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Active substance: IOPAMIDOL

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Package leaflet:
Information for the user
Scanlux 300mg Iodine/ml,
340mg Iodine/ml,
370mg Iodine/ml,
solution for injection
Read all of this leaflet carefully before
you start using this medicine because it
contains important information for
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or nurse.
• 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 nurse. This includes any
possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1. What Scanlux Injection is and what it is used
2. What you need to know before you are given
Scanlux Injection
3. How Scanlux Injection is given
4. Possible side effects
5. How to store Scanlux Injection
6. Contents of the pack and other information

Other medicines and Scanlux Injection
Before you are given Scanlux Injection, please tell
your doctor or radiographer if you have taken, or
been treated recently with any of the following:
• Other X-ray contrast media
• Papaverine
• Medicines for diabetes such as metformin
• Interleukin-2 (used to treat certain cancers)
• Beta-blockers and/or ACE-inhibitors and/or diuretics (for high blood pressure or angina)
• Medicines which change heart rhythm e.g.
amiodarone, cisapride, haloperidol.
You should stop taking the following medicines 48
hours before being given Scanlux Injection. You
should start taking them again 24 hours after your
X-ray examination:
• Medicines for epilepsy
• Medicines for depression such as tricyclic antidepressants or monoamine oxidase inhibitors.
• Medicines for treating mental illnesses
Please tell your doctor or radiographer if you are
taking or have recently taken, any other medicines
including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you are pregnant, or you
are breast-feeding, you should tell your doctor or
radiographer before you are given this medicine.
Driving and using machines
After being given this medicine, you should not
drive or use machinery for at least one hour –
longer if you don’t feel well enough.
3. How Scanlux Injection is given

1. What Scanlux Injection is and what it is
used for
Scanlux is one of a group of medicines called X-ray
contrast media. It contains the active substance
Iopamidol, which comprises about 49% iodine.

You will be given Scanlux before or during your
X-ray examination. The doctor or nurse will inject
the medicine onto a vein or artery.
After your examination, you will probably be asked
to rest quietly for about 30 minutes.

You will be given Scanlux Injection before or during
your X-ray examination. When it is injected into
the body, it shows up very well on an X-ray (because iodine blocks X-rays) and is used to help
doctors to decide what the problem is.

The amount injected depends on where the medicine is being injected and which investigation it is
being used for.

The following is a list of the most common uses of
• Examinations of the blood vessels
• Examinations of the heart and its blood vessels
• Brain or whole body scanning
• Examination of the bladder and urinary tract.

You may be given an injection of up to 100ml of
Scanlux depending on the type of examination you
are undergoing. In some cases, you may be given a
second injection.

2. What you need to know before you are
given Scanlux Injection
You should not be given Scanlux Injection if:
• you are allergic to iopamidol or any of the other
ingredients of this medicine (listed in section 6).
• you have an overactive thyroid gland
Warnings and precautions
Take special care with Scanlux Injection:
Before you are given Scanlux Injection, you should
tell the doctor or radiographer if any of the following apply to you:
• you ever had an allergic reaction to any other
contrast medium
• you have any other allergies
• you are pregnant or think you might be pregnant
• you have asthma, epilepsy, or diabetes
• you have a brain disease or brain tumour
• you have problems with your heart, lungs, liver,
or kidneys
• you have a condition called ‘myasthenia gravis’
(causing severe muscle weakness)
• you have a tumour near the kidney
• you have any blood or bone marrow disorders
• you have previously been treated for an overactive thyroid gland
• you have high levels of calcium in your blood
• you have a disease of the blood vessels, especially the arteries that supply the brain
• you have high blood pressure
• you have homocystinuria (an inherited condition
affecting the muscles, nervous system and heart)
• you suffer from alcoholism
• you are going to have a blood test (as Scanlux
may affect the results)
Before being given Scanlux Injection
• It is important that you drink plenty of non-alcoholic fluids the day before your examination with
Scanlux and also after the procedure.
• If you need to have a thyroid function test in the
next weeks after your examination with Scanlux,
please tell the doctor before the test.
Particular care should be taken in children under 1
year of age and in the elderly. These groups might
be susceptible to adverse side effects.

