Ferric carboxymaltose

Limited reviewed summaryFull monograph review pending

Historical dilution reference. Verify the preparation against the label for the product in hand.

Original GlobalRPh article: Ferric Carboxymaltose-Injectafer® (opens in a new tab)Original source URL: https://globalrph.com/dilution/ferric-carboxymaltose-inj-injectafer/ Retrieved 2026-11-04

Historical source details

Original publication date: unavailable in the retrieved article.

Source location and file checksums

Original source URL: https://globalrph.com/dilution/ferric-carboxymaltose-inj-injectafer/ (opens in a new tab)
Source date: Not established in the retrieved source
Retrieved: 2026-11-04T19:46:53.748774+00:00
Source location: div.post-content
Packaged content SHA-256: dc9ebb5f2cde1f01f9e2559d93eb3e50639d90f5aacacf8609524ae45ea6696f
Original response SHA-256: 11d6ebc71e578aae2484c8352f1eed6bcae047439a4c6fa17871fc5ef136e526
Source body SHA-256: 1c70040c7d05338425947e39baf4e4feed8d63471545eff88ce9fcab987b0a64

INJECTAFER® (ferric carboxymaltose injection)

[ Usual Diluents ]	[ Standard Dilution ]	[ Storage and Stability ]
DESCRIPTION	CLINICAL PHARMACOLOGY	INDICATIONS AND USAGE
CONTRAINDICATIONS	PRECAUTIONS	ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION	HOW SUPPLIED	WARNINGS
PRESCRIBING HIGHLIGHTS: Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Iron supplements - other

Usual Diluents Return to article top

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate] Return to article top

[Patients weighing 50 kg (110 lb) or more ] May administer undiluted slow intravenous push at ~ 100mg/min. [750mg] [15 ml] [~7.5 minutes]

Give Injectafer in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

-OR- Administer via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is in the range of 2 mg to 4 mg of iron per mL. [750mg] [250 ml] [15-20 minutes] Each mL of Injectafer contains 50 mg of elemental iron.

[Patients weighing LESS than 50 kg (110 lb) ] May administer undiluted slow intravenous push at ~ 100mg/min. [15mg/kg ] [dose (ml)= (15mg/kg) / 50 ] [~7.5 minutes]

Give Injectafer in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

Stability: When added to an infusion bag containing 0.9% sodium chloride injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Injectafer is intended for single-use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Injectafer since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Injectafer administration at that site.

WARNINGS Return to article top

See warnings and precautions below.

DESCRIPTION Return to article top

Description: Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(1?4)-O-a-D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula: [FeOx(OH)y(H2O)z]n [{(C6H10O5)m (C6H12O7)}l]k, where n ˜ 103, m ˜ 8, l ˜ 11, and k ˜ 4 (l represents the mean branching degree of the ligand). Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection. Injectafer is available in 15 mL single-use vials. Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0. Vial closure is not made with natural rubber latex.

CLINICAL PHARMACOLOGY: Return to article top

Mechanism of Action: Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

INDICATIONS AND USAGE Return to article top

INDICATIONS AND USAGE: Injectafer is indicated for the treatment of iron deficiency anemia in adult patients: >who have intolerance to oral iron or have had unsatisfactory response to oral iron; >who have non-dialysis dependent chronic kidney disease. USE IN SPECIFIC POPULATIONS -------------- Pregnancy Pregnancy Category C Risk Summary Adequate and well controlled studies in pregnant women have not been conducted. However, animal reproduction studies have been conducted with ferric carboxymaltose. In these studies, administration of ferric carboxymaltose to rabbits during the period of organogenesis caused fetal malformations and increased implantation loss at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on body surface area). The incidence of major malformations in human pregnancies has not been established for Injectafer. However, all pregnancies, regardless of exposure to any drug, has a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. Injectafer should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data Administration of ferric carboxymaltose to rats as a one-hour intravenous infusion up to 30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryofetal findings. This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. In rabbits, ferric carboxymaltose was administered as a one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18 mg/kg/day. Malformations were seen starting at the daily dose of 9 mg/kg (23% of the human weekly dose of 750 mg). Spontaneous abortions occurred starting at the daily iron dose of 4.5 mg/kg (12% of the human weekly dose based on body surface area). Pre-implantation loss was at the highest dose. Adverse embryofetal effects were observed in the presence of maternal toxicity. A pre- and post-natal development study was conducted in rats at intravenous doses up to 18 mg/kg/day of iron (approximately 23% of the weekly human dose of 750 mg on a body surface area basis). There were no adverse effects on survival of offspring, their behavior, sexual maturation or reproductive parameters. Nursing Mothers A study to determine iron concentrations in breast milk after administration of Injectafer (n=11) or oral ferrous sulfate (n=14) was conducted in 25 lactating women with postpartum iron deficiency anemia. Mean breast milk iron levels were higher in lactating women receiving Injectafer than in lactating women receiving oral ferrous sulfate. Pediatric Use Safety and effectiveness have not been established in pediatric patients. Geriatric Use Of the 1775 subjects in clinical studies of Injectafer, 50% were 65 years and over, while 25% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

