OPTIRAY 350- ioversol injection OPTIRAY 320- ioversol injection OPTIRAY 300- ioversol injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

IOVERSOL (UNII: N3RIB7X24K) (IOVERSOL - UNII:N3RIB7X24K)

Mevcut itibaren:

Liebel-Flarsheim Company LLC

INN (International Adı):

IOVERSOL

Kompozisyon:

IOVERSOL 741 mg in 1 mL

Uygulama yolu:

INTRA-ARTERIAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

OPTIRAY is indicated for: In adults - OPTIRAY 300: cerebral arteriography and peripheral arteriography. - OPTIRAY 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography. - OPTIRAY 350: peripheral arteriography coronary arteriography, and left ventriculography. In pediatric patients - OPTIRAY 320 and OPTIRAY 350: angiocardiography. In adults - OPTIRAY 300: CT imaging of the head and body, venography, and intravenous excretory urography. - OPTIRAY 320: CT imaging of the head and body, venography, and intravenous excretory urography. - OPTIRAY 350: CT imaging of the head and body, venography, intravenous excretory urography, and intravenous digital subtraction angiography (IV-DSA). - In pediatric patients OPTIRAY 320: CT imaging of the head and body, and intravenous excretory urography. Symptomatic Hyperthyroidism Risk Summary Postmarketing data with OPTIRAY use in pregnant women are insufficient to de

Ürün özeti:

OPTIRAY is a clear, colorless to pale yellow, sterile, pyrogen-free, aqueous solution available in three strengths. The products are supplied in containers from which the air has been displaced by nitrogen. OPTIRAY is supplied in the following single-dose configurations: OPTIRAY 350 NDC Number    Glass       25x50 mL bottles 0019-1333-06       12x100 mL bottles 0019-1333-11       12x150 mL bottles 0019-1333-16       12x200 mL fill/250 mL bottles 0019-1333-21    Plastic       20x50 mL hand held syringes 0019-1333-78       20x75 mL fill/125 mL power injector syringes 0019-1333-95       20x100 mL fill/125 mL power injector syringes 0019-1333-90       20x125 mL power injector syringes 0019-1333-87    RFID-Tagged Syringes*       20x100 mL fill/125 mL power injector syringes 0019-1333-00       20x125 mL power injector syringes 0019-1333-27 OPTIRAY 320    Glass       25x20 mL vials 0019-1323-02       25x50 mL bottles 0019-1323-06       12x100 mL bottles 0019-1323-11       12x150 mL bottles 0019-1323-16       12x200 mL fill/250 mL bottles 0019-1323-21    Plastic       20x50 mL hand held syringes 0019-1323-78       20x50 mL fill/125 mL power injector syringes 0019-1323-52       20x75 mL fill/125 mL power injector syringes 0019-1323-95       20x100 mL fill/125 mL power injector syringes 0019-1323-90       20x125 mL power injector syringes 0019-1323-87    RFID-Tagged Syringes*       20x75 mL fill/125 mL power injector syringes 0019-1323-85       20x100 mL fill/125 mL power injector syringes 0019-1323-00       20x125 mL power injector syringes 0019-1323-27 OPTIRAY 300    Glass       25x50 mL bottles 0019-1332-06       12x100 mL bottles 0019-1332-11       12x150 mL bottles 0019-1332-16       12x200 mL fill/250 mL bottles 0019-1332-21    Plastic       20x100 mL fill/125 mL power injector syringes 0019-1332-90    RFID-Tagged Syringes*       20x100 mL fill/125 mL power injector syringes 0019-1332-00 *Radio Frequency Identification (RFID) Technology RFID-Tagged Syringe Description This information is for UltrajectTM syringes containing OPTIRAY that have been labeled with a Radio Frequency Identification (RFID) tag. When used with an RFID-enabled OptivantageTM injector, this tag allows for the exchange of product information such as lot number, expiration, concentration, and identification of the syringe as being “unused” prior to use and “used” after product administrations. Patient information is not used in any form with this RFID technology. OPTIRAY product quality is not influenced by the use of this RFID tag. RFID-Tagged Syringe Directions for Use For the RFID Technology to function, the syringe must be used with an Optivantage Injector with RFID technology [see Dosage and Administration (2.2)] . Function of the RFID technology is not dependent on syringe orientation as it is placed in the injector. Instructions for use of injector are provided on the injector interface screen and operator’s manual. If the RFID tag is damaged or otherwise non-functional, the injector will notify the user. Should this occur the OPTIRAY syringe with the non-functional RFID tag may still be used but no data will be transferred to the injector. Regarding interference with medical devices, the RFID tag and injector system meet the IEC 60601-1-2 requirements for emission and immunity standards for medical devices. Follow all manufacturers’ guidelines and do not operate any part of the Optivantage Injector System and RFID-tagged syringes within 6 inches (15 cm) of a pacemaker and/or defibrillator.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

OPTIRAY 350- IOVERSOL INJECTION
OPTIRAY 320- IOVERSOL INJECTION
OPTIRAY 300- IOVERSOL INJECTION
LIEBEL-FLARSHEIM COMPANY LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPTIRAY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OPTIRAY.
OPTIRAY (IOVERSOL) INJECTION, FOR INTRA-ARTERIAL OR INTRA-VENOUS USE
INITIAL U.S. APPROVAL: 1988
WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION
FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY
INADVERTENT INTRATHECAL ADMINISTRATION MAY CAUSE DEATH, CONVULSIONS,
CEREBRAL
HEMORRHAGE, COMA, PARALYSIS, ARACHNOIDITIS, ACUTE RENAL FAILURE,
CARDIAC ARREST,
SEIZURES, RHABDOMYOLYSIS, HYPERTHERMIA, AND BRAIN EDEMA. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Thyroid Dysfunction in Pediatric Patients 0
to 3 Years of Age (5.8)
2/2023
INDICATIONS AND USAGE
OPTIRAY is a radiographic contrast agent indicated for the following:
Intra-arterial Procedures (1.1)
Adults:
Cerebral Arteriography (300, 320 mg iodine/mL)
Peripheral Arteriography (300, 320, 350 mg iodine/mL )
Visceral and Renal Arteriography, Aortography (320 mg iodine/mL)
Coronary Arteriography and Left Ventriculography (320, 350 mg
iodine/mL)
Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL)
Intravenous Procedures (1.2)
Adults:
Computed tomography (CT) Imaging of Head and Body (300, 320, 350 mg
iodine/mL)
Venography (300, 320, 350 mg iodine/mL)
Intravenous Excretory Urography (300, 320, 350 mg iodine/mL)
Intravenous Digital Subtraction Angiography (350 mg iodine/mL)
Pediatric Patients: CT Imaging of the Head and Body, and Intravenous
Excretory Urography (320 mg
iodine/mL)
DOSAGE AND ADMINISTRATION
Adjust the volume and concentration of OPTIRAY. Modify the dose
accounting for factors such as age, body
weight, vessel size, blood flow rate within the vessel. Please see
details in full Prescribing Information. (2)
DOSAGE FORMS AND STRENGTHS
OPTIRAY (ioversol) Injection comes in three strengths: 300 mg
iodine/mL (ioversol 64%), 320 mg