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VISIPAQUE INJECTION 320MG I/ML

Active substance(s): IODIXANOL

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SUMMARY OF PRODUCT CHARACTERISTICS

The following dosages may serve as a guide. The doses given
for intra-arterial use are for single injections that may be
repeated.
Indication/Investigation
Intra-arterial use

Concentration Volume

Arteriographies

1

VISIPAQUE 270 mg I/ml and 320 mg I/ml Solution for Injection,
glass container and polypropylene container

2

QUALITATIVE AND QUANTITATIVE
COMPOSITION

Active ingredient
Iodixanol (INN)
Iodixanol (INN)

Strength
270 mg I/ml
320 mg I/ml

270/320(1)
mg I/ml
Aortography
270/320
mg I/ml
Peripheral
270/320
mg I/ml
Selective visceral i.a. DSA 270 mg I/ml
Cardioangiography
Selective cerebral

NAME OF THE MEDICINAL PRODUCT

Content pr. ml.
550 mg equiv.
270 mg I
652 mg equiv.
320 mg I

Iodixanol is a non-ionic, dimeric, hexaiodinated, water-soluble
X-ray contrast medium.
Pure aqueous solutions of iodixanol in all clinical relevant
concentrations have a lower osmolality than whole blood
and the corresponding strengths of the non-ionic monomeric
contrast media. VISIPAQUE is made isotonic with normal body
fluids by addition of electrolytes. The osmolality and viscosity
values of VISIPAQUE are as follows:
Osmolality *
Viscosity (mPa·s)
Concentration mOsm/kg H2O
37°C
20°C
37°C
270 mg I/ml
290
11.3
5.8
320 mg I/ml
290
25.4
11.4
* Method: Vapour - pressure osmometry.

Adults
Children < 7 kg
Children > 7 kg

Venography

4

Adults

Document: 1183230 GBR Version: 2 Draft: 3

This medicinal product is for diagnostic use only.
X-ray contrast medium for cardioangiography, cerebral
angiography (conventional), peripheral arteriography
(conventional), abdominal angiography (i.a.DSA), urography,
venography, CT-enhancement. Lumbar, thoracic and cervical
myelography. Arthrography, hysterosalpingography (HSG) and
studies of the gastrointestinal tract. In children it is used for
cardioangiography, urography, CT-enhancement and studies of
the upper gastrointestinal tract.

10 - 40 ml per inj.

Adults
CT-enhancement
CT of the head
CT of the body

30 - 60 ml/inj.

320 mg I/ml

4 - 8 ml/inj.

Concentration Volume

270/320
mg I/ml
270/320
mg I/ml
270/320
mg I/ml

270 mg I/ml

270/320
mg I/ml
270/320
mg I/ml

CT of the head and body 270/320
mg I/ml

Intrathecal use

The dosage may vary depending on the type of examination,
the age, weight, cardiac output and general condition of the
patient and the technique used. Usually approximately the
same iodine concentration and volume is used as with other
iodinated X-ray contrast media in current use, but adequate
diagnostic information has also been obtained in some
studies with iodixanol injection with somewhat lower iodine
concentration. Adequate hydration should be assured before
and after administration as for other contrast media.
The product is for intravenous, intra-arterial and intrathecal
use, and for use in body cavities.

Lumbar and thoracic
myelography
(lumbar injection)
Cervical myelography
(cervical or lumbar
injection)

40 – 80 ml(2)

Small bowel follow
through
Oesophagus

320 mg I/ml
320 mg I/ml

270 mg I/ml

Stomach

320 mg I/ml

Children

320 mg I/ml

80 – 200 ml
has been studied
10 – 200 ml
has been studied
20 – 200 ml
has been studied
5 ml/kg b.w.
10-240 ml
has been studied

Rectal use
Children

270/320
mg I/ml

30 – 400 ml
has been studied

For elderly patients, patients with hepatic and/or renal
impairments, the usual/proposed doses for adults can be used.

4.3 Contraindications
2 – 4 ml/kg
2 – 3 ml/kg
All doses depending
on age, weight
and pathology
(max. 50 ml).
50 - 150 ml/leg

50 – 150 ml
75 – 150 ml

2–3 ml/kg up to
50 ml
(in a few cases up
to 150 ml may be
given)
10 – 12 ml(3)

or 320 mg I/ml 10 ml(3)
270 mg I/ml
10 – 12 ml(3)

(3)

or 320 mg I/ml 10 ml
80 ml may be exceeded in selected cases.
(3)
To minimize possible adverse reactions a total dose of 3.2 g
iodine should not be exceeded.
(2)

Adults

320 mg I/ml

Children

4.2 Posology and method of administration

1 – 15 ml
5 – 10 ml
The recommended
dose may be
exceeded several
times due to e.g.
backflow into the
vagina (up to 40 ml
has been studied).

Gastrointestinal studies

320 mg I/ml

PHARMACEUTICAL FORM

4.1 Indications

30 - 60 ml per inj.

Urography

Solution for injection.
VISIPAQUE is supplied ready to use as clear, colourless to pale
yellow aqueous solutions.

CLINICAL PARTICULARS

40 - 60 ml per inj.

