vantive us healthcare llc - Medication Listings

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DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. Table 4 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX/Plastic Container with pull ring for APD therapy Composition/100 mL *Dextrose, Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride, USP (CaCl2•2H2O) Magnesium Chloride, USP (MgCl2•6H2O) DIANEAL PD-2 1.5% Dextrose 1.5 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL PD-2 2.5% Dextrose 2.5 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL PD-2 4.25% Dextrose 4.25 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 1.5 g 538 mg 448 mg 18.3 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 2.5 g 538 mg 448 mg 18.3 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg Table 5 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy Composition/100 mL *Dextrose, Hydrous Sodium Chloride (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride (CaCl2•2H2O) Magnesium Chloride (MgCl2•6H2O) DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 1.5 g 538 mg 448 mg 18.4 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 2.5 g 538 mg 448 mg 18.4 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 4.25 g 538 mg 448 mg 18.4 mg 5.08 mg The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies. Structural Formula Dextrose Hydrous USP

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EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is: Each 100 mL of EXTRANEAL contains: Icodextrin 7.5 g Sodium Chloride, USP 535 mg Sodium Lactate 448 mg Calcium Chloride, USP 25.7 mg Magnesium Chloride, USP 5.08 mg Electrolyte content per liter: Sodium 132 mEq/L Calcium 3.5 mEq/L Magnesium 0.5 mEq/L Chloride 96 mEq/L Lactate 40 mEq/L Water for Injection, USP qs HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0 EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Image of Structural Formula of Icodextrin

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PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2 ), the two compartments contain: Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 2 • 2H 2 O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2 • 6H 2 O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO 3 . Dextrose, USP, is chemically designated D-Glucose anhydrous (C 6 H 12 O 6 ) or D-Glucose monohydrate (C 6 H 12 O 6 • H 2 O). Lactic acid, USP, is chemically designated CH 3 CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na 2 HPO 4 • 2H 2 O) Table 2 - Compartment Composition (Before Mixing) Compartment A (g/L) Compartment B (g/L) Calcium Chloride ∙ 2H 2 O Magnesium Chloride ∙ 6H 2 O Dextrose anhydrous (as monohydrate) Lactic Acid Sodium Chloride Sodium bicarbonate Potassium Chloride Sodium Phosphate ∙ 2H 2 O PRISMASOL SOLUTIONS BGK 0/2.5 3.68 3.05 20 (22) 5.40 6.46 3.09 0 0 BGK 4/2.5 3.68 3.05 20 (22) 5.40 6.46 3.09 0.314 0 BGK 2/3.5 5.15 2.03 20 (22) 5.40 6.46 3.09 0.157 0 BGK 2/0 0 2.03 20 (22) 5.40 6.46 3.09 0.157 0 B22GK 4/0 0 3.05 20 (22) 5.40 7.07 2.21 0.314 0 BK 0/0/1.2 0 2.44 0 (0) 5.40 6.46 3.09 0 0 BGK 4/0/1.2 0 2.44 20 (22) 5.40 6.46 3.09 0.314 0 PHOXILLUM SOLUTIONS BK 4/2.5 3.68 3.05 0 (0) 0 6.34 3.09 0.314 0.187 B22K 4/0 0 3.05 0 (0) 0 6.95 2.21 0.314 0.187 The pH of the final solution is in the range of 7.0 to 8.5.

INDICATIONS REGIOCIT (sodium chloride and sodium citrate) solution is indicated for use as replacement solution for regional citrate anticoagulation (RCA) of the extracorporeal circuit in patients treated with continuous renal replacement therapy (CRRT), particularly when systemic anticoagulation with heparin is contraindicated, e.g., in patients with increased bleeding risks. REGIOCIT should be administered only under the supervision of a physician experienced in the use of CRRT. Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness.