Orphan Europe, Sarl

Orphan Europe, Sarl Drugs

• Carbaglu
  

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  Carbaglu

  

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  Carbaglu� treatment should be initiated by a physician experienced in metabolic disorders.

  2.1 �� �Adult Dosage and Administration

  The recommended initial dose for acute hyperammonemia is 100 mg/kg/day to 250 mg/kg/day.� Concomitant administration of other ammonia lowering therapies is recommended.� Dosing should be titrated based on individual patient plasma ammonia levels and clinical symptoms.

  The recommended maintenance dose should be titrated to target normal plasma ammonia level for age.� Based on limited data in 22 patients receiving maintenance treatment with Carbaglu� in a retrospective case series, maintenance doses were usually less than 100 mg/kg/day.

  The total daily dose should be divided into 2 to 4 doses and rounded to the nearest 100 mg (i.e., half of a Carbaglu� Tablet).

  2.2 �� �Preparation for Oral Administration in Adults

  Carbaglu� tablets should not be swallowed whole or crushed. Disperse Carbaglu� tablets in water immediately before use.

  Each 200 mg tablet should be dispersed in a minimum of 2.5 mL of water and taken immediately.� Carbaglu� tablets do not dissolve completely in water and undissolved particles of the tablet may remain in the mixing container. �

  To ensure complete delivery of the dose, the mixing container should be rinsed with additional volumes of water and the contents swallowed immediately.

  USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

  2.3 �� �Preparation for Nasogastric Tube Administration in Adults

  For patients who have a nasogastric tube in place, Carbaglu� should be administered as follows:

  Mix each 200 mg tablet in a minimum of 2.5 mL of water. Shake gently to allow for quick dispersal. Administer the dispersion immediately through the nasogastric tube. Flush with additional water to clear the nasogastric tube.

  2.4 �� �Pediatric Dosage and Administration

  The recommended initial dose for acute hyperammonemia is 100 mg/kg/day to 250 mg/kg/day.� Concomitant administration of other ammonia lowering therapies is recommended.� Dosing should be titrated based on individual patient plasma ammonia levels and clinical symptoms.

  The recommended maintenance dose should be titrated to target normal plasma ammonia level for age.� Based on limited data in 22 patients receiving maintenance treatment with Carbaglu� in a retrospective case series, maintenance doses were usually less than 100 mg/kg/day.

  The total daily dose should be divided into 2 to 4 doses.

  2.5 �� �Preparation for Oral Administration Using an Oral Syringe in Pediatrics

  For administration via oral syringe, Carbaglu� should be administered as follows:

  Mix each 200 mg tablet in 2.5 mL of water to yield a concentration of 80 mg/mL in a mixing container.� Shake gently to allow for quick dispersal. Draw up the appropriate volume of dispersion in an oral syringe and administer immediately.� Discard the unused portion. Refill the oral syringe with a minimum volume of water (1-2 mL) and administer immediately.

  2.6 �� �Preparation for Nasogastric Tube Administration in Pediatrics

  For patients who have a nasogastric tube in place, Carbaglu� should be administered as follows:

  Mix each 200 mg tablet in 2.5 mL of water to yield a concentration of 80 mg/mL in a mixing container.� Shake gently to allow for quick dispersal. Draw up the appropriate volume of dispersion and administer immediately through a nasogastric tube.� Discard the unused portion. Flush with additional water to clear the nasogastric tube.

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