Size: 570 x 460 mm Colours: Pantone 877 C
Pantone 280 C
Pantone Process Blue C
Pantone Process Black C
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 because it
contains important information for
you.
Keep this leaflet. You may need to read
it again.
If you have any further questions, ask
your doctor or 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
for
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
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 (be-
cause 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. 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 follow-
ing 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 overac-
tive thyroid gland
you have high levels of calcium in your blood
you have a disease of the blood vessels, especial-
ly 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-alco-
holic 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.
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 diu-
retics (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 antide-
pressants 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 dont feel well enough.
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 medi-
cine is being injected and which investigation it is
being used for.
Adults:
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.
Children:
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, swell-
ing 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.
left ventriculography
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 epider-
mal 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
injection
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
Product summary clotting and thromboembolic events during
angiographic techniques. Factors such as length
systemic disease should not be exposed to
dehydration. Fluid intake should not be limited
thyroid function.
In patients scheduled for thyroid examination
administration of iodinated contrast media
because of the risk of hypothyroidism due to
of procedure, catheter and syringe material, and any abnormalities of fluid or electrolyte and/or treatment with a radioactive iodinetrac- iodine overload.
1. NAME OF THE MEDICINAL PRODUCT
Scanlux 300 mg I/ml, solution for injection underlying disease state, and concomitant balance should be corrected prior to use of this er, iodine update in the thyroid gland will be
Elderly
medications may contribute to the development hypertonic solution. reduced for several days, sometimes up to 2
The elderly are at special risk of reactions due
2. QUALITATIVE AND QUANTITATIVE of thromboembolic events. Therefore, meticu- As experience shows that warmed contrast weeks after dosing with an iodinated contrast
to reduced physiological functions, especially
COMPOSITION lous angiographic techniques are recommended media are better tolerated, the contrast medium that is eliminated through the kidneys.
including close attention to guide wire and
when high dosage of contrast medium is used.
One ml of solution for injection contains 612 mg medium should be warmed up to body temper-
catheter manipulation, use of manifold systems
Myocardial ischemia, major arrhythmias and
Iopamidol corresponding to 300 mg Iodine. ature before administration. Caution should be exercised in performing
premature ventricular complexes are more likely
and/or three-way stopcocks, frequent catheter iodinated contrast-enhanced examinations in
flushing with heparinized saline solutions, and to occur in these patients. The probability of
Osmolality at 37 C 635.9 mosmol/kg Care should be exercised in patients with patients with, or with suspicion of, hyperthy-
minimizing the length of the procedure. acute renal insufficiency is higher in these
Viscosity at 37 C 4.5 mPas moderate to severe impairment of renal roidism or autonomously functioning thyroid
patients
function. Pre-existing renal impairment may nodule(s), as thyroid storms have been reported
Method of administration
For the full list of excipients, see section 6.1. predispose to acute renal dysfunction following following administration of iodinated contrast Women of child-bearing potential
No other drugs or contrast media should be
contrast media administration. media. It is possible that hyperthyroidism may Appropriate investigations and measures should
mixed with iopamidol solution for injection.
3. PHARMACEUTICAL FORM In patients with impairment of renal function, recur in patients previously treated for Graves be taken when exposing women of childbearing
Solution for injection the administration of potentially nephrotoxic disease. In patients with hyperthyroidism, the potential to any X-ray examination, whether
Peripheral arteriography and phlebography
drugs should be avoided until the contrast radiological examination should be performed with or without contrast medium.
(venography)
Scanlux is a clear, colourless to pale yellow medium is completely excreted. In such only if thought necessary by the physician.
Percutaneous injection into the appropriate
solution free from visible particles. patients, renal function parameters should be 4.5 Interaction with other medicinal products
blood vessel is used for visualisation of periph- monitored after the procedure. Further admin- Patients with phaeochromocytoma can develop and other forms of interaction
eral arteries and veins.
