RADIOGARDASE Capsule (2019)
Βιβλιογραφική αναφορά
Συγγραφείς
Heyl Chem.-pharm. Fabrik GmbH & Co. KG
Λέξεις κλειδιά
58060-002
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1. Indications and Usage
Radiogardase is indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium, in order to increase their rates ...
2. Dosage and Administration
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 ...
3. Dosage Forms and Strengths
<u>Capsules:</u> 0.5 grams dark blue capsule is imprinted with the light blue inscription: PB
4. Contraindications
None.
5. Warnings and Precautions
5.1 Increased Radiation Absorbed Dose to Gastrointestinal Mucosa Radiogardase can decrease gastrointestinal motility, thus slowing the transit time of radioactivity in the gastrointestinal tract. The slowed ...
6. Adverse Reactions
Constipation was reported in 10 (24%) of 42 patients treated with Radiogardase. Severity of constipation was mild in 7 patients and moderate in 3 patients <em>[see Warnings and Precautions (5.2)]</em> ...
7. Drug Interactions
Based on animal data, co-administration of Radiogardase with other decorporation agents does not affect the efficacy of Radiogardase for treatment of internal contamination with radioactive cesium and/or ...
8.1. Pregnancy
<u>Pregnancy Category C</u> It is not known whether Radiogardase can cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Animal reproduction studies have not ...
8.3. Nursing Mothers
Studies to determine if Radiogardase is excreted in human milk have not been conducted. Since Radiogardase is not absorbed from the gastrointestinal tract, its excretion in milk is unlikely. However, cesium ...
8.4. Pediatric Use
Radioactive Cesium Contamination The safety and efficacy of Radiogardase in the treatment of <sup>137</sup>Cs in pediatric patients ages, 2 to 18 years old, was established from data from Radiogardase-treated ...
8.5. Geriatric Use
The safety and efficacy of Radiogardase in patients aged 65 and over have not been evaluated, to determine whether they respond differently from younger subjects.. In general, elderly patients should be ...
8.6. Hepatic Impairment
Radiogardase is not systemically bioavailable and does not rely on hepatic metabolism for activation or inactivation. However, Radiogardase may be less effective in patients with hepatic impairment, due ...
10. Overdosage
Based on reported adverse reactions and mechanism of action, possible overdosage symptoms may include constipation, obstruction, or severe decrease in electrolytes. Gastric distress was reported in 3 patients ...
11. Description
Radiogardase (prussian blue insoluble) is a decorporation agent for oral use. Radiogardase capsules contain insoluble ferric hexacyanoferrate(II), with an empirical formula of Fe<sub>4</sub>[Fe(CN)<sub> ...
12.1. Mechanism of Action
Prussian blue insoluble, ferric hexacyanoferrate(II), acts by ion-exchange, adsorption, and mechanical trapping within the crystal structure, and has a high affinity for radioactive and non-radioactive ...
12.2. Pharmacodynamics
Cesium-137 (<sup>137</sup>Cs) <sup>137</sup>Cs has a physical half-life of 30 years, with a beta energy peak at 174.0 keV. Following entry into the blood, it is distributed uniformly through all body tissues. ...
12.3. Pharmacokinetics
Absorption/Elimination Prussian blue insoluble is not absorbed through the intact gastrointestinal wall. Its clearance from the body depends on the gastrointestinal tract transit time. Food Effects Food ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies have not been performed to evaluate the carcinogenic or mutagenic potential of prussian blue insoluble. No study on impairment of male or female fertility and reproductive performance has ...
13.2. Animal Toxicology and/or Pharmacology
Absorption/Elimination In an animal study (pigs, n=38), after a single dose of 40 mg of labeled prussian blue insoluble, 99% of the administered prussian blue dose was excreted unchanged in feces. Absorption ...
14. Clinical Studies
14.1 Cesium-137 Contamination In literature reports, 72 people received Radiogardase after exposure to radioactive cesium (<sup>137</sup>Cs): 46 patients with 137Cs contamination 19 patients 137Cs contamination ...
16.1. How Supplied
Radiogardase is supplied as gelatin capsules containing 0.5 grams of prussian blue insoluble for oral administration. The dark blue capsule is imprinted with the light blue inscription: PB. It is packaged ...
16.2. Storage and Handling
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated, provided the mean kinetic temperature ...
17. Patient Counseling Information
Decreased Gastrointestinal Motility Inform patients that Radiogardase can decrease gastrointestinal motility. This can slow the transit time of cesium or thallium bound to Radiogardase and increase the ...