CONTRAINDICATIONS Return to article top

Contraindications: Hypersensitivity to Injectafer or any of its inactive components.

PRECAUTIONS Return to article top

WARNINGS AND PRECAUTIONS:

Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. [see Adverse Reactions ]. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.
Hypertension In clinical studies, hypertension was reported in 3.8% (67/1,775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1,775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Injectafer administration [see Dosage and Administration].
Laboratory Test Alterations In the 24 hours following administration of Injectafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer.

ADVERSE REACTIONS Return to article top

ADVERSE REACTIONS:

The most common adverse reactions (≥ 2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness. To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DOSAGE AND ADMINISTRATION Return to article top

DOSAGE AND ADMINISTRATION:

For patients weighing 50 kg (110 lb) or more: Give Injectafer in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Injectafer is expressed in mg of elemental iron. Each mL of Injectafer contains 50 mg of elemental iron. Injectafer treatment may be repeated if iron deficiency anemia reoccurs.

Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% sodium chloride injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Injectafer is intended for single-use only. Any unused drug remaining after injection must be discarded.

HOW SUPPLIED Return to article top

DOSAGE FORMS AND STRENGTHS: 750 mg iron/15 mL single-use vial. NDC 0517-0650-01 750 mg iron/15 mL Single-Use Vial Individually boxed NDC 0517-0650-02 750 mg iron/15 mL Single-Use Vial Packages of 2

Storage and Stability Return to article top

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See the USP controlled room temperature]. Do not freeze. Admixture stability: When added to an infusion bag containing 0.9% sodium chloride injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL

Open this historical article on its own

Reviewed product information

Applies to

Injectafer U.S. ferric carboxymaltose 50 mg iron/mL single-dose vials. Local preparation claim limited to prescribed adult 750 mg or 1000 mg infusions; no cumulative-dose selection, lower-dose schedule or IV-push instruction.

Preparation sources checked 2026-11-13.

Dilution

For a prescribed adult infusion of 750 mg or 1000 mg, 250 mL of sterile 0.9% Sodium Chloride Injection is a supported diluent volume.

Sources and exact locations

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-001

Review basis: Separately edited professional reference

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 2.4 Preparation and Administration; UUID ee8dc4fc-1a47-422e-99c0-59a5fd228ac7
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Iron as Ferric Carboxymaltose (Ferinject) Intravenous for Adults (opens in a new tab)
Exact location: Infusion fluids; Methods of intravenous administration > Intermittent intravenous infusion, dilution table 500 to 1000 mg row
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:54:48.674621+00:00
Ferinject rather than U.S. Injectafer. Both are ferric carboxymaltose 50 mg iron/mL. Guide independently edited but partly label-derived. Only explicitly concordant infusion and hypersensitivity statements transferred. Different injection rates, lower-dose infusion times and cumulative-dose schedules were excluded.

This is preparation of an already prescribed dose, not a dose recommendation. U.S. label permits no more than 250 mL; 250 mL is the common supported point.

Concentration

Keep the infusion concentration at or above 2 mg iron/mL.

Sources and exact locations

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-002

Review basis: Separately edited professional reference

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 2.4 Preparation and Administration; UUID ee8dc4fc-1a47-422e-99c0-59a5fd228ac7
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Iron as Ferric Carboxymaltose (Ferinject) Intravenous for Adults (opens in a new tab)
Exact location: Methods of intravenous administration > Intermittent intravenous infusion, minimum permitted concentration
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:54:48.674621+00:00
Ferinject rather than U.S. Injectafer. Both are ferric carboxymaltose 50 mg iron/mL. Guide independently edited but partly label-derived. Only explicitly concordant infusion and hypersensitivity statements transferred. Different injection rates, lower-dose infusion times and cumulative-dose schedules were excluded.

