SCANLUX 300 MG I/ML SOLUTION FOR INJECTION

Active substance: IOPAMIDOL

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Scanlux® 300 mg I/ml



Package leaflet:
Information for the user
Scanlux 300mg Iodine/ml, 340mg
Iodine/ml, 370mg Iodine/ml, solution
for injection
Iopamidol
Read all of this leaflet carefully before
you start using this medicine.
• 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. Do NOT pass it on to others. It may
harm them even if their symptoms are
the same as yours.
• If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
nurse.

In this leaflet:
1. What Scanlux Injection is and what it is used for
2. Before you are given Scanlux Injection
3. How Scanlux Injection is given
4. Possible side effects
5. How to store Scanlux Injection
6. Further information
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 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 following is a list of the most common uses of
Scanlux:
• 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.
2. BEFORE YOU ARE GIVEN SCANLUX INJECTION
You should not be given Scanlux Injection if:
• you are allergic (hypersensitive) to iopamidol
• you are allergic to any of the other ingredients in
Scanlux Injection
(see section 6 “Further Information”)
• you have an overactive thyroid gland

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 are going to have a blood test (as Scanlux may
affect the results)

Driving and using machines
After being giving this medicine, you should not drive
or use machinery for at least one hour – longer if you
don’t feel well enough.

Before being given Scanlux Injection
• It is important that you drink plenty of nonalcoholic 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.

Children:
Children may be given up to 2.5 ml per kg of their
bodyweight depending on the type of examination.

Taking other medicines:
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 (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 and breast-feeding:
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.

Product summary
1.

NAME OF THE MEDICINAL PRODUCT
Scanlux 300 mg I/ml, solution for injection

2.

QUALITATIVE AND QUANTITATIVE
COMPOSITION
One ml solution for injection contains 612 mg Iopamidol
corresponding to 300 mg Iodine
Osmolality at 37 °C
635.9 mosmol/kg
Viscosity at 37 °C
4.5 mPas

3. HOW SCANLUX INJECTION IS GIVEN
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.
Dosage:
The amount injected depends on where the medicine is
being injected and which investigation it is being used
for.
Adults:
You may be given an injection of up to 100 ml of
Scanlux depending on the type of examination you are
undergoing. In some cases, you may be given a second
injection.

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.
Most side effects are mild and do not last long.
However, if any become severe or last more than a few
days, you should tell your doctor.
Sometimes medical treatment may be needed.
If you get any of the following during or sometime
after the examination, you should tell your doctor
immediately as they may be signs of an allergic
reaction. These reactions are more common in
patients who have a history of allergies:
• skin reactions such as itchy skin, hives (nettle rash),
redness, blisters
• nausea (feeling sick)
• vomiting (being sick)
• sore throat or difficulty swallowing
• wheeziness, difficulty in breathing,
• dizziness or feeling faint (due to low blood pressure)
• a fever or high temperature
• spasm of the muscles around the voice box, causing
choking
• tightness or pain in the chest
• flushing
• bluish colouration of skin

For a full list of excipients, see section 6.1.
3.

PHARMACEUTICAL FORM
Solution for injection.
Scanlux is a clear, colourless to pale yellow solution free
from visible particles.

4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
X-ray contrast media for peripheral arteriography and
venography, angiocardiography, digital subtraction
angiography, left ventriculography and coronary
arteriography, computer tomography enhancement and
urography.
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 at least one
hour after the procedure, as most of the adverse events
occur in this period.
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.
Method of administration
No other drugs or contrast media should be mixed with
iopamidol solution for injection.
Peripheral arteriography and phlebography (venography)
Percutaneous injection into the appropriate blood vessel
is used for visualisation of peripheral arteries and veins.
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.
Urography
The contrast medium is injected intravenously and
rapidly eliminated through the kidneys. In patients with
severe renal failure, high dose urography should be used.
4.3. Contraindications
Iopamidol is strictly contraindicated in patients with
manifest hyperthyroidism. Hypersensitivity to iopamidol
or to any of the excipients.

The following doses are recommended as a guide.
SCANLUX SOLUTION FOR INJECTION
Procedure
Iopamidol solution for
Injection product
Peripheral
300, 340 or 370 mg Iodine/ml
Arteriography
Venography
300 mg Iodine/ml
Angiocardiography &
left ventriculography
Coronary
Arteriography
Digital Subtraction
Angiography
Intra-arterial injection

340 or 370 mg Iodine/ml
340 or 370 mg Iodine/ml

300 mg Iodine/ml

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
Enhancement
Brain Scanning
Whole Body Scanning
Intravenous Urography

340 or 370 mg Iodine/ml

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

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

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
Children***

Adults 50-100 ml
Children**
Adults 40-100 ml
Children**
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.

4.4. Special Warnings and Special 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. 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.
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 systemic
disease should not be exposed to dehydration.
Abnormalities of fluid or electrolyte balance should be
corrected prior to use.
In patients with impairment of renal function, the
administration of potentially nephrotoxic drugs should
be avoided until the contrast medium is completely

excreted. Further administration of contrast media
should be postponed until renal function has returned to
its previous level.
As experience shows that warmed contrast media are
better tolerated, the contrast medium should be warmed
up to body temperature before administration.
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.
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.
During intracardiac and/or coronary arteriography,
ventricular arrhythmias may infrequently occur.
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.
Use of this product may interfere with tests for thyroid
function.
Iopamidol Injection should be used with caution in
patients with hyperthyroidism. It is possible that
hyperthyroidism may recur in patients previously treated
for Graves' disease.

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.

Non-ionic contrast media have less anti-coagulant
activity in-vitro than ionic media. Meticulous attention
should therefore be paid to angiographic technique.
Non-ionic media should not be allowed to remain in
contact with blood in the syringe and intravascular
catheters should be flushed frequently, to minimise the
risk of clotting, which rarely has led to serious
thromboembolic complications after procedures.

The administration of iodinated contrast media may
aggravate the symptoms of myasthenia gravis.

Patients with phaeochromocytoma can develop severe
hypertensive crises following intravascular iopamidol
administration. Premedication with ␣-receptor blockers
is recommended.

This medicinal product contains less than 1 mmol of
sodium (23 mg) per maximum 250 ml dose, i.e.
essentially "sodium-free".

In patients with monoclonal gammopathy (myelomatosis, Waldenström's macroglobulinaemia), the intravascular administration of contrast media is potentially
hazardous. In such patients, the risk of deterioration in
renal function can be diminished if the patient is well
hydrated before 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.
Local tissue irritation can occur in the case of
perivascular infiltration of the contrast media.
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. Drugs
and equipment must be available for emergency
resuscitation.
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 one hour 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.
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.

Iopamidol injection should be used with caution in
patients with hypercalcaemia and cerebral vascular
disease.
No other drugs or contrast media should be mixed with
iopamidol solution for injection (see section 6.2).

4.5. Interactions 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 intra-arterial 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.
In patients with pre-existing diabetic nephropathy
administration of iopamidol can induce lactic acidosis if
patients are concomitantly receiving a biguanide such as
metformin. Treatment with the biguanide should be
suspended 48 hours before iopamidol administration and
can be resumed when renal function has returned to
pre-examination level.

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 patients receiving beta-blockers there is an elevated
risk of more severe anaphylactoid reactions. 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.

Angiography should be avoided whenever possible in
patients with homocystinuria due to an increased risk of
thrombosis and embolism.

Iopamidol should not be co administered with other
drugs that are also known to prolong the QT interval
because of the increased risk of cardiotoxicity.

Scanlux® 300 mg I/ml



4.6. 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.

