Application Information

This drug has been submitted to the FDA under the reference 020220/002.

Names and composition

"ULTRAVIST 300" is the commercial name of a drug composed of IOPROMIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
020220/002 ULTRAVIST 300 IOPROMIDE INJECTABLE/INJECTION 62.3%

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020220/001 ULTRAVIST 370 IOPROMIDE INJECTABLE/INJECTION 76.9%
020220/002 ULTRAVIST 300 IOPROMIDE INJECTABLE/INJECTION 62.3%
020220/003 ULTRAVIST 240 IOPROMIDE INJECTABLE/INJECTION 49.9%
020220/004 ULTRAVIST 150 IOPROMIDE INJECTABLE/INJECTION 31.2%
020220/005 ULTRAVIST 300 IN PLASTIC CONTAINER IOPROMIDE INJECTABLE/INJECTION 62.3%
021425/001 ULTRAVIST (PHARMACY BULK) IOPROMIDE INJECTABLE/INJECTION 62.3%
021425/002 ULTRAVIST (PHARMACY BULK) IOPROMIDE INJECTABLE/INJECTION 76.9%
021425/003 ULTRAVIST (PHARMACY BULK) IOPROMIDE INJECTABLE/INJECTION 49.9%

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Answered questions

Health Concerns about my results (Kidneys & Liver)?
I had some test done on me regarding my liver and kidneys. I need a brief interpretation of the results so that I can better understand what is going on with my health. I appreciate it if someone with knowledge can help me with this. Thank you in advance. The reports are... Asked by Kenisha Acosto 1 year ago.

I had some test done on me regarding my liver and kidneys. I need a brief interpretation of the results so that I can better understand what is going on with my health. I appreciate it if someone with knowledge can help me with this. Thank you in advance. The reports are below: ======================================... CT PELVIS W CONTRAST / ACCESSION PROCEDURE REASON: PERSISTENT ABD PAIN; R/O MASS * * * * Physician Interpretation * * * * CT ABDOMEN AND PELVIS WITH CONTRAST HISTORY: Persistent midabdominal pain COMPARISON: No prior CT available TECHNIQUE: A localizer scan was obtained. Helical images of the abdomen and pelvis were obtained using a multi detector CT. Coronal reformatted images were obtained. CT Contrast: Ultravist 300 CT Contrast Volume (ml): 150 CT Contrast Route of Administration: Intravenous CT imaging was performed using a radiation dose length product (DLP) of 446 (accession 81414564), mGy*cm. CT Dose Reduction Employed: Yes Radiation Shielding Employed: No RESULT: The liver contains several low attenuation lesions, with the largest in the right hepatic dome, measuring 1.1 cm. The largest lesion shows some peripheral enhancement. Evaluation of the smaller lesions is limited by the small sizes. The left kidney is moderately atrophic, and contains a couple of focal scars. No hydronephrosis is seen. A 3-mm high density focus in the upper calix of the right kidney may represent early contrast excretion versus a non-obstructive calculus. The appendix is not visualized. Please correlate with potential surgical history. The pelvis shows no abnormal fluid collection. Note is made of bilateral spondylolysis at L5. IMPRESSION: 1. Several small lesions in the liver. The largest one may represent a hemangioma, although the appearance is not diagnostic. Further characterization with MRI is recommended. 2. Other findings as described. ======================================... Labs Results: Component Results: Component Value Flag Low High Units Status Albumin 4.3 3.5 5.0 g/dL Fin Calcium 9.1 8.5 10.5 mg/dL Fin Phosphorus 3.5 2.5 4.5 mg/dL Fin Glucose 85 65 100 mg/dL Fin **BUN 9 L 10 25 mg/dL Fin Creatinine 0.98 0.70 1.40 mg/dL Fin Sodium 139 135 146 mmol/L Fin Potassium 3.8 3.5 5.0 mmol/L Fin Chloride 103 98 110 mmol/L Fin CO2 29 23 32 mmol/L Fin Glom Filtration Rate (AA) >60 >60 Fin Glom Filtration Rate (NAA) >60 >60 . Fin Component Results: Component Value Flag Low High Units Status Color Straw A Yellow Fin Clarity Clear Clear Fin Glucose, Urine Negative Negative mg/dL Fin Bilirubin, Urine Negative Negative Fin Ketones, Urine Negative Negative Fin Specific Gravity, Ur 1.012 1.005 1.030 Fin Hemoglobin/Blood,Ur Trace A Negative Fin pH 7.0 5.0 8.0 Fin Protein, Urine Negative Negative mg/dL Fin Urobilinogen <2.0 <2.0 Fin Nitrites Negative Negative Fin Leukest Negative Negative Fin Urine Comment Fin Microscopic Examination Performed WBC, Urine Negative Negative /HPF Fin RBC, Urine 0-5 A Negative /HPF Fin Epithelial/LPF Rare A Negative /HPF Fin Comment: Squamous Epithelial Cells Thank you Answered by Arturo Glaude 1 year ago.

I know it is very difficult to wait till you get the results of your testing...but this is the only real way to find out a diagnosis. Protein is a large molecule and normally the kidneys won't let it through, it goes back into the blood. Therefore, this does sound like a kidney problem. The liver enzymes are not all specific to the liver/biliary area itself. They can be elevated in a kidney problem, also. You mentioned pressure back in the kidney area. This would be on either side of the spinal column, about even with the last ribs. You don't mention pain....if you had a kidney stone which had formed in the kidney... there would be no pain until the stone moved out into the ducts leading down to the bladder. Then this would cause severe pain because the urine would become blocked and back up into the kidney. However, most of the time the patient will pass the stone. Since you did not mention severe pain...I'm thinking of more in the line of infection. We cannot here really know exactly what may be happening...The doctors have all your testing results including your blood work for the creatinine and Bun (blood urea nitrogen) to know how well your kidneys are functioning and also know your other medical history. If this is really bothering you to know the results of this testing, call the doctor office and ask to speak to the nurse there. She may tell you whether you need to set up an appointment to see the doctor or if the tests results turned out fine. The doctor is right in doing testing on all organs that may be involved, because your ALT is elevated and that enzymes is most specific to the liver since it is made mostly by the liver cells. But, if the liver cells are damaged and the doctors find the cause right away and it is stopped...and any inflammation is treated...the problem can be reversed. Please note that no one blood testing is ever 100% accurate and they fluctuate with every blood test that is done. The liver enzymes can be elevated if you exercised right before the testing was done. Best wishes to you. Answered by Samantha Coneway 1 year ago.


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