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IOPAMIDOL 370MG IODINE/ML INJECTION

Active substance(s): IOPAMIDOL

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Information for the Doctor
Iopamidol 370mg Iodine/ml Injection
Summary of Product Characteristics
1. Name of the Medicinal Product
Iopamidol 370mg Iodine/ml Injection.
2. Qualitative and Quantitative Composition
Contains 755.2mg iopamidol, equivalent to 370mg iodine/ml.
3. Pharmaceutical Form
Solution for injection.
4. Clinical Particulars
4.1 Therapeutic indications
Iopamidol 370mg Iodine/ml Injection, an X-ray contrast media is indicated for the following
procedures:
 peripheral arteriography
 angiocardiography and left ventriculography
 coronary arteriography
 aortography
 selective renal arteriography
 selective visceral angiography
 digital subtraction angiography
 intravenous urography
4.2 Posology and method of administration
Dosage and administration:
Adults and children:
Procedure
Peripheral arteriography
Angiocardiography and left ventriculography
Coronary arteriography
Aortography
Selective renal arteriography
Selective visceral angiography
Hepatic
Coeliac
Superior Mesenteric
Inferior Mesenteric
Digital subtraction angiography
Intravenous injection
Left ventriculography
Selective coronary arteriography by intraarterial DSA
Intraveneous urology

Dosage
Adults
20-50 **

Children
*

30-80
4-8 (per artery) **
30-80
5-10

*
Not recommended
Not recommended
*

30-70
40-70
5-30
5-30

Not recommended
Not recommended
Not recommended
Not recommended

30-50
25
2-5

0.5-0.75 ml/kg*
1.0-1.5 ml/kg*
Not recommended

40-80***

1-2.5 ml/kg

* Dose dependent on body size and age.
** Repeat as necessary.
*** For severe renal failure patients use up to 1.5ml/kg.

Elderly:
No special dosage requirements. However, the lowest effective dose to be used.
Once the vial is opened use immediately and discard any remaining solution after use.
4.3 Contra-indications
Known or suspected hypersensitivity to iodine containing preparations or to any of the
excipients detailed under section 6.1.
4.4 Special warnings and precautions for use
As with other contrast media there is the possibility that this product may provoke
anaphylactoid reactions or other signs of allergy with nausea, vomiting, dyspnoea,
erythema, urticaria and hypotension. Extra caution to be taken with patients known to have
a positive history of allergy, asthma or have reacted during previous similar investigations,
hence the benefits must be assessed against the risks.
Appropriate resuscitation procedures must be available immediately. Patients must be kept
under close observation for 15 minutes following the last injection as the majority of severe
reactions occur during this time. Patients should remain in the hospital environment (but not
necessarily in the radiology department) for 1 hour after the last injection is administered.
Patients should be advised to return to the radiology department if any symptoms develop.
Patients who have been administered the media intrathecally should rest with the head and
thorax elevated for at least 1 hour followed by subsequent ambulation or bed rest with the
head elevated to 6 hours post procedure.
The dose of iopamidol must be adjusted in patients with moderate to severe impaired renal
function or in patients known to be diabetic. In patients taking metformin for renal
impairment the use of contrast media may precipitate lacticacidosis. Hence, this drug
should be stopped 48 hours prior to the administration of the contrast media and restarted
after control of renal function has been regained. Such patients must be maintained
hydrated through the procedure and renal function monitored after the procedure.
In patients suffering from severe hepato-renal impairment no procedure should be
conducted unless absolutely required, with re-examination delayed for 5-7 days.
Investigation of the right heart can be conducted, but in patients with pulmonary
hypertension, the pulmonary artery examination should not be conducted unless absolutely
required. During intracardiac and/or coronary arteriography, ventricular arrhythmias may
infrequently occur.
Care to be taken when conducting the procedure in patients with severe functional
impairment of the liver or myocardium and severe systemic disease, especially in
myelomatosis where patients should be well hydrated. Abnormalities of fluid or electrolyte
balance should be corrected prior to the administration of the contrast media.
In patients suffering from or with known history of epilepsy, anticonvulsant therapy should
be maintained before and following myelographic procedures, with therapy increased
for 48 hours before the procedure in some patients.
Caution must be taken in patients with hyperthyroidism and those previously suffering from
Graves’ disease. Hyperthyroidism may recur in patients previously treated for Graves’
disease. Rarely, serious thromboembolic complications have occurred after the use of
contrast media. To minimise the risk of clotting, non-ionic media should not be permitted to
remain in contact with blood in the syringe and intravascular catheters should be flushed
frequently.

4.5 Interactions with other medicaments and other forms of interaction
No other drugs should be mixed with this contrast media. As a precautionary measure,
metformin should be stopped 48 hours prior to administration of this contrast media and
only restarted after renal control has been regained. Iopamidol may interfere with tests for
thyroid function.
4.6 Pregnancy and lactation
Limited data are available on the use of iopamidol during pregnancy and lactation. Caution
should therefore be exercised because of the risk of X-rays associated with this product, by
balancing the potential benefits of treatment against any possible hazard. Hence,
administration and investigational procedures should be conducted in the preovulation
phase in women.
4.7 Effects on ability to drive and use machines
None known. However, because of the risk of early reactions driving or operating
machinery is not advisable for1 hour following the time of injection. Driving or operating
machinery is not advisable for 6 hours following intrathecal administration of the media (see
section 4.4).
4.8 Undesirable effects
This medicine may cause headache, nausea, vomiting, dizziness, heat sensation, skin
rashes (e.g. erythema), dyspnoea and hypotension as seen with other contrast media.
Iopamidol will irritate the gastrointestinal tract to cause nausea, vomiting and diarrhoea with
heartburn.
In addition, for myelography procedures rare cases of seizures, transient confusion or
transient motor or sensory dysfunction may occur. Menigism or meningitis have also been
reported, the possibility of an infective meningitis should be considered.
Renal impairment developing during treatment usually responds to rehydration of the
patient, therefore the patient should not be exposed to dehydration.
During intracardiac and/or coronary arteriography, ventricular arrhythmias may infrequently
occur.
Anaphylactoid reactions and cardiac arrest may occur following use of contrast media
including iopamidol. Fatalities have been reported. There have also been isolated reports of
acute pulmonary oedema.
Resuscitation procedures should be immediately available in order to overcome more
severe reactions involving the cardiovascular system.
Delayed reactions may occur occasionally with pruritus and urticaria being the most
common reactions. Rarely, serious thromboembolic complications have occurred after the
use of contrast media.
4.9 Overdose
Iopamidol undergoes minimal metabolism, deiodination or biotransformation in vivo.
Majority of dose is excreted in the urine unchanged, therefore increase intake of fluid.
5. Pharmacological Properties
5.1 Pharmacodynamic properties
As contrast medias are administered for diagnostic purposes they have minimal
pharmacodynamic effect. In blood it may dehydrate erythrocytes resulting in a decreased
ability for circulation, combined with an inhibiting effect on platelet aggregation and
coagulation.

Adverse cardiac effects of contrast media are related to the osmolality of the product, the
presence of calcium chelating compounds, and anionic and cationic composition.
Iopamidol is a non-ionic contrast media, low osmolality, low sodium content and low
calcium chelating activity, hence exhibits a reduced evidence of adverse effect to the
cardiovascular system.
As the preparation contains iodine, there is a small amount of free iodide that has the
potential to induce a clinically significant hyperthyroidism in susceptible patients.
5.2 Pharmacokinetic properties
Peak iodine levels occur immediately following rapid intravascular injection of iopamidol. It
is rapidly absorbed into the bloodstream from the cerebrospinal fluid following
administration into the subarachnoid space, with appearance in plasma within 1 hour and
virtually all reaching the systemic circulation within 24 hours.
There is minimum protein binding, it is distributed between the circulating blood volume and
other extracellular fluid with no disposition in tissues. It does not appear to cross
the blood brain barrier following intravascular administration.
The volume of distribution at steady state is approximately 16.8 litres, equivalent to the
extracellular fluid volume.
Iopamidol undergoes minimal metabolism, deiodination or biotransformation, and no
metabolites have been detected in urine.
Excretion occurs primarily through the kidneys with minimum amount detected in the
faeces. The elimination half-life has been determined as approximately 2.5 hours (T 1/2),
this would increase in renal impairment.
5.3 Pre-clinical safety data
Acute toxicity is very low in mice, rats, rabbits and dogs.
Subacute toxicity studies have been performed in rats, dogs and rabbits. In rats and dogs,
intravenous studies for up to four weeks showed some histological alterations of the
thyroid gland only at high doses, though the weight of the thyroid gland increased at all
dose levels.
No effect on fertility was observed in rats and no teratogenic potential in rats and mice. No
mutagenic potential was detected in mice.
6. Pharmaceutical Particulars
6.1 List of excipients
Tromethamine
Sodium calcium edetate
Water for Injections
Sodium hydroxide*
Hydrochloric acid*
*Added if required, to adjust pH of the solution.
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
36 months, unopened.
6.4 Special precautions for storage
Do not store above 25°C. Keep container in outer carton.
6.5 Nature and contents of container
Colourless glass Type I vial closed with rubber stopper and aluminium flip cap.
Pack sizes: Single vial, x5 vials or x10 vials in 20ml, 50ml
100ml or 200ml volumes

6.6 Instructions for use/handling
See 4.2 Posology and method of administration.
Discard the solution if particulate matter present.
Discard any unused solution at the end of the procedure.
For immediate and single patient use only.
7. Marketing Authorisation Holder
Genus Pharmaceuticals Limited
Park View House
65 London Road
Newbury
Berkshire
RG14 1JN
UK
8. Marketing Authorisation Number
PL 06831/0066
9. Date of First Authorisation/Renewal of Authorisation
23 November 1999
10. Date of (Partial) Revision of Text
December 2007

Information for the Patient
Iopamidol 370mg Iodine/ml Injection
Please read this leaflet carefully. This leaflet does not contain the complete information
about your medicine. If you have any questions or are not sure about anything, ask your
doctor.
About your medicine
 Iopamidol 370mg Iodine/ml Injection is a clear, colourless to pale yellow solution
which contains 755.2mg of the active ingredient iopamidol. The iopamidol is
equivalent to 370mg iodine/ml.
 Each vial also contains tromethamine, sodium calcium edetate, Water for Injections,
sodium hydroxide or hydrochloric acid.
 It comes in 20ml, 50ml, 100ml and 200ml vials.
 Iopamidol is a non-ionic X-ray contrast media, allowing the different tissues of the
body to be visible under X-ray inspection.
Marketing Authorisation holder
Genus Pharmaceuticals, Park View House, 65 London Road,
Newbury, Berkshire RG14 1JN, UK.
Manufacturer
N.P.B.I., Runde ZZ41, 7881 HM Emmer-Compascuum, The
Netherlands.
Uses for your medicine
This medicine is used to help the doctor examine the following:
 peripheral arteriography-the blood vessels situated away from the main organs









angiocardiography and left ventriculography- the heart
coronary arteriography- the arteries around the heart
aortography- the main artery leaving the heart, the aorta
selective renal arteriography – the arteries in the kidney
selective visceral angiograph- any large organ in the body cavity, especially the
abdomen
digital subtraction angiograph- blood vessels in the body
intravenous urography- the urinary tract from the bladder

Before starting your treatment
If the answer to any of the following questions is yes, tell the doctor before your treatment
begins.
 Have you ever had an allergic reaction to iopamidol, iodine or any of the ingredients
listed above?
 Have you ever had an uncomfortable reaction during previous similar
investigations?
 Are you asthmatic or have a history of allergies?
 Do you suffer from liver, heart or kidney disease?
 Do you have any other disease affecting any part of your body?
 Have you experienced dehydration, especially as a result of cancer?
 Do you suffer from epilepsy, diabetes, problems with your thyroid or Graves’
disease?
 Are you pregnant, think that you may be pregnant or planning a family?
 Are you taking metformin, blood thinning medicines (anticoagulants) or any other
drugs?
No other drugs should be mixed with this contrast media.
Do not drive or operate any tools/machines for at least 6 hours following a procedure
during which iopamidol was injected into the spinal cord area of your back. For other
procedures the time you should allow before driving or operating any
tools/machines should be at least 1 hour following the last injection of iopamidol.
How is Iopamidol Injection given?
The doctor will decide the most suitable dose for the procedure to be undertaken.
The dose administered to adults will differ for children, the dose for children is according to
body size and age.
The Iopamidol Injection will be given by injecting the solution into an artery, vein or the back
around the spinal cord depending on the diagnostic purpose.
If too much iopamidol is given it can be quickly removed from your body by increasing the
amount of fluids into your body or if necessary by haemodialysis (artificial kidney).
At the end of the procedure the medical staff caring for you will observe you closely for 15
minutes. This is in case you develop side-effects to iopamidol that might require immediate
treatment. The medical staff are also likely to request that you stay on the hospital
premises for 1 hour after the last injection of iopamidol given to you. If during this time you
develop any of the side-effects listed in the next section (‘What unwanted effects can this
medicine have?’) you should return to the department where you had your procedure
(radiology department) and tell the medical staff your symptoms.
If the procedure involved you being given injections of iopamidol into the spinal cord area of
your back, the medical staff will ensure that you rest with your head and upper body kept
upright for at least 1 hour. You will then also be told to rest with your head supported for 6
hours after the last injection of iopamidol was given to you.

What unwanted effects can this medicine have?
This medicine, like most other medicines, may cause side-effects in some people.
Occasionally, kidney problems may occur which rarely may result in kidney failure. Your
doctor will ensure that you have adequate fluids in order for this to be avoided.
The following side-effects may occur; headache, nausea, vomiting, dizziness, hot flush,
skin rashes, difficulty breathing and low blood pressure. The side-effects will go away after
treatment is stopped.
Examination of your heart may result in an abnormal or irregular heartbeat.
Occasionally, reactions such as itching and rashes of the skin can occur sometime after
iopamidol has been given to you. Severe, life-threatening, allergic reactions (swelling of the
tongue, lips, face and extremities, breathlessness, fluid in the lungs, low blood pressure,
fainting and possible collapse), heart attacks and, rarely, blood vessel obstructions have
also been reported following the use of contrast media.
Rarely, other side-effects affect the nervous system, including seizures, temporary
confusion or the “shakes”. Meningitis has also been reported.
If you experience any of the above effects or any other undesirable effects, tell your doctor
immediately. Your doctor will give you advice.
How should this medicine be stored?
Do not use this medicine after the expiry date indicated on the vial and pack.
Normally, your doctor or the pharmacist will store this medicine.
Do not store above 25°C. Keep the container in the outer carton to protect from light. Once
the vial has been opened, the solution should be used immediately and any remaining
solution discarded.
If the solution is cloudy do not use.
Keep all medicines out of the reach and sight of children.
Remember: This medicine has been prescribed for you. Do not give it to others. It may
harm them even if their symptoms appear to be the same as yours.
Leaflet prepared: December 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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