OMNISCAN- gadodiamide injection

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

gadodiamide (UNII: 84F6U3J2R6) (gadodiamide - UNII:84F6U3J2R6)

Beschikbaar vanaf:

GE Healthcare Inc.

INN (Algemene Internationale Benaming):

gadodiamide

Samenstelling:

gadodiamide 287 mg in 1 mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies (14.1)]. OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see Clinical Studies (14.2)]. OMNISCAN is contraindicated in patients with: - Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2 ) or acute kidney injury - Prior hypersensitivity to OMNISCAN 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, no adverse

Product samenvatting:

OMNISCAN (gadodiamide) Injection is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of gadodiamide in rubber stoppered vials and polypropylene syringes. OMNSICAN is supplied in the following sizes: 100 mL in +PLUSPAK ™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-0690-70) SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES. DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING. Protect OMNISCAN from strong daylight and direct exposure to sunlight. Do not freeze. Freezing can cause small cracks in the vials, which would compromise the sterility of the product. Do not use if the product is inadvertently frozen. Store OMNISCAN at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP].

Autorisatie-status:

New Drug Application

Bijsluiter

GE Healthcare Inc.
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MEDICATION GUIDE
OMNISCAN™ (OMNI-scan)
(gadodiamide)
Injection for intravenous use
What is OMNISCAN?
•
OMNISCAN is a prescription medicine called a gadolinium-based contrast
agent (GBCA).
OMNISCAN, like other GBCA medicines, is used with a magnetic resonance
imaging (MRI)
scanner.
•
An MRI exam with a GBCA, including OMNISCAN, 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 OMNISCAN?
•
OMNISCAN 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, 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 Dotarem, 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 systemic
fibrosis). Your healthcare provider should screen you to see how well
your kidneys are working
before you receive OMNISCAN.
Do not receive OMNISCAN if you have had a severe allergic reaction to
OMNISCAN.
Before receiv

Productkenmerken

OMNISCAN- GADODIAMIDE INJECTION
GE HEALTHCARE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMNISCAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OMNISCAN.
OMNISCAN™ (GADODIAMIDE) INJECTION FOR INTRAVENOUS USE
PHARMACY BULK PACKAGE
INITIAL U.S. APPROVAL: 1993
WARNING: NOT FOR INTRATHECAL USE AND NEPHROGENIC SYSTEMIC FIBROSIS
(NSF)
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NOT FOR INTRATHECAL USE:
INADVERTENT INTRATHECAL USE OF OMNISCAN HAS CAUSED CONVULSIONS, COMA,
SENSORY AND MOTOR
NEUROLOGIC DEFICITS (5.1).
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.
DO NOT ADMINISTER OMNISCAN 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 (5.2).
INDICATIONS AND USAGE
OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic
resonance imaging (MRI) indicated for
intravenous use to:
Visualize lesions with abnormal vascularity in the brain, spine, and
associated tissues (1.1)
Facilitate the visualization of lesions with abnormal vascularity
within the thoracic, abdominal, pelvic cavities, and the
retroperitoneal space (1.2)
DOSAGE AND ADMINISTRATION
Pharmacy Bulk Package – Not for Direct Infusion (11)
CNS – Adults and Pediatrics; 2-16 years of age: 0.2 mL/kg (0.1
mmol/kg) (2.1, 2.4)
Body – Adults and Pediatrics; 2-16 years of age: Kidney: 0.1 mL/kg
(0.05 mmol/kg)
Intrathoracic, intra-abdominal, and pelvic cavities: 0.2 mL/kg
(0.1 mmol/kg) (2.2, 2.4)