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infed stability after reconstitution

(5.1) 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). NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. Anemias not associated with iron deficiency. HlTM6(R;!$+g}4h*I:-~`wIg;g5#I:X3Gs3dlg7E%~KyV0=^z@X,/%OE9oCz?=P%!XYUX8]hMW;2m%}?={ Pov5J%3LaA@a9"099^eiqk5r#ZH34`&`Eaj,@6kbBQ(BPt"`32n'OV4=:yOM2hf}"V@> .65 mL/kg of body weight, b. 0000013948 00000 n 5.1 Hypersensitivity Reactions (Normal Hb for Children 15 kg or less is 12 g/dl). Hatton RC, Portales IT, Finlay A, Ross EA. Children weighing >15 kg (33 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (14.8 g/dL Hbo)]+ (0.26 Wt) = total dosage of iron dextran injection (mL). PDF Vaccines with Diluents: How to Use Them - immunize.org 0000012149 00000 n Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. 0000005561 00000 n *Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs). If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. 0000047340 00000 n Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. 2001;5(1):75-7. Excretion RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T endstream endobj 55 0 obj<> endobj 56 0 obj<>stream To calculate a patient's weight in kg when lbs are known: Otherwise, the total dose may be calculated using the formula below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin for children with body weight of 15 kg (33 lbs) or less is 12 g/dL.]. Madison, NJ 07940. National Library of Medicine To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. If diluted, administer by IV infusion [off-label] over 16 hours. % 0000013099 00000 n hO4,qv(8p]4SXs?_k^ '4["G!@` \ INFeD may be used alone or with other medications. 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)]. 16.1 How Supplied . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Trace amounts of unmetabolized iron dextran are present in human milk. Delayed Reactions 5.4 Iron Overload PLEASE READ THE. 0000006673 00000 n The .gov means its official. The test dose should be administered in the same recommended test site and by the same technique as described in the last paragraph of this section. JLdddd0]`kig?yLm[}6:|Mm-g;b%&?,X,|&Y_}:|!'l%B%e]oJ\}v8l="[;`_#3B]v4ysnp6p3oQd+j_07(+g_Co;haE+1bk+|e>inBko686Jf?2o_>qfETmP@5(C7b$;HvqW!Vb(FNz& Disease-Associated Maternal and/or Embryo/Fetal Risk If hypersensitivity reactions occur during administration, stop Infed immediately and manage reaction medically. 0000039715 00000 n HHS Vulnerability Disclosure, Help Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 0000010855 00000 n 0000014709 00000 n Question patients regarding any prior history of reactions to parenteral iron products. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 0000002019 00000 n and transmitted securely. Dosage form: injection Medically reviewed by Drugs.com. Based on the above factors, individuals with normal hemoglobin levels will have approximately 33 mg of blood iron per kilogram of body weight (15 mg/lb). Intravenous IV preparation and infusion guidelines - GlobalRPH Use with extreme caution in patients with serious impairment of hepatic function. 0000035692 00000 n Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. Am J Kid Dis. Fatal reactions have occurred following a test dose of iron dextran and also in patients in whom the test dose was tolerated. Data The stability of injectable medications after reconstitution is presented. Assay methods, adriamycin and the other antitumour antibiotics. It should not be used during the acute phase of infectious kidney disease. I1US99`^cc-G:>xzV5.tD8,D\>z;qxQ)bHV\c`BWNG ni*#gU4yv{J)!VMs12EJR4>43giIU?H(MlJW52 &&RBd2i%d)jUWfk$oQs=@a+~cl e. Weight. AHFS DI Essentials. Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU Possible exacerbation of cardiovascular complications because of adverse effects of the drug in patients with preexisting cardiovascular disease. Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). A current package insert for the iron dextran product being used should always be reviewed, since these package inserts are periodically updated, and the product is currently made by more than one manufacturer. TRW3xs6's;W2YK8AAv4Qo~S ONW>dVN--sFhQe@ 0{7;;vmG+zW%Rmhh_}m?rjnY'0_i' C?U"-DA('[ If there is no reaction after 1 hour continue. ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. Sv 1989;23(4):197-207. doi: 10.1007/BF00451642. (See PRECAUTIONS: General.) Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. The adverse reactions are frequently delayed (1 to 2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting. TVFRk-ijJ>r$QK{\[8 `v,heF-ZQ4R70rj !sGE Drug class: Iron products. 0000001071 00000 n Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. Drug interactions involving Infed have not been studied. 15 kg (33 lbs) or less . 0000010567 00000 n Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Patheon Italia S.p.A. Allergan Advise the patient to consult a healthcare provider before taking any other iron containing products as this may cause serious side effects [see Warnings and Precautions (5.4)]. Evaluation of the stability of vancomycin solutions at concentrations No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. 8.4 Pediatric Use Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. David McAuley, Pharm.D. . (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). . <<7815BA97DDE94C498B4A3154474182CA>]>> 0000008022 00000 n If patient is standing, administer IM injection in buttock of the leg opposite the patients weight-bearing leg; if supine, place patient in a lateral position with the injection site uppermost. (See Iron, oral under Interactions.). 0000002644 00000 n 2.4 Administration Available for Android and iOS devices. 1984 Mar;19(3):202, 207, 211-3. . Brand names: Dexferrum, INFeD Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. Epinephrine should be immediately available. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state. Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: A subsidiary of Watson Pharmaceuticals, Inc. Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. Fatal anaphylactic reactions are possible. Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. Isoproterenol or similar beta-agonist agents may be required in these patients. DOSAGE AND ADMINISTRATION HdTn0D Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. All rights reserved. Fatal reactions have been reported following the test dose of iron dextran injection. ],kI#tp. 0000010005 00000 n Recommended formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL) for calculating total dosage of iron dextran injection (in mL): Use the following formula to calculate required total dosage of iron dextran injection (in mL): Infants weighing <5 kg (11 lbs): Maximum daily dosage is 25 mg of iron. PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer 2021 Allergan. Clinical Considerations 0000003347 00000 n .0.34% 2009;23(3):223-30. doi: 10.1080/15360280903098382. Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. Administer test dose prior to first therapeutic dose. The pH of the solution is between 4.5 to 7.0. Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary. 1986 Jul-Aug;40(4):142-63. The product should be further diluted in a suitable diluent prior to infusion. Ling J, Gupta VD. N}F( 9N(i{:%NISD;%NIS*T1 Parenteral iron dextran therapy: a review. May increase risk for anaphylaxis with concomitant use, Bone scans using imaging agents labeled with technetium Tc 99m (diphosphonate), Dense, crescentic areas of activity along the contour of the iliac crest, visualized 16 days after IM administration of iron dextran, Possible reduced bone uptake, marked renal activity, and excessive blood pool and soft tissue accumulation, Therapeutic duplication; increased risk for iron toxicity, Serum iron determinations (especially colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran, Serum ferritin concentrations peak approximately 79 days following an IV iron dextran dose and slowly return to baseline over a period of about 3 weeks, Bone marrow examination for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells, May cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium, Prolonged partial thromboplastin time following IV administration of iron dextran when the blood sample for the test is mixed with anticoagulant citrate dextrose solution but not sodium citrate solution, Blood typing and cross-matching unaffected. Use the following formula to calculate required total iron dextran dosage in mL: 0.02 blood loss (in mL) hematocrit (expressed as a decimal fraction) = total dosage of iron dextran injection (mL). Unauthorized use of these marks is strictly prohibited. If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Advise patients to consult their healthcare provider should they start to show symptoms of acute kidney infection as Infed should not be used [see Warnings and Precautions (5.3)]. Known hypersensitivity to iron dextran or any ingredient in the formulation. IV Iron Dextran Infusion Protocol | MedStar Health z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. 0000030324 00000 n %PDF-1.3 The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. 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. The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. INFeD, Dexferrum (iron dextran complex) dosing, indications - Medscape Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. PDF Significance of Reconstitution Time and Other Physical Parameters for Normal hemoglobin (males and females) 0000002803 00000 n Stability of aminophylline injection in three parenteral nutrient solutions. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Use with caution in patients with a history of clinically important allergies and/or asthma. . REFERENCES *Qp"Q!J Cancer Chemother Pharmacol. The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. Curr Opin Clin Nutr Metab Care. 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 to oral iron. 5 0 obj Int J Pharm Compd. <> Do Not Copy, Distribute or otherwise Disseminate without express permission. The half-life of total iron, including both circulating and bound, is approximately 20 hours. 5 If reconstituted vaccine is not used immediately or comes in a multidose vial, be sure to clearly mark the vial with the date and time the vaccine was reconstituted, maintain the product at 2-8C (36-46F); do not freeze, and use only within the time indicated on chart above. The site is secure. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Federal government websites often end in .gov or .mil. 0000001797 00000 n Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. 1 0 obj <> Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. sharing sensitive information, make sure youre on a federal 0000000016 00000 n Each days dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients. Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant persons with intravenous iron administration (such as Infed) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester. ], Observed Hb = the patients current hemoglobin in g/dL. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 0000002918 00000 n 0000012318 00000 n Advise pregnant persons of the potential risk to the fetus. trailer << /Size 254 /Info 216 0 R /Root 219 0 R /Prev 331519 /ID[<618a70ff49b482af49be42cc5de1ac5d><4f4e9802b6496a1513efa6cfdffb7212>] >> startxref 0 %%EOF 219 0 obj << /Type /Catalog /Pages 213 0 R /Metadata 217 0 R /PageLabels 211 0 R >> endobj 252 0 obj << /S 769 /T 901 /L 982 /Filter /FlateDecode /Length 253 0 R >> stream Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. Accessibility (See Sensitivity Testing under Dosage and Administration.) Morristown, NJ 07962 USA. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. (See PRECAUTIONS: General.) 0000007316 00000 n Stability of famotidine 20 and 40 mg/L and amino acids in total parenteral nutrient solutions. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet, For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet. 0000012898 00000 n Dilution Iron Dextran (imferon ) - GlobalRPH The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. infed stability after reconstitutionkneecap tattoo healing. This site complies with the HONcode standard for trust- worthy health information: verify here. Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. INFeD belongs to a class of drugs called Iron Products. Copyright 2021 GlobalRPH - Web Development by, The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. . 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; If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost.

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infed stability after reconstitution