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Iron Dextran (Infed)

Trade Name : INFeD

Allergan, Inc.

INJECTION

Strength 50 mg/mL

IRON DEXTRAN Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Iron Dextran (Infed) which is also known as INFeD and Manufactured by Allergan, Inc.. It is available in strength of 50 mg/mL per ml. Read more

Iron Dextran (Infed) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS
  • Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.
  • INFeDu00a0(Ironu00a0Dextranu00a0Injectionu00a0USP)u00a0isu00a0a darku00a0brown,u00a0slightlyu00a0viscousu00a0sterileu00a0liquidu00a0complexu00a0ofu00a0ferricu00a0hydroxide andu00a0dextranu00a0foru00a0intravenousu00a0or intramuscularu00a0use.
  • Eachu00a0mLu00a0containsu00a0theu00a0equivalentu00a0ofu00a050u00a0mgu00a0of elementalu00a0ironu00a0(asu00a0anu00a0ironu00a0dextranu00a0complex),u00a0approximatelyu00a00.9% sodiumu00a0chloride,u00a0in wateru00a0foru00a0injection.u00a0Sodiumu00a0hydroxideu00a0and/oru00a0hydrochloricu00a0acidu00a0mayu00a0haveu00a0beenu00a0usedu00a0tou00a0adjust pH.u00a0Theu00a0pHu00a0ofu00a0theu00a0solutionu00a0is betweenu00a04.5u00a0tou00a07.0.
  • Therapeuticu00a0Class:u00a0Hematinic
  • General:
  • Dextran, a polyglucose, is either metabolized or excreted. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran.
  • The major portion of intramuscular injections of iron dextran is absorbed within 72 hours; most of the remainingu00a0iron is absorbed over the ensuing 3 to 4 weeks.
  • Various studies involving intravenously administered Fe iron dextran to iron deficient subjects, some of whom had coexisting diseases, have yielded half-life values ranging from 5 hours to more than 20 hours. The 5-hour value was determined for Fe iron dextran from a study that used laboratory methods to separate the circulating Fe iron dextran from the transferrin-boundu00a0Fe. The 20-hour value reflects a half-life determined by measuring total Fe, both circulating and bound. It should be understood that these half-life values do not represent clearance of iron from the body. Iron is not easily eliminated from the body and accumulation of iron can be toxic.
  • In vitro
  • Intravenousu00a0oru00a0intramuscularu00a0injectionsu00a0ofu00a0INFeDu00a0areu00a0indicatedu00a0for treatmentu00a0ofu00a0patientsu00a0withu00a0documentedu00a0iron deficiencyu00a0inu00a0whomu00a0oralu00a0administrationu00a0isu00a0unsatisfactoryu00a0oru00a0impossible.
  • Hypersensitivityu00a0tou00a0theu00a0product.u00a0Allu00a0anemiasu00a0notu00a0associatedu00a0withu00a0ironu00a0deficiency.
  • Risk for Anaphylactic-type Reactions:
  • Anaphylactic-type reactions, including fatalities have followed the parenteral administration of iron dextran. Always have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Prior to the first therapeutic dose, administer a test INFeD dose of 0.5 mL. (See .) Although reactions are usually evident within a few minutes, observe patients for at least one hour before administering the therapeutic dose. During all INFeD administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.
  • 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. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products.
  • Iron dextran products differ in chemical characteristics and may differ in clinical effects. Iron dextran products are not clinically interchangeable.
  • Delayed Reactions:
  • Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse effects. The adverse effects frequently are delayed (1-2 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. The onset is usually 24-48 hours after administration and symptoms generally subside within 3-4 days. The etiology of these reactions is not known. The potential for a delayed reaction must be considered when estimating the risk/benefit of treatment.
