Νέα Ζηλανδία - Αγγλικά - Medsafe (Medicines Safety Authority)

a. menarini new zealand pty ltd - ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron - solution for injection - 200 mg/2ml - active: ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron excipient: hydrochloric acid sodium hydroxide water for injection - monofer is indicated for the treatment of iron deficiency in adults, under the following conditions: · when oral iron preparations are ineffective or cannot be used. · where there is a clinical need to deliver iron rapidly the diagnosis must be based on laboratory tests

Νέα Ζηλανδία - Αγγλικά - Medsafe (Medicines Safety Authority)

a. menarini new zealand pty ltd - ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron - solution for injection - 500 mg/5ml - active: ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron excipient: hydrochloric acid sodium hydroxide water for injection - monofer is indicated for the treatment of iron deficiency in adults, under the following conditions: · when oral iron preparations are ineffective or cannot be used. · where there is a clinical need to deliver iron rapidly the diagnosis must be based on laboratory tests

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

shield tx (uk) ltd - ferric maltol (unii: ma10qyf1z0) (ferric cation - unii:91o4lml611) - accrufer is indicated for the treatment of iron deficiency in adults. accrufer is contraindicated in patients with a history of: - hypersensitivity to the active substance or to any of the excipients [see description ( 11)] . reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. - hemochromatosis and other iron overload syndromes [see warnings and precautions ( 5.1)] . use may result in iron overdose [see overdosage ( 10)]. - receiving repeated blood transfusions. use may result in iron overload [see warnings and precautions ( 5.2) and overdosage ( 10)]. risk summary accrufer is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology ( 12.3)] . in animal reproduction studies, oral administration of ferric or ferrous compounds to gravid cd1-mice and wistar-rats during organogenesis at doses 13 to 32 times the recommended human dose resulted in no adverse developmental outcomes. an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. in animal reproduction studies, oral administration of maltol to pregnant crl: cobs-cd (sd) br rats during organogenesis at doses 6 times the recommended human dose resulted in no adverse developmental outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk untreated iron deficiency anemia (ida) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. adverse pregnancy outcomes associated with ida include increased risk for preterm delivery and low birth weight. data animal data in embryofetal development studies in mice and rats, pregnant animals received oral doses of ferric or ferrous compounds (ferrous sulfate or ferric sodium pyrophosphate) of up to 160 mg/kg/day in mice, or up to 200 mg/kg/day in rats, during the period of organogenesis. administration of ferric or ferrous compounds at doses 13 times (in mice) or 32 times (in rats) the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. in a multigeneration reproductive and developmental study in rats, pregnant animals received oral doses of maltol of 100, 200, and 400 mg/kg/day, during the period of organogenesis. administration of maltol at doses 6 times the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. risk summary there are no data on the presence of accrufer in human milk, the effects on the breastfed child, or the effects on milk production. accrufer is not absorbed systemically as an intact complex by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to accrufer. safety and effectiveness of accrufer have not been established in pediatric patients. of the 295 patients in the randomized trials of accrufer, 39% of patients were aged 65 and older, while 23% were aged 75 and older. no overall differences in safety or effectiveness were observed between these patients and younger patients.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

factors group australia pty ltd - ascorbic acid, quantity: 150 mg; folic acid, quantity: 400 microgram; cyanocobalamin, quantity: 8 microgram; ferric pyrophosphate, quantity: 50.03 mg (equivalent: iron, qty 15 mg) - capsule, hard - excipient ingredients: calcium hydrogen phosphate dihydrate; maltodextrin; lecithin; sodium chloride; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; silicon dioxide; gelatin - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support energy levels ; maintain/support energy production ; relieve weariness/tiredness/fatigue/feeling of weakness ; maintain/support general health and wellbeing ; maintain/support gum health ; helps enhance/promote teeth health ; maintain/support connective tissue health ; helps enhance/promote connective tissue health ; aid/assist/helps connective tissue production/formation ; helps enhance/promote bone health ; maintain/support bone health ; aid/assist healthy red blood cell production ; maintain/support red blood cell health ; helps maintain/support transport of oxygen in the body ; helps maintain/support haemoglobin formation/synthesis ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; enhance/improve/promote/increase (state vitamin/mineral/nutrient) levels in the body ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; helps maintains/support healthy foetal cns/brain development ; maintains/support healthy foetal development ; help to prevent neural tube defects such as spina bifida and/or anencephaly ; maintain/support wound healing

