illuccix®

Presentation 1 – Presentation for ITM Ge-68/Ga-68 Generator: lyophilized powder for injectable solution for diagnostic use, sterile and non-pyrogenic for complexation with Gallium-68 (68Ga). Intravenous route. Number of vials per kit: 3 + 2.

Kit containing:

• 1 vial of amespro hibedila 25µg;
• 1 vial of buffer solution (sodium acetate)
• 1 empty vial for elution
• It Includes a Kit of Solutions for the ITM Ge-68/Ga-68 generator, which contains 1 vial for elution of the generator (0.05 M HCl) and 1 vial for washing the generator (0.05 M HCl).

Presentation 2 – for Eckert Ziegler Ge-68/Ga-68 generator: lyophilized powder for injectable solution for diagnostic use, sterile and non-pyrogenic for complexation with Gallium-68 (68Ga). Intravenous route. Number of vials per kit: 3.

Kit containing:

• 1 vial of amespro hibedila 25µg;
• 1 vial of buffer solution (sodium acetate)
• 1 empty vial for elution

Indications: To diagnose prostate cancer recurrence and associated metastases.

Labeling activity: 0.05 to 0.06 mCi per kg of body weight.

Condition for storage:

• Pre-labeling: from 2 ºC to 8 ºC, protected from light.
• Post-labeling: room temperature from 15 ºC to 30 ºC, protected from light.

Stability post-labeling: 2 hours

Product expiration date: (P vial and auxiliary solutions): 24 months

AVAILABLE BY PRESCRIPTION ONLY – RESTRICTED USE TO HOSPITALS.

IF SYMPTOMS PERSIST, A DOCTOR SHOULD BE CONSULTED.

Contraindications, warnings, adverse reactions, drug interactions, precautions and posology: refer to package leaflet.

Authorization: SEI/ANVISA Letter 1687066 (November 29, 2021).