IOMERON- iomeprol injection injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

IOMEPROL (UNII: 17E17JBP8L) (IOMEPROL - UNII:17E17JBP8L)

थमां उपलब्ध:

BRACCO DIAGNOSTICS INC

प्रशासन का मार्ग:

INTRAVASCULAR

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

प्राधिकरण का दर्जा:

Unapproved drug for use in drug shortage

सूचना पत्रक

IOMERON- IOMEPROL INJECTION INJECTION, SOLUTION
BRACCO DIAGNOSTICS INC
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
----------
1. NAME OF THE MEDICINAL PRODUCT
Iomeron 250, solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 51.03% w/v of iomeprol equivalent to 25% iodine or 250mg
iodine/ml.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
X-ray contrast medium used for:
•
venography
•
cerebral arteriography
•
digital subtraction angiography
•
computed tomography enhancement
•
urography
•
cavernosography
•
myelography
4.2 Posology and method of administration
* Repeat as necessary
* * According to body size and age
venography
adults
10 - 100ml*
max 250ml
10 - 50ml upper
extremity
50 - 100 lower
extremity
cerebral arteriography
adults
5 - 12ml*
children
3 - 7ml or * *
digital subtraction angiography
Intra arterial
visceral
adults
2 - 20ml per artery*
aorta 25-50ml*
both 250ml max
peripheral
adults
5 - 10ml per artery*
max 250ml
intravenous
adults
30 - 60ml*
max 250ml
computed tomography
brain
adults
50 - 150
children
* *
body
adults
40 - 150ml
max 250ml
children
* *
urography
adults
50 - 150ml
intravenous
neonates
3 - 4.8ml/kg
babies
2.5 - 4ml/kg
children
1 - 2.5ml/kg or *
cavernosography
adults
40 - 250ml
myelography
adults
12 - 18ml
by lumbar injection
In elderly patients the lowest effective dose should be used.
Unless otherwise instructed by the doctor, a normal diet may be
maintained on the day of the
examination.
In myelography, lower doses may be used for lumbar or thoracic studies
and higher doses for cervical or
total columnar studies. Regardless of the nature of the myelographic
study, Iomeron should be injected
slowly over 1-2 minutes.
The X ray can be taken up to 60 minutes following injection. Post
myelographic CT of the spinal col

उत्पाद विशेषताएं

IOMERON- IOMEPROL INJECTION INJECTION, SOLUTION
BRACCO DIAGNOSTICS INC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
IMPORTANT DRUG INFORMATION
MAY BE FOUND AT THE FOLLOWING LINK:
HTTPS://IMAGING.BRACCO.COM/US-EN/PRODUCTS/CT-CT-COLONOGRAPHY/IOMERON
July 6, 2022
SUBJECT: TEMPORARY IMPORTATION OF IOMERON (IOMEPROL INJECTION) TO
ADDRESS
DRUG SHORTAGE ISSUES
Dear Healthcare Professional,
Due to the current critical shortages of Omnipaque™ (iohexol
injection), Visipaque™
(iodixanol injection), and Ultravist (iopromide injection) in the U.S.
market, Bracco
Diagnostics Inc. (hereafter “Bracco”) is coordinating with the
U.S. Food and Drug
Administration (FDA) to increase the availability of iodinated
contrast media indicated for
intravascular use.
Accordingly, Bracco has initiated temporary importation of Iomeron
(iomeprol
injection), an intravascular iodinated contrast medium, into the U.S.
market. This product
will be used in adult patients by intravenous or intraarterial route
of administration only
during the shortage. FDA has not approved Iomeron (iomeprol). Iomeron
(iomeprol)
drug product is manufactured by BIPSO GmbH in Germany and Patheon
Italia S.p.A. in
Italy. These facilities are also used to manufacture Bracco’s
FDA-approved intravascular
iodinated contrast medium Isovue (iopamidol injection).
FDA’s regulatory discretion for the importation and distribution of
Iomeron (iomeprol) is
limited to Bracco during the critical U.S. shortages of Omnipaque,
Visipaque, and
Ultravist.
Effective immediately, and during this temporary period, Bracco will
offer the following
presentations of Iomeron (iomeprol) to the U.S. market:
PRODUCT
DESCRIPTION
IODINE
CONCENTRATION (MG
IODINE/ML)
PACKAGE
SIZE
LOT
NUMBER
LABEL
LANGUAGE
NDC
NUMBER
UK
SMPC
Iomeron
(iomeprol
injection) 250
250
56 X 100
mL
2C42685 French
0270-
7250-10
Iomeron
300 UK
SmPC
SD
Iomeron
(iomeprol
inj