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Ammonia N 13 (Ammonia N 13)

Trade Name : Ammonia N 13

Spectron mrc, LLC

INJECTION

Strength 37.5 mCi/mL

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

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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 Spectron mrc, LLC. 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

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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.

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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  • 1 INDICATIONS AND USAGEn nAmmonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of then nmyocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patientsn nwith suspected or existing coronary artery disease.n
  • INDICATIONS AND USAGEn nAmmonia N 13 Injection is a radioactive diagnostic agent for Positron Emission Tomographyn n(PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologicn nstress conditions to evaluate myocardial perfusion in patients with suspected or existing coronaryn nartery disease (1).n
  • 2 DOSAGE AND ADMINISTRATIONn n2.1 Rest Imaging Studyn nu2022 Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368n nu2013 0.736 GBq) as a bolus through a catheter inserted into a large peripheral vein.n nu2022 Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes.n n2.2 Stress Imaging Studyn nu2022 If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after then nfirst Ammonia N 13 injection to allow sufficient isotope decay.n nu2022 Administer a pharmacologic stress-inducing drug in accordance with its labeling.n nu2022 Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368n nu2013 0.736 GBq) of Ammonia N 13 Injection as a bolus at 8 minutes after the administration of then npharmacologic stress-inducing drug.n nu2022 Start imaging 3 minutes after the Ammonia N 13 Injection and acquire images for a total of 10-20n nminutes.n n2.3 Patient Preparationn nTo increase renal clearance of radioactivity and to minimize radiation dose to the bladder, ensure thatn nthe patient is well hydrated before the procedure and encourage voiding as soon as a study isn ncompleted and as often as possible thereafter for at least one hour.n n2.4 Radiation Dosimetryn nThe converted radiation absorbed doses in rem/mCi are shown in Table 1. These estimates aren ncalculated from the Task Group of Committee 2 of the International Commission on Radiationn nProtection.1n nTable 1: N 13 Absorbed Radiation Dose Per Unit Activity (rem/mCi) for Adults and Pediatricn nGroups.n nOrgan Age (years)n nAdult 15 10 5 1n nAdrenals 0.0085 0.0096 0.016 0.025 0.048n nBladder wall 0.030 0.037 0.056 0.089 0.17n nBone surfaces 0.0059 0.0070 0.011 0.019 0.037n nBrain 0.016 0.016 0.017 0.019 0.027n nBreast 0.0067 0.0067 0.010 0.017 0.033n nStomach wall 0.0063 0.0078 0.012 0.019 0.037n nSmall intestine 0.0067 0.0081 0.013 0.021 0.041n n*ULI 0.0067 0.0078 0.013 0.021 0.037n nu2020LLI 0.0070 0.0078 0.013 0.020 0.037n nHeart 0.0078 0.0096 0.015 0.023 0.041n nKidneys 0.017 0.021 0.031 0.048 0.089n nLiver 0.015 0.018 0.029 0.044 0.085n nLungs 0.0093 0.011 0.018 0.029 0.056n nOvaries 0.0063 0.0085 0.014 0.021 0.041n nPancreas 0.0070 0.0085 0.014 0.021 0.041n nRed marrow 0.0063 0.0078 0.012 0.020 0.037n nSpleen 0.0093 0.011 0.019 0.030 0.056n nTestes 0.0067 0.0070 0.011 0.018 0.035n nThyroid 0.0063 0.0081 0.013 0.021 0.041n nUterus 0.0070 0.0089 0.014 0.023 0.041n nOther tissues 0.0059 0.0070 0.011 0.018 0.035n n*Upper large intestine,n nu2020Lower large intestinen n2.5 Drug Handlingn nu2022 Inspect Ammonia N 13 Injection visually for particulate matter and discoloration beforen nadministration, whenever solution and container permit.n nu2022 Do not administer Ammonia N 13 Injection containing particulate matter or discoloration;n ndispose of these unacceptable or unused preparations in a safe manner, in compliance withn napplicable regulations.n nu2022 Wear waterproof gloves and effective shielding when handling Ammonia N 13 Injection.n nu2022 Use aseptic technique to maintain sterility during all operations involved in the manipulation andn nadministration of Ammonia N 13 Injection. The contents of each vial are sterile and non-pyrogenic.n nu2022 Use appropriate safety measures, including shielding, consistent with proper patientn nmanagement to avoid unnecessary radiation exposure to the patient, occupational workers,n nclinical personnel, and other persons.n nu2022 Radiopharmaceuticals should be used by or under the control of physicians who are qualifiedn nby specific training and experience in the safe use and handling of radionuclides, and whosen nexperience and training have been approved by the appropriate governmental agencyn nauthorized to license the use of radionuclides.n nu2022 Before administration of Ammonia N 13 Injection, assay the dose in a properly calibrated dosen ncalibrator.n
  • DOSAGE AND ADMINISTRATIONn nRest Imaging Study(2.1):n nu2022 Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20n nmCi (0.368 u2013 0.736 GBq) as a bolus through a catheter inserted into a large peripheral vein.n nu2022 Start imaging 3 minutes after the injection and acquire images for a total of 10-20n nminutes.n nStress Imaging Study(2.2):n nu2022 If a rest imaging study is performed, begin the stress imaging study 40 minutes or moren nafter the first Ammonia N13 injection to allow sufficient isotope decay.n nu2022 Administer a pharmacologic stress-inducing drug in accordance with its labeling.n nu2022 Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20n nmCi (0.368 u2013 0.736 GBq) of Ammonia N 13 Injection as a bolus at 8 minutes after then nadministration of the pharmacologic stress-inducing drug.n nu2022 Start imaging 3 minutes after the Ammonia N 13 Injection and acquire images for a totaln nof 10-20 minutes.n nPatient Preparation(2.3):n nu2022 To increase renal clearance of radioactivity and to minimize radiation dose to the bladder,n nhydrate the patient before the procedure and encourage voiding as soon as each imagen nacquisition is completed and as often as possible thereafter for at least one hour.n
  • 3 DOSAGE FORMS AND STRENGTHSn nGlass vial (10, 25, 30, 50 mL) containing 0.138-1.387 GBq (3.75-37.5 mCi/mL) of Ammonia N 13 Injection inn naqueous 0.9 % sodium chloride solution (approximately 8 mL volume) that is suitable for intravenousn nadministration.n
  • DOSAGE FORMS AND STRENGTHSn nGlass vial containing 0.138-1.387 GBq (3.75-37.5 mCi/mL) of Ammonia N 13 Injection inn naqueous 0.9 % sodium chloride solution (approximately 8 mL volume)(3).n
  • 4 CONTRAINDICATIONSn nNonen
  • CONTRAINDICATIONSn nNone(4)n
  • 5 WARNINGS AND PRECAUTIONSn n5.1 Radiation Risksn nAmmonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imagingn nand ensure safe handling to protect the patient and health care worker [see Dosage andn nAdministration(2.4)].n
  • WARNINGS AND PRECAUTIONSn nAmmonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary forn nimaging and ensure safe handling to protect the patient and health care worker(5).n n
  • 6 ADVERSE REACTIONSn nNo adverse reactions have been reported for Ammonia N 13 Injection based on a review of then npublished literature, publicly available reference sources, and adverse drug reaction reporting systems.n nHowever, the completeness of these sources is not known.n
  • ADVERSE REACTIONSn nNo adverse reactions have been reported for Ammonia N 13 Injection based on a review of then npublished literature, publicly available reference sources, and adverse drug reaction reportingn nsystem(6).n nTo report SUSPECTED ADVERSE REACTIONS, contact Spectron mrc, LLC at 574-271-n n2800 or FDA at 1-800-332-1088 or www.fda.gov/medwatch. (6)n
  • 8 USE IN SPECIFIC POPULATIONSn n8.1 Pregnancyn nPregnancy Category Cn nAnimal reproduction studies have not been conducted with Ammonia N 13 Injection. It is also notn nknown whether Ammonia N 13 Injection can cause fetal harm when administered to a pregnantn nwoman or can affect reproduction capacity. Ammonia N 13 Injection should be given to a pregnantn nwoman only if clearly needed.n n8.3 Nursing Mothersn nIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in humann nmilk and because of the potential for radiation exposure to nursing infants from Ammonia N 13 Injection,n nuse alternative infant nutrition sources (e.g. stored breast milk or infant formula) for 2 hours (>10 half-livesn nof radioactive decay for N 13 isotope) after administration of the drug or avoid use of the drug, takingn ninto account the importance of the drug to the mother.n n8.4 Pediatric Usen nThe safety and effectiveness of Ammonia N 13 Injection has been established in pediatric patientsn nbased on known metabolism of ammonia, radiation dosimetry in the pediatric population, and clinicaln nstudies in adults [see Dosage and Administration(2.4)].n
  • USE IN SPECIFIC POPULATIONSn nu2022 It is not known whether this drug is excreted in human milk. Alternatives to breastfeedingn n(e.g. using stored breast milk or infant formula) should be used for 2 hours (>10 half-lives ofn nradioactive decay for N 13 isotope) after administration of Ammonia N 13 Injection (8.3).n nu2022 The safety and effectiveness of Ammonia N 13 Injection has been established in pediatricn npatients(8.4).n nSee 17 for Patient Counseling Informationn nRevised: 01/2012n
  • 7 DRUG INTERACTIONSn nThe possibility of interactions of Ammonia N 13 Injection with other drugs taken by patients undergoingn nPET imaging has not been studied.n
  • DRUG INTERACTIONSn nThe possibility of interactions of Ammonia N 13 Injection with other drugs taken by patients undergoingn nPET imaging has not been studied.n
  • 11 DESCRIPTIONn n11.1 Chemical Characteristicsn nAmmonia N 13 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposesn nin conjunction with positron emission tomography (PET) imaging. The active ingredient, [13N] ammonia,n nhas the molecular formula of 13NH3 with a molecular weight of 16.02, and has the following chemicaln nstructure:n
