Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. 0000003091 00000 n 0000026302 00000 n hO4,qv(8p]4SXs?_k^ '4["G!@` \ 0000004132 00000 n <<7815BA97DDE94C498B4A3154474182CA>]>> After reticuloendothelial cells separate iron from the iron dextran complex, iron becomes a part of the bodys total iron stores. Each days dose should not exceed 0.5 mL (25 mg of iron) for infants with body weight under 5 kg (11 lbs); 1 mL (50 mg of iron) for children with body weight under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients. Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. . . Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. . 0000040000 00000 n 0000001168 00000 n Brand and Other Names: INFeD, Dexferrum Classes: Iron Products Dosing & Uses AdultPediatric Dosage Forms & Strengths injectable solution 50mg (Fe)/mL Iron-deficiency Anemia 25-100 mg IV or deep. HONcode standard for trust- worthy health, 7 Natural Remedies for Rheumatoid Arthritis, How Prenatal Counseling Can Help You Through Pregnancy, Parenteral iron treatment should be administered only when, Milliliter Requirement of INFeD Based On Observed. Possible increased incidence of adverse effects, especially delayed reactions, associated with large IV doses of iron dextran, such as those used in total-dose infusions. CAS number: 9004-66-4. Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. . May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). 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. Disclaimer. During all Infed administrations, observe for signs or symptoms of anaphylactic-type reactions. If there is no reaction after 1 hour continue. Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. Dosage Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? J Parenter Sci Technol. 12.1 Mechanism of Action Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. Continue Infed until hemoglobin is within the normal range and iron stores are replete. <> . Last updated on Dec 1, 2022. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! . sharing sensitive information, make sure youre on a federal Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. 0000003686 00000 n <> Oral iron should be discontinued prior to administration of INFeD. Disease-Associated Maternal and/or Embryo/Fetal Risk Anemia Associated with Chronic Renal Failure, Hypersensitivity Reactions [see Warnings and Precautions (5.1)], Delayed Reactions [see Warnings and Precautions (5.2)], Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings and Precautions (5.3)], Iron Overload [see Warnings and Precautions (5.4)], Fetal bradycardia [see Use in Specific Populations (8.1)]. '* Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. PLEASE READ THE. National Library of Medicine 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.]. . . 2025C; excursions permitted to 1530C. The stability of injectable medications after reconstitution is presented. Metabolism 0000008022 00000 n 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. Clinical Considerations After reconstitution with 19 ml water for injections, the product contains 10 mg/ml voriconazole and 160 mg/ml SBECD. TRW3xs6's;W2YK8AAv4Qo~S ONW>dVN--sFhQe@ 0{7;;vmG+zW%Rmhh_}m?rjnY'0_i' C?U"-DA('[ 2009;23(3):223-30. doi: 10.1080/15360280903098382. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. An official website of the United States government. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. The site is secure. Four of the seven dilute solutions were stable after two months of storage. 0000046691 00000 n Therefore, administration of subsequent test doses during therapy should be considered. 0000011042 00000 n HlTM6(R;!$+g}4h*I:-~`wIg;g5#I:X3Gs3dlg7E%~KyV0=^z@X,/%OE9oCz?=P%!XYUX8]hMW;2m%}?={ Pov5J%3LaA@a9"099^eiqk5r#ZH34`&`Eaj,@6kbBQ(BPt"`32n'OV4=:yOM2hf}"V@> II. 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. A subsidiary of Watson Pharmaceuticals, Inc. 0000001071 00000 n Calculate the Infed dose based upon Table 1 and formulas below. Isoproterenol or similar beta-agonist agents may be required in these patients. Advise pregnant persons of the potential risk to the fetus. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. It should not be used during the acute phase of infectious kidney disease. Advise patients with pre-existing cardiovascular disease and rheumatoid arthritis that Infed administration may exacerbate symptoms and to contact their healthcare provider if any symptoms occur [see Warnings and Precautions (5.3)]. The Summary of Product Characteristics (SmPC) recommends reconstituting a 1 g vial with 20 mL of water for injection (WFI), then diluting it in 100 mL of saline solution. endobj 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. Stability of acyclovir sodium after reconstitution in 0.9% sodium chloride inje ction and storage in polypropylene syringes for pediatric use. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK I1US99`^cc-G:>xzV5.tD8,D\>z;qxQ)bHV\c`BWNG ni*#gU4yv{J)!VMs12EJR4>43giIU?H(MlJW52 &&RBd2i%d)jUWfk$oQs=@a+~cl endstream endobj 57 0 obj<> endobj 58 0 obj<>stream The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. 1985;14(2):83-95. doi: 10.1007/BF00434343. HOW SUPPLIED . The .gov means its official. The https:// ensures that you are connecting to the 2001;5(1):75-7. Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. AHFS DI Essentials. endobj Int J Pharm Compd. . Cancer Chemother Pharmacol. 