What QUADRAMET contains The active substance is samarium 153Sm lexidronam pentasodium. Each ml of solution contains 1.3 GBq Samarium 153Sm lexidronam pentasodium at the reference date corresponding to 20-46 gml of samarium per vial.
The other ingredients are Total EDTMP (as EDTMP.H2O), calcium-EDTMP sodium salt (as Ca),
total sodium (as Na), water for injections.
What QUADRAMET looks like and contents of the pack
QUADRAMET is a solution for injection.
This medicinal product is a clear, colourless to light amber solution which is packed in a 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Each vial contains 1.5 ml (2 GBq at reference) to 3.1 ml (4 GBq at reference) of solution for injection.
Marketing authorisation holder and manufacturer
CIS bio international
Boîte Postale 32
F-91192 Gif-sur-Yvette cedex
The leaflet was last approved on ().The following information is intended for medical or healthcare professionals only:
For detailed information refer to the Summary of Product Characteristics of QUADRAMET.
INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Read directions for use thoroughly before starting the preparation procedure.
All procedures should be conducted using aseptic techniques and standard precautions for handling radionuclides.
Use of radiopharmaceutical agents
Radiopharmaceuticals should only be used by qualified personnel with the appropriate government authorisation for the use and handling of radionuclides. This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the local competent official organisations.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical requirements. Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.
Method of preparation
Allow the product to thaw at room temperature before administration.
The solution for injection should be visually inspected before use. It should be clear without particles. The operator should be careful to protect the eyes while inspecting the solution for clarity.
The activity should be measured by a dose calibrator immediately before administration. Verification of the dose to be administered and patient identification are necessary prior to administration of QUADRAMET.
Usual precautions regarding sterility and radioprotection should be respected.
The administration of radiopharmaceuticals creates risks to other persons from external radiation or contamination from spills of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.
For radiation safety reasons, the patient should be treated in a facility with the appropriate agreement for the therapeutic use of radioactive non-sealed sources. He will be released when exposure rates comply with the limits prescribed by the regulations in force.
Radioactive waste must be disposed of in conformity with the relevant national and international regulations.