infed stability after reconstitution

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. . Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. Dextran, a polyglucose, is either metabolized or excreted. After slow IV injection (given over 30 seconds for INFeD or 5 minutes for Dexferrum) or IM injection (INFeD) of 25 mg of iron (0.5 mL), observe for 1 hour for sensitivity reactions (see Anaphylaxis under Cautions) before administering the remaining portion of the initial dose. 0 06\ zp#2j)kS \(nd+?5R 0000035990 00000 n Disease-Associated Maternal and/or Embryo/Fetal Risk All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. PLEASE READ THE. The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. . . CAREFULLY BEFORE ACCESSING OR USING THIS SITE. Ling J, Gupta VD. ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv This site complies with the HONcode standard for trust- worthy health information: verify here. 1-800-678-1605, Manufactured By: (See Cautions.). 0000012149 00000 n CONTRAINDICATIONS After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. 8.1 Pregnancy Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. Do not freeze. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 0000013099 00000 n 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. 0000002072 00000 n Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. . . Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. 0000002909 00000 n 4. 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? 0000011305 00000 n Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. %%EOF INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. 0000002275 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. Disclaimer. The https:// ensures that you are connecting to the % . Calculate the Infed dose based upon Table 1 and formulas below. ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. 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. tran [6]. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). . Iron storage parameters may improve prior to hematologic parameters. 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)]. 0000005561 00000 n Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. Absorption 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. (See PRECAUTIONS: General.) 0000039715 00000 n 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. Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. Do Not Copy, Distribute or otherwise Disseminate without express permission. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron: Replacement iron (in mg) = Blood loss (in mL) x hematocrit, Example: Blood loss of 500 mL with 20% hematocrit. LBW = Lean body weight in kg. N}F( 9N(i{:%NISD;%NIS*T1 5.4 Iron Overload Careers. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Bookshelf [2:/T6*cz1"Jk&n#n[[TU Br Med J (Clin Res Ed). I. CAS number: 9004-66-4. 0000006673 00000 n Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. National Library of Medicine Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. 0000008617 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. Gaithersburg, MD: Genzyme; August 2018. 0000005917 00000 n The product should be further diluted in a suitable diluent prior to infusion. (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. infed stability after reconstitutionkneecap tattoo healing. 0000026302 00000 n Niemiec PW Jr, Vanderveen TW, Hohenwarter MW, Gadsden RH Sr. Bullock L, Fitzgerald JF, Glick MR, Parks RB, Schnabel JG, Hancock BG. 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. . 0000046691 00000 n 15 kg (33 lbs) or less . Prior to the first intramuscular Infed therapeutic dose, administer an intramuscular test dose of 0.5 mL [see BOXED WARNING and Warnings and Precautions (5.1)]. Do not administer Infed to patients with evidence of iron overload. An official website of the United States government. The https:// ensures that you are connecting to the 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). 0000008737 00000 n III. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet HOW SUPPLIED Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. Patients with Renal Impairment Morristown, NJ 07962 USA. 0000001396 00000 n . For solution and drug compatibility information, see Compatibility under Stability. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 0000005669 00000 n Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. If there is no reaction after 1 hour continue. Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. startxref . Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. Please check for further notifications by email. ], Observed Hb = the patients current hemoglobin in g/dL. z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE The site is secure. 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. Assay methods, adriamycin and the other antitumour antibiotics. Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. 0000015331 00000 n Fatal reactions have occurred following a test dose of iron dextran and also in patients in whom the test dose was tolerated. 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; Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. 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. endstream endobj 47 0 obj<>stream Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. Therefore, administration of subsequent test doses during therapy should be considered. The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. MeSH Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. endobj Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. 0000036781 00000 n Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. Medically reviewed by Drugs.com on Oct 25, 2022. Am J Kid Dis. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. H|TMs6Wu*Q6i\l.` 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. Nephron. . There are no data on the effects of iron dextran in breastfed infants or effects on milk production. National Library of Medicine Dosage Brand names: Dexferrum, INFeD Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. 12.2 Pharmacodynamics fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ We comply with the HONcode standard for trustworthy health information. If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. . Advise patients to immediately report any symptoms of hypersensitivity that develop during and following Infed administration such as arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting [see Warnings and Precautions (5.1)]. Carcinogenesis 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. Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Copyright 2023, Selected Revisions November 4, 2013. If diluted, administer by IV infusion [off-label] over 16 hours. .14.8 g/dl p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 The stability of injectable medications after reconstitution is presented. Data PMC Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. [See USP Controlled Room Temperature]. Specific Populations Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. INFeD (iron dextran injection), for intravenous or . . 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. Please enable it to take advantage of the complete set of features! Allergan USA, Inc. This site complies with the HONcode standard for trust- worthy health information: verify here. 0000018000 00000 n 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: The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. 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 vitro studies have shown that removal of iron dextran by dialysis is negligible. 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. 0000009066 00000 n Injection: 100 mg/2 mL (50 mg/1 mL), dark brown, slightly viscous, sterile solution in single-dose vials. 0000003091 00000 n Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. 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?

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