Note: Multiple concentrations of polysaccharide iron complex oral liquid exist; close attention must be paid to the concentration when ordering and administering polysaccharide iron complex; incorrect selection or substitution of one polysaccharide iron complex liquid for another without proper dosage volume adjustment may result in serious over- or underdosing.
Note: Doses expressed in terms of elemental iron.
Adequate intake (AI): Note: Recommended intake from dietary sources (eg, breast milk, formula). Neonate: 0.27 mg elemental iron/day (IOM 2001).
Iron deficiency, prevention in neonates fed human milk: Oral:
GA <37 weeks:
Birthweight <2 kg: Oral: 2 to 3 mg elemental iron/kg/day divided every 12 to 24 hours; maximum daily dose: 15 mg elemental iron/day; begin at 2 to 6 weeks of age and continue until 6 to 12 months of age (AAP [Baker 2010]; CPS [Unger 2019]; ESPGHAN [Agostoni 2010]; ESPGHAN [Domellöf 2014]; ESPGHAN [Lapillonne 2019]; NIH 2021).
Birthweight 2 to 2.5 kg: Oral: 1 to 2 mg elemental iron/kg/day divided every 12 to 24 hours; maximum daily dose: 15 mg elemental iron/day; begin at 2 to 6 weeks of age and continue until 6 months of age (AAP [Baker 2010]; CPS [Unger 2019]; ESPGHAN [Domellöf 2014]; ESPGHAN [Lapillonne 2019]; NIH 2021).
Birthweight >2.5 kg: Oral: 2 mg elemental iron/kg/day divided every 12 to 24 hours; begin at 4 to 8 weeks of life; maximum daily dose: 15 mg elemental iron/day (AAP [Baker 2010]; NIH 2021; WHO 2001).
GA ≥37 weeks: In healthy, term infants (exclusively fed human milk or human milk provides >50% of nutrition without iron fortified food), AAP recommends iron supplementation beginning at 4 months of age and continued until sufficient iron is provided in complementary foods (AAP [Baker 2010]).
Iron-deficiency anemia, treatment: Oral: 3 to 6 mg elemental iron/kg/day in 1 to 3 divided doses (ASPEN [Corkins 2015]; Kliegman 2020; Rao 2009).
Note: Multiple concentrations of polysaccharide iron complex oral liquid exist; close attention must be paid to the concentration when ordering and administering polysaccharide iron complex; incorrect selection or substitution of one polysaccharide iron complex liquid for another without proper dosage volume adjustment may result in serious over- or underdosing.
Note: Dosages are expressed in terms of elemental iron.
Dietary supplementation: Note: Refer to product-specific labeling for approved pediatric ages.
Infants and Children <12 years: Oral liquid: Oral: 15 mg elemental iron daily.
Children ≥12 years and Adolescents: Oral: 50 mg elemental iron daily.
Iron-deficiency anemia, prevention:
AAP recommendations:
Infants ≥4 months (exclusively fed human milk or human milk provides >50% of nutrition without iron fortified food): Oral: 1 mg elemental iron/kg/day; supplementation should be continued until sufficient iron is provided in complementary foods (AAP [Baker 2010]).
WHO recommendations:
Areas where anemia prevalence is ≥40%:
Infants ≥6 months and Children <2 years: Oral: 10 to 12.5 mg elemental iron daily for 3 consecutive months in a year (WHO 2016b).
Children 2 to <5 years: Oral: 30 mg elemental iron daily for 3 consecutive months in a year (WHO 2016b).
Children ≥5 to 12 years: Oral: 30 to 60 mg elemental iron daily for 3 consecutive months in a year (WHO 2016b).
Adolescent menstruating patients (nonpregnant patients of reproductive potential): Oral: 30 to 60 mg elemental iron daily for 3 consecutive months in a year (WHO 2016a).
Areas where anemia prevalence 20% to <40%: Weekly intermittent dosing:
Children 2 to <5 years: Oral: 25 mg elemental iron once weekly for 3 consecutive months, then alternating 3 months off supplementation, 3 months on supplementation (WHO 2011).