Children may be given up to 2.5ml per kg of their
bodyweight depending on the type of examination.
If you think you have been given too much of
this medicine
This is unlikely to happen but if it does, the doctor
will treat any symptoms that follow.
4. Possible side effects
Like all medicines, Scanlux can cause side effects,
although not everybody gets them.
Tell your doctor straight away if you get any
sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body). These are
signs of an allergic reaction which can be serious
and might require medical treatment.
Allergic reactions may develop up to several days
after you are given Scanlux. If you develop such
reactions please consult a physician.
A widespread rash with blisters and peeling skin,
particularly around the mouth, nose, eyes and
genitals (Stevens-Johnson syndrome), and a more
severe form, causing extensive peeling of the skin
(more than 30% of the body surface-toxic epidermal necrolysis) might occur. Further, skin rash,
which may blister, and looks like small targets
(central dark spots surrounded by a paler area, with
a dark ring around the edge - erythema multiforme)
might appear.
The following side effects have been reported
following injection of Iopamidol, solution for
Common: (more than 1 out of 100 persons and
less than 1 out of 10 persons)
• headache
• feeling sick (nausea)
• feeling hot
Uncommon: (more than 1 out 1,000 persons and
less than 1 out of 100 persons)
• dizziness
• problems with sense of taste
• changes in heart rhythm

Scanlux® 300 mg I/ml

Size: 570 x 460 mm

Product summary

clotting and thromboembolic events during
angiographic techniques. Factors such as length
of procedure, catheter and syringe material,
underlying disease state, and concomitant
medications may contribute to the development
of thromboembolic events. Therefore, 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.

Scanlux 300 mg I/ml, solution for injection
One ml of solution for injection contains 612 mg
Iopamidol corresponding to 300 mg Iodine.
Osmolality at 37 °C
Viscosity at 37 °C

635.9 mosmol/kg
4.5 mPas

Method of administration
No other drugs or contrast media should be
mixed with iopamidol solution for injection.

For the full list of excipients, see section 6.1.
Solution for injection

Peripheral arteriography and phlebography
Percutaneous injection into the appropriate
blood vessel is used for visualisation of peripheral arteries and veins.

Scanlux is a clear, colourless to pale yellow
solution free from visible particles.
4.1 Therapeutic indications
This medicinal product is for diagnostic use
X-ray contrast media for peripheral arteriography and venography, angiocardiography, digital
subtraction angiography, left ventriculography
and coronary arteriography, computer tomography enhancement and urography.

Computer tomography enhancement
Contrast enhancement for brain scans can be
achieved between one and three minutes after
i.v. injection. Scanlux injection is also used for
total body scanning examinations after i.v.
administration as a bolus, as a drip infusion or
by a combination of the two methods.
The contrast medium is injected intravenously
and rapidly eliminated through the kidneys. In
patients with severe renal failure, high dose
urography should be used.

4.2 Posology and method of administration
For intravenous or intra arterial use.
The dosage must be adapted to the examination, the age, body weight, cardiac output, renal
function, general condition of the patient and
the technique used.
Usually the same iodine concentration and
volume are used as for other iodinated X-ray
contrast media in current use.
The Special Warnings and Precautions for Use
detailed in section 4.4 must be considered
before administering this product. All patients
should be observed for 20 to 30 minutes after
the procedure, as most of the adverse events
occur in this period.
In patients with suspected or known hypersensitivity to contrast media, sensitivity testing is
not recommended, as severe or fatal reactions
to contrast media are not predictable from
sensitivity tests.
Caution during injection of contrast media is
necessary to avoid extravasation.
As with all contrast media, the lowest dose
necessary to obtain adequate visualisation
should be used. The total volume that must not
be exceeded is 250 ml. There are no special
dosage requirements for elderly patients.

4.3 Contraindications
Iopamidol is strictly contraindicated in patients
with manifest hyperthyroidism.
Hypersensitivity to the active ingredient
iopamidol and/or iodine or to any of the
excipients listed in section 6.1.
4.4 Special warnings and precautions for use
As with all other contrast media this product
may provoke anaphylaxis or other manifestations of allergy with nausea, vomiting, dyspnoea, erythema, urticaria and hypotension.
Occasional severe reactions with fatal outcome
have been reported. A positive history of
allergy, asthma or untoward reaction during
previous similar investigations indicates a need
for extra caution; the benefit should clearly
outweigh the risk in such patients. Pre-treatment with antihistamines or corticosteroids to
prevent or minimise possible allergic reactions
in such patients may be considered. Appropriate resuscitative measures should be immediately available.

