thiamine hydrochloride, quantity: 50 mg (equivalent: thiamine, qty 39.34 mg); riboflavin sodium phosphate, quantity: 20 mg (equivalent: riboflavin, qty 15.73 mg); nicotinamide, quantity: 50 mg; calcium pantothenate, quantity: 50 mg (equivalent: pantothenic acid, qty 45.8 mg); pyridoxal 5-phosphate monohydrate, quantity: 20 mg (equivalent: pyridoxine, qty 12.76 mg); levomefolate calcium, quantity: 108.3 microgram (equivalent: levomefolic acid, qty 100 microgram); calcium ascorbate dihydrate, quantity: 60.52 mg (equivalent: ascorbic acid, qty 50 mg); d-alpha-tocopheryl acid succinate, quantity: 82.64 mg; biotin, quantity: 1.2 mg; mecobalamin, quantity: 200 microgram; selenomethionine, quantity: 186.29 microgram (equivalent: selenium, qty 75 microgram); manganese amino acid chelate, quantity: 5 mg (equivalent: manganese, qty 1 mg); calcium citrate tetrahydrate, quantity: 118.6 mg (equivalent: calcium, qty 25 mg); choline bitartrate, quantity: 50 mg; inositol, quantity: 50 mg; zinc glycinate, quantity: 49.5 mg (equivalent: zinc, qty 15 mg); magnesium glycinate, quantity: 115.5 mg (equivalent: magnesium, qty 15 mg); betacarotene, quantity: 4 mg; copper gluconate, quantity: 1.43 mg (equivalent: copper, qty 200 microgram); retinol acetate, quantity: 0.43 mg; colecalciferol, quantity: 0.0125 mg; menaquinone 7, quantity: 0.03 mg - capsule, hard - excipient ingredients: silicon dioxide; microcrystalline cellulose; magnesium stearate; glycine; citric acid; colloidal anhydrous silica; modified food starch; maize starch; dl-alpha-tocopherol; sodium starch glycollate; trehalose dihydrate; hydrogenated vegetable oil; starch sodium octenyl succinate; sodium ascorbate; sucrose; medium chain triglycerides; acacia; calcium phosphate; titanium dioxide; hypromellose; purified water; potassium acetate; carrageenan - antioxidant/reduce free radicals formed in the body ; maintain/support collagen formation ; maintain/support energy levels ; helps convert (state food) into energy ; maintain/support energy production ; maintain/support healthy eye function ; maintain/support eye health ; maintain/support healthy eyesight/vision ; maintain/support body mucous membrane health ; maintain/support general health and wellbeing ; maintain/support hair growth ; maintain/support hair health ; maintain/support healthy teeth ; aid/assist nail growth ; maintain/support nail health/strength/thickness ; helps enhance/promote connective tissue health ; aid/assist/helps connective tissue production/formation ; maintain/support healthy body tissues ; maintain/support bone health ; maintain/support bone strength ; help maintain/support bone mineralisation ; vitamin d helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life ; aid/assist healthy red blood cell production ; maintain/support red blood cell health ; maintain/support blood health ; helps maintain/support haemoglobin formation/synthesis ; maintain/support cardiovascular system health ; maintain/support heart health ; maintain/support blood capillary health ; maintain/support blood vessel health ; maintain/support healthy thyroid gland function ; maintain/support healthy thyroid hormones ; aid/assist thyroid hormone production ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support muscle function ; maintain/support healthy neuromuscular system/function ; aid/assist/helps protein synthesis in the body ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; aids/assists the body to cope with environmental stress ; support healthy stress response in the body ; maintain/support cognitive function/mental function ; maintain/support nerve conduction ; aid/assist/helps synthesis of neurotransmitters ; maintain/support nervous system health ; maintain/support nervous system function ; maintain/support female reproductive system health ; maintain/support preconception health ; maintain/support healthy reproductive hormones ; maintain/support skin health ; maintain/support skin integrity/structure ; maintain/support skin regeneration ; maintain/support wound healing