Children 5 to 12 years: Oral: 45 mg elemental iron once weekly for 3 consecutive months, then alternating 3 months off supplementation, 3 months on supplementation (WHO 2011).
Iron-deficiency anemia, treatment: Infants, Children, and Adolescents: Oral: Initial: 3 mg elemental iron/kg/day as a single daily dose (Kazal 2002; Oski 1993; Powers 2017; Reeves 1985) up to 60 to 120 mg elemental iron once daily (AAP [Kleinman 2019]); higher doses may be needed in select patients; dosage range: 3 to 6 mg elemental iron/kg/day in 1 to 3 divided doses; usual maximum daily dose: 150 to 200 mg elemental iron/day (ASPEN [Corkins 2015]; Kliegman 2020; Zlotkin 2001); once-daily administration may be preferred for ease of administration and adherence (Zlotkin 2001). Studies in iron-depleted adults suggest that iron absorption may be improved by less frequent dosing (alternate-day dosing, or once daily versus multiple daily doses) (Moretti 2015; Stoffel 2017).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosing adjustments provided in the manufacturer's labeling.
There are no dosing adjustments provided in the manufacturer's labeling.
(For additional information see "Polysaccharide-iron complex: Drug information")
Note: Dosage expression: Dose is expressed in terms of elemental iron; the strength of each capsule or concentration of liquid represents the amount of elemental iron (eg, a 150 mg capsule contains 150 mg of elemental iron). Formulation: Enteric-coated and slow/sustained-release preparations are generally not preferred due to poor absorption (Hershko 2014; Liu 2012). Route of administration: IV iron replacement is preferred over oral replacement in several clinical situations (eg, poor GI absorption, lack of response to or poor tolerability of oral iron, chronic kidney disease, active inflammatory bowel disease, cancer, chronic or extensive blood loss) (Auerbach 2021).
Iron deficiency or iron-deficiency anemia: Oral: 50 to 200 mg of elemental iron (1 tablet or equivalent as liquid) once every other day or on Monday, Wednesday, and Friday (Liu 2012; Stoffel 2017; Stoffel 2020; Stoltzfus 1998; WHO 2001). Note: Daily dosing has been shown to result in decreased absorption but may be reasonable in some individuals to improve adherence (Auerbach 2021; Stoffel 2017; Stoffel 2020).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosing adjustments provided in the manufacturer’s labeling.
There are no dosing adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Gastrointestinal: Constipation, darkening of stools, epigastric pain, gastrointestinal irritation, nausea, stomach cramps, vomiting
1% to 10%:
Gastrointestinal: Dental discoloration, diarrhea, heartburn
Genitourinary: Urine discoloration
<1%, postmarketing, and/or case reports: Local irritation
Known hypersensitivity to polysaccharide-iron complex or any component of the formulations; hemochromatosis; hemosiderosis
Concerns related to adverse effects:
• Stool discoloration: Oral iron preparations commonly cause dark or black stools; patients should be informed of the effect.
Special populations:
• Pediatric: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of the reach of children. In case of accidental overdose call the poison control center immediately.
Dosage form specific issues:
• Oral iron formulations: Immediate-release oral iron products are preferred for treatment of iron deficiency anemia; enteric-coated and slow-/sustained-release preparations are not desired due to poor absorption (Hershko 2014; Liu 2012).
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions and intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.
• Excipient: Some formulations may contain tartrazine, which is associated with allergic-type reactions. Although rare, hypersensitivity is more frequently seen in individuals with aspirin allergy.
Other warnings/precautions:
• Appropriate use: Investigate type of anemia and potential underlying causes (eg, recurrent blood loss) prior to initiating iron supplementation.