Non-ionic contrast media should not be allowed
to remain in contact with blood in the syringe
or intravascular catheters which should be
flushed frequently to minimize the risk of

Patients must be sufficiently hydrated before
and after radiographic procedures. Patients
with severe functional impairment of the liver
or myocardium, myelomatosis, diabetes,
polyuria or oliguria, hyperuricemia, infants,
elderly patients and patients with severe

The following doses are recommended as a guide.

Iopamidol solution for
Injection product



300, 340 or 370 mg Iodine/ml

Angiocardiography &
left ventriculography
Digital Subtraction
Intra-arterial injection

340 or 370 mg Iodine/ml

Adults 20-50 ml*
Adults 20-50 ml*
Adults 30-80 ml*
Adults 4-8 ml per artery*

Intra-venous injection

340 or 370 mg Iodine/ml

Left ventriculography

300, 340 or 370 mg Iodine/ml

Selective coronary
arteriography by
intra-arterial DSA
Computed Tomography
Brain Scanning
Whole Body Scanning
Intravenous Urography

300 mg Iodine/ml

340 or 370 mg Iodine/ml

300 mg Iodine/ml

340 or 370 mg Iodine/ml

340 mg Iodine/ml
300 mg Iodine/ml
300, 340 or 370 mg Iodine/ml

Adults 0.5-20 ml
Children 0.25-0.375 ml/kg
Adults 30-50 ml
Children 0.5-0.75 ml/kg**
Adults 25 ml
Children 0.5-0.75 ml/kg
Adults 2-5 ml

Adults 50-100 ml
Adults 40-100 ml
Adults 40-80 ml
In severe renal failure the usual high dose
methods should be employed (up to 1.5 ml/kg)
Children 1-2.5 ml/kg**

* Repeat as necessary.
** Proportional to the adult dose according to body size and age.
*** Procedure not normally applicable to children.

systemic disease should not be exposed to
dehydration. Fluid intake should not be limited
and any abnormalities of fluid or electrolyte
balance should be corrected prior to use of this
hypertonic solution.
As experience shows that warmed contrast
media are better tolerated, the contrast
medium should be warmed up to body temperature before administration.
Care should be exercised in patients with
moderate to severe impairment of renal
function. Pre-existing renal impairment may
predispose to acute renal dysfunction following
contrast media administration.
In patients with impairment of renal function,
the administration of potentially nephrotoxic
drugs should be avoided until the contrast
medium is completely excreted. In such
patients, renal function parameters should be
monitored after the procedure. Further administration of contrast media should be postponed
until renal function has returned to its previous

thyroid function.
In patients scheduled for thyroid examination
and/or treatment with a radioactive iodinetracer, iodine update in the thyroid gland will be
reduced for several days, sometimes up to 2
weeks after dosing with an iodinated contrast
medium that is eliminated through the kidneys.
Caution should be exercised in performing
iodinated contrast-enhanced examinations in
patients with, or with suspicion of, hyperthyroidism or autonomously functioning thyroid
nodule(s), as thyroid storms have been reported
following administration of iodinated contrast
media. It is possible that hyperthyroidism may
recur in patients previously treated for Graves’
disease. In patients with hyperthyroidism, the
radiological examination should be performed
only if thought necessary by the physician.
Patients with phaeochromocytoma can develop
severe hypertensive crises following intravascular iopamidol administration. Premedication
with α-receptor blockers is recommended.

Patients with severe hepatic, renal or combined
hepato-renal insufficiency should not be
examined unless absolutely indicated. Re-examination should be delayed for 5-7 days.
Patients on dialysis may receive contrast media
such as iopamidol, which can be removed
without difficulty by dialysis.
The presence of renal damage in diabetic
patients is one of the factors predisposing to
acute renal impairment following intravascular
contrast media administration. This may
precipitate lactic acidosis in patients who are
taking biguanides (see section 4.5).

Patients with paraproteinaemia of Waldenström, with multiple myeloma or severely
compromised hepatic and renal impairment are
also more at risk: in these cases adequate
hydration is recommended after contrast
medium administration.
To prevent crises in patients with sickle cell
disease adequate hydration should be assured
and a minimal volume of low concentration
should be used.

The risk associated with a particular investigation may be increased by conditions such as
advanced arteriosclerosis and hypertension.

