Optiray 300 mg I/ml PFS solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ioversol

Available from:

Guerbet

ATC code:

V08AB; V08AB07

INN (International Name):

Ioversol

Dosage:

300 mg I/ millilitre(s)

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2000-04-14

Patient Information leaflet

1
POM
PA 686/007/004
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTIRAY
® 300 MG I/ML PFS,
solution for injection
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 for several
types of X-ray procedures
including:
•
IMAGING OF VESSELS
, both arteries and veins (in adults and children)
•
KIDNEYS
(in adults and children)
•
CT
SCANS
(in adults)
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
•
certa

Summary of Product characteristics

Health Products Regulatory Authority
02 February 2023
CRN00CR0R
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optiray 300 mg I/ml PFS solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 636 mg ioversol equivalent to 300 mg Iodine
Osmolality: 645 mosmoles/kg
Viscosity: 8.2 mPa · s (at 25°C)
Viscosity: 5.5 mPa · s (at 37°C)
Contains Iodine per ml: 300 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection. Clear, colourless to faint yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Optiray 300 PFS is a non-ionic X-ray contrast medium that is indicated
in adults for use in cerebral, peripheral, visceral, and
renal arteriography, venography, intravenous urography and in
intra-arterial and intravenous digital subtraction angiography
(IA-DSA and IV-DSA). Optiray 300 PFS is also indicated in adults for
use in computed tomography (CT) of the head and body.
Optiray 300 PFS may also be used in children for cerebral, peripheral
and visceral arteriography and for intravenous urography.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS_
Recommended dosage schedule:
Procedure
Dosage *
Maximum Total Dose
Cerebral Arteriography
- Carotid or vertebral artery
2-12 ml
200 ml
- Aortic arch
20-50 ml
200 ml
Peripheral Arteriography
10-90 ml
250 ml
Venography
50-100 ml
250 ml
Visceral Arteriography
12-60 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_
Recommended dosage schedule:
Procedure
Dosage *
Maximum Total Dose
Cerebral Arteriography
1-3 ml/kg
10