Consider all iron sources when evaluating the dose of iron, including combination products, infant formulas, and liquid nutritional supplements.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
EZFE 200: 200 mg [non-toxic; contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]
Ferrex 150: 150 mg [contains fd&c blue #1 (brill blue) aluminum lake, fd&c red #40(allura red ac)aluminum lake, fd&c yellow #5 (tartrazine)aluminum lake]
Ferric x-150: 150 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #5 (tartrazine)]
IFerex 150: 150 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]
NovaFerrum 50: 50 mg
Nu-Iron: 150 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]
Poly-Iron 150: 150 mg [contains fd&c blue #1 (brill blue) aluminum lake, fd&c red #40(allura red ac)aluminum lake, fd&c yellow #5 (tartrazine)aluminum lake]
Generic: 150 mg
Liquid, Oral:
NovaFerrum: Polysaccharide-iron complex 125 mg and cholecalciferol 100 units per 5 mL (180 mL) [contains sodium benzoate]
NovaFerrum Pediatric Drops: 15 mg/mL (120 mL) [alcohol free, dye free, gluten free, lactose free, sodium free, sugar free; contains sodium benzoate; raspberry-grape flavor]
May be product dependent
Capsules (EZFE 200 Oral)
434.8 (200 Fe) mg (per each): $0.41
Capsules (Ferrex 150 Oral)
150 mg (per each): $0.15
Capsules (IFerex 150 Oral)
150 mg (per each): $0.34
Capsules (NovaFerrum 50 Oral)
50 mg (per each): $0.22
Capsules (Nu-Iron Oral)
150 mg (per each): $0.51
Capsules (Poly-Iron 150 Oral)
150 mg (per each): $0.14
Capsules (Polysaccharide Iron Complex Oral)
150 mg (per each): $0.28
Liquid (Hematex Oral)
100 mg/5 mL (per mL): $0.08
Liquid (NovaFerrum Oral)
125 mg/5 mL (per mL): $0.14
Liquid (NovaFerrum Pediatric Drops Oral)
15 mg/mL (per mL): $0.19
Tablets (Hematex Iron Complex Oral)
150 mg (per each): $0.30
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer with water or juice prior to breakfast and/or between meals for maximum absorption (Kliegman 2020; Oski 1993); may administer with food if GI upset occurs; do not administer with milk or milk products (Powers 2017). Shake liquid well prior to administration.
Oral: Shake liquid well prior to administration.
Store between 15°C and 30°C (59°F and 86°F).
Prevention and treatment of iron deficiency anemia (OTC: FDA approved in adults; refer to product-specific labeling for specific information regarding FDA approval in pediatric patients).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Alpha-Lipoic Acid: Iron Preparations may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Iron Preparations. Management: Separate administration of alpha-lipoic acid from that of any iron-containing compounds by several hours. If alpha-lipoic acid is given 30 minutes before breakfast, then administer oral iron-containing products at lunch or dinner. Risk D: Consider therapy modification
Antacids: May decrease the absorption of Iron Preparations. Management: No action is likely necessary for the majority of patients who only use antacids intermittently or occasionally. Consider separating doses of oral iron and antacids in patients who require chronic use of both agents and monitor for reduced iron efficacy. Risk D: Consider therapy modification
Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. Risk X: Avoid combination
Bictegravir: Iron Preparations may decrease the serum concentration of Bictegravir. Management: Bictegravir can be given with iron under fed conditions. Under fasting conditions, coadministration with, or 2 hours after, iron is not recommended. In pregnancy, bictegravir can be given 2 hours before or 6 hours after iron under fasting conditions. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Risk D: Consider therapy modification
Cabotegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Cabotegravir. Management: Administer polyvalent cation containing products at least 2 hours before or 4 hours after oral cabotegravir. Risk D: Consider therapy modification
Cefdinir: Iron Preparations may decrease the serum concentration of Cefdinir. Red-appearing, non-bloody stools may also develop due to the formation of an insoluble iron-cefdinir complex. Management: Avoid concurrent cefdinir and oral iron when possible. Separate doses by at least 2 hours if combined. Iron-containing infant formulas do not appear alter cefdinir pharmacokinetics, but red-appearing, non-bloody stools may develop when combined. Risk D: Consider therapy modification
Deferiprone: Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Risk D: Consider therapy modification
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Risk X: Avoid combination
Dolutegravir: Iron Preparations may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral iron. Administer dolutegravir/rilpivirine at least 4 hours before or 6 hours after oral iron. Alternatively, dolutegravir and oral iron can be taken together with food. Risk D: Consider therapy modification
