Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pinax Pharma GmbH, Lausitz Mühlenweg 5, 04924 Bad Liebenwerda, Germany
Celsunax 74 MBq/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear colourless solution. |
Each mL of solution contains 74 MBq of ioflupane (123I) at reference time (0.07 to 0.13 μg/mL of ioflupane).
Each 2.5 mL single dose vial contains 185 MBq ioflupane (123I) (specific activity range 2.5 to 4.5 × 1014 Bq/mmol) at reference time.
Each 5 mL single dose vial contains 370 MBq ioflupane (123I) (specific activity range 2.5 to 4.5 × 1014 Bq/mmol) at reference time.
Iodine-123 has a physical half-life of 13.2 hours. It decays emitting gamma radiation with a predominant energy of 159 keV and X-rays of 27 keV.
Excipient with known effect: This medicinal product contains 39.5 g/L ethanol, resulting in a maximum of 197 mg of ethanol in 5 mL solution.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ioflupane ¹²³I |
Ioflupane ¹²³I is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). |
| List of Excipients |
|---|
|
Acetic acid, glacial (E260) |
Sterile 10 mL glass vial (Type I) with a rubber stopper and a flip cap.
The vial is placed into a lead container for protective shielding.
Pack size of 1 vial containing 2.5 mL or 5 mL of solution.
Not all pack sizes may be marketed.
Pinax Pharma GmbH, Lausitz Mühlenweg 5, 04924 Bad Liebenwerda, Germany
EU/1/21/1560/001 (2.5 mL)
EU/1/21/1560/002 (5 mL)
| Drug | Countries | |
|---|---|---|
| CELSUNAX | Estonia, Croatia, Ireland, Lithuania, Poland |
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