Depending on
age, weight
and pathology
(recommended max
total dose 10 ml/kg)
(1)
Both strengths are documented, but 270 mg I/ml is
recommended in most cases.
Indication/Investigation
Intravenous use

Arthrography
270 mg I/ml
Hysterosalpingography 270 mg I/ml
(HSG)

Oral use

For a full list of excipients, see section 6.1.

3

5 - 10 ml per inj

Adults
Left ventricle and aortic
root inj.
Selective coronary
arteriography
Children

Concentration Volume
The dosage must
be adjusted
individually to
allow optimal
visualisation

Adults

Adults

IODIXANOL

Indication/Investigation
Use in body cavities

Hypersensitivity to the active substance or to any of the
excipients. Manifest thyrotoxicosis.

4.4 Special warnings and precautions for use.
Special precautions for use of non-ionic contrast media in
general:
Hypersensitivity:
A positive history of allergy, asthma, or untoward reactions to
iodinated contrast media indicates a need for special caution.
Premedication with corticosteroids or histamine H1 and H2
antagonists might be considered in these cases.
The risk of serious reactions in connection with use of
VISIPAQUE is regarded as remote. However, iodinated
contrast media may provoke anaphylactoid reactions or other
manifestations of hypersensitivity. A course of action should
therefore be planned in advance, with necessary drugs and
equipment available for immediate treatment, should a serious
reaction occur. It is advisable always to use an indwelling
cannula or catheter for quick intravenous access throughout
the entire X-ray procedure.
The possibility of hypersensitivity including serious,
life-threatening, fatal anaphylactic/ anaphylactoid reactions
should always be considered. The majority of serious
undesirable occur within the first 30 minutes. Late onset
(that is 1 hour or more after application) hypersensitivity
reactions can occur.
Patients should be observed for at least 30 minutes after
administration of VISIPAQUE.
Patients using beta blockers may present with atypical
symptoms of hypersensitivity which may be misinterpreted
as a vagal reaction.
Coagulopathy:
Non-ionic, iodinated contrast media inhibit blood coagulation
in vitro less than ionic contrast media. Clotting has been
reported when blood remains in contact with syringes
containing contrast media including non-ionic media. The use
of plastic syringes in place of glass syringes has been reported
to decrease but not eliminate the likelihood of in vitro clotting.
Serious, rarely fatal, thromboembolic events causing
myocardial infarction and stroke have been reported
during angio-cardiographic procedures with both ionic and
non-ionic contrast media. Numerous factors, including length

of procedure, catheter and syringe material, underlying disease
state, and concomitant medications, may contribute to the
development of thromboembolic events. For these reasons,
meticulous angiographic techniques are recommended,
including close attention to guide wire and catheter
manipulation, use of manifold systems and/or three-way
stopcocks, frequent catheter flushing with heparinized saline
solutions, and minimizing the length of the procedure.) so
as to minimize the risk of procedure-related thrombosis and
embolism.
Advanced life support facilities should be readily available.
Care should be taken in patients with homocystinuria.
(Risk for thromboembolism).
Hydration
Adequate hydration should be assured before and after
contrast media administration. This applies especially to
patients with multiple myeloma, diabetes mellitus, renal
dysfunction, as well as to infants, small children and elderly
patients. Young infants (age < 1 year) and especially neonates
are susceptible to electrolyte disturbance and haemodynamic
alterations.
Cardio-circulatory reactions
Care should also be taken in patients with serious cardiac
disease and pulmonary hypertension as they may develop
haemodynamic changes or arrhythmias. Rarely severe
life-threatening reactions and fatalities of cardiovascular
origin such as cardiac-, cardio-respiratory arrest and
myocardial infarction have occurred.
CNS disturbances
Patients with acute cerebral pathology, tumours or a history of
epilepsy are predisposed for seizures and merit particular care.
Also alcoholics and drug addicts have an increased risk for
seizures and neurological reactions.
In regard to intravascular application care should be taken in
patients with acute stroke or acute intracranial bleeding, in
patients with altered blood brain barrier, cerebral oedema or
acute demyelinisation.
Renal reactions
Major risk factor for contrast medium-induced nephropathy is
underlying renal dysfunction.
Diabetes mellitus and the volume of iodinated contrast medium
administered are contributing factors in the presence of renal
dysfunction. Additional concerns are dehydration, advanced
arteriosclerosis, poor renal perfusion and the presence of other
factors that may be nephrotoxic, such as certain medications
or major surgery.
To prevent acute renal failure following contrast media
administration, special care should be exercised in patients
with pre-existing renal impairment and diabetes mellitus
as they are at risk. Patients with paraproteinemias
(myelomatosis and Waldenström’s macroglobulinemia) are
also at risk.
Preventive measures include:
- Identification of high risk patients
- Ensuring adequate hydration. If necessary by maintaining
an i.v. infusion from before the procedure until the contrast
medium has been cleared by the kidneys.
- Avoiding additional strain on the kidneys in the form of
nephrotoxic drugs, oral cholecystographic agents, arterial
clamping, renal arterial angioplasty, or major surgery, until
the contrast medium has been cleared.
- Dose reducing to a minimum.
- Postponing a repeat contrast medium examination until renal
function returns to pre-examination levels.
Iodinated contrast agents can be used by patients on
haemodialysis as the agents are removed by the dialysis
process.
Diabetic patients receiving metformin:
There is a risk of the development of lactic acidosis when
iodinated contrast agents are administered to diabetic patients
treated with metformin, particularly in those with impaired
renal function. To prevent lactic acidosis, the serum creatinine
level should be measured in diabetic patients treated with
metformin prior to intravascular administration of iodinated
contrast media
Normal serum creatinine (<130μmol/litre)/normal renal
function: Administration of metformin should be stopped at the
time of administration of contrast medium and not resumed for
48 hours unless renal function/serum creatinine remains in the
normal range.