4. CLINICAL PARTICULARS istration of contrast media should be postponed severe hypertensive crises following intravascu- Following administration of iopamidol, the
until renal function has returned to its previous lar iopamidol administration. Premedication capacity of the thyroid tissue to take up iodine
4.1 Therapeutic indications Computer tomography enhancement
This medicinal product is for diagnostic use level. with -receptor blockers is recommended. is reduced for 2 6 weeks.
Contrast enhancement for brain scans can be
only. achieved between one and three minutes after
Patients with severe hepatic, renal or combined Patients with paraproteinaemia of Walden- Arterial thrombosis has been reported when
X-ray contrast media for peripheral arteriogra- i.v. injection. Scanlux injection is also used for
phy and venography, angiocardiography, digital hepato-renal insufficiency should not be strm, with multiple myeloma or severely iopamidol was given following papaverine.
total body scanning examinations after i.v.
subtraction angiography, left ventriculography examined unless absolutely indicated. Re-ex- compromised hepatic and renal impairment are
administration as a bolus, as a drip infusion or
and coronary arteriography, computer tomogra- amination should be delayed for 5-7 days. also more at risk: in these cases adequate The administration of vasopressors strongly
by a combination of the two methods.
phy enhancement and urography. Patients on dialysis may receive contrast media hydration is recommended after contrast potentiates the neurological effects of intra-
such as iopamidol, which can be removed medium administration. arterial contrast media.
Urography
4.2 Posology and method of administration without difficulty by dialysis. To prevent crises in patients with sickle cell
The contrast medium is injected intravenously
For intravenous or intra arterial use. The presence of renal damage in diabetic disease adequate hydration should be assured Renal toxicity has been reported in patients
and rapidly eliminated through the kidneys. In
patients is one of the factors predisposing to and a minimal volume of low concentration with liver dysfunction who were given oral
patients with severe renal failure, high dose
The dosage must be adapted to the examina- acute renal impairment following intravascular should be used. cholecystographic agents followed by intravas-
urography should be used.
tion, the age, body weight, cardiac output, renal contrast media administration. This may cular contrast agents. Therefore, administration
function, general condition of the patient and precipitate lactic acidosis in patients who are Local tissue irritation can occur in the case of of intravascular contrast agents should be
4.3 Contraindications postponed in patients who have recently been
the technique used. taking biguanides (see section 4.5). perivascular infiltration of the contrast media.
Iopamidol is strictly contraindicated in patients
Usually the same iodine concentration and given a cholecystographic contrast agent.
with manifest hyperthyroidism.
volume are used as for other iodinated X-ray The risk associated with a particular investiga- As in the case of all iodinated contrast agents,
Hypersensitivity to the active ingredient
contrast media in current use. tion may be increased by conditions such as iopamidol can cause severe or fatal intolerance Contrast media may interfere with laboratory
iopamidol and/or iodine or to any of the
advanced arteriosclerosis and hypertension. reactions. During the examination an intrave- tests for bilirubin, proteins or inorganic
excipients listed in section 6.1.
The Special Warnings and Precautions for Use nous route for emergency treatment in the substances (e.g. iron, copper, calcium, phos-
detailed in section 4.4 must be considered In patients undergoing angiocardiographic event of a reaction is required. After the phate). These substances should not be assayed
4.4 Special warnings and precautions for use
before administering this product. All patients procedures special attention should be paid to administration of the contrast medium, during the same day following the administra-
As with all other contrast media this product
should be observed for 20 to 30 minutes after the status of the right heart and pulmonary competent personnel, drugs and equipment for tion of contrast media.
may provoke anaphylaxis or other manifesta-
the procedure, as most of the adverse events circulation. Right heart insufficiency and emergency resuscitation must be available.
tions of allergy with nausea, vomiting, dysp-
occur in this period. pulmonary hypertension may precipitate Diagnostic procedures which involve the use of To prevent onset of lactic acidosis in diabetic
noea, erythema, urticaria and hypotension.
