Heyl Chem.-pharm. Fabrik Gmbh & Co. Kg

Heyl Chem.-pharm. Fabrik Gmbh & Co. Kg Drugs

• Radiogardase
  

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  Radiogardase

  

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  2.1 Important Administration Instructions

  • Obtain quantitative baseline of the internalized contamination by radioactive cesium (137Cs) and/or thallium by appropriate whole-body counting and/or by bioassay (e.g., biodosimetry), or feces/urine samples, whenever possible prior to Radiogardase treatment. • Initiate treatment with Radiogardase as soon as possible after contamination is suspected. Even when delayed, treatment with Radiogardase is effective and should not be withheld. • Take Radiogardase capsules with food to stimulate excretion of cesium or thallium. • In patients who cannot tolerate swallowing large numbers of capsules, open the capsules and mix with bland food or liquids.

  2.2 Decontamination Procedures for Radioactive Cesium or Thallium Contamination

  Prior to initiating treatment with Radiogardase, follow radioactive decontamination safety procedures including:

  • Use appropriate radiation protective attire and closely monitor personnel and treatment area for radiation levels using radiation detection, indication, and computation devices (RADIAC) or thermal luminescent devices (TLD). • Control spread of radiation contamination through the establishment of a patient decontamination area and a contaminated material disposal site (with proper labeling, handling, and disposal of contaminated material).

  2.3 Recommended Dosage

  • Adults and Adolescents: 3 grams (6 capsules) taken orally three times a day (a total daily dose of 9 grams) • Pediatric Patients (2 – 12 years): 1 gram (2 capsules) taken orally three times a day (a total daily dose of 3 grams)

  2.4 Treatment of Radioactive Cesium Contamination

  • Anticipate that treatment with Radiogardase may last 30 days or longer. • Base duration of Radiogardase treatment on weekly measurements of radioactivity in urine and fecal samples to monitor cesium elimination rate. • Obtain weekly laboratory evaluations (complete blood count, serum chemistry and electrolytes).

  2.5 Treatment of Radioactive and Non-radioactive Thallium Contamination

  • Anticipate that treatment with Radiogardase may last 30 days or longer. • For radioactive thallium: o Base duration of Radiogardase treatment on weekly measurements of radioactivity inurine and fecal samples to monitor thallium elimination rate. o Continue Radiogardase treatment until a 24-hour urine thallium test is normal (less than 5 micrograms per liter) and radiation level is acceptable. • For non-radioactive thallium: Continue Radiogardase treatment until a 24-hour urine thallium test is normal (less than 5 micrograms per liter). • Obtain weekly laboratory evaluations (complete blood count, serum chemistry and electrolytes). • In cases of severe thallium intoxication, additional types of treatment may be necessary, such as: o Induced emesis, followed by gastric intubation and lavage o Forced diuresis until urinary thallium excretion is less than 1 mg/24 hours o Charcoal hemoperfusion may be useful during the first 48 hours after thallium ingestion (biodistribution phase). o Hemodialysis has also been reported to be effective in thallium intoxication.

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