Abnormal serum creatinine (>130μmol/litre)/impaired renal
function: Metformin should be stopped and the contrast
medium examination delayed for 48 hours. Metformin should
only be restarted if renal function is not diminished (if serum
creatinine is not increased) compared to pre-contrast values.
Emergency cases: In emergency cases where renal function is
impaired or unknown, the physician should evaluate the risk/
benefit of the contrast medium examination, and the following
precautions should be implemented: Metformin should be
stopped. The patient should be fully hydrated prior to contrast
medium administration and for 24 hours afterwards. Renal
function (e.g. serum creatinine), serum lactic acid and blood pH
should be monitored. A pH< 7.25 or a lactic acid level of
>5 mmol/litre are indicative of lactic acidosis. The patient
should be observed for symptoms of lactic acidosis. These
include vomiting, somnolence, nausea, epigastric pain,
anorexia, hyperpnoea, lethargy, diarrhoea and thirst.
Impaired renal and hepatic function
Particular care is required in patients with severe disturbance
of both renal and hepatic function as they may have
significantly delayed contrast medium clearance. Patients
on haemodialysis may receive contrast media for radiological
procedures. Correlation of the time of contrast media injection
with the haemodialysis session is unnecessary.
Myasthenia gravis
The administration of iodinated contrast media may aggravate
the symptoms of myasthenia gravis.
Phaeochromocytoma
In patients with phaeochromocytoma undergoing
interventional procedures, alpha blockers should be given as
prophylaxis to avoid a hypertensive crisis.
Disturbances in thyroid function
Patients at risk of thyrotoxicosis should be carefully evaluated
before any use of iodinated contrast medium.
Special care should be exercised in patients with
hyperthyroidism.
Patients with multinodular goitre may be at risk of developing
hyperthyroidism following injection of iodinated contrast
media.
Paediatric population
One should also be aware of the possibility of inducing
transient hypothyroidism in premature infants receiving
contrast media.
Thyroid function should be checked in neonates during the
first week of life, following administration of iodinated contrast
agents to the mother during pregnancy.
Repeat testing of thyroid function is recommended at
2 to 6 weeks of age, particularly in low birth weight newborn
or premature newborn.
See also section 4.6.
Extravasation
It is likely that VISIPAQUE due to its isotonicity gives rise to
less local pain and extravascular oedema than hyperosmolar
contrast media. In case of extravasation, elevating and cooling
the affected site is recommended as routine measures. Surgical
decompression may be necessary in cases of compartment
syndrome.
Observation-time
After contrast medium administration the patient should be
observed for at least 30 minutes, since the majority of serious
side effects occur within this time. However, experience shows
that hypersensitivity reactions may appear up to several
hours or days post injection. The patient should remain in
the hospital environment (but not necessarily the radiology
department) for one hour after the last injection, and should
return to the radiology department if any symptoms develop.
Intrathecal use
Following myelography the patient should rest with the head
and thorax elevated by 20° for one hour. Thereafter he/she
may ambulate carefully but bending down must be avoided.
The head and thorax should be kept elevated for the first
6 hours if remaining in bed. Patients suspected of having a
low seizure threshold should be observed during this period.
Outpatients should not be completely alone for the first
24 hours.
Hysterosalpingography
Hysterosalpingography should not be performed during
pregnancy or in the presence of acute pelvic inflammatory
disease (PID).

Pregnancy and breast-feeding

1183230 GBR
1183230

PACKAGE LEAFLET:
INFORMATION FOR THE USER

IODIXANOL

Visipaque 270 mg I/ml solution for injection
Visipaque 320 mg I/ml solution for injection
Iodixanol

Read all of this leaflet carefully before you
start using Visipaque:

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Visipaque is and what it is used for
Before you use Visipaque
How to use Visipaque
Possible side effects
How to store Visipaque
Further information

1. What Visipaque is and what it is
used for

This medicine is for diagnostic use only. It is used only to
help identify an illness.
Visipaque is a ‘contrast medium’. It is given before an X-ray
to make the picture that your doctor takes clearer.
• Once injected, it can help your doctor tell apart normal
or abnormal appearance and shape of some organs in
your body.
• It can be used for X-rays of your urinary system, spine or
blood vessels, including blood vessels of your heart.
• Some other people are given this medicine before or
during a scan of their head or body using ‘computed
tomography’ (also called a CAT scan). This type of scan
uses X-rays.
• It can also be used to look at your gullet (oesophagus),
stomach and intestine, or for looking in body cavities,
such as in your joints or womb and ovarian tubes.
Your doctor will explain which part of your body will be
scanned.

2. Before you use Visipaque
Do not use Visipaque:

• If you suffer from severe thyroid problems.
• If you are allergic (hypersensitive) to iodixanol or any of
the other ingredients of Visipaque (listed in Section 6).

Take special care with Visipaque

Check with your doctor before having Visipaque:
• If you have ever had an allergic reaction after
a medicine similar to Visipaque, called a ‘contrast
medium’.
• If you have any thyroid problems.
• If you have ever had any allergies.
• If you have asthma.
• If you have diabetes.
• If you have any brain disease or tumours.
• If you have severe heart disease.
• If you have kidney problems, or both liver and kidney
problems.
• If you have an illness called ‘myasthenia gravis’
(a condition causing severe muscle weakness).
• If you have ‘phaeochromocytoma’ (constant or attacks
of high blood pressure due to a rare tumour of your
adrenal gland).
• If you have “homocystinuria” (a condition with
increased excretion of the amino acid cysteine in urine)
• If you have any problems with your blood or your bone
marrow.
• If you have ever been dependent on alcohol or drugs.
• If you have epilepsy.
• If you are having a thyroid function test in the next few
weeks.
• If you are having blood or urine samples taken on the
same day.
If you are not sure if any of the above apply to you, talk to
your doctor before having Visipaque.

Taking other medicines

Please tell your doctor if you are taking other medicines or
if you recently have taken any other medicines.
This includes medicines obtained without a prescription or
medicines bought abroad.
Tell your doctor if you
• Take metformin for diabetes
• Take medicine to inhibit the immune defence,
e.g. in connection with transplantation (interleukin-2).
• Take medicines to lower the blood pressure
(beta blockers)

You must tell your doctor if you are pregnant or think you
may be pregnant. Your doctor will only use this product if it
is considered that the benefit outweighs the risk.
If Visipaque has been given to the mother during
pregnancy, the thyroid function of the newborn should be
tested during the first week after birth. It is recommended
that the testing is repeated again between 2 and 6 weeks
of age in premature and low birth weight newborns.
Breast-feeding may be continued normally after an
examination with Visipaque.

Driving and using machines

Do not drive or use tools or machines after your last
injection of Visipaque for:
• 24 hours after an injection into your skull or spinal cord
(intrathecal examination)
• one hour in all other cases.
This is because you may feel dizzy or have other signs of
a reaction afterwards.

3. How to use Visipaque

Visipaque will always be given to you by a specially trained
and qualified person.
• Visipaque will always be used in a hospital or clinic.
• They will tell you anything you need to know for its safe
use.
Your doctor will decide the dose that is best for you.

The usual dose is:

• One single injection or you may be asked to swallow it.

After you have been given Visipaque

You will be asked:
• to drink plenty of fluids afterwards (to help flush the
medicine from your body), and
• to stay in or around the area where you had your scan
or X-ray for around 15 minutes, and
• to stay in the clinic or hospital for one hour.
If you have any side effects during this time, tell your
doctor straight away (see section 4 “Possible side effects”).
The advice above applies to all patients who have had
Visipaque. If you are not sure about any of the above ask
your doctor.
Visipaque may be given in lots of different ways,
a description of the ways it is usually given can be
found below:

Injection into an artery or vein

Visipaque will most commonly be injected into an arm
vein or leg vein. Sometimes it will be given through a thin
plastic tube (catheter), inserted into an artery usually in
your arm or groin.

Injection into your spine

Visipaque will be injected into the space around your spinal
cord to see your spinal canal.
If you have been given Visipaque into your spine
afterwards you will be asked to follow the advice below:
• to rest with your head and body upright for one hour, or
six hours if you stay in bed, and
• to walk carefully and try not to bend down for six hours,
and
• not to be completely alone for the first 24 hours after
having Visipaque, if you are an outpatient and have
ever had fits.
The advice above applies only if you have had Visipaque
injected into your spine. If you are not sure about any of the
above ask your doctor.

Use in your body cavities or joints

Body cavities may be the joints, uterus and ovarian tubes.
How and where Visipaque is given will vary.

Use by mouth

For examination of the gullet, stomach or small bowel,
Visipaque is normally given by mouth. Visipaque may be
diluted with water for these examinations.

4. Possible side effects

Like all medicines Visipaque can cause side effects,
although not everybody gets them.

Allergic reactions

If you have an allergic reaction when you are in hospital or
a clinic having Visipaque, tell the doctor straight away.
The signs may include:
• wheeziness, difficulty breathing, or tightness or pain in
your chest
• skin rash, lumps, itchy spots, blisters on skin and in
mouth, or other allergic symptoms
• swelling of your face
• dizziness or fainting (caused by low blood pressure)
The above side effects may happen several hours or days
after Visipaque is given. If any of these side effects happen
after you leave the hospital or clinic, go straight to the
casualty department of your nearest hospital.
Other side effects that you may have are listed below,
these depend on how or why Visipaque was given to you.
Ask your doctor if you are not sure how you were given
Visipaque.