In patients with suspected or known hypersen- bradycardia and systemic hypotension, when any radiopaque medium should be carried out patients under treatment with oral anti-diabetic
Occasional severe reactions with fatal outcome
sitivity to contrast media, sensitivity testing is the organic iodine solution is injected. Right under the direction of personnel with the agents of the biguanide class, biguanides should
have been reported. A positive history of
not recommended, as severe or fatal reactions heart angiography should be carried out only prerequisite training and with a thorough be stopped 48 hours before the administration
allergy, asthma or untoward reaction during
when absolutely indicated. knowledge of the particular procedure to be of the contrast medium and re-instated only
to contrast media are not predictable from previous similar investigations indicates a need
Great caution should be paid when injecting the performed. Appropriate facilities should be after renal function has been demonstrated to
sensitivity tests. for extra caution; the benefit should clearly
contrast medium into the heart chambers, available for coping with any complication of have returned to pre-examination values (see
Caution during injection of contrast media is outweigh the risk in such patients. Pre-treat-
especially in cyanotic neonates with pulmonary the procedure, as well as for emergency section 4.4).
necessary to avoid extravasation. ment with antihistamines or corticosteroids to
prevent or minimise possible allergic reactions hypertension and impaired cardiac function. treatment of severe reaction to the contrast
During intracardiac and/or coronary arteriogra- medium itself. In patients receiving beta-blockers there is an
As with all contrast media, the lowest dose in such patients may be considered. Appropri-
phy, ventricular arrhythmias may infrequently elevated risk of more severe anaphylactoid
necessary to obtain adequate visualisation ate resuscitative measures should be immedi-
occur. Patients with congestive heart failure should be reactions.
should be used. The total volume that must not ately available.
be exceeded is 250 ml. There are no special observed for several hours following the Cardiac and/or hypertensive patients under
In angiographic procedures, the possibility of procedure to detect delayed haemodynamic treatment with diuretics, ACE-inhibitors, and/or
dosage requirements for elderly patients. Patients must be sufficiently hydrated before
and after radiographic procedures. Patients dislodging plaque or damaging or perforating disturbances, which may be associated with a beta-blocking agents are at higher risk of
the vessel wall should be considered during transitory increase in the circulating osmotic adverse reactions when administered iodinated
Non-ionic contrast media should not be allowed with severe functional impairment of the liver
to remain in contact with blood in the syringe or myocardium, myelomatosis, diabetes, catheter manipulation and contrast medium load. All other patients should be observed contrast media.
or intravascular catheters which should be polyuria or oliguria, hyperuricemia, infants, injection. Test injections to ensure proper for at least 20-30 minutes after the proce-
catheter placement are recommended. In dure, as most of the adverse events occur in Following administration of iopamidol atypical
flushed frequently to minimize the risk of elderly patients and patients with severe
examinations of the aortic arch, the tip of the this period. The patient should also be adverse reactions e.g. erythema, fever and flu
The following doses are recommended as a guide. catheter should be positioned carefully to avoid informed that allergic reactions may develop up symptoms have been reported in patients
SCANLUX SOLUTION FOR INJECTION hypotension, bradycardia and CNS injury due to to several days after the procedure; in such treated with interleukin-2.
excess pressure transmitted from the injector case, a physician should be consulted immedi-
Procedure Iopamidol solution for Dosage
Injection product pump to the brachiocephalic branches of the ately. There is an elevated risk of seizures in patients
aorta. with epilepsy or cerebral focal lesions treated
Peripheral 300, 340 or 370 mg Iodine/ml Adults 20-50 ml* The administration of iodinated contrast media with specific psychotropic drugs e.g. antipsy-
Arteriography Children** Angiography should be avoided whenever may aggravate the symptoms of myasthenia chotic and analeptic drugs, tricyclic antidepres-
Venography 300 mg Iodine/ml Adults 20-50 ml* possible in patients with homocystinuria due to gravis. sants and monoamine oxidase inhibitors. Such
Children** an increased risk of thrombosis and embolism. agents should be suspended- if possible - 48
Angiocardiography & 340 or 370 mg Iodine/ml Adults 30-80 ml* Iopamidol injection should be used with caution hours before iopamidol administration and
Children** In patients undergoing peripheral angiography, in patients with hypercalcaemia and cerebral resumed 24 hours later.