Infusion

Infuse the reviewed 750 mg or 1000 mg adult preparation over at least 15 minutes.

Sources and exact locations

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-003

Review basis: Separately edited professional reference

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 2.4 Preparation and Administration; UUID ee8dc4fc-1a47-422e-99c0-59a5fd228ac7
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Iron as Ferric Carboxymaltose (Ferinject) Intravenous for Adults (opens in a new tab)
Exact location: Methods of intravenous administration > Intermittent intravenous infusion, dilution table 500 to 1000 mg row
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:54:48.674621+00:00
Ferinject rather than U.S. Injectafer. Both are ferric carboxymaltose 50 mg iron/mL. Guide independently edited but partly label-derived. Only explicitly concordant infusion and hypersensitivity statements transferred. Different injection rates, lower-dose infusion times and cumulative-dose schedules were excluded.

Boxed Warning

Injectafer can cause severe, prolonged hypophosphatemia, with serious outcomes including hospitalization, osteomalacia and fractures.

Sources and exact locations

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-004

Review basis: FDA postmarketing safety assessment

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: Boxed Warning: Symptomatic Hypophosphatemia; UUID 3752161e-cce5-482b-9fb5-5e41f88bd163; 5.1 Symptomatic Hypophosphatemia
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
FDA adds boxed warning to Injectafer for symptomatic hypophosphatemia (opens in a new tab)
Exact location: What Is FDA Doing?; What Did FDA Find?
Publisher: U.S. FDA Drug Safety Communication
Source family: FDA postmarketing safety assessment
Retrieved: 2026-11-04T18:54:47.961615+00:00
FDA communication describes separate postmarketing assessment using FAERS/AEMS, literature and Sentinel. Same regulatory decision as updated label, but additional safety assessment beyond a label mirror.

Monitoring

Check serum phosphate before a repeat course in patients at risk, and before any repeat course within 3 months; correct pre-existing hypophosphatemia.

Sources and exact locations

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-005

Review basis: FDA postmarketing safety assessment

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: Boxed Warning; 2.1 Laboratory Testing; 5.1 Symptomatic Hypophosphatemia, UUID 88fa8329-1f43-4fa0-ba3b-0659154d8057
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
FDA adds boxed warning to Injectafer for symptomatic hypophosphatemia (opens in a new tab)
Exact location: What Should Health Care Providers Do?, first two bullets
Publisher: U.S. FDA Drug Safety Communication
Source family: FDA postmarketing safety assessment
Retrieved: 2026-11-04T18:54:47.961615+00:00
FDA communication describes separate postmarketing assessment using FAERS/AEMS, literature and Sentinel. Same regulatory decision as updated label, but additional safety assessment beyond a label mirror.

Monitoring

Observe for hypersensitivity during treatment and for at least 30 minutes after administration.

Sources and exact locations

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-006

Review basis: Separately edited professional reference

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 5.2 Hypersensitivity Reactions
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Iron as Ferric Carboxymaltose (Ferinject) Intravenous for Adults (opens in a new tab)
Exact location: Important information, monitoring bullet; Further information, intravenous iron monitoring paragraph
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:54:48.674621+00:00
Ferinject rather than U.S. Injectafer. Both are ferric carboxymaltose 50 mg iron/mL. Guide independently edited but partly label-derived. Only explicitly concordant infusion and hypersensitivity statements transferred. Different injection rates, lower-dose infusion times and cumulative-dose schedules were excluded.

Mechanism

Ferric carboxymaltose is an iron(III) hydroxide complex with a carbohydrate polymer that releases iron.

Mechanism provenance: Independently corroborated

Sources and exact locations

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-007

Review basis: Separately authored drug specific review

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 12.1 Mechanism of Action; UUID 528d89e9-b665-4bc1-aeee-564e7a4bb201
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Ferric carboxymaltose: a review of its use in iron-deficiency anaemia. (opens in a new tab)
Exact location: Abstract: first sentence (ferric hydroxide core and carbohydrate shell) and the paragraph beginning with the macromolecular complex description; PubMed XML PubmedArticle[MedlineCitation/PMID="19405553"]/MedlineCitation/Article/Abstract/AbstractText
Publisher: Peer reviewed scientific literature indexed by NCBI PubMed
Source family: Lyseng-Williamson KA et al. 2009 drug specific scientific review
Retrieved: 2026-11-04T18:57:55.140225+00:00
Separately authored drug-specific review, distinct from an FDA/DailyMed label mirror. The abstract discusses Ferinject ferric carboxymaltose chemistry; it supports this molecular mechanism but not U.S. Injectafer package identity. Historical review, not an independent new experimental study. Its administration-time and safety summaries were not used.

