GADOTERATE MEGLUMINE injection

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

gadoterate meglumine (UNII: L0ND3981AG) (GADOLINIUM CATION (3+) - UNII:AZV954TZ9N)

Dostupné s:

Fresenius Kabi USA, LLC

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. History of clinically important hypersensitivity reactions to Gadoterate Meglumine Injection [see Warnings and Precautions (5.2)] . Risk Summary GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data) . In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses up to 16 and 10 times, respectively, the recommended human dose (see Data) . Because of the potential risks of gadolinium to the f

Přehled produktů:

Gadoterate Meglumine Injection, USP is a clear, colorless to yellow solution containing 0.5 mmol per mL of gadoterate meglumine. Each Pharmacy Bulk Package vial is closed with a rubber stopper and sealed with an aluminum cap and the contents are sterile. Gadoterate Meglumine Injection, USP Pharmacy Bulk Package vials are individually packaged in a box of 6, in the following configurations: Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Should solidification occur in the vial because of exposure to the cold, bring Gadoterate Meglumine Injection, USP to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, Gadoterate Meglumine Injection, USP should return to a clear, colorless to yellow solution. Before use, examine the product to assure that all solids are dissolved and that the container and closure have not been damaged. Discard the vial if solids persist.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Fresenius Kabi USA, LLC
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MEDICATION GUIDE
Gadoterate Meglumine (GAD oh TER ate MEG loo meen) Injection
(gadoterate meglumine)
Injection for intravenous use
What is Gadoterate Meglumine Injection?
•
Gadoterate Meglumine Injection is a prescription medicine called a
gadolinium-based contrast agent
(GBCA). Gadoterate Meglumine Injection, like other GBCAs, is injected
into your vein and used
with a magnetic resonance imaging (MRI) scanner.
•
An MRI exam with a GBCA, including Gadoterate Meglumine Injection,
helps your doctor to see
problems better than an MRI exam without a GBCA.
•
Your doctor has reviewed your medical records and has determined that
you would benefit from
using a GBCA with your MRI exam.
What is the most important information I should know about Gadoterate
Meglumine Injection?
•
Gadoterate Meglumine Injection contains a metal called gadolinium.
Small amounts of gadolinium
can stay in your body including the brain, bones, skin and other parts
of your body for a long time
(several months to years).
•
It is not known how gadolinium may affect you, but so far, studies
have not found harmful effects in
patients with normal kidneys.
•
Rarely patients have reported pains, tiredness, and skin, muscle or
bone ailments for a long time, but
these symptoms have not been directly linked to gadolinium.
•
There are different GBCAs that can be used for your MRI exam. The
amount of gadolinium that
stays in the body is different for different gadolinium medicines.
Gadolinium stays in the body more
after Omniscan or Optimark than after Eovist, Magnevist or MultiHance.
Gadolinium stays in the
body the least after Gadoterate Meglumine Injection, Gadavist or
ProHance.
•
People who get many doses of gadolinium medicines, women who are
pregnant and young children
may be at increased risk from gadolinium staying in the body.
•
Some people with kidney problems who get gadolinium medicines can
develop a condition with
severe thickening of the skin, muscles and other organs in the body
(nephrogenic

Charakteristika produktu

GADOTERATE MEGLUMINE- GADOTERATE MEGLUMINE INJECTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GADOTERATE MEGLUMINE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GADOTERATE
MEGLUMINE INJECTION.
GADOTERATE MEGLUMINE INJECTION FOR INTRAVENOUS USE
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
INITIAL U.S. APPROVAL: 2013
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.
THE RISK FOR NSF APPEARS HIGHEST AMONG PATIENTS WITH:
CHRONIC, SEVERE KIDNEY DISEASE (GFR LESS THAN 30 ML/MIN/1.73 M ), OR
ACUTE KIDNEY INJURY.
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 MORE THAN 60 YEARS, HYPERTENSION OR DIABETES), ESTIMATE THE
GLOMERULAR
FILTRATION RATE (GFR) THROUGH LABORATORY TESTING (5.1).
INDICATIONS AND USAGE
Gadoterate Meglumine Injection is a gadolinium-based contrast agent
indicated for intravenous use with
magnetic resonance imaging (MRI) in brain (intracranial), spine and
associated tissues in adult and
pediatric patients (including term neonates) to detect and visualize
areas with disruption of the blood brain
barrier (BBB) and/or abnormal vascularity. (1)
DOSAGE AND ADMINISTRATION
Adult and pediatric patients: The recommended dose of Gadoterate
Meglumine Injection is 0.2 mL/kg (0.1
mmol/kg) body weight administered as an intravenous bolus injection at
a flow rate of approximately 2
mL/second for adults and 1 to 2 mL/second for pediatric patients
(including term neonates). The dose is
delivered by manual or power injection. (2)
DOSAGE FORMS AND STRENGTHS
G