Turn over



1183230



1183230 GBR

Uncommon (affects less than 1 in 100 people)
• allergic reaction also known as hypersensitivity
reaction, see “Allergic reactions” above for the signs
• headache,
• flushing
• nausea, vomiting
• feeling hot
• chest pain
Rare (affects less than 1 in 1,000 people)
• feeling dizzy, irregular heartbeats, low blood pressure,
• heart attack
• cough, shivers, fever
• pain and local reactions (where it was injected)
• feeling uncomfortable
Very rare (affects less than 1 in 10,000 people)
• feeling agitated
• anxiety
• stroke
• changes in your senses e.g. eyesight, or hearing or
taste
• fainting
• high blood pressure
• difficulty breathing
• feeling cold
• pain or discomfort around your stomach area
(abdominal pain)
• kidney problems
• arrest of the heart
• short term memory loss
• unease
• tiredness
• tingling sensation
• back pain
• muscle spasm
• decreased blood supply (ischaemia)
• temporary blindness
• reduced eyesight
Unknown (the number of people affected is not known)
• allergic reaction, allergic shock leading to shock and
collapse, see “Allergic reactions” above for the other
signs
• feeling confused
• coma
• difficulty moving around for a while
• cramps
• blood clots (thrombosis)
• pain and swelling of your vein
• severe breathing difficulties (due to fluid in your lungs),
stopped breathing
• pancreatic problems (acute or worsening inflammation
of the pancreas)
• enlarged salivary gland (swelling and tenderness (pain)
of your saliva glands)
• pain in your joints
• pain and local reactions (where it was injected)
• Heart and lung arrest
• Short term brain disorders (encephalopathy) which
can cause confusion, memory loss, hallucinations and
movement problems
• including hallucinations
seizures (fits)
• iodine poisoning ( iodism)

After an injection into your spine

Uncommon (affects less than 1 in 100 people)
• headache (may be severe and lasting for hours)
• vomiting
Unknown (the number of people affected is not known)
• feeling dizzy
• nausea
• shivering
• pain (where it was injected)
• allergic reaction, see “Allergic reactions” above for the
signs
• Short term brain disorders (encephalopathy) including
feeling confused, memory loss, hallucinations and
movement problems
• muscle spasm

After use in body cavities

(such as uterus and ovarian tubes)
Very common (affects more than 1 in 10 people)
• pain around your stomach area
• bleeding from your vagina
Common (affects less than 1 in 10 people)
• headache, feeling sick (nausea), high temperature
Unknown (the number of people affected is not known)
• vomiting
• shivering
• local reactions (where it was injected)
• allergic reaction, see “Allergic reactions” above for the
signs

Document: 1183230 GBR Version: 2 Draft: 3

After injection into your joints

Common (affects less than 1 in 10 people)
• pain where it was injected
Unknown (the number of people affected is not known)
• shivering
• allergic reactions, see “Allergic reactions” above for the
signs

After being given it by mouth

Common (affects less than 1 in 10 people)
• diarrhoea, feeling sick (nausea)
• pain around your stomach area

Uncommon (affects less than 1 in 100 people)
• vomiting
Unknown (the number of people affected is not known)
• shivering
• allergic reaction, see “Allergic reactions” above for the
signs
If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme
at the website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Visipaque

• Keep out of the reach and sight of children.
• Do not use Visipaque after the expiry date which is
stated on the label EXP.
• Store in the outer carton in order to protect from light.

6. Further information
What Visipaque contains

The active substance is iodixanol.
Visipaque 270 mg l/ml contains 550 mg iodixanol per ml
(equivalent to 270 mg iodine per ml).
Visipaque 320 mg l/ml contains 652 mg iodixanol per ml
(equivalent to 320 mg iodine per ml).
The other ingredients are small amounts of trometamol,
sodium chloride, calcium chloride, sodium calcium edetate,
hydrochloric acid (for pH adjustment), and water.

What Visipaque looks like and contents of the
pack
Visipaque is a solution for injection. The product is a clear,
colourless to pale yellow, aqueous solution.
Visipaque is supplied as:
270 mg I/ml
10 vials of 20 ml
10 bottles of 50 ml
10 bottles of 75 ml
1 bottle of 100 ml
10 bottles of 100 ml
1 bottle of 200 ml
6 bottles of 200 ml
1 polypropylene bottle of 50 ml
10 polypropylene bottles of 50 ml
1 polypropylene bottle of 75 ml
10 polypropylene bottles of 75 ml
1 polypropylene bottle of 100 ml
10 polypropylene bottles of 100 ml
1 polypropylene bottle of 150 ml
10 polypropylene bottles of 150 ml
1 polypropylene bottle of 175 ml
10 polypropylene bottles of 175 ml
1 polypropylene bottle of 200 ml
10 polypropylene bottles of 200 ml
320 mg I/ml
10 vials of 20 ml
10 bottles of 50 ml
1 bottle of 100 ml
10 bottles of 100 ml
1 bottle of 200 ml
6 bottles of 200 ml
1 polypropylene bottle of 50 ml
10 polypropylene bottles of 50 ml
1 polypropylene bottle of 75 ml
10 polypropylene bottles of 75 ml
1 polypropylene bottle of 100 ml
10 polypropylene bottles of 100 ml
1 polypropylene bottle of 150 ml
10 polypropylene bottles of 150 ml
1 polypropylene bottle of 175 ml
10 polypropylene bottles of 175 ml
1 polypropylene bottle of 200 ml
10 polypropylene bottles of 200 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
GE Healthcare AS
Nycoveien 1-2
P.O.Box 4220 Nydalen
NO-0401 Oslo, Norway

Manufacturer:

GE Healthcare AS
Nycoveien 1-2
P.O.Box 4220 Nydalen
NO-0401 Oslo, Norway
or
GE Healthcare Ireland
IDA Business Park
Carrigtohill
Co.Cork, Ireland

Local representative:
GE Healthcare Limited
Amersham Place
Little Chalfont,
Buckinghamshire HP7 9NA
England

This leaflet was last approved in July 2015.
Visipaque is a trademark of GE Healthcare.
GE and the GE monogram are trademarks of General
Electric Company.



