OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES- human albumin microspheres and perflutren injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

HUMAN ALBUMIN MICROSPHERES (UNII: T8C6W1N6NW) (HUMAN ALBUMIN MICROSPHERES - UNII:T8C6W1N6NW), PERFLUTREN (UNII: CK0N3WH0SR) (PERFLUTREN - UNII:CK0N3WH0SR)

Dostopno od:

GE Healthcare Inc.

INN (mednarodno ime):

Human Albumin Microspheres

Sestava:

Human Albumin Microspheres 10 mg in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

OPTISON is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. Do not administer OPTISON to patients with known or suspected hypersensitivity to perflutren or albumin [see Warnings and Precautions (5.5)] . Risk Summary There are no data with OPTISON use in pregnant women to inform any drug-associated risks. No adverse developmental outcomes were observed in animal reproduction studies with intravenous administration of OPTISON to pregnant rats and rabbits during organogenesis at doses up to at least 5 and 10 times the recommended human dose based on body surface area (see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data OPTISON was administered intravenously to rats at doses of 0.25, 5 and 10 mL/kg/day (approximately 0.2, 5 and 10 times the recommended maximum human dose of 8.7 mL, respectively, based on body surface area) and to rabbits at 0.25, 2.5 and 5 mL/kg/day (approximately 0.5, 5 and 10 times the recommended maximum human dose, respectively, based on body surface area) during organogenesis. No significant findings attributable solely to a direct effect on the fetus were detected in the studies. There are no data on the presence of perflutren protein-type A microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OPTISON and any potential adverse effects on the breastfed infant from OPTISON or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Of the total number of subjects in a clinical study of OPTISON, 35% were 65 and over, while 14% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Povzetek izdelek:

OPTISON is supplied as 3 mL single-patient use vials containing a clear liquid lower layer, a white liquid upper layer, and a headspace filled with perflutren gas and is homogeneous, opaque, and milky-white after resupsension. Each mL contains 5-8 ×108 protein-type A microspheres, 10 mg albumin human, and 0.22 ± 0.11 mg perflutren: Store OPTISON refrigerated between 2° to 8°C (36° to 46°F). Storage at room temperature (up to 25°C or 77°F) for up to 24 hours is permitted. Do not freeze.

Status dovoljenje:

New Drug Application

Lastnosti izdelka

OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES- HUMAN ALBUMIN
MICROSPHERES AND PERFLUTREN INJECTION, SOLUTION
GE HEALTHCARE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPTISON SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OPTISON.
OPTISON (PERFLUTREN PROTEIN-TYPE A MICROSPHERES) INJECTABLE
SUSPENSION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1997
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS CARDIOPULMONARY REACTIONS, INCLUDING FATALITIES, HAVE OCCURRED
UNCOMMONLY
DURING OR FOLLOWING PERFLUTREN-CONTAINING MICROSPHERE ADMINISTRATION.
MOST SERIOUS
REACTIONS OCCUR WITHIN 30 MINUTES OF ADMINISTRATION (5.1).
ASSESS ALL PATIENTS FOR THE PRESENCE OF ANY CONDITION THAT PRECLUDES
OPTISON
ADMINISTRATION (4).
ALWAYS HAVE RESUSCITATION EQUIPMENT AND TRAINED PERSONNEL READILY
AVAILABLE (5.1).
RECENT MAJOR CHANGES
Contraindications (4)
09/2021
INDICATIONS AND USAGE
OPTISON is an ultrasound contrast agent indicated for use in patients
with suboptimal echocardiograms to
opacify the left ventricle and to improve the delineation of the left
ventricular endocardial borders (1)
DOSAGE AND ADMINISTRATION
Recommended Dosage (2.1)
Recommended dose of OPTISON is 0.5 mL intravenously injected into a
peripheral vein
Maximum total dose should not exceed 5 mL in any 10 minute period
Maximum total dose should not exceed 8.7 mL in any one patient study
If contrast enhancement is inadequate after the dose of 0.5 mL,
additional doses of increments of 0.5
mL up to 5 mL in a 10 minutes period may be injected intravenously up
to a maximum total dose of 8.7
mL
Administration Instructions (2.3)
For intravenous injection. Do not administer by intra-arterial
injection (5.3)
Injection rate should not exceed 1 mL per second
Follow the OPTISON injection with a flush of 0.9% Sodium Chloride
Injection, USP, or 5% Dextrose
Injection, USP
DOSAGE FORMS AND STRENGTHS
Injectable suspension: 5-8 ×10 pro