Coronary 340 or 370 mg Iodine/ml Adults 4-8 ml per artery* there should be pulsation in the artery into vascular disease.
Arteriography Children*** which the X-ray contrast medium will be Iopamidol should not be co administered with
Digital Subtraction injected. In patients with thromboangiitis oblit- Vasospasm and subsequent cerebral ischemic other drugs that are also known to prolong the
Angiography erans or ascending infections in combination phenomena may be caused by intra-arterial QT interval because of the increased risk of
Intra-arterial injection 300 mg Iodine/ml Adults 0.5-20 ml with serious ischaemia the angiography should injections of contrast media. cardiotoxicity.
Children 0.25-0.375 ml/kg be performed, if at all, with special caution.
Intra-venous injection 340 or 370 mg Iodine/ml Adults 30-50 ml In patients undergoing venography, special No other drugs or contrast media should be 4.6 Fertility, pregnancy and lactation
Children 0.5-0.75 ml/kg** caution should be exercised in patients with mixed with iopamidol solution for injection (see The safety of iopamidol injection during
Left ventriculography 300, 340 or 370 mg Iodine/ml Adults 25 ml suspected phlebitis, serious ischaemia, local section 6.2). pregnancy has not been established. Since
Children 0.5-0.75 ml/kg infections, or a complete venous occlusion. radiation exposure during pregnancy should be
Selective coronary 340 or 370 mg Iodine/ml Adults 2-5 ml This medicinal product contains less than 1 avoided anyway, regardless of whether a
arteriography by Children*** Patients who are known epileptic or have a mmol of sodium (23 mg) per maximum 250 ml contrast agent is used or not, the benefit of
intra-arterial DSA history of epilepsy should have their medicine dose, i.e. essentially sodium-free. X-ray examination has to be considered
Computed Tomography maintained. In some instances, anticonvulsant carefully. Apart from radiation exposure of the
Enhancement therapy may be increased for 48 hours before Use in Special Populations foetus, benefit-risk consideration for io-
Brain Scanning 340 mg Iodine/ml Adults 50-100 ml the examination. Newborns, children dine-containing contrast agents should also
Children** Iopamidol should be administered with caution Infants (age<1year), and especially newborns take into account the sensitivity of the foetal
Whole Body Scanning 300 mg Iodine/ml Adults 40-100 ml in patients with symptomatic cerebrovascular are particularly susceptible to electrolyte imbal- thyroid towards iodine.
Children** diseases, recent stroke, or frequent TIA, altered ances and haemodynamic alterations. Care
Intravenous Urography 300, 340 or 370 mg Iodine/ml Adults 40-80 ml permeability of the blood-brain barrier, should be taken regarding the dosage to be Iodine-containing x-ray contrast agents are
In severe renal failure the usual high dose increased intracranial pressure, suspicion of used, the details of the procedure, and the excreted into the breast milk in low amounts. It
methods should be employed (up to 1.5 ml/kg) intracranial tumor, abscess or hematoma/ patients status is recommended that they are administered to
Children 1-2.5 ml/kg** hemorrhage, history of convulsive disorder, In neonates, and particularly in premature lactating women only if considered essential by
* Repeat as necessary. alcoholism. neonates, it is recommended that tests of the physician. Breast-feeding should be
** Proportional to the adult dose according to body size and age. thyroid function (typically TSH and T4), should stopped for 48 hours after administration of the
*** Procedure not normally applicable to children. Use of this product may interfere with tests for be checked 7-10 days and 1 month after the contrast medium.

Scanlux 300 mg I/ml 4.7 Effects on ability to drive and use
machines
if necessary specific treatment initiated via
a venous access. More severe reactions
In addition, the following adverse events can
occur with unknown frequency:
Iopamidol is a second generation, non-ionic
radiographic contrast medium that is stable in
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients


low and high blood pressure
flushing
6. Contents of the pack and other information
There is no known effect on the ability involving the cardiovascular system such as solution. Because of its non-ionic character, it Trometamol, Hydrochloric acid, Sodium calcium vomiting What Scanlux Injection contains
to drive and operate machines. vasodilatation with pronounced hypotension, Metabolism and nutrition disorders: lacks charged particles and is lower in osmolali- edetate, Water for injections. diarrhoea - The active substance is iopamidol (equivalent to
However, because of the risk of early tachycardia, dyspnoea, agitation, cyanosis and Acidosis, abnormalities in blood electrolyte ty than ionic agents of equivalent iodine abdominal pain 300, 340, or 370mg iodine/ml)
reactions, driving or operating loss of consciousness (syncope) may require values. concentration. Results of clinical and animal 6.2 Incompatibilities dry mouth - The other ingredients are trometamol, sodium
machinery is not advisable for one emergency treatment. Hypersensitivity reac- studies have indicated that Iopamidol causes Many radio-opaque contrast agents are itching; skin rash, urge to itch, rednesss of the calcium edetate, hydrochloric acid and water for
hour following the last injection. tions are more frequent in patients with an Nervous system disorders: less disturbance of cardiac function than do incompatible in vitro with some antihistamines skin injections.
allergic disposition or who have shown hyper- amnesia, paresis and paralysis, tremors, ionic contrast agents. and many other drugs; therefore, no other increased sweating
4.8 Undesirable effects sensitivity reactions during a previous examina- somnolence. pharmaceuticals should be admixed with back pain What Scanlux Injection looks like and contents
Iopamidol may cause adverse reac- tion with an iodinated contrast agent. There is no evidence of teratogenic effects in contrast agents. kidney failure of the pack
tions, which are generally mild or Eye disorders: rats or rabbits and no evidence of mutagenicity chest pain, injection site pain Scanlux Injection is a clear, colourless to pale yellow
moderate and transient although rare Injection site pain and swelling may occur. On watery/itchy eyes, lacrimation. in the micronucleus test. However, there is 6.3 Shelf life fever solution.
severe and life-threatening reactions very rare occasions extravasation of contrast evidence that, in common with all other 2 years feeling cold It is available in 50 ml, 75 ml, 100 ml and 200 ml
sometimes leading to death have been medium led to inflammation (manifested with Ear and labyrinth disorders: iodinated contrast agents, Iopamidol Injection abnormal laboratory test results for creatinine glass bottles.
reported. local erythema, oedema and blisters), skin Impaired hearing, echoacousia, progressive is able to produce a synergistic cytotoxicity in After first opening, the product should be used (this can be detected by a test carried out by a
necrosis and compartment syndrome. transitory hearing loss or other auditory the presence of X-radiation. Chromosomal immediately doctor) Marketing Authorisation Holder:
Following intravascular administration, in most symptoms. injury in human lymphocytes has been de- Sanochemia Pharmazeutika AG
cases reactions occur within minutes of dosage. As with other iodinated contrast media, very scribed in-vitro and in-vivo. The clinical 6.4 Special precautions for storage Rare: (more than 1 out 10,000 persons and less Boltzmanngasse 11
However, delayed reactions, usually involving rare cases of mucocutaneous syndromes, Gastrointestinal disorders: significance of these observations is unclear. Protect the solution from light and X-rays. than 1 out of 1,000 persons) 1090 Vienna
skin, may occur, mostly within 2-3 days, more including Stevens-Johnson syndrome, toxic Anorexia, severe retching and choking. Do not store above 25C. confusion Austria
rarely within 7 days, after the administration of epidermal necrolysis (Lyell syndrome) and Iopamidol Injection has no conventional clinical Store in the original package. sensation of tingling, pricking or numbness
the contrast medium. erythema multiforme, have been reported Renal and urinary disorders: pharmacology, its intended action being a slow heart beat Manufacturer:
following the administration of Iopamidol. Transient changes in renal chemistry tests passive one of increasing the absorption of 6.5 Nature and contents of container pulmonary oedema (difficulty breathing, cough- Sanochemia Pharmazeutika AG
Anaphylaxis (anaphylactoid reactions/hypersen- indicating renal impairment, anuria, oliguria, X-radiation by the tissues. It does, however, Scanlux 300 mg I/ml is available in 50 ml, 75 ml, ing, accelerated breathing) Landeggerstrasse 7
sitivity) may manifest with: mild localized or In clinical trials, the most commonly reported urinary retention or incontinence, pain, have a variety of incidental physiological, 100 ml and 200 ml clear Type II glass bottles asthma 2491 Neufeld/Leitha
more diffuse angioneurotic oedema, tongue adverse reactions are headache (1.5 %), nausea haematuria. biochemical and haematological effects. with bromobutyl stoppers, either individually or difficulty in breathing Austria
oedema, laryngospasm or laryngeal oedema, (1.2 %) and feeling hot (3.5%) after intravascu- in the following pack sizes: muscle cramps
dysphagia, pharyngitis and throat tightness, lar administration. Mainly after cardiovascular procedures/ 5.2 Pharmacokinetic properties 10 x 50 ml, 10 x 75 ml, 10 x 100 ml, 10 x 200 ml, This leaflet was last revised in July 2015.