Separately authored drug-specific review, distinct from an FDA/DailyMed label mirror. The abstract discusses Ferinject ferric carboxymaltose chemistry; it supports this molecular mechanism but not U.S. Injectafer package identity. Historical review, not an independent new experimental study. Its administration-time and safety summaries were not used.
The current product-specific U.S. label and a separate scientific document support this bounded mechanism statement.

Safety resources for this medication (2)

FDA Injectafer safety communication (September1,2026) (opens in a new tab)
FDA AEMS Q1 2026: hypophosphatemia signal history (June 4 status; later FDA boxed-warning action applies) (opens in a new tab)
Source date and scope
Potential-signal tables are safety-review resources. Inclusion alone does not establish causality or a treatment change.
Status date: 2026-06-04
Status in that table: FDA is evaluating the need for regulatory action.
Exact table location: January - March 2026 safety table, data row 13 (header excluded): Product Name / Product Class = Injectafer (ferric carboxymaltose injection); Signal = Hypophosphatemia; Additional Information (as of 2026-06-04)
Scope: Matches the expressly listed product/ingredient for safety-resource navigation only. It does not reconcile a stocked manufacturer, package NDC, lot or full monograph and does not establish causality.

Read the linked communication and current prescribing information before use. Resource dates and affected product scopes differ; a listed resource is not a full monograph or a lot-specific clearance.

Product identifiers and clinical review status

Selected prescribing information available. Full monograph review pending.

Selected product identity

Exact selected U.S. product traced to current SPL; full identity reconciliation incomplete.

View product identifiers and primary-label provenance

Selected product scope: Injectafer U.S. ferric carboxymaltose 50 mg iron/mL single-dose vials. Local preparation claim limited to prescribed adult 750 mg or 1000 mg infusions; no cumulative-dose selection, lower-dose schedule or IV-push instruction.
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-PRODUCT-SCOPE
Primary source (opens in a new tab) | Product data elements and the claim-specific formulation described in the cited preparation sections
Complete product reconciliation: pending.
Labeler: American Regent, Inc.
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-LABELER
Primary source (opens in a new tab) | SPL author/assignedEntity/representedOrganization/name
Complete product reconciliation: pending.
Application number(s): NDA203565
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-APPLICATION-NUMBERS
Primary source (opens in a new tab) | SPL subjectOf/approval/id/@extension
Complete product reconciliation: pending.
NDC(s): 0517-0602-01; 0517-0650-01; 0517-0620-01
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-NDCS
Primary source (opens in a new tab) | SPL manufacturedProduct/asContent/containerPackagedProduct/code/@code and How Supplied
Complete product reconciliation: pending.
DailyMed Set ID: 517b4a19-45b3-4286-9f6a-ced4e10447de
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-SETID
Primary source (opens in a new tab) | SPL document/setId/@root
Complete product reconciliation: pending.
SPL version: 30
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-SPL-VERSION
Primary source (opens in a new tab) | SPL document/versionNumber/@value
Complete product reconciliation: pending.
Label printed revision date: August 2026; SPL effective August 19, 2026
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-LABEL-REVISION-DATE
Primary source (opens in a new tab) | Printed revision statement in the selected label; distinct from SPL effectiveTime
Complete product reconciliation: pending.
SPL effective date: 2026-08-19
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-REVISION-DATE
Primary source (opens in a new tab) | SPL document/effectiveTime/@value
Complete product reconciliation: pending.
Retrieved: 2026-11-04T18:47:16.185362+00:00
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-RETRIEVED-AT
Primary source (opens in a new tab) | Timestamp recorded when source bytes were retrieved
Complete product reconciliation: pending.
Downloaded XML SHA-256: 6a7dd1d7996aba40a3ece4cdfc904a2112706ba57df15418896696818f63ea3a
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-XML-SHA256
Primary source (opens in a new tab) | SHA-256 computed over the exact downloaded XML bytes
Complete product reconciliation: pending.

What remains to be completed

Extract and verify presentation-specific IV preparation.
Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.

Open the original GlobalRPh site monograph (historical; not revalidated) (opens in a new tab)

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