Amespro Fluorinated-Nicotinamide (18F)

Image for illustration purposes only.

Used for the diagnosis and staging of prostate cancer, this radiopharmaceutical is also known as PSMA-1007 (18 F). Because it is radiolabeled with F-18, PSMA-1007 (18 F) can be used in PET-CT or PET/MRI images.

Manufactured and distributed by:

São José do Rio Preto/SP location (Official Letter No 4754588227)

  • Presentation: Shielded packaging containing 1 multidose vial.
  • Pharmaceutical form: Sterile solution.
  • Route of administration: Intravenous.
  • Ingredients: Each mL of solution contains 555-5550 MBq of Amespro Fluorinated-Nicotinamide (18F) at the reference time, with a maximum of 10 ml per vial.
  • Excipients: Each mL of solution contains up to 80 mg of ethanol, 6 mg of sodium, 0.1 mg of potassium.
  • Physical half-life: 110 minutes.
  • Indication: Amespro Fluorinated-Nicotinamide (18F) is indicated for imaging using Positron Emission Tomography (PET) in order to locate recurrent prostate cancer in adult men with suspicion of elevation of serum levels of prostate-specific antigen (PSA).
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Duque de Caxias/RJ location (Official Letter No 0972796215)

  • Presentation: Shielded packaging containing 1 multidose vial.
  • Pharmaceutical form: Sterile solution.
  • Route of administration: Intravenous.
  • Ingredients: Each mL of solution contains: up to 10 mL.
  • Excipients: 0.9% Sodium Chloride and water for injection.
  • Physical half-life: 109.7 minutes.
  • Indication: Amespro Fluorinated-Nicotinamide (18F) is indicated for imaging using Positron Emission Tomography (PET) in order to locate recurrent prostate cancer in adult men with suspicion of elevation of serum levels of prostate-specific antigen (PSA).
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Vitória de Santo Antão/PE (Official Letter No. 0630081252)

  • Presentation: AMESPRO FLUORNICOTINAMIDE (18 F) 555-5550 MBq/mL solution for injection.
  • Pharmaceutical form: Solution for injection.
  • Route of administration: Intravenous administration
  • Composition: AMESPRO FLUORNICOTINAMIDE (18 F)
  • Excipients: water for injection, ethyl alcohol, sodium ascorbate, sodium chloride, potassium dihydrogen phosphate, potassium chloride and disodium hydrogen phosphate.
  • Physical half-life: 110 minutes
  • Indication: Amespro fluornicotinamide (18 F) is indicated for imaging using Positron Emission Tomography (PET) to locate recurrent prostate cancer in adult men with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels after radical primary treatment.
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Porto Alegre/RS in partnership with InsCer – PUCRS (Official letter No. 0023362235)

  • Presentation: Shielded packaging containing 1 multidose vial.
  • Pharmaceutical form: Sterile solution.
  • Route of administration: Intravenous.
  • Ingredients: Each vial may contain up to 14 mL of:
    Amespro Fluorinated-Nicotinamide (18F) 296 MBq (8 mCi) at the date and time of calibration;
    Amespro Fluorinated-Nicotinamide (18F) 592 MBq (16 mCi) at the date and time of calibration;
    Amespro Fluorinated-Nicotinamide (18F) 888 MBq (24 mCi) at the date and time of calibration;
    Amespro Fluorinated-Nicotinamide (18F) 1184 MBq (32 mCi) at the date and time of calibration
    Amespro Fluorinated-Nicotinamide (18F) 1480 MBq (40 mCi) at the date and time of calibration
    Amespro Fluorinated-Nicotinamide (18F) 1776 MBq (48 mCi) at the date and time of calibration
    Amespro Fluorinated-Nicotinamide (18F) 2072 MBq (56 mCi) at the date and time of calibration
    Amespro Fluorinated-Nicotinamide (18F) 2368 MBq (64 mCi) at the date and time of calibration
    Amespro Fluorinated-Nicotinamide (18F) 2664 MBq (72 mCi) at the date and time of calibration
    Amespro Fluorinated-Nicotinamide (18F) 2960 MBq (80 mCi) at the date and time of calibration
    Amespro Fluorinated-Nicotinamide (18F) 3256 MBq (88 mCi) at the date and time of calibration
  • Excipients: Disodium hydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, ethanol, water for injection, and sodium ascorbate.
  • Physical half-life: 110 minutes.
  • Indication: Amespro Fluorinated-Nicotinamide (18F) is indicated for imaging using Positron Emission Tomography (PET) in order to locate recurrent prostate cancer in adult men with suspicion of elevation of serum levels of prostate-specific antigen (PSA).
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R2Pharma products are available only by means of medical prescription from a licensed physician.

IF SYMPTOMS PERSIST, A DOCTOR SHOULD BE CONSULTED.

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

The content of this page is destined to health professionals.

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