  • The maximum daily dose should not exceed 2 mL undiluted iron dextran.
  • Risk in Patients with Underlying Conditions:
  • INFeD should be used with extreme care in patients with serious impairment of liver function. It should not be used during the acute phase of infectious kidney disease.
  • Adverse reactions experienced following administration of INFeD may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease.
  • Carcinogenesis:
  • A risk of carcinogenesis may attend the intramuscular injection of iron-carbohydrateu00a0complexes. Such complexes have been found under experimental conditions to produce sarcoma when large doses or small doses injected repeatedly at the same site were given to rats, mice, and rabbits, and possibly in hamsters.
  • The long latent period between the injection of a potential carcinogen and the appearance of a tumor makes it impossible to measure accurately the risk in man. There have, however, been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections ofu00a0iron-carbohydrate complexes.
  • No data
  • Severe/Fatal:n- Arrayn- Array
  • Cardiovascularn- :
  • Dermatologic:
  • Gastrointestinal:
  • Hematologic/lymphatic:
  • Musculoskeletal/soft tissue:n- Array
  • Neurologic:
  • Respiratory:
  • Urologic:
  • Delayed reactions:n- Array
  • Miscellaneous:
  • Overdosageu00a0withu00a0ironu00a0dextranu00a0isu00a0unlikelyu00a0tou00a0beu00a0associatedu00a0withu00a0anyu00a0acuteu00a0manifestations.u00a0Dosagesu00a0ofu00a0ironu00a0dextran inu00a0excessu00a0ofu00a0theu00a0requirementsu00a0foru00a0restorationu00a0ofu00a0hemoglobinu00a0and replenishmentu00a0ofu00a0iron storesu00a0mayu00a0leadu00a0to hemosiderosis.u00a0Periodicu00a0monitoringu00a0of serumu00a0ferritinu00a0levels mayu00a0beu00a0helpfulu00a0inu00a0recognizingu00a0au00a0deleteriousu00a0progressive accumulationu00a0of ironu00a0resultingu00a0fromu00a0impairedu00a0uptakeu00a0ofu00a0ironu00a0fromu00a0theu00a0reticuloendothelialu00a0systemu00a0inu00a0concurrentu00a0medicalu00a0conditionsu00a0suchu00a0asu00a0chronicu00a0renalu00a0failure,u00a0Hodgkinu2019su00a0disease,u00a0andu00a0rheumatoidu00a0arthritis.u00a0Theu00a0LDn of ironu00a0dextranu00a0is notu00a0lessu00a0thanu00a0500u00a0mg/kgu00a0inu00a0theu00a0mouse.
  • Oralu00a0ironu00a0shouldu00a0beu00a0discontinuedu00a0prioru00a0tou00a0administrationu00a0of INFeD.
  • INFeDu00a0(Ironu00a0Dextranu00a0Injectionu00a0USP)u00a0containingu00a050u00a0mgu00a0of elementalu00a0ironu00a0peru00a0mL,u00a0is availableu00a0inu00a02u00a0mLu00a0singleu00a0dose amberu00a0vialsu00a0(foru00a0intramuscularu00a0oru00a0intravenousu00a0use)u00a0inu00a0cartonsu00a0ofu00a010u00a0(n n n ).
  • Storeu00a0atu00a020 -25u00b0Cu00a0(68u00a0-77u00b0F)u00a0[Seeu00a0USPu00a0Controlledu00a0Roomu00a0Temperature].
  • Rn- xn- u00a0n- On- nly
  • Foru00a0all medicalu00a0inquiriesu00a0contact:Allergan Medical Communications1-800-678-1605
  • Distributedu00a0by:u00a0Allergan USA, Inc. Madison, NJ 07940
  • Manufacturedu00a0by:Patheonu00a0Italiau00a0S.p.A.Ferentino,u00a0Italyu00a003013
  • u00a9 2019 Allergan. All rights reserved.INFED is a registered trademark ofu00a0Allergan Sales, LLC.Allergan and its design are trademarks of Allergan, Inc.
  • Content Updated: November 2018
  • v.1.1USPI6082
  • NDC 0023-6082-10
  • 10 x 2 mL Single Dose VialsINFeD(IRON DEXTRAN Injection USP)100 mg elemental iron/2 mL (50 mg/mL)FOR INTRAMUSCULAR OR INTRAVENOUS USERx Only

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