HdTn0D Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. Assay methods, adriamycin and the other antitumour antibiotics. . After reconstitution with 19 ml water for injections, the product contains 10 mg/ml voriconazole and 160 mg/ml SBECD. FOIA Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. and transmitted securely. J Pediatr Pharmacol Ther. 0000015331 00000 n An official website of the United States government. 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. over 15 kg (33 lbs) . National Library of Medicine There are no data on the effects of iron dextran in breastfed infants or effects on milk production. Patheon Italia S.p.A. Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. . official website and that any information you provide is encrypted Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. 0000027226 00000 n sharing sensitive information, make sure youre on a federal Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. d. Hemoglobin deficit 2001;5(1):75-7. 2 0 obj Abstract. Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. Following administration of Infed, circulating iron dextran is split by the cells of the reticuloendothelial system into its components of iron and dextran. Drug class: Iron products. (See PRECAUTIONS: General.) Each days dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients. 0000004715 00000 n Sv Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 0000024030 00000 n 0000040000 00000 n FOIA Infusion should then be stopped for 1 hour. Administer a test Infed dose prior to the first therapeutic dose. '* the 6 time points after injection.15 A 94-subject rater-blinded randomized control study of EDP action potentials compared toxin used within 2 hours, 72 hours, 1, 2, 3, or 4 weeks after reconstitution; at 1 week after injection, the point of maximum effect, there was no difference in quantitative paralysis . Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Parenteral iron dextran therapy: a review. Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. Infed is a registered trademark of Allergan Sales, LLC. AHFS DI Essentials. Systemic exposure to iron dextran may be increased. 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. Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. The stability of injectable medications after reconstitution is presented. Anemia Associated with Chronic Renal Failure. The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. 0000004132 00000 n Oral iron should be discontinued prior to administration of INFeD. II. Infed (iron dextran injection), for intravenous or intramuscular use Please enable it to take advantage of the complete set of features! Clinical Considerations N}F( 9N(i{:%NISD;%NIS*T1 0000008504 00000 n infed stability after reconstitutionkneecap tattoo healing. 0000002986 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: Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. 0000011536 00000 n 1989;23(4):197-207. doi: 10.1007/BF00451642. 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. REFERENCES Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. . 0000002041 00000 n Excess storage of iron and a syndrome similar to hemosiderosis possible when used for anemia not attributable to iron deficiency (e.g., those with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias). 0000004098 00000 n 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)]. Would you like email updates of new search results? 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. 0000004233 00000 n %%EOF Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. 0000003686 00000 n Cancer Chemother Pharmacol. Stability and compatibility of histamine H2-receptor antagonists in parenteral nutrition mixtures. Anemias not associated with iron deficiency. 0000010567 00000 n LBW = Lean body weight in kg. For information on systemic interactions resulting from concomitant use, see Interactions. PLEASE READ THE. 0000005669 00000 n Package insert / product label Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. Discontinue oral iron therapy prior to initiation of iron dextran therapy. The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. <> 2.4 Administration Advise patients to consult their healthcare provider should they start to show symptoms of acute kidney infection as Infed should not be used [see Warnings and Precautions (5.3)]. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. Dosage Four of the seven dilute solutions were stable after two months of storage. The animals used in these tests were not iron deficient. 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. 8600 Rockville Pike 0000010855 00000 n Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. 0000008737 00000 n . Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. The https:// ensures that you are connecting to the 0000026302 00000 n . !m J Pain Palliat Care Pharmacother. . 88 0 obj<>stream 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. 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. Do not exceed a total daily dose of 2 mL undiluted Infed. 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. Do Not Copy, Distribute or otherwise Disseminate without express permission. (5.3). Accessibility 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. <> 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. Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. . Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. Obstetric clinical pharmacy: A necessary birth of a new specialty, Sister Mary Louise Degenhart dies at 85 years, Infection risk and management strategies for patients with cirrhosis taking proton pump inhibitors, Cold chain experts look to future during latest ASHP forum, National trends in prescription drug expenditures and projections for 2023, ASHP National Surveys of Pharmacy Practice in Hospital Settings, Population Health Management Theme Issues, Practice Advancement Initiative Collection, Transitions of Care/Medication Reconciliation, Emergency Preparedness and Clinician Well-being, Author Instructions for Residents Edition, Receive exclusive offers and updates from Oxford Academic, Copyright 2023 American Society of Health-System Pharmacists. . Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. . Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. 0000047340 00000 n Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. 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? Dilution not recommended by manufacturers, but there have been reports of the total calculated dose of iron dextran being diluted in 2501000 mL of 0.9% sodium chloride injection for IV infusion [off-label]. Corrections in compilation of information on stability of injectable medications after reconstitution. (See Boxed Warning.). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. %PDF-1.4 % Infed (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). 0000007595 00000 n Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet 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)]. Do not freeze. rFsh4Js$[i =I.oF&G,6FLVs : :z!V VU55j}yMZN)!9~os6y;\Gc-b#`A`KKUq- `x9[nV&! Hb```f`` l,/`"`FOB/r7}UL 8.1 Pregnancy SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Monitor response to therapy by evaluating hematologic parameters (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin). 15 kg (33 lbs) or less . Int J Pharm Compd. .0.34% Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. An official website of the United States government. Therefore, administration of subsequent test doses during therapy should be considered. Cancer Chemother Pharmacol. Data 0000013156 00000 n Use the following formula to calculate required total iron dextran dosage in mL: 0.02 blood loss (in mL) hematocrit (expressed as a decimal fraction) = total dosage of iron dextran injection (mL). 0000008617 00000 n Elimination INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response. The etiology of these reactions is not known. Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. Administer the test dose at a gradual rate over at least 30 seconds. m$K~*&S)j5-Df"F d (8-s)h#=xF9+47{%CDQ$EMDH7x$k"$>~ynvloopxfG? Bonnie E. Kirschenbaum, M.S., Clifton J. Latiolais, Sc.D., Stability of injectable medications after reconstitution, American Journal of Hospital Pharmacy, Volume 33, Issue 8, 1 August 1976, Pages 767791, https://doi.org/10.1093/ajhp/33.8.767. endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. (See Special Populations under Pharmacokinetics.). Use with caution in patients with a history of clinically important allergies and/or asthma. Watson Pharma, Inc. 1-800-678-1605, Manufactured By: Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. trailer II. 5 0 obj xref 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. Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. I. fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ Available as iron dextran; dosage expressed in terms of elemental iron. KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 0000008494 00000 n a. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. Crosses the placenta and small amounts of iron apparently reach the fetus. % The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. PMC In iron-deficient patients with coexistent end-stage renal disease and other clinical problems, the serum elimination half-life of iron averaged 58.9 hours (range: 9.487.4 hours) following IV administration of iron dextran. . 3 0 obj Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. If diluted, administer by IV infusion [off-label] over 16 hours. 16.2 Stability and Storage 1972;9:94-98. HOW SUPPLIED DOSAGE FORMS AND STRENGTHS VIDAZA (azacitidine for injection) is supplied as lyophilized powder in 100 mg single-use vials. Brand names: Dexferrum, INFeD 0000037333 00000 n Each monograph contains stability data, administration guidelines, and methods of preparation. Last updated on Dec 1, 2022. 0000002275 00000 n Fatal reactions have also occurred in situations where the test dose was tolerated. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. Medically reviewed by Drugs.com on Oct 25, 2022. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. HR0~ Would you like email updates of new search results? BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). HHS Vulnerability Disclosure, Help CONTRAINDICATIONS 0000003746 00000 n It should be recognized that iron storage may lag behind the appearance of normal blood morphology. MeSH 0 $]: During administration of any iron dextran dose, observe for manifestations of anaphylactic-type reactions. Ling J, Gupta VD. Infed (iron dextran injection USP) is an iron replacement product provided as a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Indian J Anaesth. Blood volume . WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS The site is secure. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. 0000002803 00000 n Vascular disorders: Cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site. Niemiec PW Jr, Vanderveen TW, Hohenwarter MW, Gadsden RH Sr. Bullock L, Fitzgerald JF, Glick MR, Parks RB, Schnabel JG, Hancock BG. @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ Iron Overload Gaithersburg, MD: Genzyme; August 2018. Dosage form: injection 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. (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: 0000002909 00000 n official website and that any information you provide is encrypted 4. ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. government site. Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. J Parenter Sci Technol. The total volume of Infed required for the treatment of iron replacement for blood loss is determined from an appropriate formula listed [see Dosage and Administration (2.3)]. 0000002696 00000 n All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. 0000036781 00000 n 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. 2007 Jan;12(1):53-9. doi: 10.5863/1551-6776-12.1.53. INFeD may be used alone or with other medications. 8600 Rockville Pike 2021 Allergan. [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK 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). The stability of injectable medications after reconstitution is presented. 2.1 Important Pre-Treatment Information W = body weight in kg 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. Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. 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. 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. Am J Kid Dis. Known hypersensitivity to iron dextran or any ingredient in the formulation. (See PRECAUTIONS: General.) 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. 4. If patient is standing, administer IM injection in buttock of the leg opposite the patients weight-bearing leg; if supine, place patient in a lateral position with the injection site uppermost. Each monograph contains stability data, administration guidelines, and methods of preparation. Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. Iron storage parameters may improve prior to hematologic parameters. In mice, rats, rabbits, and possibly hamsters, it has been demonstrated that these complexes may produce sarcoma following repeated administration of large or small doses of iron-carbohydrate complexes at a single injection site. Question patients regarding any prior history of reactions to parenteral iron products. A subsidiary of Watson Pharmaceuticals, Inc. Unable to load your collection due to an error, Unable to load your delegates due to an error. Importance of informing patients of other important precautionary information. Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. 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 to oral iron. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. Do not administer Infed to patients with evidence of iron overload. 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). 0000002441 00000 n Medical Communications ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. Delayed Reactions 4 0 obj NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. 0000006673 00000 n Use with extreme caution in patients with serious impairment of hepatic function. 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)]. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. 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. 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.]. INFeD (iron dextran injection), for intravenous or . 7.1 Drug/Laboratory Test Interactions 0000002294 00000 n Copyright 1993-2021 The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. 0000005019 00000 n 0000046285 00000 n Cancer Chemother Pharmacol. Fatal reactions have been reported following the test dose of iron dextran injection. Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. PMC . Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to Infed. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: The maximum daily dose of INFeD should not exceed 2 mL. 0000039715 00000 n 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. . It is not known if INFeD is safe and effective in children younger than 4 months of age. Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. . For solution and drug compatibility information, see Compatibility under Stability. 0000002072 00000 n 1986 Jul-Aug;40(4):142-63. INFeD preparation: Administer by deep IM injection using a 2- or 3-inch, 19- or 20-gauge needle into the upper outer quadrant of the buttock only. Fatal anaphylactic reactions are possible. 0000018000 00000 n 3. Disease-Associated Maternal and/or Embryo/Fetal Risk Please enable it to take advantage of the complete set of features! The stability of Meropenemreconstituted in solution is influenced by the following factors: Storage temperature: The drug is stable for longer time in solutions stored at 4 to 5C than in solutions stored at 21 to 26C. endstream endobj 46 0 obj<>stream Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
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