VISIPAQUE- iodixanol injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

IODIXANOL (UNII: HW8W27HTXX) (IODIXANOL - UNII:HW8W27HTXX)

Tilgjengelig fra:

GE Healthcare Inc.

INN (International Name):

Iodixanol

Sammensetning:

Iodine 320 mg in 1 mL

Administreringsrute:

INTRAVASCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

VISIPAQUE is indicated in for: Adult and pediatric patients 12 years of age and older - (270 and 320 mg Iodine/mL) intra-arterial digital subtraction angiography (IA-DSA). - (320 mg Iodine/mL) angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography. Pediatric patients less than 12 years of age - (320 mg Iodine/mL) angiocardiography, cerebral arteriography, and visceral arteriography. Adult and pediatric patients 12 years of age and older - (270 and 320 mg Iodine/mL) CT imaging of the head and body. - (270 and 320 mg Iodine/mL) excretory urography. - (270 mg Iodine/mL) peripheral venography. - (320 mg Iodine/mL) coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of patients with suspected coronary artery disease. Pediatric patients less than 12 years of age - (270 mg Iodine/mL) CT imaging of the head and body. - (270 mg Iodine/mL) excretory urography. VISIPAQUE is contraindicated for intrathecal use [see Warnings and Precautions (5.1)]. Risk Summary There are no data with iodixanol use in pregnant women to inform any drug-associated risks. In animal reproduction studies, no developmental toxicity occurred with intravenous iodixanol administration to rats and rabbits at doses up to 0.24 (rat) or 0.48 (rabbit) times the maximum recommended human intravenous dose ( see Data ). All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproduction studies were performed in rats and rabbits with intravenous administration of iodixanol at doses up to 2 g Iodine/kg, daily, from implantation of the embryo (gestation day 7 in rat; 6 in rabbit) through closure of the hard palate (gestation day 17 in rats; 18 in rabbits). No maternal toxicity occurred, and no adverse effects occurred on fetal survival, embryo-fetal development, or the ability of dams to rear a litter. Risk Summary There are no data on the presence of iodixanol in human milk, the effects on the breastfed infant or the effects on milk production. Iodinated contrast agents are poorly excreted into human milk and are poorly absorbed by the gastrointestinal tract of a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VISIPAQUE and any potential adverse effects on the breastfed infant from VISIPAQUE or from the underlying maternal condition. Clinical Considerations Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after VISIPAQUE administration in order to minimize drug exposure to a breast fed infant. The safety and efficacy of VISIPAQUE have been established in pediatric patients down to birth for angiocardiography, cerebral arteriography, visceral arteriography, CT imaging of the head and body, and excretory urography. The safety and efficacy of VISIPAQUE have also been established in pediatric patients 12 years and older for intra-arterial digital subtraction angiography, peripheral arteriography, peripheral venography and CCTA. Use of VISIPAQUE is supported by evidence from adequate and well controlled studies of VISIPAQUE in adults and additional safety data obtained in 459 pediatric patients. In general, the types of adverse reactions reported are similar to those of adults. A higher number of adverse events in patients less than 1 year of age compared to older patients were observed in a study of VISIPAQUE [see Adverse Events (6.3)] . The elimination of VISIPAQUE is slower in this age group [see Clinical Pharmacology (12.3)] . Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates. Some patients were treated for hypothyroidism. After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see Warnings and Precautions (5.8)and Adverse Reactions (6.2)]. Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent may include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL. Pediatric patients with immature renal function or dehydration may be at increased risk for adverse events due to slower elimination of iodinated contrast agents [see Clinical Pharmacology (12.3)]. In clinical studies of VISIPAQUE, 254/757 (34%) of patients were 65 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Produkt oppsummering:

VISIPAQUE injection is a ready-to-use sterile, pyrogen-free, preservative free, colorless to pale yellow solution. It is supplied in the following configurations: VISIPAQUE (iodixanol) Injection 320 mg Iodine/mL: Protect VISIPAQUE from direct exposure to sunlight. Store VISIPAQUE at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F). Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.

Autorisasjon status:

New Drug Application

Preparatomtale

VISIPAQUE- IODIXANOL INJECTION, SOLUTION
GE HEALTHCARE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VISIPAQUE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VISIPAQUE.
VISIPAQUE (IODIXANOL) INJECTION, FOR INTRA-ARTERIAL OR INTRA-VENOUS
USE
INITIAL U.S. APPROVAL: 1996
WARNING: NOT FOR INTRATHECAL USE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
INADVERTENT INTRATHECAL ADMINISTRATION MAY CAUSE DEATH,
CONVULSIONS/SEIZURES, CEREBRAL
HEMORRHAGE, COMA, PARALYSIS, ARACHNOIDITIS, ACUTE RENAL FAILURE,
CARDIAC ARREST,
RHABDOMYOLYSIS, HYPERTHERMIA, AND BRAIN EDEMA. (4,5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Thyroid Dysfunction in Pediatric Patients 0
to 3 Years
of Age ( 5.8)
4/2023
INDICATIONS AND USAGE
VISIPAQUE injection is a radiographic contrast agent indicated for the
following:
INTRA-ARTERIAL PROCEDURES (1.1)
Adults and pediatric patients 12 years of age and over
Intra-arterial digital subtraction angiography (270 and 320 mg
Iodine/mL).
Angiocardiography (left ventriculography and selective coronary
arteriography), peripheral
arteriography, visceral arteriography, and cerebral arteriography (320
mg Iodine/mL).
Pediatric patients less than 12 years of age
Angiocardiography, cerebral arteriography, and visceral arteriography
(320 mg Iodine/mL).
INTRAVENOUS PROCEDURES ( 1.2)
Adults and pediatric patients 12 years of age and over
Computed tomography (CT) imaging head and body (270 and 320 mg
Iodine/mL).
Excretory urography (270 and 320 mg Iodine/mL).
Peripheral venography (270 mg Iodine/mL).
Coronary computed tomography angiography (CCTA) to assist diagnostic
evaluation of patients with
suspected coronary artery disease (320 mg Iodine/mL).
Pediatric patients less than 12 years of age
CT imaging of the head and body (270 mg Iodine/mL).
Excretory urography (270 mg Iodine/mL).
DOSAGE AND ADMINISTRATION
Individualize the combination of volume and concentration of VISIPAQUE
Injection considering age, body
weigh