VASOVIST- gadofosveset trisodium injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

gadofosveset trisodium (UNII: XM33Q67UVH) (gadofosveset - UNII:E65RW73PHS)

Saatavilla:

Bayer Healthcare, Inc.

INN (Kansainvälinen yleisnimi):

gadofosveset trisodium

Lääkemuoto:

INJECTION

Koostumus:

244 mg in 1 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

VASOVIST is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease [see Clinical Studies (14) ]. History of a prior allergic reaction to a gadolinium-based contrast agent. Pregnancy Category C There are no adequate and well-controlled studies of VASOVIST in pregnant women. In animal studies, pregnant rabbits treated with gadofosveset trisodium at doses 3 times the human dose (based on body surface area) experienced higher rates of fetal loss and resorptions. Because animal reproduction studies are not always predictive of human response, only use VASOVIST during pregnancy if the diagnostic benefit justifies the potential risks to the fetus. In reproductive studies, pregnant rats and rabbits received gadofosveset trisodium at various doses up to approximately 11 (rats) and 21.5 (rabbits) times the human dose (based on body surface area). The highest dose resulted in maternal t

Tuoteyhteenveto:

VASOVIST Injection is a sterile, clear, colorless to pale yellow solution containing 244 mg/mL (0.25 mmol/mL) of gadofosveset trisodium in rubber-stoppered vials with an aluminum seal. VASOVIST Injection is supplied as follows: Store VASOVIST Injection at 25°C (77°F: excursions permitted to 15 to 30°C [59 to 86°F]). Protect from light and freezing.

Valmisteyhteenveto

VASOVIST- GADOFOSVESET TRISODIUM INJECTION
BAYER HEALTHCARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
GADOLINIUM-BASED CONTRAST AGENTS INCREASE THE RISK OF NEPHROGENIC
SYSTEMIC FIBROSIS (NSF) IN PATIENTS
WITH:
ACUTE OR CHRONIC SEVERE RENAL INSUFFICIENCY (GLOMERULAR FILTRATION
RATE <30 ML/MIN/1.73M ), OR
ACUTE RENAL INSUFFICIENCY OF ANY SEVERITY DUE TO THE HEPATO-RENAL
SYNDROME OR IN THE PERIOPERATIVE
LIVER TRANSPLANTATION PERIOD.
IN THESE PATIENTS, AVOID USE OF GADOLINIUM-BASED CONTRAST AGENTS
UNLESS THE DIAGNOSTIC INFORMATION IS
ESSENTIAL AND NOT AVAILABLE WITH NON-CONTRAST ENHANCED MAGNETIC
RESONANCE IMAGING (MRI). NSF MAY
RESULT IN FATAL OR DEBILITATING SYSTEMIC FIBROSIS AFFECTING THE SKIN,
MUSCLE, AND INTERNAL ORGANS. SCREEN ALL
PATIENTS FOR RENAL DYSFUNCTION BY OBTAINING A HISTORY AND/OR
LABORATORY TESTS. WHEN ADMINISTERING A
GADOLINIUM-BASED CONTRAST AGENT, DO NOT EXCEED THE RECOMMENDED DOSE
AND ALLOW A SUFFICIENT PERIOD OF
TIME FOR ELIMINATION OF THE AGENT FROM THE BODY PRIOR TO ANY
RE-ADMINISTRATION [_SEE WARNINGS AND_
_PRECAUTIONS (5.1)_]
INDICATIONS AND USAGE
VASOVIST Injection is a gadolinium-based contrast agent indicated for
use as a contrast agent in magnetic resonance
angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in
adults with known or suspected peripheral vascular
disease . (1)
DOSAGE AND ADMINISTRATION
Administer VASOVIST Injection by an intravenous bolus, manually or by
power injection, at a dose of 0.12 mL/kg body
weight (0.03 mmol/kg) over a period of time up to 30 seconds followed
by a 25-30 mL normal saline flush. (2)
Imaging is performed in two stages, the dynamic stage which begins
immediately following VASOVIST Injection and the
steady-state stage, which begins following dynamic imaging; generally
5 to 7 minutes after VASOVIST Injection. (2)
DOSAGE FORMS AND STRENGTHS
Each mL of VASOVIST Injection contains 244 mg gadofosveset trisodium
(equivalent to