4.7. Effects on Ability to Drive and Use Machines
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.
4.8. Undesirable Effects
a) 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 reported.
Adverse reactions often occur early but are sometimes
delayed. Delayed intolerance reactions, most commonly
pruritus and urticaria, have been reported up to several
days post administration.
The most frequently observed adverse reactions have
been nausea, vomiting, pain, burning sensation, hot
flushes, a general feeling of warmth or cold and taste
perversion. Others include localised pain at the injection
site or in the lumbar, abdominal or chest region,
headache, chills, fever, tremor, dizziness, rhinitis,
oedema, dyspnoea, hypo or hypertension, tachycardia,
angina pectoris, asthma, bronchospasm, confusion and
convulsions.
Skin reactions may occur in the form of various types of
rash, widespread erythema, diffuse blister formation,
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.
Anaphylaxis may manifest with symptoms including
nausea, vomiting, diffuse erythema, mild localized or
more diffuse angioedema, oedema of the tongue or
larynx, laryngeal spasm or pain, dysphagia, sore throat
and tightness, coughing, conjunctivitis, rhinitis,
excessive sneezing, headache, fever, generalized heat
sensation, sweating, asthenia, dizziness, pallor,
dyspnoea, wheezing, bronchospasm, and moderate
hypotension.
b) The spontaneously reported adverse reactions after
intravascular administration are:

Blood and lymphatic system disorders: A few cases of
thrombocytopenia have occurred.
Endocrine disorders: Hyperthyroidism may recur in
patients previously treated for Graves' disease.
Metabolism and nutrition disorders: Acidosis, abnormalities in blood electrolyte values.
Nervous system disorders: Faintness, amnesia, confusion,
alteration or loss of consciousness, coma, paraesthesia,
dizziness, paresis and paralysis, tremors, convulsions,
involuntary muscle contractions, somnolence.
Eye disorders: Vision disturbances, watery/itchy eyes,
lacrimation, conjunctivitis, photophobia, transient
cortical blindness.
Ear and labyrinth disorders: Impaired hearing, echoacousia, progressive transitory hearing loss or other auditory
symptoms.
Cardiovascular disorders: Mainly after cardiovascular
procedures/interventions: tachycardia, bradycardia,
haemodynamic changes manifested with hypotension
decreased systolic pressure, increase of left ventricular
end diastolic pressure, hypertension, myocardial
ischemia or infarction, heart failure, circulatory collapse,
transient ischemic attack, ventricular arrhythmias,
electrocardiographic changes including S-T segment
depression, increased QT, increased R-R, T-wave
amplitude.
Mostly after cardiac angiographic and coronary
catheterisation procedures: cardiac rhythm disturbances
such as bigeminy, extrasystoles, atrial fibrillation,
ventricular tachycardia, and ventricular fibrillation,
angina pectoris, chest pain, 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, chest pain, arterial thrombosis, displacement
of arterial plaques and serious thromboembolic events,
venous thrombosis. Dissection of the coronary vessels
and transient sinus arrest are rare complications.
Respiratory, thoracic and mediastinal disorders:
Dyspnoea and respiratory distress, asthma, apnoea,
throat constriction, coughing, sneezing, chest pain or
tightness, bronchospasm, rhinitis, transient disturbance
in respiratory rate, pulmonary oedema, laryngeal
oedema, respiratory insufficiency or arrest.
Gastrointestinal disorders: Nausea, vomiting, anorexia,
severe retching and choking, abdominal pain.
Skin and subcutaneous tissue disorders: Periorbital
oedema, facial oedema, various rashes, urticaria,
pruritus, flushing, erythema multiforme, pallor. Rarely,
Stevens-Johnson syndrome has been reported.
Musculoskeletal, connective tissue and bone disorders:
Muscle and lumbosacral weakness, muscoloskeletal pain
and muscle cramps.
Renal and urinary disorders: Transient changes in renal
chemistry tests indicating renal impairment, acute renal
failure, anuria, oliguria, urinary retention or incontinence, pain, haematuria.
General disorders and administration site conditions:
Headache, fever, chills, excessive sweating, back spasm,

