Balziva
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Uses
ULTRAVIST® Injection is an iodinated contrast agent indicated for:
- •
- 150 mg I/mL for intra-arterial digital subtraction angiography (IA-DSA)
- •
- 300 mg I/mL for cerebral arteriography and peripheral arteriography
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- 370 mg I/mL for coronary arteriography and left ventriculography, visceral angiography, and aortography
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- 240 mg I/mL for peripheral venography
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- 300 mg I/mL for excretory urography
- •
- 300 mg I/mL and 370 mg I/mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.
*For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration (2.3) and Use in Specific Populations (8.4)].
History
There is currently no drug history available for this drug.
Other Information
ULTRAVIST(iopromide) Injection is a nonionic, water soluble x-ray contrast agent for intravascular administration. The chemical name for iopromide isN,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%).
Iopromide has the following structural formula:
ULTRAVIST Injection is a nonionic sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg/mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer.
ULTRAVIST Injection is available in four strengths:
150 mg I/mL provides 311.7 mg/mL iopromide
240 mg I/mL provides 498.72 mg/mL iopromide
300 mg I/mL provides 623.4 mg/mL iopromide
370 mg I/mL provides 768.86 mg/mL iopromide
During the manufacture of ULTRAVIST Injection, sodium hydroxide or hydrochloric acid may be added for pH adjustment. ULTRAVIST Injection has a pH of 7.4 (6.5–8) at 25± 2°C, is sterilized by autoclaving and contains no preservatives.
The iodine concentrations (mg I/mL) available have the following physicochemical properties:
| ULTRAVIST INJECTION |
ULTRAVIST INJECTION |
ULTRAVIST INJECTION |
ULTRAVIST INJECTION |
||
| Property |
150 mg I/mL |
240 mg I/mL |
300 mg I/mL |
370 mg I/mL |
|
| Osmolality*(mOsmol/kg water) |
@ 37°C |
328 |
483 |
607 |
774 |
| Osmolarity*(mOsmol/L) |
@ 37°C |
278 |
368 |
428 |
496 |
| Viscosity (cP) |
@ 20°C @ 37°C |
2.3 1.5 |
4.9 2.8 |
9.2 4.9 |
22 10 |
| Density (g/mL) |
@ 20°C @ 37°C |
1.164 1.157 |
1.262 1.255 |
1.330 1.322 |
1.409 1.399 |
- *Osmolality was measured by vapor-pressure osmometry. Osmolarity was calculated from the measured osmolal concentrations.
Solutions of ULTRAVIST Injection 150 mg I/mL, 240 mg I/mL, 300 mg I/mL and 370 mg I/mL have osmolalities from approximately 1.1 to 2.7 times that of plasma (285 mOsmol/kg water).
Sources
Balziva Manufacturers
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Barr Laboratories Inc.
![Balziva (Norethindrone And Ethinyl Estradiol) Kit [Barr Laboratories Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Balziva | Bayer Healthcare Pharmaceuticals Inc.
• Visually inspect ULTRAVIST for particulate matter and/or discoloration, whenever solution and container permit. Do not administer ULTRAVIST if particulate matter and/or discoloration is observed. • Determine the volume and concentration of ULTRAVIST Injection to be used taking into account factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel; consider also extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Specific dose adjustments for age, gender, weight and renal function have not been studied for ULTRAVIST Injection. As with all iodinated contrast agents, lower doses may have less risk. The efficacy of ULTRAVIST Injection below doses recommended has not been established. • The maximum recommended total dose of iodine in adults is 86 grams; a maximum recommended total dose of iodine has not been established for pediatric patients. • Hydrate patients adequately prior to and following the administration of ULTRAVIST [see Warnings and Precautions ( 5.2)]. • Warming ULTRAVIST to body temperature shortly before administration may help improve tolerability and ease of injection [see How Supplied/Storage and Handling (16)]. 2.1 Intra-Arterial ProceduresThe volume and rate of injection of the contrast agent will vary depending on the injection site and the area being examined. Inject contrast at rates approximately equal to the flow rate in the vessel being injected.
• Cerebral Arteriography (300 mg I/mL), Coronary Arteriography and Left Ventriculography (370 mg I/mL), Peripheral Arteriography (300 mg I/mL), Intra-arterial Digital Subtraction Angiography (IA-DSA) (150 mg I/mL): see Table 1. • Aortography and Visceral Angiography (370 mg I/mL): Use a volume and rate of contrast injection proportional to the blood flow and related to the vascular and pathological characteristics of the specific vessels being studied. Do not exceed 225 mL as total dose for the procedure.Table 1: Suggested Single Injection Doses for Adult Intra-Arterial Procedures
IA-DSA*
(150 mg I/mL)
Cerebral Arteriography
(300 mg I/mL)
Peripheral Arteriography
(300 mg I/mL)
Coronary Arteriography and
Left Ventriculography(370 mg I/mL)
Intra-Arterial Injection SitesCarotid Arteries
Vertebral Arteries
Aortic Arch Injection (4 vessel study)
6–10 mL
4–8 mL
-
3–12 mL
4–12 mL
20–50 mL
-
-
-
-
-
-
Right Coronary Artery
Left Coronary Artery
Left Ventricle
-
-
-
-
-
-
-
-
-
3–14 mL
3–14 mL
30–60 mL
Aorta
Major Branches of the Abdominal Aorta
20–50 mL
2–20 mL
-
-
-
-
-
-
Subclavian or Femoral Artery
Aortic Bifurcation (distal runoff)
-
-
-
-
5–40 mL
25–50 mL
-
-
Maximum Total Dose
250 mL
150 mL
250 mL
225 mL
2.2 Intravenous Procedures • Peripheral Venography (240 mg I/mL): Inject the minimum volume necessary to visualize satisfactorily the structures under examination. Do not exceed 250 mL as total dose for the procedure. • Contrast Computed Tomography (CT) (300 mg I/mL and 370 mg I/mL) and Excretory Urography (300 mg I/mL): see Table 2.Table 2: Suggested ULTRAVIST Injection Dosing for Adult Intravenous Contrast Administration
Excretory Urography (300 mg I/mL)
Contrast Computed Tomography (300 mg I/mL)
Contrast Computed Tomography (370 mg I/mL)
Excretory Urography
Approximately 300 mg I/kg body wt. (Adults with normal renal function)
-
-
Head
-
50–200 mL
41–162 mL
Body
Bolus Injection50–200 mL
41–162 mL
Rapid Infusion100–200 mL
81–162 mL
Maximum Total Dose
100 mL (30 g iodine)
200 mL (60 g iodine)
162 mL (60 g iodine)
2.3 Pediatric DosingThe recommended dose in children over 2 years of age for the following evaluations is:
• Intra-arterial:Cardiac chambers and related arteries (370 mg I/mL):
Inject 1 to 2 milliliters per kilogram (mL/kg). Do not exceed 4 mL/kg as total dose.
• Intravenous:Contrast Computerized Tomography or Excretory Urography (300 mg I/mL):
Inject 1 to 2 mL/kg. Do not exceed 3 mL/kg as total dose.
The safety and efficacy relationships of other doses, concentrations or procedures have not been established [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].
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