Dosage form: injection 0000013156 00000 n IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: MeSH Federal government websites often end in .gov or .mil. s sw?s4 rA,Pg_F\6IV5fbZW[Xo3tvR>el#Fd+9#Q|M-:bp6(-Ua7y3|b'O1:B`#Q)oTdQ~} B7&y"p$dKHo$zqx)|{JOj?aaZ=*#s}#;{ wQ&vYAv6bUd`l!k3X*4V. (See Boxed Warning.). Excess storage of iron and a syndrome similar to hemosiderosis possible when used for anemia not attributable to iron deficiency (e.g., those with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias). INFeD should be injected only into the muscle mass of the upper outer quadrant of the buttock - never into the arm or other exposed areas - and should be injected deeply, with a 2-inch or 3-inch 19 or 20 gauge needle. Allergan USA, Inc. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. Clipboard, Search History, and several other advanced features are temporarily unavailable. Infed is a registered trademark of Allergan Sales, LLC. crobiological stability and recovery of the active drug after dilution or reconstitution should be evaluated during drug development to provide healthcare professionals with the necessary information about in-use stability. 2 0 obj Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. Fetal/Neonatal Adverse Reactions 1 INDICATIONS AND USAGE 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 . Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia* Alternatively, the total dose may be calculated using the formulas below: Adults and Children over 15 kg (33 lbs) Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW) Based on: 0000002041 00000 n Monitor response to therapy by evaluating hematologic parameters (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin). The half-life of total iron, including both circulating and bound, is approximately 20 hours. Unauthorized use of these marks is strictly prohibited. Unable to load your collection due to an error, Unable to load your delegates due to an error. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. Madison, NJ 07940. 0000027226 00000 n Nephron. 0000008504 00000 n (See Anaphylaxis under Cautions.) PDF Evaluation of the stability of vancomycin solutions at concentrations Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. The total amount of INFeD in mL required to treat the anemia and replenish iron stores may be approximated as follows: Adults and Children over 15 kg (33 lbs): See Dosage Table. INFeD (iron dextran injection), for intravenous or . Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose. 0000001877 00000 n In patients with chronic kidney disease (CKD) on hemodialysis, IV iron superior to orally administered iron for increasing hemoglobin concentrations and/or minimizing dosage of an erythropoiesis-stimulating agent (ESA); the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines state that the IV route is preferred for iron administration in such patients. The amount of vancomycin to treat an adult infection is superior to 1 g and so the volume administered can be higher than 100 mL. Dilution Iron Dextran (imferon ) - GlobalRPH Unauthorized use of these marks is strictly prohibited. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. 0000036781 00000 n Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. endstream endobj 55 0 obj<> endobj 56 0 obj<>stream

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