Eltrombopag: Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product. Risk D: Consider therapy modification
Elvitegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Elvitegravir. Management: Administer elvitegravir 2 hours before or 6 hours after the administration of polyvalent cation containing products. Risk D: Consider therapy modification
Entacapone: Iron Preparations may decrease the serum concentration of Entacapone. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Risk D: Consider therapy modification
Ferric Hydroxide Polymaltose Complex: May decrease the serum concentration of Iron Preparations. Specifically, the absorption of oral iron salts may be reduced. Management: Do not administer intravenous (IV) ferric hydroxide polymaltose complex with other oral iron preparations. Therapy with oral iron preparations should begin 1 week after the last dose of IV ferric hydroxide polymaltose complex. Risk D: Consider therapy modification
Levodopa: Iron Preparations may decrease the serum concentration of Levodopa. Only applies to oral iron preparations. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Risk D: Consider therapy modification
Levonadifloxacin: Iron Preparations may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
Levothyroxine: Iron Preparations may decrease the serum concentration of Levothyroxine. Management: Separate oral administration of iron preparations and levothyroxine by at least 4 hours. Separation of doses is not required with parenterally administered iron preparations or levothyroxine. Risk D: Consider therapy modification
Methyldopa: Iron Preparations may decrease the serum concentration of Methyldopa. Management: Consider separating doses of methyldopa and orally administered iron preparation by 2 or more hours. Monitor for decreased efficacy of methyldopa if an oral iron preparation is initiated/dose increase, or increased efficacy if discontinued/dose decreased. Risk D: Consider therapy modification
PenicillAMINE: Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour. Risk D: Consider therapy modification
Phosphate Supplements: Iron Preparations may decrease the absorption of Phosphate Supplements. Management: Administer oral phosphate supplements as far apart from the administration of an oral iron preparation as possible to minimize the significance of this interaction. Risk D: Consider therapy modification
Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Iron Preparations. Management: Give oral iron products at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider therapy modification
Quinolones: Iron Preparations may decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, oflox-, peflox, or nalidixic acid) oral iron. Risk D: Consider therapy modification
Raltegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Raltegravir. Management: Administer raltegravir 2 hours before or 6 hours after administration of the polyvalent cations. Dose separation may not adequately minimize the significance of this interaction. Risk D: Consider therapy modification
Roxadustat: Polyvalent Cation Containing Products may decrease the serum concentration of Roxadustat. Management: Administer roxadustat at least 1 hour after the administration of oral polyvalent cation containing products. Risk D: Consider therapy modification
Tetracyclines: May decrease the absorption of Iron Preparations. Iron Preparations may decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. Administer oral iron preparations at least 2 hours before, or 4 hours after, the dose of the oral tetracycline derivative. Monitor for decreased therapeutic effect of oral tetracycline derivatives. Risk D: Consider therapy modification
Trientine: Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant use of trientine and polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. For other oral polyvalent cations, give trientine 1 hour before, or 1 to 2 hours after the polyvalent cation. Risk D: Consider therapy modification
Unithiol: May diminish the therapeutic effect of Polyvalent Cation Containing Products. Risk X: Avoid combination
Vadadustat: Iron Preparations may decrease the serum concentration of Vadadustat. Management: Administer vadadustat at least 1 hour before oral iron supplements. Risk D: Consider therapy modification
Dietary sources of iron include beans, cereal (enriched), clams, beef, lentils, liver, oysters, shrimp, and turkey. Foods that enhance dietary absorption of iron include broccoli, grapefruit, orange juice, peppers and strawberries. Foods that decrease dietary absorption of iron include coffee, dairy products, soy products, spinach, and tea.
