Ammonia N-13 (Ammonia N 13)

Trade Name : Ammonia N 13

PETNET Solutions, Inc.

INJECTION

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 PETNET Solutions, Inc.. 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 N 13 Injection 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.
  • Ammonia N 13 Injection is a radioactivendiagnostic agent for Positron Emission Tomography (PET) indicated forndiagnostic PET imaging of the myocardium under rest or pharmacologic stressnconditions to evaluate myocardial perfusion in patients with suspected ornexisting coronary artery disease ().
  • Rest Imaging Study ():u2022u00a0 Aseptically withdraw Ammonia N 13 Injection from its container and administer 10u00a0mCi u2013 20 mCi (0.368 GBq u2013 0.736 GBq) as a bolus through a catheter inserted into a large peripheral vein.u2022u00a0 Start imaging 3 minutes after the injection and acquire images for a total of 10 minutes u2013 20 minutes.u00a0u00a0u00a0
  • Stress Imaging Study ():u2022u00a0 If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N13 injection to allow sufficient isotope decay.u2022u00a0 Administer a pharmacologic stress-inducing drug in accordance with its labeling.u2022u00a0 Aseptically withdraw Ammonia N 13 Injection from its container and administeru00a010 mCi u2013 20 mCi (0.368 GBq u2013 0.736 GBq) of Ammonia N 13 Injection as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug.u2022u00a0 Start imaging 3 minutes after the Ammonia N 13 Injection and acquire images for a total of 10 minutesu00a0u2013 20 minutes.u00a0u00a0u00a0
  • Patient Preparation ():u2022u00a0 To increase renal clearance of radioactivity and to minimize radiation dose to the bladder, hydrate the patient before the procedure and encourage voiding as soon as each image acquisition is completed and as often as possible thereafter for at least one hour.
  • Glass vial (30 mL) containing 0.138 GBq/mL u2013 1.387 GBq/mL (3.75 mCi/mL u2013 37.5 mCi/mL) of Ammonia N 13 Injection in aqueous 0.9 % sodium chloride solution (approximately 7 mL volume) that is suitable for intravenous administration.
  • Glass vial containing 0.138 GBq/mL u2013 1.387 GBq/mL (3.75 mCi/mL u201337.5 mCi/mL) of Ammonia N 13 Injection in aqueous 0.9 % sodium chloride solution (approximately 7 mL volume)u00a0().
  • None
  • None ()
  • Ammonia N 13 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 N 13 Injection may increase the risk ofncancer. Use the smallest dose necessary for imaging and ensure safe handling tonprotect the patient and health care worker ().
  • No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems.u00a0However, the completeness of these sources is not known.
  • No adverse reactions have been reported for Ammonia N 13 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 PETNET Solutions, Inc. at 877-473-8638 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Thenpossibility of interactions of Ammonia N 13 Injection with otherndrugs taken by patients undergoing PET imaging has not been studied.
  • No data
  • Itnis not known whether this drug is excreted in human milk. Alternatives to breastfeeding (e.g. using storednbreast milk or infant formula) should be used for 2 hours (>10 half-lives ofnradioactive decay for N 13 isotope) after administration of Ammonia N 13nInjection ().n
  • The safety and effectiveness of Ammonia N 13nInjection has been established in pediatric patients ().
  • No data
  • No data
  • Long term animal studies have not been performed to evaluate the carcinogenic potential of Ammonia N 13 Injection.u00a0 Genotoxicity assays and impairment of male and female fertility studies with Ammonia N 13 Injection 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.u00a0 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.u00a0 SFR scores ranged from 0 (total occlusion) to 5 (normal).
  • With increasing impairment of flow reserve, the subjective PET defect severity increased.u00a0 A PET defect score of 2 or higher was positively correlated with flow reserve impairment (SFR<3).
  • No data
  • Ammonia N 13 Injection is packaged in 30 mL multiple dose glass vial containing between 1.11 GBq to 11.1 GBq (30 mCi to 300 mCi) of [N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 7 mL volume.u00a0 The recommended dose of radioactivity (10 mCi u2013 20 mCi) is associated with a theoretical mass dose of 0.5 picomoles u2013 1.0 picomoles (8.47 picograms u2013 16.94 picograms) of Ammonia.
  • Storage
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C u2013 30u00b0C (59u00b0F u2013 86u00b0F).u00a0 Use the solution within 30 minutes of the End of Synthesis (EOS) calibration.
  • No data
  • No data

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