Ultravist® 370, Injectable solution, 76.9% (37% iodine)

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

IODINE

Prieinama:

Bayer Hellas S.A 6-8 Agisilaou Street 151 23 Marousi Attiki, , Greece

ATC kodas:

V08AB05

INN (Tarptautinis Pavadinimas):

IODINE 768,86 mg/ml

Vaisto forma:

SOLUTION FOR INJECTION

Sudėtis:

IODINE 768,86 mg/ml

Recepto tipas:

POM

Gydymo sritis:

CONTRAST MEDIA

Autorizacija statusas:

Authorised

Leidimo data:

2007-02-06

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
ULTRAVIST® 370, INJECTABLE SOLUTION, 76.9% (37% IODINE)
Iopromide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4..
WHAT IS IN THIS LEAFLET:
1.
What is Ultravist® and what it is used for
2.
What you need to know before you are given Ultravist®
3.
How you will be given Ultravist®
4.
Possible side effects
5.
How to store Ultravist®
6.
Contents of the pack and other information
1.
WHAT ULTRAVIST® IS AND WHAT IT IS USED FOR
WHAT IS ULTRAVIST® AND HOW DOES IT WORK?
The injectable solution Ultravist® contains the active substance
iopromide that
belongs to a group of products known as water soluble, nephrotropic
(specially
related to the nephric tissue), with low osmolarity, contrast agents
via X-Rays.
Ultravist® contains iodine. The X-Rays cannot penetrate the contrast
agents
because they are absorbed by the iodine. The body areas where
Ultravist® is
distributed after the infusion into blood circulation or the body
cavities become
visible during the examination with X-Rays.
The product will be injected by a trained healthcare professional.
WHAT ULTRAVIST® IS USED FOR
Ultravist® is only for diagnostic usage and used as contrast agent
for examinations
at various body areas.
For intravascular use and use at body cavities.
Ultravist® 370:
Intravenous pyelography
Angiocardiography
Computerized Tomography
Digital Subtraction Angiography
Contrast
enhancement
of
cavities
(except
for
myelography,
ventriculography and cerebral ventricles radiography)
for
use
in
adult
women
in
contrast-enhan

Prekės savybės

_ _
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1.
NAME OF THE MEDICINAL PRODUCT
ULTRAVIST® 370, INJECTABLE SOLUTION, 76.9% (37% IODINE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml Ultravist® 370 contains 768,86 mg iopromide (equivalent to 370 mg
iodine)
Excipient: Each ml contains up to 0.01109 mmol (equivalent to 0.2549
mg) sodium
(see Annex 1).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Injectable solution
Clear, colorless to pale yellow solution.
Ultravist has the following physical-chemical properties at various
concentrations:
IODINE CONCENTRATION (MG/ML)
370
Osmotic mole content (osm/kg H
2
O)
at 37
o
C
0.77
Viscosity
at 20
o
C
at 37
o
C
22.0
10.0
Density
at 20
o
C
at 37
o
C
1.409
1.399
pH Value
6.5-8.0
4.
CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
This product is for diagnostic use only.
For contrast enhancement. For intravascular use and use in body
cavities.
Ultravist 370:
Intravenous pyelography
Angiocardiography
Computerized Tomography
Digital Subtraction Angiography
Contrast
enhancement
of
cavities
(except
for
myelography,
ventriculography and cerebral ventricles radiography)
for
use
in
adult
women
in
contrast-enhanced
mammography
to
evaluate and detect known or suspected lesions of the breast, as an
adjunct to mammography (with or without ultrasound) or as an
alternative
to
magnetic
resonance
imaging
(MRI)
when
MRI
is
contraindicated or unavailable.
Ultravist is not recommended for intrathecal use.
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL INFORMATION
_Warning before use_
The contrast agent that has been warmed to body temperature is better
tolerated and
can be more easily infused due to reduced viscosity.
For additional information see section 6.6 “Use/Handling
Instructions”
POSOLOGY
POSOLOGY FOR INTRAVASCULAR USE
Dosage must be individualized depending on the age, the weight, the
clinical
request and the examination technique.
The dosages referenced herein below are indicative and refer to the
usual doses for
adults with average weight 70kg. The d