Dietary reference intake (elemental iron) (IOM 2001):
0 to 6 months: Adequate intake: 0.27 mg elemental iron daily.
7 to 12 months: Recommended dietary allowance (RDA): 11 mg elemental iron daily.
1 to 3 years: RDA: 7 mg elemental iron daily.
4 to 8 years: RDA: 10 mg elemental iron daily.
9 to 13 years: RDA: 8 mg elemental iron daily.
14 to 18 years: RDA:
Males: 11 mg elemental iron daily.
Females: 15 mg elemental iron daily.
Pregnancy: 27 mg elemental iron daily.
Lactation: 10 mg elemental iron daily.
19 to 50 years: RDA:
Males: 8 mg elemental iron daily.
Females: 18 mg elemental iron daily.
Pregnancy: 27 mg elemental iron daily.
Lactation: 9 mg elemental iron daily.
≥50 years: RDA: 8 mg elemental iron daily.
Iron transfer to the fetus is regulated by the placenta (BSH [Pavord 2020]; NAS 2020).
Maternal iron requirements increase during pregnancy. Untreated iron deficiency and iron-deficiency anemia (IDA) in pregnant patients are associated with adverse pregnancy outcomes, including low birth weight, preterm birth, and increased perinatal mortality (ACOG 2021; BSH [Pavord 2020]). Maternal iron deficiency is also associated with fatigue, increased risk of postpartum depression, and possibly postpartum hemorrhage (BSH [Pavord 2020]).
Oral and parenteral iron are effective at replacing iron stores in pregnant patients (ACOG 2021). Most studies note iron therapy improves maternal hematologic parameters; however, data related to clinical outcomes in the mother and neonate are limited (FIGO 2019; NAS 2020; USPSTF [Siu 2015]). Use of low-dose supplemental iron is recommended for all pregnant patients beginning in the first trimester or first prenatal visit to prevent anemia at term (ACOG 2021).
A product containing a ferrous salt may be preferred for the oral management of IDA in pregnancy (BSH [Pavord 2020]). Iron supplementation is recommended for 3 months once hemoglobin is within the normal range, and at least 6 weeks postpartum to replenish maternal iron stores (BSH [Pavord 2020]; FIGO 2019). Iron supplementation is recommended in addition to use of prenatal vitamins in pregnant patients diagnosed with IDA (ACOG 2021). Enteric-coated and slow/sustained-release preparations may be less effective due to decreased absorption, and use should be avoided (ACOG 2021; BSH [Pavord 2020]).
Hemoglobin and hematocrit; consider additional tests such as RBC count, RBC indices, serum ferritin, transferrin saturation, total iron-binding capacity, serum iron concentration, and erythrocyte protoporphyrin concentration (CDC 1998).
Serum iron (AAP [Kleinman 2019]):
≤6 weeks: 100 to 250 mcg/dL.
7 weeks to 11 months: 40 to 100 mcg/dL.
1 to 10 years: 50 to 120 mcg/dL.
≥11 years:
Female: 30 to 160 mcg/dL.
Male: 50 to 170 mcg/dL.
Total iron binding capacity (AAP [Kleinman 2019]):
≤2 months: 59 to 175 mcg/dL.
3 months to 17 years: 250 to 400 mcg/dL.
≥18 years: 240 to 450 mcg/dL.
Onset of action: Hematologic response: Red blood cells form within 3 to 10 days; similar onset as parenteral iron salts; Maximum effect: Peak reticulocytosis occurs in 5 to 10 days, and hemoglobin values increase within 2 to 4 weeks
Absorption: Oral: Iron is absorbed in the duodenum and upper jejunum; in persons with normal iron stores 10% of an oral dose is absorbed; this is increased to 20% to 30% in persons with inadequate iron stores; food and achlorhydria will decrease absorption
Protein binding: To transferrin
Excretion: Urine, sweat, sloughing of intestinal mucosa, and by menses
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