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Rx Item-Ultravist 300Mg/Ml Vial 10X150Ml By Mckesson Specialty

NDC 50419-0344-15 UPC/GTIN No.3-50419-34415-9 Mfg.Part No.34415BRAND: ULTRAVIST NDC: 50419-0344-15,50419034415 UPC: 3-50419-34415-9,350419344159 Mckesson Specialty LlcOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Ultravist 300Mg/Ml Vial 10X150Ml By Mckesson Specialty

$718.80$674.29

Item No.: RX241513 NDC No.50419034415 UPC No.:350419344159 NDC No. 50419-0344-15 UPC/GTIN No. 3-50419-34415-9 MPN 34415 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx241513 Ultravist 300mg/ml Vial 10X150ml by Mckesson Specialty Item No. 3241513 NDC No. 50419034415 UPC No. 350419344159 Other Nam

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ULTRAVIST- iopromide injection
Bayer HealthCare Pharmaceuticals Inc.

WARNING: NOT FOR INTRATHECAL USE

Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
INDICATIONS AND USAGE



ULTRAVIST� Injection is an iodinated contrast agent indicated for:

1.1 Intra-Arterial Procedures*

300 mg Iodine per mL for cerebral arteriography and peripheral arteriography

370 mg Iodine per mL for coronary arteriography and left ventriculography, visceral angiography, and aortography
1.2 Intravenous Procedures*

240 mg Iodine per mL for peripheral venography

300 mg Iodine per mL for excretory urography

300 mg Iodine per mL and 370 mg Iodine per 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)].

2 DOSAGE AND ADMINISTRATION


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)].
2.1 Intra-Arterial Procedures
The 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 Iodine per mL), Coronary Arteriography and Left Ventriculography (370 mg Iodine per mL), Peripheral Arteriography (300 mg Iodine per mL): see Table 1.

Aortography and Visceral Angiography (370 mg Iodine per 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.
Intravenous Procedures

Peripheral Venography (240 mg Iodine per 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 Iodine per mL and 370 mg Iodine per mL) and Excretory Urography (300 mg Iodine per mL
Pediatric Dosing
The recommended dose in children over 2 years of age for the following evaluations is:


Intra-arterial:
Cardiac chambers and related arteries (370 mg Iodine per 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 Iodine per 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)].

3 DOSAGE FORMS AND STRENGTHS

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 PHARMACY BULK PACKAGE is available in three strengths:

240 mg Iodine per mL provides 498.72 mg/mL iopromide

300 mg Iodine per mL provides 623.4 mg/mL iopromide

370 mg Iodine per mL provides 768.86 mg/mL iopromide

4 CONTRAINDICATIONS


Do not administer ULTRAVIST Injection intrathecally. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

Preparatory dehydration (for example, prolonged fasting and the administration of a laxative) before ULTRAVIST Injection is contraindicated in pediatric patients because of risk of acute renal failure.
Drug-Drug Interactions
In patients with renal impairment, biguanides can cause lactic acidosis. ULTRAVIST appears to increase the risk of biguanide induced lactic acidosis, possibly as a result of worsening renal function [see Warnings and Precautions (5.2)].

Patients on beta-blockers may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. Because of the risk of hypersensitivity reactions, use caution when administering iodinated contrast agents to patients taking beta-blockers.

Interleukins are associated with an increased prevalence of delayed hypersensitivity reactions after iodinated contrast agent administration. These reactions include fever, chills, nausea, vomiting, pruritus, rash, diarrhea, hypotension, edema, and oliguria.

Renal toxicity has been reported in a few patients with liver dysfunction who were given an oral cholecystographic agent followed by intravascular contrast agents. Administration of any intravascular contrast agent should therefore be postponed in patients who have recently received a cholecystographic contrast agent.

Do not mix other drugs with ULTRAVIST Injection [see How Supplied/Storage and Handling (16)].

7.2 Drug-Laboratory Test Interactions
Thyroid Function Tests:

The results of protein bound iodine and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for at least 16 days following administration of iodinated contrast agents. However, thyroid function tests which do not depend on iodine estimations, for example, T3 resin uptake and total or free thyroxine (T4 ) assays are not affected.

Laboratory Assay of Coagulation Parameters, Fibrinolysis and Complement System:

The effect of iopromide on coagulation factors in in vitro assays increased with the administered dose. Coagulation, fibrinolysis and complement activation were evaluated with standard citrated human plasma in the following assays: thrombin time, thrombin coagulase time, calcium thromboplastin time, partial thromboplastin time, plasminogen, thrombin, alpha-2 antiplasmin and factor XIIa activity. Thrombin inhibition was almost complete. Data on reversibility are not available. The thrombin time increased from approximately 20 seconds at an iopromide concentration of 10 mg Iodine per mL, up to 100 seconds at an iopromide concentration of 70 mg Iodine per mL.
OVERDOSAGE

The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.

ULTRAVIST Injection binds negligibly to plasma or serum protein and can, therefore, be dialyzed.

11 DESCRIPTION

ULTRAVIST (iopromide) Injection is a nonionic, water soluble x-ray contrast agent for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device. The chemical name for iopromide is N,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%).
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 Pharmacy Bulk Package is available in three strengths:

240 mg Iodine per mL provides 498.72 mg/mL iopromide

300 mg Iodine per mL provides 623.4 mg/mL iopromide

370 mg Iodine per 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.
CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Iopromide is a nonionic, water soluble, tri-iodinated x-ray contrast agent for intravascular administration.

Intravascular injection of iopromide opacifies those vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs.

NDC 50419-0344-15 UPC/GTIN No.3-50419-34415-9 Mfg.Part No.34415
RX ITEM-Ultravist 300Mg/Ml Vial 10X150Ml
NDC 50419-0344-15 UPC/GTIN No.3-50419-34415-9 Mfg.Part No.34415

BRAND: ULTRAVIST NDC: 50419-0344-15,50419034415 UPC: 3-50419-34415-9,350419344159 Mckesson Specialty Llc
Ultravist 300Mg/Ml Vial 10X150Ml By Mcke
BRAND: ULTRAVIST NDC: 50419-0344-15,50419034415 UPC: 3-50419-34415-9,350419344159 Mckesson Specialty Llc

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
IOPROMIDE INJECTION VIAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.