ULTRAVIST 370

Land: Indonesia

Språk: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv ingrediens:

IOPROMIDE

Tilgjengelig fra:

BAYER INDONESIA - Indonesia

INN (International Name):

IOPROMIDE

Dosering :

370 MGI/ML

Legemiddelform:

INFUS

Enheter i pakken:

DUS, 10 BOTOL @ 100 ML

Produsert av:

BAYER AG., - GERMANY

Autorisasjon dato:

2018-05-23

Preparatomtale

Name of Product/Active ingredient/Dosage form/Version/Date of approval
ULTRAVIST 300 & 370/Iopromide/Solution for injection/BEC 19581 & 19924
- CCDS #15&16/
1
ULTRAVIST
®
300 / 370
SOLUTION FOR INJECTION/INFUSION
Important information, please read carefully! COMPOSITION
Ultravist 300: 1 ml contains 623 mg iopromide (equivalent to 300 mg
iodine)
Ultravist 370: 1 ml contains 769 mg iopromide (equivalent to 370 mg
iodine)
PHARMACEUTICAL FORM
Solution for injection/infusion. PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Watersoluble, nephrotropic, low osmolar
X-ray contrast media
ATC code: V08AB05
The contrast-giving substance in the Ultravist formulations is
iopromide, a non-ionic, water-soluble derivative of triiodi nated
isophthalic acid with a molecular weight of 791.12 in which the firmly
bound iodine absorbs the X-rays.
Injection of iopromide opacifies those vessels or body cavities in the
path of flow of the contrast ag en t, p ermi tti n g rad i o-
graphic visualization of the internal structures until significant
dilution occurs.
PHARMACOKINETIC PROPERTIES
GENERAL INFORMATION
Iopromide behaves in the organism like other highly hydrophilic
biologically inert, renally excreted compounds (e.g. mannitol
or inulin).
ABSORPTION AND DISTRIBUTION
Following intravenous administration, plasma concentrations of
iopromide decline rapidly due to distribution into the
extracellular space and subsequent elimination. The total distribution
volume at steady state is about 16 L corresponding
roughly to the volume of the extracellular space.
Protein binding is negligible (about 1%). There is no indication that
iopromide crosses the intact blood-brain-barrier. A smal l
amount crossed the placental barrier in animal studies (≤ 0.3 % of
the dose were found in rabbit fetuses). Following
intrathecal administration, maximum iodine concentrations of 4.5 % of
the administered dose per total plasma volume were
observed after 3.8 hours.
Following administration in the biliary and/or pancreatic duct