CELSUNAX Solution for injection Ref.[50434] Active ingredients: Ioflupane ¹²³I

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Pinax Pharma GmbH, Lausitz Mühlenweg 5, 04924 Bad Liebenwerda, Germany

Product name and form

Celsunax 74 MBq/mL solution for injection.

Pharmaceutical Form

Solution for injection.

Clear colourless solution.

Qualitative and quantitative composition

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)
Sodium acetate trihydrate (E262)
Ethanol (96%) (E1510)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Pinax Pharma GmbH, Lausitz Mühlenweg 5, 04924 Bad Liebenwerda, Germany

Marketing authorization dates and numbers

EU/1/21/1560/001 (2.5 mL)
EU/1/21/1560/002 (5 mL)

Drugs

Drug Countries
CELSUNAX Estonia, Croatia, Ireland, Lithuania, Poland

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