As in the case of all iodinated contrast agents,
iopamidol can cause severe or fatal intolerance
reactions. During the examination an intravenous route for emergency treatment in the
event of a reaction is required. After the
administration of the contrast medium,
competent personnel, drugs and equipment for
emergency resuscitation must be available.
Diagnostic procedures which involve the use of
any radiopaque medium should be carried out
under the direction of personnel with the
prerequisite training and with a thorough
knowledge of the particular procedure to be
performed. Appropriate facilities should be
available for coping with any complication of
the procedure, as well as for emergency
treatment of severe reaction to the contrast
medium itself.

In patients undergoing angiocardiographic
procedures special attention should be paid to
the status of the right heart and pulmonary
circulation. Right heart insufficiency and
pulmonary hypertension may precipitate
bradycardia and systemic hypotension, when
the organic iodine solution is injected. Right
heart angiography should be carried out only
when absolutely indicated.
Great caution should be paid when injecting the
contrast medium into the heart chambers,
especially in cyanotic neonates with pulmonary
hypertension and impaired cardiac function.
During intracardiac and/or coronary arteriography, ventricular arrhythmias may infrequently
In angiographic procedures, the possibility of
dislodging plaque or damaging or perforating
the vessel wall should be considered during
catheter manipulation and contrast medium
injection. Test injections to ensure proper
catheter placement are recommended. In
examinations of the aortic arch, the tip of the
catheter should be positioned carefully to avoid
hypotension, bradycardia and CNS injury due to
excess pressure transmitted from the injector
pump to the brachiocephalic branches of the
Angiography should be avoided whenever
possible in patients with homocystinuria due to
an increased risk of thrombosis and embolism.
In patients undergoing peripheral angiography,
there should be pulsation in the artery into
which the X-ray contrast medium will be
injected. In patients with thromboangiitis obliterans or ascending infections in combination
with serious ischaemia the angiography should
be performed, if at all, with special caution.
In patients undergoing venography, special
caution should be exercised in patients with
suspected phlebitis, serious ischaemia, local
infections, or a complete venous occlusion.
Patients who are known epileptic or have a
history of epilepsy should have their medicine
maintained. In some instances, anticonvulsant
therapy may be increased for 48 hours before
the examination.
Iopamidol should be administered with caution
in patients with symptomatic cerebrovascular
diseases, recent stroke, or frequent TIA, altered
permeability of the blood-brain barrier,
increased intracranial pressure, suspicion of
intracranial tumor, abscess or hematoma/
hemorrhage, history of convulsive disorder,
Use of this product may interfere with tests for

Local tissue irritation can occur in the case of
perivascular infiltration of the contrast media.

Patients with congestive heart failure should be
observed for several hours following the
procedure to detect delayed haemodynamic
disturbances, which may be associated with a
transitory increase in the circulating osmotic
load. All other patients should be observed
for at least 20-30 minutes after the procedure, as most of the adverse events occur in
this period. The patient should also be
informed that allergic reactions may develop up
to several days after the procedure; in such
case, a physician should be consulted immediately.
The administration of iodinated contrast media
may aggravate the symptoms of myasthenia
Iopamidol injection should be used with caution
in patients with hypercalcaemia and cerebral
vascular disease.
Vasospasm and subsequent cerebral ischemic
phenomena may be caused by intra-arterial
injections of contrast media.
No other drugs or contrast media should be
mixed with iopamidol solution for injection (see
section 6.2).
This medicinal product contains less than 1
mmol of sodium (23 mg) per maximum 250 ml
dose, i.e. essentially “sodium-free”.
Use in Special Populations
Newborns, children
Infants (age<1year), and especially newborns
are particularly susceptible to electrolyte imbalances and haemodynamic alterations. Care
should be taken regarding the dosage to be
used, the details of the procedure, and the
patient’s status
In neonates, and particularly in premature
neonates, it is recommended that tests of
thyroid function (typically TSH and T4), should
be checked 7-10 days and 1 month after the

administration of iodinated contrast media
because of the risk of hypothyroidism due to
iodine overload.
The elderly are at special risk of reactions due
to reduced physiological functions, especially
when high dosage of contrast medium is used.
Myocardial ischemia, major arrhythmias and
premature ventricular complexes are more likely
to occur in these patients. The probability of
acute renal insufficiency is higher in these
Women of child-bearing potential
Appropriate investigations and measures should
be taken when exposing women of childbearing
potential to any X-ray examination, whether
with or without contrast medium.
4.5 Interaction with other medicinal products
and other forms of interaction
Following administration of iopamidol, the
capacity of the thyroid tissue to take up iodine
is reduced for 2 – 6 weeks.
Arterial thrombosis has been reported when
iopamidol was given following papaverine.
The administration of vasopressors strongly
potentiates the neurological effects of intraarterial contrast media.
Renal toxicity has been reported in patients
with liver dysfunction who were given oral
cholecystographic agents followed by intravascular contrast agents. Therefore, administration
of intravascular contrast agents should be
postponed in patients who have recently been
given a cholecystographic contrast agent.
Contrast media may interfere with laboratory
tests for bilirubin, proteins or inorganic
substances (e.g. iron, copper, calcium, phosphate). These substances should not be assayed
during the same day following the administration of contrast media.
To prevent onset of lactic acidosis in diabetic
patients under treatment with oral anti-diabetic
agents of the biguanide class, biguanides should
be stopped 48 hours before the administration
of the contrast medium and re-instated only
after renal function has been demonstrated to
have returned to pre-examination values (see
section 4.4).
In patients receiving beta-blockers there is an
elevated risk of more severe anaphylactoid
Cardiac and/or hypertensive patients under
treatment with diuretics, ACE-inhibitors, and/or
beta-blocking agents are at higher risk of
adverse reactions when administered iodinated
contrast media.
Following administration of iopamidol atypical
adverse reactions e.g. erythema, fever and flu
symptoms have been reported in patients
treated with interleukin-2.
There is an elevated risk of seizures in patients
with epilepsy or cerebral focal lesions treated
with specific psychotropic drugs e.g. antipsychotic and analeptic drugs, tricyclic antidepressants and monoamine oxidase inhibitors. Such
agents should be suspended- if possible - 48
hours before iopamidol administration and
resumed 24 hours later.
Iopamidol should not be co administered with
other drugs that are also known to prolong the
QT interval because of the increased risk of
4.6 Fertility, pregnancy and lactation
The safety of iopamidol injection during
pregnancy has not been established. Since
radiation exposure during pregnancy should be
avoided anyway, regardless of whether a
contrast agent is used or not, the benefit of
X-ray examination has to be considered
carefully. Apart from radiation exposure of the
foetus, benefit-risk consideration for iodine-containing contrast agents should also
take into account the sensitivity of the foetal
thyroid towards iodine.
Iodine-containing x-ray contrast agents are
excreted into the breast milk in low amounts. It
is recommended that they are administered to
lactating women only if considered essential by
the physician. Breast-feeding should be
stopped for 48 hours after administration of the
contrast medium.

Scanlux® 300 mg I/ml

– if necessary – specific treatment initiated via
a venous access. More severe reactions
involving the cardiovascular system such as
vasodilatation with pronounced hypotension,
tachycardia, dyspnoea, agitation, cyanosis and
loss of consciousness (syncope) may require
emergency treatment. Hypersensitivity reactions are more frequent in patients with an
allergic disposition or who have shown hypersensitivity reactions during a previous examination with an iodinated contrast agent.

4.8 Undesirable effects
Iopamidol may cause adverse reactions, which are generally mild or
moderate and transient although rare
severe and life-threatening reactions
sometimes leading to death have been

Injection site pain and swelling may occur. On
very rare occasions extravasation of contrast
medium led to inflammation (manifested with
local erythema, oedema and blisters), skin
necrosis and compartment syndrome.

Following intravascular administration, in most
cases reactions occur within minutes of dosage.
However, delayed reactions, usually involving
skin, may occur, mostly within 2-3 days, more
rarely within 7 days, after the administration of
the contrast medium.

As with other iodinated contrast media, very
rare cases of mucocutaneous syndromes,
including Stevens-Johnson syndrome, toxic
epidermal necrolysis (Lyell syndrome) and
erythema multiforme, have been reported
following the administration of Iopamidol.

Anaphylaxis (anaphylactoid reactions/hypersensitivity) may manifest with: mild localized or
more diffuse angioneurotic oedema, tongue
oedema, laryngospasm or laryngeal oedema,
dysphagia, pharyngitis and throat tightness,
pharyngolaryngeal pain, cough, conjunctivitis,
rhinitis, sneezing, feeling hot, sweating increased, asthenia, dizziness, pallor, dyspnoea,
wheezing, bronchospasm, and moderate
hypotension. Skin reactions may occur in the
form of various types of rash, diffuse erythema,
diffuse blisters, urticaria, and pruritus. These
reactions, which occur irrespective of the dose
administered and the route of administration,
may represent the first signs of incipient state
of shock. Administration of the contrast
medium must be discontinued immediately and

Organ Class

In clinical trials, the most commonly reported
adverse reactions are headache (1.5 %), nausea
(1.2 %) and feeling hot (3.5%) after intravascular administration.
The adverse reactions reported in clinical trials
among 2,680 adult subjects and 35 paediatric
patients, and from post marketing surveillance
are presented in the tables below by frequency
and classified by MedDRA system organ classes.
Within each frequency grouping, adverse
reactions are presented in order of decreasing
Adult patients involved in clinical trials with
intravascular administration of Iopamidol were
2,548, of whom 1,597 with intra-arterial and
951 with intravenous administration.

Adverse Reactions

Clinical Trials
to <1/10

≥1/1,000 to <1/100

Blood and
lymphatic system
Immune system
Nervous system

to <1/1,000

Anaphylactoid reaction
Confusional state


Taste alteration


Eye disorders
Cardiac dysrhythmias such as
extrasystoles, atrial
fibrillation, ventricular tachycardia
and ventricular
Hypotension, Hypertension, Flushing


thoracic and
Skin and subcutaneous tissue
and connective
tissue disorders
Renal and urinary
General disorders
and administration
site conditions

Frequency unknown*


oedema, Asthma,


Vomiting, Diarrhea,
Abdominal pain, Dry
Rash, Urticaria,
Pruritus, Erythema,
Sweating increased
Back pain

Coma, Transient ischaemic
attack, Syncope, Depressed
level of consciousness
or loss of consciousness,
Blindness transient, Visual
disturbance, Conjunctivitis,
Myocardial ischaemia or
infarction, Cardiac failure,
Cardio-respiratory arrest,
Circulatory collapse or
Respiratory arrest, Respiratory failure, Acute respiratory distress syndrome,
Respiratory distress,
Apnoea, Laryngeal oedema,
Salivary hypersecretion,
Salivary gland enlargement
Face oedema

Muscle spasms

Musculoskeletal pain, Muscular weakness

Acute renal failure
Feeling hot

Chest pain, Injection site pain,
Pyrexia, Feeling cold
Blood creatinine

Rigors, Pain, Malaise
Electrocardiogram change
including ST segment

* Since the reactions were not observed during clinical trials with 2,548 patients, best estimate is that their
relative occurrence is rare (≥1/10,000 to <1/1000). The most appropriate MedDRA term is used to describe a
certain reaction and its symptoms and related conditions.
** Cardiac dysrhythmias may occur mostly after cardiac angiographic and coronary catheterization procedures

In addition, the following adverse events can
occur with unknown frequency:
Metabolism and nutrition disorders:
Acidosis, abnormalities in blood electrolyte
Nervous system disorders:
amnesia, paresis and paralysis, tremors,
Eye disorders:
watery/itchy eyes, lacrimation.
Ear and labyrinth disorders:
Impaired hearing, echoacousia, progressive
transitory hearing loss or other auditory
Gastrointestinal disorders:
Anorexia, severe retching and choking.
Renal and urinary disorders:
Transient changes in renal chemistry tests
indicating renal impairment, anuria, oliguria,
urinary retention or incontinence, pain,

Iopamidol is a second generation, non-ionic
radiographic contrast medium that is stable in
solution. Because of its non-ionic character, it
lacks charged particles and is lower in osmolality than ionic agents of equivalent iodine
concentration. Results of clinical and animal
studies have indicated that Iopamidol causes
less disturbance of cardiac function than do
ionic contrast agents.
There is no evidence of teratogenic effects in
rats or rabbits and no evidence of mutagenicity
in the micronucleus test. However, there is
evidence that, in common with all other
iodinated contrast agents, Iopamidol Injection
is able to produce a synergistic cytotoxicity in
the presence of X-radiation. Chromosomal
injury in human lymphocytes has been described in-vitro and in-vivo. The clinical
significance of these observations is unclear.
Iopamidol Injection has no conventional clinical
pharmacology, its intended action being a
passive one of increasing the absorption of
X-radiation by the tissues. It does, however,
have a variety of incidental physiological,
biochemical and haematological effects.

