Optiray 350 mg I/ml solution for injection or infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Ioversol

Disponível em:

Guerbet

Código ATC:

V08AB; V08AB07

DCI (Denominação Comum Internacional):

Ioversol

Dosagem:

350 mg I/ millilitre(s)

Forma farmacêutica:

Solution for injection/infusion

Tipo de prescrição:

Product subject to Restricted Prescription (C)

Área terapêutica:

Watersoluble, nephrotropic, low osmolar X-ray contrast media; ioversol

Status de autorização:

Marketed

Data de autorização:

1993-04-22

Folheto informativo - Bula

1
POM
PA 686/007/006
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTIRAY
® 350 MG I/ML,
solution for injection or infusion
Active substance: Iodine (as Ioversol)
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.
•
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 Optiray is and what it is used for
2.
What you need to know before you use Optiray
3.
How to use Optiray
4.
Possible side effects
5.
How to store Optiray
6.
Contents of the pack and other information
1.
WHAT OPTIRAY IS AND WHAT IT IS USED FOR
This medicine is for diagnostic use only. Optiray is used in adults
for several types of X-ray
procedures including:
•
IMAGING OF VESSELS
, both arteries and veins
•
KIDNEYS
•
CT
SCANS
Optiray is an X-ray contrast medium containing iodine. The iodine
blocks the X-rays, allowing vessels
and the inner organs supplied with blood to be seen.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OPTIRAY
DO NOT USE OPTIRAY
•
if you are
ALLERGIC
to
CONTRAST MEDIA
substances containing iodine or to any of the other
ingredients of this medicine (listed in section 6)
•
if you have
AN OVERACTIVE THYROID GLAND
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Optiray if you have
•
or previously had an allergic reaction (symptoms of an allergic
reaction can be difficulty
breathing, collapse, swelling, nausea, vomiting, low blood pressure,
skin symptoms)
•
asthma
•
heart failure
•
diabetes
•
kidney or liver disease
•
brain disorders including problems with the mechanism that controls
the passage of molecules
from the blood into the brain
•
problems with bone marrow, such as certain blood cancers known as
paraproteinaemia, multiple
myeloma
•
certain red blood cell abnormalities, known as si

Características técnicas

Health Products Regulatory Authority
02 February 2023
CRN00CR0R
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optiray 350 mg I/ml solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 741 mg ioversol equivalent to 350 mg Iodine
Osmolality: 780 mosmoles/kg
Viscosity: 14.3 mPa · s (at 25°C)
Viscosity: 9 mPa · s (at 37°C)
Contains Iodine per ml: 350 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless to faint yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Optiray 350 is a non-ionic X-ray contrast medium that is indicated in
adults for use in coronary, peripheral, visceral, and renal
arteriography, aortography and left ventriculography. Optiray 350 is
also indicated in adults for use in computed tomography
(CT) of the head and body, intravenous urography, venography, and in
intraarterial and intravenous digital subtraction
angiography (IA-DSA and IV-DSA).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS_
Recommended dosage schedule:
Procedure
Dosage *
Maximum Total Dose
Peripheral Arteriography
10-90 ml
250 ml
Venography
50-100 ml
250 ml
Left Ventriculography
30-50 ml
250 ml
Coronary Arteriography
1-10 ml
250 ml
Visceral Arteriography
12-60 ml
250 ml
Aortography
10-80 ml
250 ml
Renal Arteriography
6-15 ml
250 ml
Intravenous Urography
50-75 ml
150 ml
Head Computed Tomography
50-150 ml
150 ml
Body Computed Tomography
25-150 ml
150 ml
Intraarterial Digital Subtraction Angiography
5-80 ml
250 ml
Intravenous Digital Subtraction Angiography
30-50 ml
250 ml
* Repeated as necessary
_ELDERLY_
Dosage as for adults. Where poor demonstration is to be expected, the
dosage can be increased to the maximum.
_PAEDIATRIC POPULATION_
Health Products Regulatory Authority
02 February 2023
CRN00CR0R
Page 2 of 10
The safety and efficacy of Optiray 350 in children have not been
established. The medicinal produ