After an injection into an artery or vein

4.5 Interaction with other medicinal products and other
forms of interaction

A minor transient increase in serum creatinine is common after
iodinated contrast media, but is usually of no clinical relevance.

All iodinated contrast media may interfere with tests on thyroid
function, thus the iodine binding capacity of the thyroid may be
reduced for up to several weeks.

The frequencies of undesirable effects are defined as follows:
Very common (≥1/10), common ((≥1/100 to < 1/10), uncommon
(((≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
(<1/10,000) and not known (cannot be estimated from the
available data).

High concentrations of contrast media in serum and urine
can interfere with laboratory tests for bilirubin, proteins
or inorganic substances (e.g. iron, copper, calcium and
phosphate). These substances should therefore not be assayed
on the day of examination.
Use of iodinated contrast media may result in a transient
impairment of renal function and this may precipitate lactic
acidosis in diabetics who are taking metformin (see section 4.4).
Patients treated with interleukin-2 less than two weeks prior to
an iodinated contrast medium injection have an increased risk
for delayed reactions (flu-like symptoms or skin reactions).
There is some evidence that use of beta blockers is a risk
factor for anaphylactoid reactions to X-ray contrast media
(severe hypotension has been seen with X-ray contrast media
on beta blocker therapy).

4.6 Fertility, Pregnancy and lactation
Pregnancy:
The safety of VISIPAQUE for use in human pregnancy has not
been established. An evaluation of experimental animal studies
does not indicate direct or indirect harmful effects with respect
to reproduction, development of the embryo or foetus, the
course of gestation and peri- and postnatal development.
Since, wherever possible, radiation exposure should be avoided
during pregnancy, the benefits of any X-ray examination, with
or without contrast media, should be carefully weighed against
the possible risk. The product should not be used in pregnancy
unless benefit outweighs risk and it is considered essential by
the physician.
Thyroid function should be checked in neonates during the
first week of life, following administration of iodinated contrast
agents to the mother during pregnancy.
Repeat testing of thyroid function is recommended at
2 to 6 weeks of age, particularly in low birth weight newborn
or premature newborn.
Breast-feeding:
Contrast media are poorly excreted in human breast milk and
minimal amounts are absorbed by the intestine. Breast feeding
may be continued normally when iodinated contrast media are
given to the mother.

4.7 Effects on ability to drive and use machines
No studies on the ability to drive or use machines have been
performed. However, it is not advisable to drive a car or use
machines for one hour after the last injection or during the first
24 hours following intrathecal examination (see section 4.4).

4.8 Undesirable effects
Below are listed possible side effects in relation with
radiographic procedures which include the use of VlSIPAQUE.
Undesirable effects associated with Visipaque are usually mild
to moderate and transient in nature. Serious reactions as well
as fatalities are only seen on very rare occasions, these may
include acute-on-chronic renal failure, acute renal failure,
anaphylactic or anaphylactoid shock, hypersensitivity reaction
followed by cardiac reactions (Kounis’ syndrome), cardiac or
cardio-respiratory arrest and myocardial infarction. Cardiac
reaction may be promoted by the underlying disease or the
procedure.
Hypersensitivity reactions may present as respiratory or
cutaneous symptoms like dyspnoea, rash, erythema, urticaria,
pruritus, skin reactions angioneurotic oedema, hypotension,
fever, laryngeal oedema, bronchospasm or pulmonary oedema.
In patients with autoimmune diseases cases of vasculitis and
SJS-like syndrome were observed.
They may appear either immediately after the injection or up to
a few days later.
Hypersensitivity reactions may occur irrespectively of the dose
and mode of administration and mild symptoms may represent
the first signs of a serious anaphylactoid reaction/shock.
Administration of the contrast medium must be discontinued
immediately and, if necessary, specific therapy instituted via
the vascular access. Patients using beta blockers may present
with atypical symptoms of hypersensitivity which may be
misinterpreted as a vagal reaction.

The listed frequencies are based on internal clinical
documentation and published studies, comprising more than
48,000 patients.