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

swisse wellness pty ltd - pyridoxine hydrochloride, quantity: 4.996 mg (equivalent: pyridoxine, qty 4.11 mg); ascorbic acid, quantity: 8.26 mg; ferric pyrophosphate, quantity: 40.12 mg (equivalent: iron, qty 10.03 mg) - pastille - excipient ingredients: potable water; mannitol; glycerol; medium chain triglycerides; gelatin; cherry; citric acid; steviol glycosides; carrot; carnauba wax; maltitol solution; maltodextrin; sodium chloride; lecithin; flavour - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support collagen formation ; maintain/support collagen health ; maintain/support energy production ; relieve weariness/tiredness/fatigue/feeling of weakness ; aid/assist healthy red blood cell production ; maintain/support red blood cell health ; maintain/support blood health ; helps maintain/support transport of oxygen in the body ; maintain/support immune system health ; maintain/support healthy immune system function ; 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 ; maintain/support wound healing ; maintain/support skin repair/healing/regeneration

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

pentavite pty ltd - thiamine hydrochloride, quantity: 0.5 mg/ml (equivalent: thiamine, qty 0.446 mg/ml); riboflavin sodium phosphate, quantity: 0.5 mg/ml (equivalent: riboflavin, qty 0.365 mg/ml); nicotinamide, quantity: 3 mg/ml; pyridoxine hydrochloride, quantity: 0.15 mg/ml (equivalent: pyridoxine, qty 0.123 mg/ml); ascorbic acid, quantity: 12 mg/ml; colecalciferol, quantity: 0.001 mg/ml; ferric pyrophosphate, quantity: 2.5751 mg/ml (equivalent: iron, qty 0.72 mg/ml) - oral liquid - excipient ingredients: purified water; sorbitol solution (70 per cent) (non-crystallising); xanthan gum; saccharin sodium; potassium sorbate; polysorbate 80; vegetable oil; dl-alpha-tocopherol; maltodextrin; sodium chloride; lecithin; flavour - maintain/support energy levels ; maintain/support healthy growth and development ; maintain/support general health and wellbeing ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support (state vitamin/mineral/nutrient) levels in the body

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

pentavite pty ltd - retinol palmitate, quantity: 27.8 microgram/ml (equivalent: vitamin a, qty 15 re/millilitre); calcium pantothenate, quantity: 0.572 mg/ml (equivalent: pantothenic acid, qty 0.524 mg/ml); levomefolate calcium, quantity: 27.86 microgram/ml (equivalent: levomefolic acid, qty 22.5 microgram/ml); nicotinamide, quantity: 0.9 mg/ml; zinc citrate dihydrate, quantity: 1.246 mg/ml (equivalent: zinc, qty 0.4 mg/ml); potassium iodide, quantity: 0.0059 mg/ml (equivalent: iodine, qty 4.5 microgram/ml); biotin, quantity: 1.5 microgram/ml; mecobalamin, quantity: 0.138 microgram/ml; ascorbic acid, quantity: 12 mg/ml; thiamine hydrochloride, quantity: 0.084 mg/ml (equivalent: thiamine, qty 75 microgram/ml); pyridoxal 5-phosphate monohydrate, quantity: 0.118 mg/ml (equivalent: pyridoxine, qty 75 microgram/ml); riboflavin sodium phosphate, quantity: 0.103 mg/ml (equivalent: riboflavin, qty 50 microgram/ml); ferric pyrophosphate, quantity: 1.6625 mg/ml (equivalent: iron, qty 0.5 mg/ml); colecalciferol, quantity: 0.0005 mg/ml - oral liquid - excipient ingredients: maize starch; stevia rebaudiana; sucrose; glycerol; cochineal; purified water; citric acid; xanthan gum; gelatin; dl-alpha-tocopherol; xylitol; potassium sorbate; dextrin; sodium chloride; lecithin; acacia; silicon dioxide; medium chain triglycerides; flavour - maintain/support energy levels ; maintain/support healthy growth and development ; maintain/support general health and wellbeing ; maintain/support teeth strength ; maintain/support bone strength ; maintain/support healthy appetite ; maintain/support healthy immune system function ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral/nutrient) levels in the body