pharyngolaryngeal pain, cough, conjunctivitis, The adverse reactions reported in clinical trials interventions: Absorption 20 x 50 ml, 20 x 75 ml, 20 x 100 ml, 20 x 200 ml, Not known: (cannot be estimated).
rhinitis, sneezing, feeling hot, sweating in- among 2,680 adult subjects and 35 paediatric haemodynamic changes manifested with Iopamidol is rapidly absorbed into the blood- 30 x 50 ml, 30 x 75 ml, 30 x 100 ml, 30 x 200 ml. reduced blood platelet count (this can be
creased, asthenia, dizziness, pallor, dyspnoea, patients, and from post marketing surveillance hypotension decreased systolic pressure, stream from cerebrospinal fluid (CSF); following detected by a test carried out by a doctor),
wheezing, bronchospasm, and moderate are presented in the tables below by frequency increase of left ventricular end diastolic intrathecal administration, iopamidol appears in Not all pack sizes may be marketed. allergic reaction
hypotension. Skin reactions may occur in the and classified by MedDRA system organ classes. pressure, transient ischemic attack, electrocar- plasma within one hour and virtually all of the coma 200809/04
form of various types of rash, diffuse erythema, Within each frequency grouping, adverse diographic changes including S-T segment drug reaches the systemic circulation within 24 6.6 Special precautions for disposal mini-stroke
diffuse blisters, urticaria, and pruritus. These reactions are presented in order of decreasing depression, increased QT, increased R-R, T-wave hours. Scanlux 300 mg I/ml Injection is intended for fainting, low level of consciousness, loss of
reactions, which occur irrespective of the dose seriousness. amplitude. single use only; any unused portions should be consciousness
administered and the route of administration, Adult patients involved in clinical trials with Mostly after cardiac angiographic and coronary Distribution discarded. temporary loss of vision, vision difficulties,
may represent the first signs of incipient state intravascular administration of Iopamidol were catheterisation procedures: angina pectoris, Iopamidol injection is distributed throughout inflamed eyes, excessive sensitivity to light,
of shock. Administration of the contrast 2,548, of whom 1,597 with intra-arterial and thrombophlebitis, cardiopulmonary arrest, the extracellular fluid but does not enter cells. Discard if solution is not free from particulate watery/itchy eyes
medium must be discontinued immediately and 951 with intravenous administration. arterial spasms, flushing, vasodilation, cyanosis. The volume of distribution is 0.28 l/kg and its matter. heart attack, heart failure, the cessation of
Other cardiovascular reactions may occur as a plasma half-life is 121 minutes, which is normal circulation of the blood due to failure of
consequence of the procedural hazard, these prolonged in renal impairment. Iopamidol The product should be introduced into the the heart to contract effectively, increased heart
System include haemorrhage or pseudoaneurysms at displays little tendency to bind to serum or syringe immediately before use. rate
Adverse Reactions the puncture site, brachial plexus paralysis plasma proteins. Animal studies indicate that failure of the blood circulation
Organ Class
Post-marketing following axillary artery punctures, arterial iopamidol does not cross the blood-brain Iodinated contrast media can react with stopped breathing, respiratory failure, acute
Clinical Trials thrombosis, displacement of arterial plaques barrier to any significant extent following respiratory distress syndrome (a severe lung
surveillance metallic surfaces containing copper (e.g. brass),
and serious thromboembolic events, venous intravascular administration. therefore the use of equipment in which disease), abnormal breathing, suspension of
Common Rare
Uncommon thrombosis. Dissection of the coronary vessels iopamidol comes into contact with such breathing, shortness of breath
1/100 1/10,000 Frequency unknown*
1/1,000 to <1/100 and transient sinus arrest are rare complica- Metabolism surfaces should be avoided. swelling of the throat, swelling of the face,
