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. The .gov means its official. After reconstitution with 19 ml water for injections, the product contains 10 mg/ml voriconazole and 160 mg/ml SBECD. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. e. Weight. Attached to this memorandum is a copy of a package insert for iron dextran (Infed). HHS Vulnerability Disclosure, Help Corrections in compilation of information on stability of injectable medications after reconstitution. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. 0000010118 00000 n Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. 0000009066 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. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Package insert / product label 0000002019 00000 n 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)]. 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. endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream REFERENCES Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. 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. Epinephrine should be immediately available. Do not freeze. 12.2 Pharmacodynamics 8600 Rockville Pike 1986 Jul-Aug;40(4):142-63. . Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V 1 0 obj Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. 0000037133 00000 n There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). 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)]. Crosses the placenta and small amounts of iron apparently reach the fetus. . NoPEF(djUMPU}ocl`<0yxk0R7?+9Ks,y 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). Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. These half-life values do not represent clearance of iron from the body. 1986;17(1):1-10. doi: 10.1007/BF00299858. INFeD may be used alone or with other medications. Bethesda, MD 20894, Web Policies INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). Advise patients with history of significant allergies and/or asthma to inform their healthcare provider as the risk of hypersensitivity reactions may be increased [see Warnings and Precautions (5.3)]. infed stability after reconstitutionkneecap tattoo healing. endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream 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. 0000012149 00000 n 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. 16.2 Stability and Storage 3. 2001;5(1):75-7. . 0000035692 00000 n Infusion should then be stopped for 1 hour. 0000004693 00000 n . 8.4 Pediatric Use . Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. 0000035990 00000 n Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. 3. We comply with the HONcode standard for trustworthy health information. The 5 hour value was determined for 59Fe iron dextran from a study that used laboratory methods to separate the circulating 59Fe iron dextran from the transferrin bound 59Fe. Cancer Chemother Pharmacol. Blood volume . 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. Unauthorized use of these marks is strictly prohibited. Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. This site complies with the HONcode standard for trust- worthy health information: verify here. Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, 5. Infed Dosage Guide - Drugs.com Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. government site. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 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). S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%].