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

factors group australia pty ltd - ascorbic acid, quantity: 150 mg; cyanocobalamin, quantity: 8 microgram; ferric pyrophosphate, quantity: 50.03 mg (equivalent: iron, qty 15 mg); folic acid, quantity: 400 microgram - capsule, hard - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; maltodextrin; lecithin; sodium chloride; magnesium stearate; silicon dioxide; calcium hydrogen phosphate dihydrate; hypromellose; carrageenan; pectin; purified water - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support energy levels ; maintain/support energy production ; relieve weariness/tiredness/fatigue/feeling of weakness ; maintain/support general health and wellbeing ; maintain/support gum health ; helps enhance/promote teeth health ; maintain/support connective tissue health ; helps enhance/promote connective tissue health ; aid/assist/helps connective tissue production/formation ; helps enhance/promote bone health ; maintain/support bone health ; aid/assist healthy red blood cell production ; maintain/support red blood cell health ; helps maintain/support transport of oxygen in the body ; helps maintain/support haemoglobin formation/synthesis ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; enhance/improve/promote/increase (state vitamin/mineral/nutrient) levels in the body ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; maintain/support wound healing

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

phytologic holdings pty limited - pyridoxal 5-phosphate monohydrate, quantity: 78.4 microgram/ml (equivalent: pyridoxine, qty 50 microgram/ml); ferric pyrophosphate, quantity: 4 mg/ml (equivalent: iron, qty 1 mg/ml); mecobalamin, quantity: 0.09 microgram/ml; levomefolate glucosamine, quantity: 26.7 microgram/ml (equivalent: levomefolic acid, qty 15 microgram/ml) - oral liquid - excipient ingredients: purified water; xanthan gum; glycerol; potassium sorbate; citric acid; flavour - maintain/support energy levels ; maintain/support heat/energy production/thermogenesis ; maintain/support healthy growth and development ; maintain/support general health and wellbeing ; aid/assist healthy red blood cell production ; maintain/support blood health ; helps maintain/support transport of oxygen in the body ; aid/assist/helps oxygen transport to body tissues ; helps maintain/support haemoglobin formation/synthesis ; maintain/support immune system health ; aid/assist/helps protein synthesis in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; maintain/support cognitive development ; aid/assist/helps synthesis of neurotransmitters ; maintain/support nervous system health

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

pharmacare laboratories pty ltd - ferric pyrophosphate, quantity: 92.1999 mg (equivalent: iron, qty 23.9999 mg) - pastille - excipient ingredients: gelatin; glycerol; carnauba wax; vegetable oil; purified water; maltitol solution; steviol glycosides; citric acid; colour; lecithin; hydrolysed maize starch; flavour; hypromellose; sorbitol; medium chain triglycerides; pectin - maintain/support energy levels ; maintain/support energy production ; relieve weariness/tiredness/fatigue/feeling of weakness ; maintain/support general health and wellbeing ; aid/assist healthy red blood cell production ; maintain/support red blood cell health ; maintain/support blood health ; helps maintain/support transport of oxygen in the body ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency