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Ammonia N-13 (Ammonia N 13)

Trade Name : Ammonia N 13

Biomedical Research Foundation of Northwest Louisiana

INJECTION, SOLUTION

Strength 37.5 mCi/mL

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

Delivery Process

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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 (Ammonia N 13) which is also known as Ammonia N 13 and Manufactured by Biomedical Research Foundation of Northwest Louisiana. It is available in strength of 37.5 mCi/mL per ml. Read more

Ammonia 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 Nu00a013 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 Nu00a013 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: tttttttt
  • Patient Preparation:
  • Glass vial (30 mL) containing 0.138 GBq -1.387 GBq (3.75 mCi/mL-37.5 mCi/mL) of Ammonia N 13 Injection in aqueous 0.9% sodium chloride solution (approximately 13 mL volume) that is suitable for intravenous administration.
  • Glass vial (30 mL) containing 0.138GBq-1.387 GBq (3.75mCi/mL-37.5 mCi/mL) of Ammonia N 13 Injection in aqueous 0.9 % sodium chloride solution (approximately 13mL volume) ().
  • None
  • Nonen
  • Ammonia Nu00a013 Injection 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 Nu00a013 Injection 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 Nu00a013 Injection 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 Nu00a013 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system.
  • To report SUSPECTED ADVERSE REACTIONS, contact BIOMEDICAL RESEARCH FOUNDATION OF NORTHWEST LOUISIANA at 1-318-675-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The possibility of interactions of Ammonia Nu00a013 Injection 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 Nu00a013 Injection.u00a0 Genotoxicity assays and impairment of male and female fertility studies with Ammonia Nu00a013 Injection have not been performed. tttttttt
  • 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 Nu00a013 (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 Nu00a013 Injection, USP is packaged in 30 mL multiple dose glass vial containing between 1.80 GBq to 18.0 GBq (48.75 mCi to 487.5 mCi) of [N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 13 mL volume. The recommended dose of radioactivity (10 mCi-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 picograms) of Ammonia.
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F), excursions permitted between 15u00b0C and 30u00b0C (between 59u00b0F and 86u00b0F) [see USP Controlled Room Temperature]. Use the solution within 60 minutes of the End of Synthesis (EOS) calibration.
  • No data
  • Manufactured and Distributed by: Biomedical Research Foundation of Northwest Louisiana, Shreveport, LA 71103
  • Revised: May 2015
  • PRINCIPAL DISPLAY PANEL - 30 mL Vial Label
  • NDC#24562-004-30Multiple-Dose Vial
  • Ammonia N 13 Injection, USP
  • Sterile, Non-pyrogenicCalibration (EOS*) TimeCalibration Date
  • Diagnostic - For Intravenous Use OnlyExp. Date/Time Lot#(Expires 60 minutes after EOS*)
  • Contains:
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F);excursions permitted to 15-30u00b0C(59-86u00b0F) [See USP Controlled RoomTemperature]Store upright in a shielded container.Aseptically withdraw and handle doses.[N] Half-Life = 9.96 minutes
  • Calculate correct dosage from date andtime of calibration.
  • Do not use if cloudy or if it contains particulate matter.*EOS = End of Synthesis
  • CAUTION: RADIOACTIVE MATERIAL
  • Manufactured for:Biomedical Research Foundation of NorthwestLouisianaShreveport, LA 71103
  • Rx ONLY

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