ISOVUE 200/250/300/370 Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

BRACCO DIAGNOSTICS INC

Λέξεις κλειδιά

0270-1316 0270-1317 0270-1315 0270-1314

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BOXED WARNING SECTION

NOT FOR INTRATHECAL USE.

1. Description

ISOVUE (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration. Each mL of ISOVUE-200 (lopamidol Injection 41%) provides 408 mg iopamidol ...

2. Clinical Pharmacology

Intravascular injection of a radiopaque diagnostic agent opacifies those vessels in the path of flow of the contrast medium, permitting radiographic visualization of the internal structures of the human ...

3. Indications and Usage

ISOVUE (lopamidol Injection) is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, ...

4. Contraindications

None.

5. Warnings

Severe Adverse Events-lnadvertent Intrathecal Administration Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media ...

6.1. General

Diagnostic procedures which involve the use of any radiopaque agent should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular ...

6.2. Information for Patients

Patients receiving injectable radiopaque diagnostic agents should be instructed to: Inform your physician if you are pregnant. Inform your physician if you are diabetic or if you have multiple myeloma, ...

6.3. Laboratory Tests

Laboratory Test Findings In vitro studies with animal blood showed that many radiopaque contrast agents, including iopamidol, produced a slight depression of plasma coagulation factors including ...

6.4. Drug Interactions

Renal toxicity has been reported in a few patients with liver dysfunction who were given oral cholecystographic agents followed by intravascular contrast agents. Administration of intravascular agents ...

6.5. Drug/Laboratory Test Interactions

The results of PBI and radioactive iodine uptake studies, which depend on iodine estimations, will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. No evidence of genetic toxicity was obtained in in vitro tests.

6.7. Pregnancy

Teratogenic Effects Reproduction studies have been performed in rats and rabbits at doses up to 2.7 and 1.4 times the maximum recommended human dose (1.48 gl/kg in a 50 kg individual), respectively, and ...

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when iopamidol is administered to a nursing woman.

6.10. Pediatric Use

Safety and effectiveness in children has been established in pediatric angiocardiography, computed tomography (head and body) and excretory urography. Pediatric patients at higher risk of experiencing ...

7. Adverse Reactions

Adverse reactions following the use of iopamidol are usually mild to moderate, self-limited, and transient. In angiocardiography (597 patients), the adverse reactions with an estimated incidence of one ...

9. Overdosage

Treatment of an overdose of an injectable radiopaque contrast medium is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.

10. Dosage and Administration

General Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Iopamidol solutions should be used ...

11. How Supplied

ISOVUE-200 (lopamidol Injection 41%): Ten 50 mL single dose vials (NDC 0270-1314-30) Ten 200 mL single dose bottles (NDC 0270-1314-15) ISOVUE-250 (lopamidol Injection 51%): Ten 50 mL single ...

12. Storage and Handling

Store at 20-25°C (68-77°F). [See USP]. Protect from light.