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NORMOCARB HF™, after dilution, is indicated in adult and pediatric patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace water and to correct electrolytes and acid-base imbalance.
DOSAGE AND ADMINISTRATION
Important Preparation Information
NORMOCARB HF™ MUST BE DILUTED BEFORE USE. Dilute only with Sterile Water for Injection. For dilution, one 240 mL vial of NORMOCARB HF™ should be added to 3 Liters of Sterile Water for Injection to make 3.24 Liters of infusate solution. Shake to mix by rocking or rolling the bag and contents thoroughly. Additives can be introduced after initial dilution (see Additives below).
Individualization of Treatment
Pre- or Post-Filter: The volume of solution (diluted NORMOCARB HF™) administered will depend upon the fluid balance of the individual patient, the target fluid balance to be achieved, the body weight and the amount of fluid removed from the patient's circulation during the hemofiltration process. When administered post-filter, the replacement rate should not be greater than one third of the blood flow rate; e.g., for blood flow of 100 mL per min, equivalent to 6000 mL per hour, post-filter replacement rate should not exceed 2000 mL per hour.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. NORMOCARB HF™ must not be used if a precipitate has been formed or if container seals have been damaged.
Table 1 describes the components of diluted NORMOCARB HF™ 25 and NORMOCARB HF™ 35 solutions when prepared as directed.
Table 1: Components of Diluted
NORMOCARB HF™ 25 and NORMOCARB HF™ 35
|Diluted NORMOCARB HF™ 25||Diluted NORMOCARB HF™ 35|
|Component||mEq per Liter||mEq per Liter|
|Magnesium (Mg)||1.5 (0.75 mMol per L)||1.5 (0.75 mMol per L)|
|Theoretical Osmolarity||283 mOsm per Liter||283 mOsm per Liter|
|pH||8.55 ± 0.25||8.55 ± 0.25|
Diluted NORMOCARB HF™ should be used within 24 hours. It may be stored at normal room temperature or refrigerated (2° to 30°C). Do not freeze infusate solution or expose to excessive heat.
When introducing additives, use aseptic techniques.
Potassium: Potassium chloride up to 4 mEq per Liter may be added to the diluted solution.
Calcium: Calcium chloride up to 1.25 mMol per Liter (2.5 mEq per Liter) may be added to the diluted solution.
Glucose: Up to 12 mL of D50W may be added to the diluted solution to provide a concentration of up to 10.2 mMol per Liter of dextrose.
Phosphate: Potassium phosphate up to 1.2 mMol per Liter (2.4 mEq per Liter) may be added to the diluted solution. The total potassium concentration should not exceed 4 mEq per Liter.
Drugs should not be added to NORMOCARB HF™.
Dosage Forms And Strengths
NORMOCARB HF™ is a Sterile Electrolyte Concentrate for Infusion. NORMOCARB HF™ comes in two strengths that differ in bicarbonate concentration.
Undiluted NORMOCARB HF™ 25 contains 90.73 g per Liter sodium chloride (NaCl), 2.06 g per Liter magnesium chloride hexahydrate (MgCl2•6H2O) and 28.35 g per Liter sodium bicarbonate (NaHCO3) in water for injection.
Undiluted NORMOCARB HF™ 35 contains 82.84 g per Liter sodium chloride (NaCl), 2.06 g per Liter magnesium chloride hexahydrate (MgCl2•6H2O) and 39.70 g per Liter sodium bicarbonate (NaHCO3) in water for injection.
|240 mL vial||NDC|
|NORMOCARB HF™ 25||16951-0125-1|
|NORMOCARB HF™ 35||16951-0135-1|
Storage and Handling
Undiluted NORMOCARB HF™ should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze. Do not use if a precipitate has formed or if container seals have been damaged.
Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9. Revised: 04/2012
Last reviewed on RxList: 7/6/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Normocarb HF Information
Report Problems to the Food and Drug Administration
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