malaise, warmth or cold sensation, vasovagal reactions,
salivary gland secretion abnormalities, taste perversion,
pain in the lumbar, abdominal or chest region, general
pain. Local pain and non-inflammatory swelling may
occur at the injection site. In the majority of cases it is
due to extravasation of contrast medium. Reactions are
usually transient and recover without sequelae, however,
inflammation and even skin necrosis have been seen on
very rare occasions.
c) An adverse reaction can develop independently of the
quantity of contrast medium and way of administration,
and a mild adverse reaction might be the first sign of a
developing anaphylactic shock. Administration of the
contrast medium must be discontinued immediately and
if necessary specific treatment initiated.
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.
More severe reactions involving the cardiovascular
system such as peripheral vasodilatation with pronounced hypotension, reflex tachycardia, angina,
bronchospasm, dyspnoea, agitation, cyanosis and loss of
consciousness (syncope), may require emergency
treatment, appropriate resuscitative measures should be
immediately available.
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 arrythmias are most common in
elderly patients and in those with pre-existing heart
disease.
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 hydrated. Contrast agents may be
removed by dialysis.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Pharmacotherapeutic group: Water soluble, nephrotropic, low osmolar X-ray contrast media
ATC code: V08AB04
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.
5.2. Pharmacokinetic Properties
Absorption
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 hours.
Distribution
Iopamidol injection is distributed throughout the
extracellular fluid but does not enter cells. The volume
of distribution is 0.28 I/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.
Metabolism
Iopamidol is excreted unchanged.
Excretion
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.
5.3. Pre-clinical 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
intramuscular injection into the aorta. In comparison
with ionic imaging agents the pharmaceutical tolerance
of Iopamidol was equal or better.
Accidental paravariceal 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. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Trometamol, Hydrochloric acid, Sodium calcium edetate,
Water for injections.
6.2. Incompatibilities
Many radiopaque 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, product should be used immediately.
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 Content 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. Instruction for Use, Handling and Disposal
Scanlux 300 mg I/ml Injection is intended for single use
only; any unused portions should be discarded.
Discard if solution is not free from particulate matter.
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.
7.

MARKETING AUTHORISATION HOLDER
Sanochemia Pharmazeutika AG
Boltzmanngasse 11
1090 Vienna, Austria

8.

MARKETING AUTHORISATION NUMBER
PL 19206/0001

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/01/2007

10. DATE OF REVISION OF THE TEXT
22/01/2007












racing heartbeat
fits (seizures)
blistering of the mouth, eyes and genitals
swelling of the face, tongue or throat
coughing
watery/itchy eyes
itchy, runny nose
sneezing more than usual
pale skin
feeling weak

The most common side effects are:
• hot flushes
• pain
• changes in taste
• feeling cold
• burning sensations
The following side effects have also been reported:
• pain at or near the injection site
• pain in the back or chest
• headache
• chills
• effects on the eyesight including watery and/or
itchy eyes, sensitivity
to light and temporary blindness
• difficulty urinating (passing water)
• decreased or increased production of urine
• uncontrollable, involuntary passing of urine
• kidney problems or kidney failure
• blood in the urine
• swelling of the hands or feet
• tremor (shaking)
• dizziness
• over-active thyroid in patients previously treated for
this condition
• high blood pressure
• a fast heart beat
• chest pains
• asthma
• feeling confused
• memory loss
• pins and needles
• effects on hearing including difficulty or loss of
hearing, or hearing echos
• changes in blood, which increases risk of bleeding or
bruising
• muscle twitching
• feeling sleepy
• loss of appetite
• too much acid in the blood, which may cause faster
breathing
• loss of consciousness or coma
• inability to move
• weakness causing loss of movement
• retching
• tummy pain
• sweating more than usual
• generally feeling unwell
• producing too much or too little saliva






muscle weakness or pain
muscle cramps
back spasm
backache

The following side effects have occurred mainly after
examinations of the heart and its blood vessels:
• 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
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or your pharmacist.
5. HOW TO STORE SCANLUX INJECTION
Keep out of the reach and sight of children. Do not use
Scanlux Injection 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. FURTHER 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
injections.
What Scanlux Injection looks like and contents of
the pack:
Scanlux Injection is a clear, colourless to pale yellow
solution.
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
Austria
Manufacturer:
Sanochemia Pharmazeutika AG
Landeggerstrasse 7
A-2491 Neufeld/Leitha
Austria
This leaflet was last revised in November 2011.
200809/03

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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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