Leaflet ISOPROTRACE 10mcg kit for radiopharmaceutical preparations


Indicated for: diagnostic imaging

Route of administration: injectable

Substance: gallium gozetotide (68Ga) (contrast agent)

ATC: V09IX14 (Various | Tumour detection | Other diagnostic radiopharmaceuticals for tumour detection)

Gallium (68Ga) gozetotide is a radiopharmaceutical agent used in PET imaging for the detection of recurrent or metastatic prostate cancer. It binds to the prostate-specific membrane antigen (PSMA) present on cancer cells.

The medication is administered intravenously and helps accurately identify the location of cancer, providing essential information for treatment planning.

Adverse reactions may include nausea, headache, injection site reactions, or, in rare cases, allergic responses. Radiation exposure is minimal and well-controlled.

It is important to discuss your medical history with your doctor and follow all instructions before the procedure.

General data about ISOPROTRACE 10mcg

  • Substance: gallium gozetotide (68Ga)
  • Date of last drug list: 01-05-2026
  • Commercial code: W71522001
  • Concentration: 10mcg
  • Pharmaceutical form: kit for radiopharmaceutical preparations
  • Quantity: 5
  • Product type: generic
  • Price: 39415.70 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: ISOTOPIA MOLECULAR IMAGING LTD. - ISRAEL
  • Holder: TORUS PHARMA COMPANY S.R.L. - ROMANIA
  • Number: 1141/2025/01

Concentrations available for gallium gozetotide (68Ga)

  • 10mcg
  • 25mcg