Mainly after cardiovascular procedures/
haemodynamic changes manifested with
hypotension decreased systolic pressure,
increase of left ventricular end diastolic
pressure, transient ischemic attack, electrocardiographic changes including S-T segment
depression, increased QT, increased R-R, T-wave
Mostly after cardiac angiographic and coronary
catheterisation procedures: angina pectoris,
thrombophlebitis, cardiopulmonary arrest,
arterial spasms, flushing, vasodilation, cyanosis.
Other cardiovascular reactions may occur as a
consequence of the procedural hazard, these
include haemorrhage or pseudoaneurysms at
the puncture site, brachial plexus paralysis
following axillary artery punctures, arterial
thrombosis, displacement of arterial plaques
and serious thromboembolic events, venous
thrombosis. Dissection of the coronary vessels
and transient sinus arrest are rare complications.

5.2 Pharmacokinetic properties
Iopamidol is rapidly absorbed into the bloodstream from cerebrospinal fluid (CSF); following
intrathecal administration, iopamidol appears in
plasma within one hour and virtually all of the
drug reaches the systemic circulation within 24

There is an increased risk of severe reactions in
patients with severe cardiac disease, particularly in those with heart failure or coronary artery
disease. The intravascular contrast medium
injection can induce pulmonary oedema in
patients with manifest heart failure, whereas
contrast medium administration in pulmonary
hypertension and valvular heart diseases can
lead to pronounced haemodynamic changes.
Ischaemic ECG changes and major arrhythmias
are most common in elderly patients and in
those with pre-existing heart disease.

Iopamidol is excreted mainly through the
kidneys following intrathecal administration,
and the drug is essentially undetectable in the
plasma 48 hours later. In the absence of renal
dysfunction, the cumulative urinary excretion
for iopamidol, expressed as a percentage of
administered intravenous dose, is approximately
35 to 40 percent at 60 minutes, 80 to 90
percent at 8 hours, and 90 percent or more in
the 72 to 96 hour period after administration.
In normal subjects, approximately 1 percent or
less of the administered dose appears in
cumulative 72 to 96 hour faecal specimens.
No evidence of in vivo complement activation
has been found in normal subjects.

Paediatric patients:
The Iopamidol safety profile is similar in
children and adults.
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, Website:
4.9 Overdose
Treatment of overdose is directed toward the
immediate symptomatic therapy, support of all
vital functions and the elimination of the
contrast medium while keeping the patient well
Dosages exceeding the specific package insert
dose are not recommended, as they might lead
to life-threatening adverse effects. If needed,
hemodialysis can be used to eliminate iopamidol from the body. Treatment of overdosage is
directed toward the support of all vital functions and prompt institution of symptomatic
In the event of accidental intravascular
overdose in humans, the water and electrolyte
losses must be compensated by infusion. Renal
function should be monitored for at least three
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Watersoluble,
nephrotropic, low osmolar X-ray contrast
media, ATC code: V08AB04

Iopamidol injection is distributed throughout
the extracellular fluid but does not enter cells.
The volume of distribution is 0.28 l/kg and its
plasma half-life is 121 minutes, which is
prolonged in renal impairment. Iopamidol
displays little tendency to bind to serum or
plasma proteins. Animal studies indicate that
iopamidol does not cross the blood-brain
barrier to any significant extent following
intravascular administration.
Iopamidol is excreted unchanged.

5.3 Preclinical safety data
Intravenous LD50 -values in various animal
species were determined to be approximately
15-35 times the maximum clinical dose.
Iopamidol did not show a teratogenic potential.
In rats, dosages above 1.5 g/kg iodine had
embryotoxic effect and reduced the number of
live foetuses and their weights. In rabbits, the
weights of the foetuses were reduced at a
dosage of 2.0 g/kg iodine.
Iopamidol did not impair the fertility of rats and
the peri- and postnatal development of their
offspring. However, in mice a reversible
impairment of spermatogenesis was observed
after a single dose of iopamidol.
Local tolerance:
The local pharmaceutical tolerance of Iopamidol, 370 mg Iodine/ml, was examined in rats
after intravascular injection into the aorta. In
comparison with ionic imaging agents the
pharmaceutical tolerance of Iopamidol was
equal or better.
Accidental paravascular injection can cause a
local swelling, pain and erythema. Normally
these reactions will abate without complications. Supporting the concerned extremity in a
raised position and treating with cold compresses are favourable measures.

