INFED PRESCRIBING INFORMATION PDF

Anemia, hemochromatosis, hemoglobinopathy, hemosiderosis. Concurrent use of deferiprone with iron supplements has not been studied. Iron dextran is contraindicated for use in patients with anemia not associated with iron deficiency. Prescribing Information Disclaimer Each 1 mL of iron dextran injection contains 50 mg of elemental iron.

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Fatal reactions have followed the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated. Circulating iron dextran is removed from the plasma by cells of the reticuloendothelial system, which split the complex into its components of iron and dextran. The iron is immediately bound to the available protein moieties to form hemosiderin or ferritin, the physiological forms of iron, or to a lesser extent to transferrin.

This iron which is subject to physiological control replenishes hemoglobin and depleted iron stores. 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. 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. All anemias not associated with iron deficiency. 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. 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.

The adverse effects frequently are delayed 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 hours after administration and symptoms generally subside within days. The etiology of these reactions is not known. The maximum daily dose should not exceed 2 mL undiluted iron dextran. 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. 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.

Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administer a test dose prior to the first therapeutic dose of Infed.

Epinephrine should be immediately available in the event of acute hypersensitivity reactions. Usual adult dose: 0. Note: Patients using beta-blocking agents may not respond adequately to epinephrine.

Isoproterenol or similar beta-agonist agents may be required in these patients. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. Reports in the literature from countries outside the United States in particular, New Zealand have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E.

The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Serum iron determinations especially by colorimetric assays may not be meaningful for 3 weeks following the administration of iron dextran.

Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and slowly returns to baseline after about 3 weeks. Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells. Bone scans involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of iron dextran.

Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following iron dextran infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.

Pregnancy: 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. The animals used in these tests were not iron deficient. There are no adequate and well-controlled studies in pregnant women.

Infed should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It appears that some iron does reach the fetus, but the form in which it crosses the placenta is not clear. Traces of unmetabolized iron dextran are excreted in human milk.

Because fatal anaphylactic reactions have been reported after administration of iron dextran injection, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available.

Flushing and hypotension may occur from too rapid injections by the intravenous route. Dosage: I. It should be recognized that iron storage may lag behind the appearance of normal blood morphology.

Serum iron, total iron binding capacity TIBC and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state. After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count. 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.

Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required. 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.

It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well.

Factors contributing to the formula are shown below. 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. Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. 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.

Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. The test dose should be administered in the buttock using the same technique as described in the last paragraph of this section. 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.

If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total amount required has been reached. 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. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique displacement of the skin laterally prior to injection is recommended.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Rx Only.

INTRAHOSPITALNE INFEKCIJE PDF

INFED PRESCRIBING INFORMATION PDF

JoJoramar To avoid staining of subcutaneous tissue, use the Z-track technique of injection. Because informatin reactions are known to occur after uneventful test doses, test doses prescrbing subsequent doses should be considered. Observe the patient for at least 1 hour after test dose administration. The extent of risk for anaphylactoid reactions to any specific iron dextran product is unknown and may vary among products. Slow intermittent intravenous IV injection: Use of iron dextran in infants younger than 4 months of age and neonates is not recommended; there have been reports from other countries of an increased incidence of gram-negative sepsis e.

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