Intravascular administration:
Blood and lymphatic system disorders
Not known: Thrombocytopenia
Immune system disorders:
Uncommon: Hypersensitivity
Not known: Anaphylactoid reaction, anaphylactoid shock;
Psychiatric disorders:
Very rare: Agitation, anxiety
Not known: Confusional state
Nervous system disorders:
Uncommon: Headache
Rare: Dizziness
Very rare: Cerebrovascular accident, sensory abnormalities
including taste disturbance, amnesia, paraesthesia, syncope.
Not known: Coma, motor dysfunction, disturbance in
consciousness, convulsion, transient contrast induced
encephalopathy (including hallucination), tremor.
Eye disorders:
Very rare: Transient cortical blindness, visual impairment
Cardiac disorders:
Rare: Arrhythmia (including bradycardia, tachycardia),
myocardial infarction
Very rare: Cardiac arrest
Not known: Cardiac failure, Ventricular hypokinesia, myocardial
ischaemia, cardio-respiratory arrest, conduction abnormalities,
coronary artery thrombosis, angina pectoris, spasm of
coronary arteries.
Vascular disorders:
Uncommon: Flushing
Rare: Hypotension
Very rare: Hypertension, ischaemia
Not known: Arterial spasm, thrombosis, thrombophlebitis,
shock.
Respiratory, thoracic and mediastinal disorders:
Rare: Cough
Very rare: Dyspnoea
Not known: Pulmonary oedema, respiratory arrest, respiratory
failure.
Gastrointestinal disorders:
Uncommon: Nausea, vomiting
Very rare: Abdominal pain/discomfort
Not known: Acute pancreatitis, pancreatitis aggravated,
salivary gland enlargement
Skin and subcutaneous system disorders
Uncommon: Rash, pruritus, urticaria
Very rare: angioedema, erythema
Not known: Bullous dermatitis, Stevens-Johnson syndrome,
erythema multiforme, toxic epidermal necrolysis, acute
generalised exanthematous pustulosis, drug rash with
eosinophilia and systemic symptoms, drug eruption, dermatitis
allergic, skin exfoliation
Musculoskeletal and connective tissue disorders:
Very rare: Back pain, muscle spasm
Not known: Arthralgia
Renal and urinary disorders:
Very rare: Impairment of renal function including acute renal
failure
General disorders and administration site conditions:
Uncommon: Feeling hot, chest pain.
Rare: Pain, discomfort, shivering (chills), pyrexia, administration
site reactions including extravasation
Very rare: Feeling cold, asthenic conditions
(e.g. malaise, fatigue)
Injury, poisoning and procedural complications:
Not known: Iodism

The frequency is similar to lumbar puncture alone.
Meningeal irritation giving photophobia and meningism and
frank chemical meningitis have been observed with other
non-ionic contrast media. The possibility of infective meningitis
should also be considered.
Immune system disorders:
Not known: Hypersensitivity, including anaphylactic/
anaphylactoid reactions
Nervous system disorders:
Uncommon: Headache (may be severe and lasting)
Not known: Dizziness, transient contrast induced
encephalopathy (including amnesia, hallucinations, confusion)
Gastrointestinal disorders:
Uncommon: Vomiting
Not known: Nausea
Musculoskeletal and connective tissue disorders:
Not known: Muscle spasm
General disorders and administration site conditions:
Not known: Shivering, pain at injection site
Hysterosalpingography (HSG):
Immune system disorders:
Not known: Hypersensitivity
Nervous system disorders:
Common: Headache
Gastrointestinal disorders:
Very common: Abdominal pain
Common: Nausea
Not known: Vomiting
Reproductive system and breast disorders:
Very common: Vaginal haemorrhage
General disorders and administration site conditions:
Common: Pyrexia
Not known: Shivering, injection site reaction

Arthrography:
Immune system disorders:
Not known: Hypersensitivity, including anaphylactic/
anaphylactoid reactions
General disorders and administration site conditions:
Common: Injection site pain
Not known: Shivering

Examination of the GI tract:
Immune system disorders:
Not known: Hypersensitivity, including anaphylactic/
anaphylactoid reactions
Gastrointestinal disorders:
Common: Diarrhoea, abdominal pain, nausea
Uncommon: Vomiting
General disorders and administration site reaction
Not known: Shivering
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation
of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected
adverse reactions via the Yellow Card Scheme at the website:
www.mhra.gov.uk/yellowcard.

injection of iodixanol in healthy volunteers, no significant
deviation from preinjection values has been found. The few
changes observed in the laboratory parameters were minor
and considered to be of no clinical importance.
VISIPAQUE induces only minor effects on renal function in
patients. In 64 diabetic patients with serum creatinine levels
of 115 - 308 μmol/L, VISIPAQUE use resulted in 3% of patients
experiencing a rise in creatinine of ≥44.2 μmol/Land 0% of
patients with a rise of ≥88.4 μmol/L. The release of enzymes
(alkaline phosphatase and N-acetyl-ß-glucosaminidase) from
the proximal tubular cells is less than after injections of
non-ionic monomeric contrast media and the same trend is
seen compared to ionic dimeric contrast media. VISIPAQUE is
also well tolerated by the kidney.

5.2 Pharmacokinetic properties
Iodixanol is rapidly distributed in the body with a mean
distribution half-life of approximately 21 minutes. The apparent
volume of distribution is of the same magnitude as the
extracellular fluid (0.26 l/kg b.w.), indicating that iodixanol is
distributed in the extra-cellular volume only.
No metabolites have been detected. The protein binding is less
than 2%.
The mean elimination half-life is approximately 2 hours
in normal adults. In infants the elimination of iodixanol is
prolonged (t½ approx. 4 hours in newborns). Iodixanol is
excreted mainly through the kidneys by glomerular filtration.
Approximately 80% of the administered dose is recovered
unmetabolised in the urine within 4 hours and 97% within
24 hours after intravenous injection in healthy volunteers.
Only about 1.2% of the injected dose is excreted in faeces
within 72 hours. The maximum urinary concentration appears
within approximately 1 hour after injection.
No dose dependent kinetics have been observed in the
recommended dose range.
After intrathecal administration the half-life of iodixanol is
prolonged reflecting the rate of elimination from the central
nervous system compartment into systemic circulation.
The apparent elimination half-life varies, but with a mean
value around 12 hours.

