SCANLUX 300 MG I/ML SOLUTION FOR INJECTION

Active substance: IOPAMIDOL

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SUMMARY OF PRODUCT CHARACTERISTICS
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 612mg Iopamidol corresponding to
300mg Iodine
Osmolality at 37ºC
Viscosity at 37ºC

635.9 mosmol/kg
4.5 mPas

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.
The following doses are recommended as a guide.

SCANLUX SOLUTION FOR INJECTION
Procedure

Iopamidol solution for
Injection product

Dosage

Peripheral
Arteriography

300, 340 or 370mg Iodine/ml

Adults 20-50 ml*
Children**

Venography

300mg Iodine/ml

Adults 20-50 ml
Children**

Angiocardiography &
left ventriculography

340 or 370mg Iodine/ml

Adults 30-80 ml
Children**

Coronary Arteriography

340 or 370mg Iodine/ml

Adults 4-8 ml per
artery*
Children***

Intra-arterial injection

300mg Iodine/ml

Adults 0.5-20 ml
Children 0.25-0.375
ml/kg

Intra-venous injection

340 or 370mg Iodine/ml

Adults 30-50 ml
Children 0.5-0.75
ml/kg**

Left ventriculography

300, 340 or 370mg Iodine/ml

Adults 25 ml
Children 0.5-0.75
ml/kg

Selective coronary
arteriography by intraarterial DSA

340 or 370mg Iodine/ml

Adults 2-5 ml
Children***

Brain Scanning

340mg Iodine/ml

Adults 50-100 ml
Children**

Whole Body Scanning

300mg Iodine/ml

Adults 40-100 ml
Children**

300, 340 or 370mg Iodine/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**

Digital Subtraction
Angiography

Computed Tomography
Enhancement

Intravenous Urography

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

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

4.4

Contraindications
Iopamidol is strictly contraindicated in patients
hyperthyroidism.
Hypersensitivity to iopamidol or to any of the excipients.

with

manifest

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. 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. Pretreatment 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.
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.
Patients with phaeochromocytoma can develop severe hypertensive crises
following intravascular iopamidol administration. Premedication with αreceptor blockers is recommended.
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.

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.
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.
The administration of iodinated contrast media may aggravate the symptoms
of myasthenia gravis.
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).
This medicinal product contains less than 1 mmol of sodium (23mg) per
maximum 250 ml dose, i.e. essentially “sodium-free”.

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 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 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.
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.

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.

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 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.
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

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 1.5g/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 2.0g/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 (370mg 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 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

PHARMACEUTICAL PARTICULARS

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, product should be used immediately.

6.4

Special precautions for storage
Protect the solution from light and X-rays
Do not store above 25ºC
Store in the original package

6.5

Nature and contents of container
Scanlux 300mg 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 300mg 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(S)
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

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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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