pictures [0.01:<20% and/or serum ferritin> <100 ng/mL) pediatric hemodialysis patients, 6 to 15 years of age, inclusive who were receiving a stable erythropoietin dosing regimen. Sodium Ferric Gluconate Complex in sucrose injection at a dose of 1.5 mg/kg or 3.0 mg/kg (up to a maximum dose of 125 mg of elemental iron) in 25 mL 0.9% sodium chloride was infused intravenously over 1 hour during each hemodialysis session for eight sequential dialysis sessions. Thirty-two patients received the 1.5 mg/kg dosing regimen (47% male, 53% female; 66% Caucasian, 25% Hispanic, and 3% Black, Asian, or Other; mean age 12.3 years). Thirty-four patients received the 3.0 mg/kg dosing regimen (56% male, 44% female; 77% Caucasian, 12% Hispanic, 9% Black, and 3% Other; mean age 12.0 years). The primary endpoint was the change in hemoglobin concentration from baseline to 2 weeks after last Sodium Ferric Gluconate Complex in sucrose injection administration. There was no significant difference between the treatment groups. Improvements in hematocrit, transferrin saturation, serum ferritin, and reticulocyte hemoglobin concentrations compared to baseline values were observed 2 weeks after the last Sodium Ferric Gluconate Complex in sucrose injection infusion in both the 1.5 mg/kg and 3.0 mg/kg treatment groups (Table 3). Table 3: Study C: Hemoglobin, Hematocrit, and Iron Status Mean Change from Baseline to Two Weeks After Cessation of Therapy in Patients Completing Treatment 1.5 mg/kg Sodium Ferric Gluconate Complex in Sucrose Injection (N=25) 3.0 mg/kg Sodium Ferric Gluconate Complex in Sucrose Injection (N=32) Hemoglobin (g/dL) 0.8 0.9 Hematocrit (%) 2.6 3.0 Transferrin Saturation (%) 5.5 10.5 Serum Ferritin (ng/mL) 192 314 Reticulocyte Hemoglobin Content (pg) 1.3 1.2 The increased hemoglobin concentrations were maintained at 4 weeks after the last Sodium Ferric Gluconate Complex in sucrose injection infusion in both the 1.5 mg/kg and the 3.0 mg/kg Sodium Ferric Gluconate Complex in sucrose injection dose treatment groups. How Supplied/Storage and Handling How Supplied NDC 0143-9298-10 Sodium Ferric Gluconate Complex in sucrose injection is supplied in colorless glass vials. Each sterile, single dose vial contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 vials. Storage Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) [See USP Controlled Room Temperature]. Do not freeze. Keep out of the reach of children. Patient Counseling Information Prior to Sodium Ferric Gluconate Complex in sucrose injection administration: Question patients regarding any prior history of reactions to parenteral iron products. Advise patients of the risks associated with Sodium Ferric Gluconate Complex in sucrose injection. Advise patients to report adverse reactions associated with the use of Sodium Ferric Gluconate Complex in sucrose injection, including hypersensitivity, allergic reactions, dizziness, light-headedness, swelling, and breathing problems [see Warnings and Precautions ( 5.1 , 5.2 ) and Adverse Reactions ( 6.1 , 6.2 ) ]. Advise patients that Sodium Ferric Gluconate Complex in sucrose injection may reduce the absorption of concomitantly administered oral iron preparations [see Drug Interactions ( 7 ) ]. Manufactured by HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, nº 8, 8A e 8B Fervença 2705 - 906 Terrugem SNT, PORTUGAL Distributed by WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA NOVAPLUS is a registered trademark of Vizient, Inc. NOVAPLUS Issued September 2017 PIN473-NOV/1 PRINCIPAL DISPLAY PANEL NDC 0143-9298-01 5 mL Single Dose Vial Rx ONLY Sodium Ferric Gluconate Complex in Sucrose Injection 62.5 mg elemental iron/5 mL (12.5 mg/mL) For Intravenous Use Only PRINCIPAL DISPLAY PANEL NDC 0143-9298-10 PLB111-NOV/1 Sodium Ferric Rx ONLY Gluconate Complex in Sucrose Injection 62.5 mg elemental iron/5 mL (12.5 mg/mL) For Intravenous Use Only 10 x 5 mL Single Dose Vials NOVAPLUS Sodium Ferric Gluconate Complex IN SUCROSE Sodium Ferric Gluconate Complex in sucrose injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0143-9298 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Ferric Gluconate Complex (FERRIC CATION) FERRIC CATION 12.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SUCROSE 195 mg in 1 mL BENZYL ALCOHOL 9 mg in 1 mL WATER Packaging # Item Code Package Description 1 NDC:0143-9298-10 10 VIAL, SINGLE-DOSE in 1 CARTON 1 NDC:0143-9298-01 5 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078215 03/31/2011 Labeler - West-Ward Pharmaceuticals Corp (001230762) Registrant - HIKMA FARMACEUTICA (PORTUGAL), S.A. (452742943) Revised: 09/2017 West-Ward Pharmaceuticals Corp Next Interactions Print this page Add to My Med List More about sodium ferric gluconate complex Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 2 Reviews Add your own review/rating Drug class: iron products Consumer resources Sodium ferric gluconate complex Ferric Gluconate Sodium ferric gluconate complex Intravenous (Advanced Reading) Professional resources Sodium Ferric Gluconate (AHFS Monograph) Other brands: Ferrlecit , Nulecit Related treatment guides Anemia Associated with Chronic Renal Failure> ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturers Teva Pharmaceuticals USA, Inc. West-Ward Pharmaceuticals Drug Class Iron products Related Drugs iron products ferrous sulfate , Feosol Original , Iron-150 , Dialyvite Anemia Associated with Chronic Renal Failure ferrous sulfate , Procrit , Aranesp , Feosol Original , Epogen , epoetin alfa , Fergon , Ferrousal , FeroSul , darbepoetin alfa , Ferrlecit , Slow Fe , Feraheme , Hemocyte , Infed , iron dextran , Ferrocite , ferumoxytol , Ferate , More... Sodium ferric gluconate complex Rating 2 User Reviews 5.0 /10 2 User Reviews 5.0 Rate it! provides you with
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