to <1/10 to <1/1,000
tions. Iopamidol is excreted unchanged. swollen salivary glands
Blood and increased salivation
lymphatic system Thrombocytopenia 7. MARKETING AUTHORISATION HOLDER
There is an increased risk of severe reactions in Excretion Sanochemia Pharmazeutika AG pain in the bones, muscles, ligaments, tendons
disorders Iopamidol is excreted mainly through the and /or nerves
patients with severe cardiac disease, particular- Boltzmanngasse 11
Immune system Anaphylaxis, ly in those with heart failure or coronary artery kidneys following intrathecal administration, pain, feeling of general discomfort or uneasiness
1090 Vienna
disorders Anaphylactoid reaction disease. The intravascular contrast medium and the drug is essentially undetectable in the abnormal electrocardiogram (this can be
Austria
Psychiatric injection can induce pulmonary oedema in plasma 48 hours later. In the absence of renal detected by a test carried out by a doctor)
Confusional state
disorders patients with manifest heart failure, whereas dysfunction, the cumulative urinary excretion 8. MARKETING AUTHORISATION NUMBER(S) abnormalities in blood tests
Coma, Transient ischaemic contrast medium administration in pulmonary for iopamidol, expressed as a percentage of PL 19206/0001 memory loss
attack, Syncope, Depressed hypertension and valvular heart diseases can administered intravenous dose, is approximately paresis, paralysis, tremor (shivering), seizures,
Nervous system Dizziness,
Headache Paraesthesia level of consciousness lead to pronounced haemodynamic changes. 35 to 40 percent at 60 minutes, 80 to 90 9. DATE OF FIRST AUTHORISATION/RENEWAL muscular rigidity
disorders Taste alteration
or loss of consciousness, Ischaemic ECG changes and major arrhythmias percent at 8 hours, and 90 percent or more in OF THE AUTHORISATION effects on hearing including difficulty or loss of
Convulsion are most common in elderly patients and in the 72 to 96 hour period after administration. 22/01/2007 hearing, or hearing echos
Blindness transient, Visual those with pre-existing heart disease. In normal subjects, approximately 1 percent or loss of appetite, retching and choecking
Eye disorders disturbance, Conjunctivitis, less of the administered dose appears in 10. DATE OF REVISION OF THE TEXT transient changes in renal function test, changed
Photophobia Paediatric patients: cumulative 72 to 96 hour faecal specimens. 29/07/2015 frequency of urination, incontinence, pain, blood
Cardiac dysrhyth- The Iopamidol safety profile is similar in No evidence of in vivo complement activation in urine
mias such as children and adults. has been found in normal subjects. changes in blood flow
Myocardial ischaemia or
extrasystoles, atrial
Cardiac infarction, Cardiac failure, Reporting of suspected adverse reactions 5.3 Preclinical safety data The following side effects have occurred mainly
fibrillation, ven- Bradycardia
disorders Cardio-respiratory arrest, Reporting suspected adverse reactions after Intravenous LD50 -values in various animal after examinations of the heart and its blood
tricular tachycardia
Tachycardia authorisation of the medicinal product is species were determined to be approximately vessels:
and ventricular
fibrillation** important. It allows continued monitoring of 15-35 times the maximum clinical dose. fast or slow heartbeat
the benefit/risk balance of the medicinal low or high blood pressure
Vascular Hypotension, Hy- Circulatory collapse or
product. Healthcare professionals are asked to Iopamidol did not show a teratogenic potential. heart attack, heart failure or collapse due to very
disorders pertension, Flushing shock
report any suspected adverse reactions via the In rats, dosages above 1.5 g/kg iodine had low blood pressure
Respiratory arrest, Respira- embryotoxic effect and reduced the number of stroke
Yellow Card Scheme, Website:
Respiratory, Pulmonary tory failure, Acute respira- live foetuses and their weights. In rabbits, the changes in heart rhythm
www.mhra.gov.uk/yellowcard.