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

ashaya pty ltd - crocus sativus, quantity: 7 mg/g (equivalent: crocus sativus, qty 21 mg/g); withania somnifera, quantity: 60 mg/g (equivalent: withania somnifera, qty 750 mg/g); actaea racemosa, quantity: 12.5 mg/g (equivalent: actaea racemosa, qty 50 mg/g); humulus lupulus, quantity: 50 mg/g (equivalent: humulus lupulus, qty 375 mg/g); piper nigrum, quantity: 10 mg/g (equivalent: piper nigrum, qty 205 mg/g); astragalus membranaceus, quantity: 50 mg/g (equivalent: astragalus membranaceus, qty 500 mg/g); magnesium glycinate - powder, oral - excipient ingredients: dextrin; maltodextrin; colloidal anhydrous silica; stevia rebaudiana; citric acid; glycine; beta vulgaris; flavour - antioxidant/reduce free radicals formed in the body ; traditionally used in chinese medicine to relieve feelings of general malaise/general debility ; maintain/support energy production ; traditionally used in ayurvedic medicine to relieve weariness/tiredness/fatigue/feeling of weakness ; traditionally used in chinese medicine to relieve weariness/tiredness/fatigue/feeling of weakness ; helps maintain/support eye macula health ; traditionally used in chinese medicine to decrease/reduce/relieve spontaneous sweating ; decrease/reduce/relieve spontaneous sweating ; traditionally used in chinese medicine to longevity tonic ; traditionally used in ayurvedic medicine to rejuvenating tonic ; maintain/support general health and wellbeing ; maintain/support hair growth ; maintain/support hair health ; anti-inflammatory/relieve inflammation ; maintain/support bone mass/density/integrity ; maintain/support bone strength ; help maintain/support bone mineralisation ; traditionally used in wester

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

phytologic holdings pty limited - magnesium amino acid chelate, quantity: 300 mg/g (equivalent: magnesium, qty 60 mg/g); magnesium citrate, quantity: 181.23 mg/g (equivalent: magnesium, qty 28 mg/g); eschscholzia californica, quantity: 13.34 mg/g (equivalent: eschscholzia californica, qty 200.1 mg/g); magnolia officinalis, quantity: 14.3 mg/g (equivalent: honokiol (of magnolia officinalis), qty 0.78 mg/g; equivalent: magnolia officinalis, qty 143 mg/g); phellodendron amurense, quantity: 4.68 mg/g (equivalent: phellodendron amurense, qty 51.48 mg/g; equivalent: berberine, qty 0.052 mg/g); colecalciferol, quantity: 0.002 mg/g - powder, oral - excipient ingredients: citric acid; stevia rebaudiana; colloidal anhydrous silica; glycine; maize starch; silicon dioxide; high amylose maize starch; acacia; sodium ascorbate; d-alpha-tocopherol; fractionated coconut oil; liquid glucose; flavour - maintain/support general health and wellbeing ; decrease/reduce/relieve muscle cramps ; helps decrease/reduce/relieve mild muscle spasms/twitches ; maintain/support muscle health ; maintain/support muscle function ; helps enhance/promote/increase absorption of dietary (state vitamin/mineral/nutrient) ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of stress ; decrease/reduce/relieve symptoms of stress ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of mild anxiety ; maintain/support nervous system health ; maintain/support nervous system function ; traditionally used in western herbal medicine to soporific/induces sleep ; traditionally used in western herbal medicine to decrease/reduce time to fall asleep ; traditionally used in western herbal medicine to decrease/reduce/relieve disturbed/restless sleep ; traditionally used in western herbal medicine to enhance/improve/promote/increase sleep quality/deep sleep

