GADOPENTETATE DIMEGLUMINE- gadopentetate dimeglumine injection

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

GADOPENTETATE DIMEGLUMINE (UNII: RH248G8V27) (GADOPENTETATE - UNII:V7OK6J19HQ)

Dostupné z:

Alvogen, Inc

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Gadopentetate dimeglumine Injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. Gadopentetate dimeglumine Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors. Gadopentetate dimeglumine is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck. Gadopentetate dimeglumine Injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart). Gadopentetate dimeglumine Injection is contraindicated in patients with:

Prehľad produktov:

Gadopentetate dimeglumine Injection is a clear, colorless to slightly yellow solution containing 469.01 mg/mL of gadopentetate dimeglumine. Gadopentetate dimeglumine Injection is supplied in the following sizes: 50 mL Pharmacy Bulk Package, rubber stoppered, 10 per box NDC 47781-147-25 100 mL Pharmacy Bulk Package, rubber stoppered, 10 per box NDC 47781-147-23

Stav Autorizácia:

New Drug Application Authorized Generic

Súhrn charakteristických

GADOPENTETATE DIMEGLUMINE- GADOPENTETATE DIMEGLUMINE INJECTION
ALVOGEN, INC
----------
GADOPENTETATE DIMEGLUMINE
INJECTION
FOR INTRAVENOUS ADMINISTRATION
PHARMACY BULK PACKAGE—NOT FOR DIRECT INFUSION
RX ONLY
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
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.
•
•
Do not exceed the recommended gadopentetate dimeglumine dose and allow
a sufficient period of
time for elimination of the drug from the body prior to any
re-administration (see WARNINGS
AND PRECAUTIONS).
DESCRIPTION
Gadopentetate dimeglumineInjection is the N-methylglucamine salt of
the gadolinium complex of
diethylenetriamine pentaacetic acid, and is an injectable contrast
medium for magnetic resonance imaging
(MRI). Gadopentetate dimeglumine Injection is provided as a sterile,
clear, colorless to slightly yellow
aqueous solution for intravenous injection.
Gadopentetate dimeglumine Injection is a 0.5- mol/L solution of
1-deoxy-1-(methylamino)-D-glucitol
dihydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]- glycinato
(5-)]gadolinate(2- ) (2:1) with a
molecular weight of 938, an empirical formula of C
H GdN O , and has the following structural
formula:
Each mL contains 469.01 mg gadopentetate dimeglumine, 0.99 mg
meglumine, 0.40 mg
diethylenetriamine pentaacetic acid and water for injection.
Gadopentetate dimeglumine Injection
Do not administer gadopentetate dimeglumine to patients with:
•
•
chronic, severe kidney disease (GFR < 30 mL/min/1.73m ), or
2
acute kidney injury (see CONTRAINDICATIONS).
Screen patients for acute kidney injury and other conditions that may
reduce renal function.
For patients at risk for chronically reduced renal function (for
example, age >60 years,
hypertension or d