Source: European Medicines Agency (EU) Revision Year: 2015 Publisher: CIS bio international, Boîte Postale 32, F-91192 GIF-SUR-YVETTE Cedex, FRANCE
Quadramet 1.3 GBq/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to light amber solution with pH ranging between 7.0 and 8.5. |
Each ml of solution contains 1.3 GBq Samarium (153Sm) lexidronam pentasodium at the reference date (corresponding to 20 to 80 µg/ml of samarium per vial)
Samarium specific activity is approximately 16–65 MBq/µg of samarium.
Each vial contains 2-4 GBq at the reference date.
Samarium-153 emits both medium-energy beta particles and an imageable gamma photon, and has a period of 46.3 hours (1.93 days). The primary radiation emissions of samarium-153 are shown in Table 1.
Table 1. Samarium-153 principal radiation emission data:
| Radiation | Energy (keV)* | Abundance |
|---|---|---|
| Beta | 640 | 30% |
| Beta | 710 | 50% |
| Beta | 810 | 20% |
| Gamma | 103 | 29% |
* Maximum energies are listed for the beta emissions, the average beta particle energy is 233 keV.
Excipient with known effect: sodium 8.1 mg/mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Samarium ¹⁵³Sm lexidronam |
Samarium has an affinity for skeletal tissue and concentrates in areas of bone turnover in intimate association with hydroxyapatite. It is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium (99mTc)-labelled biphosphonates on bone scan. |
| List of Excipients |
|---|
|
Total EDTMP (as EDTMP.H2O) |
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 calibration) to 3.1 ml (4 GBq at calibration) of solution for injection.
CIS bio international, Boîte Postale 32, F-91192 GIF-SUR-YVETTE Cedex, FRANCE
EU/1/97/057/001
Date of first authorisation: 05 February 1998
Date of latest renewal: 12 December 2007
| Drug | Countries | |
|---|---|---|
| QUADRAMET | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom, United States |
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