  • 12 CLINICAL PHARMACOLOGYn n12.1 Mechanism of Actionn nAmmonia N 13 Injection is a radiolabeled analog of ammonia that is distributed to all organs of then nbody after intravenous administration. It is extracted from the blood in the coronary capillaries into then nmyocardial cells where it is metabolized to glutamine N 13 and retained in the cells. The presence ofn nammonia N 13 and glutamine N 13 in the myocardium allows for PET imaging of the myocardium.n n12.2 Pharmacodynamicsn nFollowing intravenous injection, ammonia N 13 enters the myocardium through the coronary arteries.n nThe PET technique measures myocardial blood flow based on the assumption of a threecompartmentaln ndisposition of intravenous ammonia N 13 in the myocardium. In this model, the value ofn nthe rate constant, which represents the delivery of blood to myocardium, and the fraction of ammonian nN 13 extracted into the myocardial cells, is a measure of myocardial blood flow. Optimal PET imaging ofn nthe myocardium is generally achieved between 10 to 20 minutes after administration.n n12.3 Pharmacokineticsn nFollowing intravenous injection, Ammonia N 13 Injection is cleared from the blood with a biologic halflifen nof about 2.84 minutes (effective half-life of about 2.21 minutes). In the myocardium, its biologic halflifen nhas been estimated to be less than 2 minutes (effective half-life less than 1.67 minutes).n nThe mass dose of Ammonia N 13 Injection is very small as compared to the normal range of ammonia inn nthe blood (0.72-3.30 mg) in a healthy adult man [see Description(11.1)].n nPlasma protein binding of ammonia N 13 or its N 13 metabolites has not been studied.n nAmmonia N 13 undergoes a five-enzyme step metabolism in the liver to yield urea N 13 (the mainn ncirculating metabolite). It is also metabolized to glutamine N 13 (the main metabolite in tissues) byn nglutamine synthesis in the skeletal muscles, liver, brain, myocardium, and other organs. Othern nmetabolites of ammonia N 13 include small amounts of N 13 amino acid anions (acidic amino acids) inn nthe forms of glutamate N 13 or aspartate N 13.n nAmmonia N 13 is eliminated from the body by urinary excretion mainly as urea N 13.n nThe pharmacokinetics of Ammonia N 13 Injection have not been studied in renally impaired, hepaticallyn nimpaired, or pediatric patients.n
  • 13 NONCLINICAL TOXICOLOGYn n13.1 Carcinogenesis, Mutagenesis, Impairment of Fertilityn nLong term animal studies have not been performed to evaluate the carcinogenic potential ofn nAmmonia N 13 Injection. Genotoxicity assays and impairment of male and female fertility studies withn nAmmonia N 13 Injection have not been performed.n
  • 14 CLINICAL STUDIESn nIn a descriptive, prospective, blinded image interpretation study2 of adult patients with known orn nsuspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images obtainedn nwith Ammonia N 13 (N=111) or Rubidium 82 (N=82) were compared to changes in stenosis flow reserven n(SFR) as determined by coronary angiography. The principal outcome of the study was the evaluationn nof PET defect severity relative to SFR.n nPET perfusion defects at rest and stress for seven cardiac regions (anterior, apical, anteroseptal,n nposteroseptal, anterolateral, posterolateral, and inferior walls) were graded on a 0 to 5 scale defined asn nnormal (0), possible (1), probable (2), mild (3), moderate (4), and severe (5) defects. Coronaryn nangiograms were used to measure absolute and relative stenosis dimensions and to calculate stenosisn nflow reserve defined as the maximum value of flow at maximum coronary vasodilatation relative to restn nflow under standardized hemodynamic conditions. SFR scores ranged from 0 (total occlusion) to 5n n(normal)n nWith increasing impairment of flow reserve, the subjective PET defect severity increased. A PET defectn nscore of 2 or higher was positively correlated with flow reserve impairment (SFR<3)n
  • 15 REFERENCESn n1Annals of the ICRP. Publication 53. Radiation dose to patients from radiopharmaceuticals. New York:n nPergamon Press, 1988.n n2Demer, L.L.K.L.Gould, R.A.Goldstein, R.L.Kirkeeide, N.A.Mullani, R.W. Smalling, A.Nishikawa, andn nM.E.Merhige. Assessment of coronary artery disease severity by PET: Comparison with quantitativen narteriography in 193 patients. Circulation 1989; 79: 825-35.n
  • 16 HOW SUPPLIEDn nAmmonia N 13 Injection is packaged in a multiple dose glass vial (10, 25, 30, or 50 mL) containingn nbetween 1.11 GBq to 11.1 GBq (30 mCi to 300 mCi) of [13N] ammonia, at the end of synthesis (EOS)n nreference time, in 0.9% sodium chloride injection solution in approximately 8 mL volume. Then nrecommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1.0n npicomoles (8.47-16.94 picograms) of Ammonia.n nStore at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F). Use the solution within 30 minutes of then nEnd of Synthesis (EOS) calibration.n
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