United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pharmacosmos uk ltd - ferric derisomaltose - solution for injection - 100mg/1ml

Australia - English - 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: - oral liquid - excipient ingredients: maize starch; stevia rebaudiana; sucrose; glycerol; cochineal; purified water; citric acid; xanthan gum; gelatin; dl-alpha-tocopherol; xylitol; potassium sorbate; acacia; silicon dioxide; medium chain triglycerides; flavour; maltodextrin; sodium chloride; lecithin - 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

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

akebia therapeutics, inc. - tetraferric tricitrate decahydrate (unii: q91187k011) (ferric cation - unii:91o4lml611) - ferric cation 210 mg - auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. auryxia is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see warnings and precautions (5.1)] . risk summary there are no available data on auryxia use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted using auryxia. skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9. however, oral administration of other ferric or ferrous compounds to gravid cd1-mice and wistar-rats caused no fetal malformation. an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. clinical considerations the effect of auryxia on the absorption of vitamins and other nutrients has not been studied in pregnant women. requirements for vitamins and other nutrients are increased in pregnancy. risk summary there are no human data regarding the effect of auryxia in human milk, the effects on the breastfed child, or the effects on milk production. data from rat studies have shown the transfer of iron into milk by divalent metal transporter-1 (dmt-1) and ferroportin-1 (fpn-1). hence, there is a possibility of infant exposure when auryxia is administered to a nursing woman. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for auryxia and any potential adverse effects on the breastfed child from auryxia or from the underlying maternal condition. the safety and efficacy of auryxia have not been established in pediatric patients. juvenile animal toxicity data in animal studies, greater gastrointestinal toxicity was observed when ferric citrate was administered by gavage as compared to administration with solid food. because auryxia is recommended to be taken with meals and patients under 6 months of age are unlikely to be eating solid food, they may be at greater risk of gastrointestinal toxicity. clinical studies of auryxia included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of auryxia.

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

sanofi-aventis u.s. llc - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions (5.1)] , which may have serious consequences, such as fetal bradycardia (see clinical considerations) . advise pregnant women of the potential risk to the fetus. available data from postmarketing reports with ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. ferrlecit contains benzyl alcohol as a preservative. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

baxter healthcare (malaysia) sdn. bhd. - iron (iii)- hydroxide sucrose complex -

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

evolution health pty ltd - nicotinamide, quantity: 3 mg/ml; colecalciferol, quantity: 1 microgram/ml; ascorbic acid, quantity: 12 mg/ml; thiamine hydrochloride, quantity: 500 microgram/ml; pyridoxine hydrochloride, quantity: 150 microgram/ml (equivalent: pyridoxine, qty 123.4 microgram/ml); riboflavine sodium phosphate, quantity: 500 microgram/ml (equivalent: riboflavine, qty 365 microgram/ml); ferric chloride hexahydrate, quantity: 3.48 mg/ml (equivalent: iron, qty 720 microgram/ml) - oral liquid - excipient ingredients: sorbitol solution (70 per cent) (crystallising); xanthan gum; saccharin sodium; potassium sorbate; polysorbate 80; purified water; 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

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

bnutrition pty ltd - levomefolate glucosamine, quantity: 27 microgram/ml (equivalent: levomefolic acid, qty 15 microgram/ml); mecobalamin, quantity: 0.09 microgram/ml; pyridoxal 5-phosphate monohydrate, quantity: 88 microgram/ml (equivalent: pyridoxine, qty 50 microgram/ml); ferric pyrophosphate, quantity: 3.325 mg/ml (equivalent: iron, qty 1 mg/ml) - oral liquid - excipient ingredients: purified water; xanthan gum; glycerol; potassium sorbate; dextrin; sodium chloride; lecithin; 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 ; maintain/support healthy immune system function ; aid/assist/helps protein synthesis in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; maintain/support cognitive development ; aid/assist/helps synthesis of neurotransmitters ; maintain/support nervous system health ; maintain/support nervous system function