Intrathecal administration:
Undesirable effects following intrathecal use may be delayed
and present some hours or even days after the procedure.

For most of the haemodynamic, clinical-chemical and
coagulation parameters examined following intravenous

10 vials of 20 ml
10 bottles of 50 ml
1 bottle of 100 ml, 10 bottles of 100 ml
1 bottle of 200 ml, 6 bottles of 200 ml
Polypropylene Containers:
270 mg I/ml:
Bottles with rubber stopper and plastic screw cap:
1 bottle of 50 ml, 10 bottles of 50 ml
1 bottle of 75 ml, 10 bottles of 75 ml
1 bottle of 100 ml, 10 bottles of 100 ml
1 bottle of 150 ml, 10 bottles of 150 ml
1 bottle of 175 ml, 10 bottles of 175 ml
1 bottle of 200 ml, 10 bottles of 200 ml
320 mg I/ml:
Bottles with rubber stopper and plastic screw cap:
1 bottle of 50 ml, 10 bottles of 50 ml
1 bottle of 75 ml, 10 bottles of 75 ml
1 bottle of 100 ml, 10 bottles of 100 ml
1 bottle of 150 ml, 10 bottles of 150 ml
1 bottle of 175 ml, 10 bottles of 175 ml
1 bottle of 200 ml, 10 bottles of 200 ml
Not all pack sizes may be marketed.

6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
The following excipients are included:
Trometamol,
Sodium chloride,
Calcium chloride,
Sodium calcium edetate,
Hydrochloric acid (pH adjustment),
Water for injections.
The pH of the product is 6.8 - 7.6.

6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product
must not be mixed with other medicinal products. A separate
syringe should be used.
The shelf life is 3 years.

The organically bound iodine absorbs radiation in the blood
vessels/tissues when it is injected.

320 mg I/ml:

6.6 Special precautions for disposal and other handling

Overdosage is unlikely in patients with a normal renal function.
The duration of the procedure is important for the renal
tolerability of high doses of contrast media (t½ ~ 2 hours). In the
event of accidental overdosing, the water and electrolyte losses
must be compensated by infusion. Renal function should be
monitored for at least the next 3 days. If needed, haemodialysis
may be used to remove iodixanol from the patient’s system.
There is no specific antidote, treatment of overdose is
symptomatic.

Pharmacotherapeutic group: X-ray contrast medium, iodinated
ATC nr: V08A B09

10 vials of 20 ml
10 bottles of 50 ml
10 bottles of 75 ml
1 bottle of 100 ml, 10 bottles of 100 ml
1 bottle of 200 ml, 6 bottles of 200 ml

Non-clinical data reveal no special hazard for humans based
on conventional studies of safety pharmacology, repeated dose
toxicity, genotoxicity, and toxicity to reproduction.

6.3 Shelf life

5.1 Pharmacodynamic properties

The product is supplied as:
270 mg I/ml:

5.3 Preclinical safety data

4.9 Overdose

5. PHARMACOLOGICAL PROPERTIES

rubber stoppers (Ph.Eur. Type I), and supplied with a screw cap
which is provided with a tamper proof ring.

6.4 Special precautions for storage
Keep the container in the outer carton. The product in glass
containers 40, 50, 75, 100, 150, 175 and 200 ml in polypropylene
bottles can be stored for up to 1 month at 37 ºC, protected from
light.

6.5 Nature and content of container
Glass containers:
The product is filled in injection vials (20 ml) and infusion
bottles (50, 75, 100, and 200 ml). The glass vials/bottles
containers are made of colourless highly resistant borosilicate
glass (Ph.Eur. Type I), closed with black chlorobutyl rubber
stoppers (Ph.Eur. Type I), and sealed with complete tear off
caps with coloured plastic “flip-off” tops.
Polypropylene bottles:
The product is filled in polypropylene bottles. The bottles of
50, 75, 100, 150, 175 and 200 ml are closed with chlorobutyl

Like all parenteral products, Visipaque should be inspected
visually for particulate matter, discolouration and the integrity
of the container prior to use.
The product should be drawn into the syringe immediately
before use. Vials are intended for single use only, any unused
portions must be discarded.
Visipaque may be warmed to body temperature (37°C) before
administration. Any unused
product or waste material should be disposed of in accordance
with local requirements.

7. MARKETING AUTHORISATION HOLDER
GE Healthcare AS
Nycoveien 1-2
P.O. Box 4220 Nydalen
NO-0401 OSLO
NORWAY
LOCAL REPRESENTATIVE
GE Healthcare Ltd.
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
Telephone: 1494 544 000
Telefax: 1494 542 266

8. MARKETING AUTHORISATION NUMBER(S)
PL 00637/0018 (270 mg I/ml glass+USB
PL 00637/0019 (320 mg I/ml glass+USB

9. DATE OF FIRST AUTHORISATION/RENEWAL OF
THE AUTHORISATION
31 March 1993

10. DATE OF REVISION OF THE TEXT
10-Apr-2015
1183230 GBR

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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