Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
METHYLENE DIPHOSPHONIC ACID DI- AND TRISODIUM SALT
GE Healthcare Limited
METHYLENE DIPHOSPHONIC ACID DI- AND TRISODIUM SALT
6.25 Milligram
Pdr for Soln for Injection
Product subject to Restricted Prescription (C)
Withdrawn
2012-01-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amerscan Medronate II Agent 6.25 milligrams kit for radiopharmaceutical preparation 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Methylene diphosphonic acid 6.25 milligrams/vial (as the sodium salt), equivalent to 5.0mg medronic acid/vial. Amerscan Medronate II Agent is reconstituted with Sodium Pertechnetate ( 99m Tc) Injection (not included in this kit) to prepare Technetium ( 99m Tc) Medronate Injection. Technetium-99m disintegrates with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium-99 which can be regarded as quasi stable. The product before reconstitution contains: Sodium: 1.60 mg/vial. This needs to be taken into consideration for patients on a controlled sodium diet. Sodium p-aminobenzoate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation White to off-white powdery solid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After reconstitution with Sodium Pertechnetate ( 99m Tc) Injection the agent may be used for bone scintigraphy, where it delineates areas of altered osteogenesis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The average activity administered by a single intravenous injection is 500MBq (300-700MBq). Other activities may be justifiable. Images obtained shortly after injection (e.g. in the so-called "3-phase bone scan" procedure) will only partly reflect metabolic bone activity. Late phase static scintigraphy should be performed not earlier than 2 hours after injection. The patient should void before scanning. The dose to be administered to a child should be a fraction of the adult dose calculated from the body weight according to the following Læs hele dokumentet