0000002803 00000 n Fatal anaphylactic reactions are possible. Iron Deficiency Anemia: Periodic hematologic determination (hemoglobin and hematocrit) is a simple and accurate technique for monitoring hematological response, and should be used as a guide in therapy. Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). 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. 0000010567 00000 n 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Risk Summary Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. 5.3 Increased Risk of Toxicity in Patients with Underlying Conditions Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The stability of injectable medications after reconstitution is presented. 0000036574 00000 n 1986 Jul-Aug;40(4):142-63. Bethesda, MD 20894, Web Policies 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. The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. This site needs JavaScript to work properly. 0000004693 00000 n 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. . 0000003913 00000 n For information on systemic interactions resulting from concomitant use, see Interactions. Iron Overload 1-800-678-1605, Manufactured By: 5.4 Iron Overload Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. Do not administer Infed to patients with iron overload [see Warnings and Precautions (5.4)]. Department of Pharmacy, Ohio State University Hospitals, Columhus 43210. RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T Available for Android and iOS devices. Brand names: Dexferrum, INFeD 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. . Copyright 1993-2021 Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. If hypersensitivity reactions occur during administration, stop Infed immediately and manage reaction medically. Children weighing 59 kg (1121 lbs): Maximum daily dosage is 50 mg of iron. This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. Figure 1. stream Package insert / product label This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document 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. A test dose of 25 mg infused over 5 minutes should be given. Allergan Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. Possible exacerbation of cardiovascular complications because of adverse effects of the drug in patients with preexisting cardiovascular disease. Note: The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss. 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 . 0000037133 00000 n Indian J Anaesth. Accessibility Anemias not associated with iron deficiency. 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. National Library of Medicine 0000010118 00000 n 1972;9:94-98. Unauthorized use of these marks is strictly prohibited. 0000009983 00000 n These half-life values do not represent clearance of iron from the body. official website and that any information you provide is encrypted Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. Federal government websites often end in .gov or .mil. ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. Use with caution in patients with a history of clinically important allergies and/or asthma. Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. 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 David McAuley, Pharm.D. After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. %PDF-1.3 % David McAuley, Pharm.D. The study suggests that addition of recommended daily doses of iron dextran to parenteral nutrient solutions creates no stability problems; however, further study of the effects of temperature, pH, light, and storage time are recommended. Women's Bond NFT Collection Discontinue administration of any iron-containing products prior to administration of Infed. Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported following the parenteral administration of iron dextran products, including Infed. Before During administration of any iron dextran dose, observe for manifestations of anaphylactic-type reactions. Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. 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. Should be administered by qualified individuals with ready access to resuscitation equipment and appropriate agents for the treatment of a severe allergic or anaphylactic reaction (e.g., epinephrine, or isoproterenol in patients receiving -adrenergic blocking agents). All Rights Reserved. The half-life of free iron in the plasma circulation is approximately 5 hours. Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. 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; INFeD (iron dextran injection), for intravenous or . Unable to load your collection due to an error, Unable to load your delegates due to an error. Bookshelf For all medical inquiries contact: Risk Summary Madison, NJ 07940. (See Cautions.). Do not administer Infed to patients with evidence of iron overload. Parenteral iron dextran therapy: a review. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. Excretion We comply with the HONcode standard for trustworthy health information. III. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet . 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. 3 0 obj Crosses the placenta and small amounts of iron apparently reach the fetus. . NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. 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). 