Do not exceed a total daily dose of 2 mL undiluted Infed. Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. 0000026302 00000 n Stability of injectable medications after reconstitution INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. CAS number: 9004-66-4. used within 6 hours after reconstitution.If RZV is stored after reconstitution, store at recommended storage conditions and reagitate prior to administration. General considerations, the nitrosoureas and alkylating agents. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. endstream endobj 57 0 obj<> endobj 58 0 obj<>stream Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli. 0000003091 00000 n FOIA 4 0 obj LBW = Lean body weight in kg. Each monograph contains stability data, administration guidelines, and methods of preparation. Infusion should then be stopped for 1 hour. Risk Summary INFeD belongs to a class of drugs called Iron Products. Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. 0000005917 00000 n Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. Clipboard, Search History, and several other advanced features are temporarily unavailable. National Library of Medicine Package insert / product label Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Hilleman DE, McEvoy GK, Bailey RT Jr, Reich J. Hosp Pharm. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. The 5 hour value was determined for 59Fe iron dextran from a study that used laboratory methods to separate the circulating 59Fe iron dextran from the transferrin bound 59Fe. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Accessibility The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. Infed (iron dextran injection), for intravenous or intramuscular use IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: 0000002441 00000 n Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. Risk Summary w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. Question patients regarding any prior history of reactions to parenteral iron products. 0000008022 00000 n Infed (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). Do Not Copy, Distribute or otherwise Disseminate without express permission. Please check for further notifications by email. d. Hemoglobin deficit The following information about each drug is given in tabular format: drug to be reconstituted and size of package; recommended route(s) of administration; recommended diluent, quantity to be used and resultant concentration; stability after initial dilution; and stability after further dilution; and stability . . H|TMs6Wu*Q6i\l.` Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. <> Disease-Associated Maternal and/or Embryo/Fetal Risk Cancer Chemother Pharmacol. In patients with CKD receiving an ESA, administer sufficient iron to maintain selected targets of iron therapy (i.e., transferrin saturation and serum ferritin concentrations); periodically monitor these iron indices and use results (in conjunction with hemoglobin concentrations and ESA dosage) to guide iron therapy. .0.34% (See Special Populations under Pharmacokinetics.). David McAuley, Pharm.D. Do not freeze. Accessibility What are the possible side effects of INFeD? Before (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.). Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. [See USP Controlled Room Temperature]. Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. The stability of injectable medications after reconstitution is presented. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. tran [6]. 0000006695 00000 n endobj This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. INFeD (IRON DEXTRAN COMPLEX) INJECTION SDS EFFECTIVE DATE: SEPTEMBER 24, 2018 PAGE 1 OF 8 SAFETY DATA SHEET Prepared to U.S. OSHA, CMA, ANSI, Canadian WHMIS Standards, European Union CLP EC 1272/2008 and the Global Harmonization Standard 1. PDF SCIENTIFIC DISCUSSION - European Medicines Agency 0000032198 00000 n *Qp"Q!J FLeQI!/r5=J aJp0s bEl$6uwK6).d>)bdJ6z!oGUayaZ`Z5$+=6mF2xzh[*'_L'T+Rbs VJlJ-2RSJrJIRSJxJ O))%Rs9PSJ~h]@?:4O~AQ@%{Ik@Ks1y,u?%s O))%\cy c ::y[%6b;+.:.=.7WKEbWd? Blood volume . J Pain Palliat Care Pharmacother. Administer only in a setting where resuscitation equipment and medications are available. A current package insert for the iron dextran product being used should always be reviewed, since these package inserts are periodically updated, and the product is currently made by more than one manufacturer. Assay methods, adriamycin and the other antitumour antibiotics. PDF Storage and Reuse of Reconstituted Neuromodulators Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. (See Iron, oral under Interactions.). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Women's Bond NFT Collection . General (See Sensitivity Testing under Dosage and Administration.)