thoracic and oedema, Asthma, tory distress syndrome, weights of the foetuses were reduced at a swelling and tenderness along a vein
mediastinal Bronchospasm Respiratory distress, dosage of 2.0 g/kg iodine.
4.9 Overdose
disorders Apnoea, Laryngeal oedema, Iopamidol did not impair the fertility of rats and Reporting of side effects
Treatment of overdose is directed toward the
Dyspnoea the peri- and postnatal development of their If you get any side effects, talk to your doctor or
immediate symptomatic therapy, support of all
Vomiting, Diarrhea, vital functions and the elimination of the offspring. However, in mice a reversible nurse. This includes any possible side effects not
Gastrointestinal Salivary hypersecretion,
Nausea Abdominal pain, Dry contrast medium while keeping the patient well impairment of spermatogenesis was observed listed in this leaflet. You can also report side effects
disorders Salivary gland enlargement
mouth hydrated. after a single dose of iopamidol. directly via the Yellow Card Scheme, Website:
Skin and sub- Rash, Urticaria, Dosages exceeding the specific package insert www.mhra.gov.uk/yellowcard.
cutaneous tissue Pruritus, Erythema, Face oedema dose are not recommended, as they might lead Local tolerance: By reporting side effects you can help provide more
disorders Sweating increased to life-threatening adverse effects. If needed, The local pharmaceutical tolerance of Iopami- information on the safety of this medicine.
Musculoskeletal hemodialysis can be used to eliminate iopami- dol, 370 mg Iodine/ml, was examined in rats
Musculoskeletal pain, Mus-
and connective Back pain Muscle spasms dol from the body. Treatment of overdosage is after intravascular injection into the aorta. In
cular weakness
tissue disorders directed toward the support of all vital func- comparison with ionic imaging agents the 5. How to store Scanlux Injection
Renal and urinary tions and prompt institution of symptomatic pharmaceutical tolerance of Iopamidol was
Acute renal failure Keep this medicine out of the sight and reach of
disorders therapy. equal or better.
children.
General disorders Chest pain, In- In the event of accidental intravascular Do not use Scanlux after the expiry date which is
Rigors, Pain, Malaise overdose in humans, the water and electrolyte Accidental paravascular injection can cause a
and administration Feeling hot jection site pain, printed on the label and carton.
site conditions Pyrexia, Feeling cold losses must be compensated by infusion. Renal local swelling, pain and erythema. Normally
Protect the solution from light and X-rays. Do not
function should be monitored for at least three these reactions will abate without complica-
Electrocardiogram change store above 25C. Store in the original package.
Blood creatinine days. tions. Supporting the concerned extremity in a
Investigations including ST segment Your doctor, pharmacist or nurse will know how to
increased raised position and treating with cold com-
depression store Scanlux Injection properly.
5. PHARMACOLOGICAL PROPERTIES presses are favourable measures.
* Since the reactions were not observed during clinical trials with 2,548 patients, best estimate is that their 5.1 Pharmacodynamic properties
relative occurrence is rare (1/10,000 to <1/1000). The most appropriate MedDRA term is used to describe a Pharmacotherapeutic group: Watersoluble,
certain reaction and its symptoms and related conditions. nephrotropic, low osmolar X-ray contrast
** Cardiac dysrhythmias may occur mostly after cardiac angiographic and coronary catheterization procedures media, ATC code: V08AB04