RADIOGARDASE(Heyl Chem.-pharm. Fabrik GmbH & Co. KG)(八)
77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
PATIENT TREATMENT DATA
To develop long-term response data, detailed information on patient treatment should be provided to the manufacturer whenever this drug is administered. These data should include a record of the radioactive body burden and bioassay results at defined time intervals, a description of measurement methods to facilitate analysis of data, and adverse events (see attached patient data form). In cases where exposure is limited in terms of number of patients, it may be possible to collect more detailed patient information. Please see the following website, www.heyltex.com for additional suggested data collection.
Questions regarding patient treatment data collection and the use of Prussian blue insoluble for the treatment of patients exposed to radioactive cesium and/or radioactive or non-radioactive thallium may be submitted to
Dr. Johann Ruprecht, Email: info@heyl-berlin.de, Fax +49 30 817 4049
Rev. 03/2008
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(click image for full-size original) RADIOGARDASE prussian blue insoluble capsules capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58060-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERRIC FERROCYANIDE (FERRIC FERROCYANIDE) FERRIC FERROCYANIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE 38 mg
GELATIN 83.12 mg
WATER 14.21 mg
INDIGOTINDISULFONATE SODIUM 0.67 mg
SODIUM LAURYL SULFATE 0.15 mg
Product Characteristics
Color blue (Heyl;PB) Score no score
Shape CAPSULE (Heyl;PB) Size 22mm
Flavor Imprint Code Heyl;PB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58060-002-02 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 36 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (58060-002-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021626 03/24/2010
Labeler — Heyl Chem.-pharm. Fabrik GmbH & Co. KG (317151645)
Registrant — Heyl Chem.-pharm. Fabrik GmbH & Co. KG (317151645)
Establishment
Name Address ID/FEI Operations
Haupt Pharma Berlin GmbH 316070416 manufacture (58060-002)
Establishment
Name Address ID/FEI Operations
Laborchemie Apolda GmbH 331821462 api manufacture (58060-002)
Revised: 02/2013 Heyl Chem.-pharm. Fabrik GmbH & Co. KG
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