5 0 obj Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. 2021 Allergan. Drug class: Iron Preparations Observed Hb = the patients current hemoglobin in g/dl. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. l Sm3G.E7=" r7/[^;q|= Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. "3#$-Irc8x=B_}>_W@HqAP!I`H9+.@F.ix;i1E]"EOQ4E7M9$PB em$ Ie2} %+}hIIU}E+rS_OENx(tF_)@nRAtZn#JHg221^m+U|"vy ]yakuU 0000012898 00000 n Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. ],kI#tp. DOSAGE FORMS AND STRENGTHS VIDAZA (azacitidine for injection) is supplied as lyophilized powder in 100 mg single-use vials. . The stability of injectable medications after reconstitution is presented. Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. 0000008617 00000 n 12.2 Pharmacodynamics Do Not Copy, Distribute or otherwise Disseminate without express permission. 0000002019 00000 n .65 mL/kg of body weight, b. What are the possible side effects of INFeD? 4GWVI~p`1x_7G|_Wz/ev5%b[~?w>ZG/*p%\/??w~=+ |O?~po>u|.@uM=Nvm_~~>\.%>?_mk+mp_{"ly"Y{JlqgIl#Y!Y@osLu]Mt=xx? The development and health benefits of breastfeeding should be considered along with the mothers clinical need for Infed in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Do not freeze. Elimination Protect from light. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given. Assess baseline hematologic (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin) to monitor response to therapy. Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following Infed infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. 34 55 F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' 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. The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. 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). If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. 0000001396 00000 n It should be understood that these half-life values do not represent clearance of iron from the body. Dextran, a polyglucose, is either metabolized or excreted. The easiest-to-prepare dilute solution (iron dextran, benzyl alcohol, and sterile water for injection) was stable for three months; stability was greater when refrigerated. Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.). N}F( 9N(i{:%NISD;%NIS*T1 1986;17(1):1-10. doi: 10.1007/BF00299858. 8.1 Pregnancy 0000000016 00000 n 0000002041 00000 n . p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 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. a. 2 0 obj . INFeD should not normally be given in the first four months of life. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` MeSH There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). Bookshelf 0000030324 00000 n Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Would you like email updates of new search results? 1989;23(4):197-207. doi: 10.1007/BF00451642. official website and that any information you provide is encrypted P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU 2007 Jan;12(1):53-9. doi: 10.5863/1551-6776-12.1.53. General considerations, the nitrosoureas and alkylating agents. [2:/T6*cz1"Jk&n#n[[TU 0000024030 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. General 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. Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. and transmitted securely. %%EOF Medically reviewed by Drugs.com. . Delayed Reactions HdTr0+(R^ Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. . Available as iron dextran; dosage expressed in terms of elemental iron. Accessibility The pH of the solution is between 4.5 to 7.0. (5.1) Children weighing 515 kg (1133 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (12 g/dL Hbo)]+ (0.26 Wt) = total dosage of iron dextran injection (mL). Anemia Associated with Chronic Renal Failure. Fetal/Neonatal Adverse Reactions Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. Oxford University Press is a department of the University of Oxford. 0000005561 00000 n CONTRAINDICATIONS xb```f``= @Q#3108-. )U!$5X3/9 ($5EO1'G!X! Therefore, administration of subsequent test doses during therapy should be considered. 0000036781 00000 n Federal government websites often end in .gov or .mil. Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 0000002441 00000 n This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. 15 kg (33 lbs) or less . Importance of informing patients of other important precautionary information. 0000011305 00000 n The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. PMC 16.1 How Supplied Removal of Iron Dextran by Hemodialysis: An In Vitro Study. Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. I. Question patients regarding any prior history of reactions to parenteral iron products. J Pediatr Pharmacol Ther. 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. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. Abstract. . It is not known if INFeD is safe and effective in children younger than 4 months of age. 0000008494 00000 n !m Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. 2.2 Recommended Dosage for Iron Deficiency Anemia Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. over 15 kg (33 lbs) . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 2 DOSAGE AND ADMINISTRATION Take precautions to be prepared to treat potential allergic reactions. Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations).
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