0000002072 00000 n To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Stability of famotidine 20 and 40 mg/L and amino acids in total parenteral nutrient solutions. $ Alternatively, the total dose may be calculated using the formulas below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin (males and females) for body weight over 15 kg (33 lbs) is 14.8 g/dL. Women's Bond NFT Collection 0000005669 00000 n Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. Administer test dose prior to first therapeutic dose. F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' . %PDF-1.3 % 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 . infed stability after reconstitution - womensbond.com Do Not Copy, Distribute or otherwise Disseminate without express permission. Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Continue Infed until hemoglobin is within the normal range and iron stores are replete. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. 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 . In mice, rats, rabbits, and possibly hamsters, it has been demonstrated that these complexes may produce sarcoma following repeated administration of large or small doses of iron-carbohydrate complexes at a single injection site. 1995; 26(2):327-330. . The total volume of Infed required for the treatment of iron deficiency anemia is determined from Table 1 or the appropriate formula listed [see Dosage and Administration (2.2)]. xref 4. 0000047340 00000 n 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 of frozen antibiotics. 2 0 obj 0000006673 00000 n It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. 0000026943 00000 n Attached to this memorandum is a copy of a package insert for iron dextran (Infed). Animal Data 0000039715 00000 n 8.4 Pediatric Use Large doses of iron dextran (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration. Trace amounts of unmetabolized iron dextran are present in human milk. 1985;14(2):83-95. doi: 10.1007/BF00434343. (See Iron, oral under Interactions.). Pregnancy Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. Based on: Desired Hb = the target Hb in g/dl. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. The molecular weights of INFeD and DexFerrum are 165,000 and 267,000 daltons, respectively. BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. 1972;9:94-98. COMMENTARY Biological parenteral products ar - American Society of )U!$5X3/9 ($5EO1'G!X! 0000004233 00000 n government site. Such blood losses may occur periodically in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) and on a repetitive basis from procedures such as renal hemodialysis. .14.8 g/dl A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. 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. INFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02).

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