OPTIMARK gadoversetamide injection solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

GADOVERSETAMIDE (UNII: RLM74T3Z9D) (GADOLINIUM CATION (3+) - UNII:AZV954TZ9N)

Tilgjengelig fra:

Liebel-Flarsheim Company LLC

INN (International Name):

GADOVERSETAMIDE - UNII:AZV954TZ9N)

Sammensetning:

GADOVERSETAMIDE 0.5 mmol in 1 mL

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

OPTIMARK- GADOVERSETAMIDE INJECTION, SOLUTION
LIEBEL-FLARSHEIM COMPANY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPTIMARK™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OPTIMARK.
OPTIMARK (GADOVERSETAMIDE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
GADOLINIUM-BASED CONTRAST AGENTS (GBCAS) INCREASE THE RISK FOR NSF
AMONG PATIENTS WITH IMPAIRED
ELIMINATION OF THE DRUGS. AVOID USE OF GBCAS IN THESE PATIENTS UNLESS
THE DIAGNOSTIC INFORMATION IS
ESSENTIAL AND NOT AVAILABLE WITH NON-CONTRASTED MRI OR OTHER
MODALITIES. NSF MAY RESULT IN FATAL OR
DEBILITATING FIBROSIS AFFECTING THE SKIN, MUSCLE AND INTERNAL ORGANS
(5.1).
DO NOT ADMINISTER OPTIMARK TO PATIENTS WITH:
CHRONIC, SEVERE KIDNEY DISEASE (GFR <30 ML/MIN/1.73M ), OR
ACUTE KIDNEY INJURY (4).
SCREEN PATIENTS FOR ACUTE KIDNEY INJURY AND OTHER CONDITIONS THAT MAY
REDUCE RENAL FUNCTION. FOR
PATIENTS AT RISK FOR CHRONICALLY REDUCED RENAL FUNCTION (E.G. AGE >60
YEARS, HYPERTENSION OR DIABETES),
ESTIMATE THE GLOMERULAR FILTRATION RATE (GFR) THROUGH LABORATORY
TESTING (5.1).
INDICATIONS AND USAGE
Optimark is a gadolinium-based paramagnetic contrast agent for
diagnostic magnetic resonance imaging (MRI) indicated
for intravenous use:
In patients with abnormal blood-brain barrier or abnormal vascularity
of the brain, spine and associated tissues (1)
To provide contrast enhancement and facilitate visualization of
lesions with abnormal vascularity in the liver in patients
who are highly suspect for liver structural abnormalities on computed
tomography (1)
DOSAGE AND ADMINISTRATION
Bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1
mmol/kg) (2)
Follow injection with a 5 mL normal saline flush. (2)
Complete imaging procedure within 1 hour of injection. (2)
DOSAGE FORMS AND STRENGTHS
Injection: Each ml of Optimark contains 330.9 mg gadoversetamide (3)