6.1 List of excipients
Trometamol, Hydrochloric acid, Sodium calcium
edetate, Water for injections.
6.2 Incompatibilities
Many radio-opaque contrast agents are
incompatible in vitro with some antihistamines
and many other drugs; therefore, no other
pharmaceuticals should be admixed with
contrast agents.
6.3 Shelf life
2 years
After first opening, the product should be used
6.4 Special precautions for storage
Protect the solution from light and X-rays.
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
Scanlux 300 mg I/ml is available in 50 ml, 75 ml,
100 ml and 200 ml clear Type II glass bottles
with bromobutyl stoppers, either individually or
in the following pack sizes:
10 x 50 ml, 10 x 75 ml, 10 x 100 ml, 10 x 200 ml,
20 x 50 ml, 20 x 75 ml, 20 x 100 ml, 20 x 200 ml,
30 x 50 ml, 30 x 75 ml, 30 x 100 ml, 30 x 200 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Scanlux 300 mg I/ml Injection is intended for
single use only; any unused portions should be
Discard if solution is not free from particulate
The product should be introduced into the
syringe immediately before use.
Iodinated contrast media can react with
metallic surfaces containing copper (e.g. brass),
therefore the use of equipment in which
iopamidol comes into contact with such
surfaces should be avoided.
Sanochemia Pharmazeutika AG
Boltzmanngasse 11
1090 Vienna
PL 19206/0001

4.7 Effects on ability to drive and use
There is no known effect on the ability
to drive and operate machines.
However, because of the risk of early
reactions, driving or operating
machinery is not advisable for one
hour following the last injection.

low and high blood pressure
abdominal pain
dry mouth
itching; skin rash, urge to itch, rednesss of the
increased sweating
back pain
kidney failure
chest pain, injection site pain
feeling cold
abnormal laboratory test results for creatinine
(this can be detected by a test carried out by a

Rare: (more than 1 out 10,000 persons and less
than 1 out of 1,000 persons)
• confusion
• sensation of tingling, pricking or numbness
• slow heart beat
• pulmonary oedema (difficulty breathing, coughing, accelerated breathing)
• asthma
• difficulty in breathing
• muscle cramps
Not known: (cannot be estimated).
• reduced blood platelet count (this can be
detected by a test carried out by a doctor),
• allergic reaction
• coma
• mini-stroke
• fainting, low level of consciousness, loss of
• temporary loss of vision, vision difficulties,
inflamed eyes, excessive sensitivity to light,
watery/itchy eyes
• heart attack, heart failure, the cessation of
normal circulation of the blood due to failure of
the heart to contract effectively, increased heart
• failure of the blood circulation
• stopped breathing, respiratory failure, acute
respiratory distress syndrome (a severe lung
disease), abnormal breathing, suspension of
breathing, shortness of breath
• swelling of the throat, swelling of the face,
swollen salivary glands
• increased salivation
• pain in the bones, muscles, ligaments, tendons
and /or nerves
• pain, feeling of general discomfort or uneasiness
• abnormal electrocardiogram (this can be
detected by a test carried out by a doctor)
• abnormalities in blood tests
• memory loss
• paresis, paralysis, tremor (shivering), seizures,
muscular rigidity
• effects on hearing including difficulty or loss of
hearing, or hearing echos
• loss of appetite, retching and choecking
• transient changes in renal function test, changed
frequency of urination, incontinence, pain, blood
in urine
• changes in blood flow
The following side effects have occurred mainly
after examinations of the heart and its blood
• fast or slow heartbeat
• low or high blood pressure
• heart attack, heart failure or collapse due to very
low blood pressure
• stroke
• changes in heart rhythm
• swelling and tenderness along a vein
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme, Website:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Scanlux Injection
Keep this medicine out of the sight and reach of
Do not use Scanlux after the expiry date which is
printed on the label and carton.
Protect the solution from light and X-rays. Do not
store above 25°C. Store in the original package.
Your doctor, pharmacist or nurse will know how to
store Scanlux Injection properly.

6. Contents of the pack and other information
What Scanlux Injection contains
- The active substance is iopamidol (equivalent to
300, 340, or 370mg iodine/ml)
- The other ingredients are trometamol, sodium
calcium edetate, hydrochloric acid and water for
What Scanlux Injection looks like and contents
of the pack
Scanlux Injection is a clear, colourless to pale yellow
It is available in 50 ml, 75 ml, 100 ml and 200 ml
glass bottles.
Marketing Authorisation Holder:
Sanochemia Pharmazeutika AG
Boltzmanngasse 11
1090 Vienna
Sanochemia Pharmazeutika AG
Landeggerstrasse 7
2491 Neufeld/Leitha
This leaflet was last revised in July 2015.


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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.