Ammonia N-13 - N 13 (Ammonia N 13)

Trade Name : Ammonia N 13

NCM USA Bronx LLC

INJECTION

Strength 260 mCi/mL

AMMONIA N-13 Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ammonia N-13 - N 13 (Ammonia N 13) which is also known as Ammonia N 13 and Manufactured by NCM USA Bronx LLC. It is available in strength of 260 mCi/mL per ml. Read more

Ammonia N-13 - N 13 (Ammonia N 13) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Ammonia N 13 Injection, USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.n
  • Ammonia N 13 Injection, USP is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease .
  • Rest Imaging Studyn
  • Stress Imaging Study:
  • Patient Preparation:
  • Glass vial 30 mL containing 0.139-9.620 GBq/mL (3.75-260 mCi/mL) of Ammonia N 13 Injection, USP in aqueous 0.9 % sodium chloride solutionu00a0 that is suitable for intravenous administration.
  • Glass vial containing 0.139-9.620 GBq (3.75-260 mCi/mL) of Ammonia N 13 Injection, USP in aqueous 0.9 % sodium chloride solution .
  • None
  • Nonen
  • Ammonia N 13 Injection, USP may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [].
  • Ammonia N 13 Injection, USP may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.
  • No adverse reactions have been reported for Ammonia N 13 Injection, USP based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.
  • No adverse reactions have been reported for Ammonia N 13 Injection, USP based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system.
  • To report SUSPECTED ADVERSE REACTIONS, contact NCM-USA Bronx at 212-719-2322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The possibility of interactions of Ammonia N 13 Injection, USP with other drugs taken by patients undergoing PET imaging has not been studied.
  • No data
  • No data
  • No data
  • Long term animal studies have not been performed to evaluate the carcinogenic potential of Ammonia N 13 Injection, USP.u00a0 Genotoxicity assays and impairment of male and female fertility studies with Ammonia N 13 Injection, USP have not been performed.
  • In a descriptive, prospective, blinded image interpretation study of adult patients with known or suspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images obtained with Ammonia N 13 (N=111) or Rubidium 82 (N=82) were compared to changes in stenosis flow reserve (SFR) as determined by coronary angiography. The principal outcome of the study was the evaluation of PET defect severity relative to SFR.
  • PET perfusion defects at rest and stress for seven cardiac regions (anterior, apical, anteroseptal, posteroseptal, anterolateral, posterolateral, and inferior walls) were graded on a 0 to 5 scale defined as normal (0), possible (1), probable (2), mild (3), moderate (4), and severe (5) defects. Coronary angiograms were used to measure absolute and relative stenosis dimensions and to calculate stenosis flow reserve defined as the maximum value of flow at maximum coronary vasodilatation relative to rest flow under standardized hemodynamic conditions. SFR scores ranged from 0 (total occlusion) to 5 (normal).
  • With increasing impairment of flow reserve, the subjective PET defect severity increased. A PET defect score of 2 or higher was positively correlated with flow reserve impairment (SFR<3).
  • No data
  • Ammonia N 13 Injection, USP is packaged in 30 mL multiple dose glass vial containing between 0.139 - 9.620 GBq/mL (3.75 - 260 mCi/mL) of [N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution. The recommended dose of radioactivity (10-20 mCi, 370-740 MBq) is associated with a theoretical mass dose of 0.5-1 picomoles (8.47-16.94 picograms) of Ammonia.
  • NDC Code: 24445-643-30
  • This radiopharmaceutical is licensed by the State of New York, Department Of Health, Bureau of Environmental Radiation Protection, for distribution to persons licensed pursuant to New York's Regulatory Code for Radioactive material specified in Chapter 1-Part 16 of the State Sanitary Code, as appropriate, or under equivalent licenses of an Agreement State or Licensing State.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F). Use the solution within 60 minutes of the End of Synthesis (EOS) calibration.
  • No data
  • Expiration Date and Time
  • The expiration date and time are provided on the container label.
  • Caution:u00a0 Rx ONLY
  • Manufactured by:u00a0u00a0u00a0 NCM-USA Bronx LLC, Bronx, NY 10454
  • Distributed by:u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NCM-USA Bronx LLC, Bronx, NY 10454
  • A. Label for the lead storage container

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