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

honest health co pty ltd - magnesium glycinate dihydrate, quantity: 279.12 mg/g (equivalent: magnesium, qty 31.82 mg/g); glycine, quantity: 272.73 mg/g; withania somnifera, quantity: 54.55 mg/g (equivalent: withania somnifera, qty 545.5 mg/g); passiflora incarnata, quantity: 36.36 mg/g (equivalent: passiflora incarnata, qty 363.6 mg/g) - powder, oral - excipient ingredients: citric acid; stevia rebaudiana; colloidal anhydrous silica; beta vulgaris; maltodextrin; glycine; flavour - maintain/support healthy muscle contraction function ; maintain/support muscle function ; maintain/support muscle relaxation ; support healthy stress response in the body ; traditionally used in western herbal medicine to calms the mind ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of stress (linked indication:decrease/reduce/relieve disturbed/restless sleep); maintain/support nervous system function ; maintain/support healthy sleeping patterns ; enhance/improve/promote/increase sleep quality/deep sleep

Canada - English - Health Canada

fresenius kabi canada ltd - glycine; proline; histidine; serine; taurine; tyrosine; sodium acetate; potassium chloride; sodium glycerophosphate; magnesium sulfate; calcium chloride; zinc sulfate heptahydrate; dextrose; soybean oil; medium chain triglycerides (mct); olive oil; fish oil; lysine (lysine acetate); phenylalanine; leucine; valine; threonine; methionine; isoleucine; tryptophan; alanine; arginine - emulsion - 0.72g; 0.73g; 0.2g; 0.43g; 0.065g; 0.026g; 0.16g; 0.23g; 0.23g; 0.061g; 0.028g; 0.00066g; 8.5g; 0.87g; 0.87g; 0.72g; 0.43g; 0.43g; 0.33g; 0.48g; 0.41g; 0.29g; 0.28g; 0.33g; 0.13g; 0.92g; 0.79g - glycine 0.72g; proline 0.73g; histidine 0.2g; serine 0.43g; taurine 0.065g; tyrosine 0.026g; sodium acetate 0.16g; potassium chloride 0.23g; sodium glycerophosphate 0.23g; magnesium sulfate 0.061g; calcium chloride 0.028g; zinc sulfate heptahydrate 0.00066g; dextrose 8.5g; soybean oil 0.87g; medium chain triglycerides (mct) 0.87g; olive oil 0.72g; fish oil 0.43g; lysine (lysine acetate) 0.43g; phenylalanine 0.33g; leucine 0.48g; valine 0.41g; threonine 0.29g; methionine 0.28g; isoleucine 0.33g; tryptophan 0.13g; alanine 0.92g; arginine 0.79g - replacement preparations

Israel - English - Ministry of Health

remedix care ltd - glycine; l- alanine; l- aspartic acid; l- cysteine; l- glutamic acid; l- isoleucine; l- leucine; l- lysine; l- methionine; l- ornithine hydrochloride; l- phenylalanine; l- proline; l- serine; l- threonine; l- tryptophan; l- tyrosine; l- valine; l-arginine; l-histidine; taurine - solution for infusion - l- valine 0.76 g / 100 ml; l- tyrosine 0.045 g / 100 ml; l- tryptophan 0.2 g / 100 ml; l- threonine 0.37 g / 100 ml; taurine 0.06 g / 100 ml; l- serine 0.4 g / 100 ml; l- proline 0.3 g / 100 ml; l- phenylalanine 0.42 g / 100 ml; l- ornithine hydrochloride 0.318 g / 100 ml; l- methionine 0.24 g / 100 ml; l- lysine 1.1 g / 100 ml; l- leucine 1.0 g / 100 ml; l- isoleucine 0.67 g / 100 ml; l-histidine 0.38 g / 100 ml; glycine 0.4 g / 100 ml; l- glutamic acid 1.0 g / 100 ml; l- cysteine 0.189 g / 100 ml; l- aspartic acid 0.6 g / 100 ml; l-arginine 0.84 g / 100 ml; l- alanine 0.8 g / 100 ml - lysine - lysine - primene 10 % is indicated in 1) children and infants 2) neonates at term or premature of normal or low birth weight when oral or enteral nutrition is impossible insufficient or contraindicated.משטר מינון: 3/7/2019 שינוי בפרק 4.2 בעלון ללא שינוי ברשיון הנמוקים לבקשה: בהתאם לעלון רפרנס spc-uk ו-clinical overview