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

pharmametics products a division of max biocare pty ltd - calcium folinate, quantity: 127 microgram (equivalent: folinic acid, qty 100 microgram); ascorbic acid, quantity: 100 mg; folic acid, quantity: 400 microgram; iron (ii) glycinate, quantity: 92.25 mg (equivalent: iron, qty 24 mg) - tablet, film coated - excipient ingredients: carnauba wax; citric acid; colloidal anhydrous silica; silicon dioxide; maltodextrin; hypromellose; povidone; silicified microcrystalline cellulose; crospovidone; magnesium stearate; titanium dioxide; lecithin; medium chain triglycerides; ferrosoferric oxide; chlorophyllin-copper complex - antioxidant/reduce free radicals formed in the body ; aid/assist healthy red blood cell production ; maintain/support blood health ; helps maintain/support haemoglobin formation/synthesis ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; maintain/support (state vitamin/mineral) within normal range ; maintain/support healthy pregnancy ; help to prevent neural tube defects such as spina bifida and/or anencephaly

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

bnutrition pty ltd - biotin, quantity: 1.6 microgram/ml; mecobalamin, quantity: 0.18 microgram/ml; calcium ascorbate dihydrate, quantity: 3.41 mg/ml (equivalent: ascorbic acid, qty 2.8 mg/ml; equivalent: calcium, qty 320 microgram/ml); riboflavin sodium phosphate, quantity: 80 microgram/ml (equivalent: riboflavin, qty 60 microgram/ml); zinc glycinate, quantity: 4 mg/ml (equivalent: zinc, qty 1.2 mg/ml); nicotinamide, quantity: 400 microgram/ml; manganese amino acid chelate, quantity: 1 mg/ml (equivalent: manganese, qty 200 microgram/ml); levomefolate glucosamine, quantity: 72.13 microgram/ml (equivalent: levomefolic acid, qty 40 microgram/ml); pyridoxal 5-phosphate monohydrate, quantity: 176 microgram/ml (equivalent: pyridoxine, qty 100 microgram/ml); d-alpha-tocopheryl acetate, quantity: 2 mg/ml; dibasic magnesium phosphate trihydrate, quantity: 24 mg/ml (equivalent: magnesium, qty 3.3 mg/ml); thiamine hydrochloride, quantity: 89 microgram/ml (equivalent: thiamine, qty 80 microgram/ml); potassium iodide, quantity: 11.8 microgram/ml (equivalent: iodine, qty 9 microgram/ml); choline bitartrate, quantity: 20 mg/ml (equivalent: choline, qty 8.26 mg/ml); betacarotene, quantity: 1 mg/ml; calcium phosphate, quantity: 26.4325 mg/ml (equivalent: calcium, qty 10.0007 mg/ml); ferric pyrophosphate, quantity: 3.325 mg/ml (equivalent: iron, qty 1 mg/ml); colecalciferol, quantity: 0.5 microgram/ml - oral liquid - excipient ingredients: citric acid; xanthan gum; potassium sorbate; glycerol; purified water; maize starch; ascorbyl palmitate; gelatin; maize oil; dl-alpha-tocopherol; sucrose; lecithin; flavour; dextrin; sodium chloride; vegetable oil - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support collagen formation ; maintain/support energy levels ; helps convert (state food) into energy ; maintain/support body metabolism/metabolic rate ; maintain/support energy production ; maintain/support heat/energy production/thermogenesis ; maintain/support healthy eye function ; maintain/support eye health ; maintain/support healthy eyesight/vision ; maintain/support healthy growth and development ; maintain/support general health and wellbeing ; aids/assists teeth development ; maintain/support healthy teeth ; maintain/support teeth mineralisation ; maintain/support connective tissue health ; aid/assist/helps connective tissue production/formation ; maintain/support healthy body tissues ; maintain/support bone health ; aids/assists healthy bone development/growth/building ; maintain/support bone strength ; help maintain/support bone mineralisation ; 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 ; aid/assist/helps oxygen transport to body tissues ; helps maintain/support haemoglobin formation/synthesis ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support muscle function ; maintain/support healthy neuromuscular system/function ; aid/assist/helps glucose/sugar/carbohydrate metabolism ; 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) ; maintain/support cognitive development ; 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 skin health ; maintain/support skin integrity/structure ; maintain/support skin regeneration ; maintain/support wound healing

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

organon pharma pty ltd - carbidopa monohydrate, quantity: 54 mg (equivalent: carbidopa, qty 50 mg); levodopa, quantity: 200 mg - tablet, modified release - excipient ingredients: hyprolose; magnesium stearate; ferric oxide; va/crotonates copolymer; quinoline yellow aluminium lake - idiopathic parkinsonism, where standard formulations containing levodopa/carbidopa have produced inadequate control. experience is limited with sinemet cr 200/50 in patients who have not been treated with levodopa before.