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IOPAMIGITA 370 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): IOPAMIDOL

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Among patients with autoimmune diseases cases of serious inflammatory reactions of blood
vessels or Stevens-Johnson-like syndromes (life-threatening conditions affecting the skin) were
reported.

Package leaflet: Information for the user

Iopamigita 370 mg/ml
solution for injection/infusion

Catheter X-ray investigation with dyes is connected with the risk to induce sudden blocking of
blood vessels or blood clots.

Iodine (as Iopamidol)

Excitation, anxiety or pain may increase the risk of undesirable effects. Patients with marked
anxiety may receive calming treatment.

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Ÿ
Keep this leaflet. You may need to read it again.
Ÿ
If you have any further questions, ask your doctor or pharmacist.
Ÿ
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.
Ÿ
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

Contrast media may promote changes in red blood cells in individuals with sickle cell disease
when injected intravenously and intra-arterially.

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

Beta-blockers, vasoactive substances (medicines causing constriction or dilation of blood vessels),
angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin receptor antagonists (blood
pressure lowering medicines).
These medicinal products reduce your body's ability to manage changes in blood pressure: the
doctor must be informed before injection of the X-ray dye and resuscitation equipment must be at
hand.
Children
Toddlers aged less than 1 year and new-born infants are especially susceptible to an imbalance
of salts in the body and haemodynamic changes (blood changes). Caution is, therefore, advised
with regard to dosage of the contrast medium, conducting the examination and the patient's
condition. Premature new-born infants should be monitored very carefully as application of the
contrast medium can result in temporary decline in the functioning of the thyroid gland.

1.What Iopamigita is and what it is used for
Iopamigita is one of a group of medicines called X-ray contrast media.. This medicine is for
diagnostic use only.
You will be given Iopamigita before or during X-ray examination or other imaging techniques (CTscan) . 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 Iopamigita:
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Examinations of the blood vessels
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Examinations of the heart and its blood vessels
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Computerised tomography (CT) enhancement such as brain or whole body scanning

2.What you need to know before you use Iopamigita
Do not use Iopamigita
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if you are allergic to Iodine (as Iopamidol) or any of the other ingredients of this medicine (listed
in section 6).
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if you have overactivity of the thyroid gland (hyperthyroidism).
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if you have a history of major immediate or delayed skin reaction (see section 4 " Possible side
effects; Tell the radiologist or X-ray staff immediately “) to injection of iopamidol.
Warnings and precautions
Talk to your doctor or pharmacist before using Iopamidol
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if you have an overactive thyroid without symptoms (latent hyperthyroidism) and/or thyroid
nodule(s) without signs of inflammation (euthyroid goitre)
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if you have kidney or severe liver problems
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if you have (a history of) severe heart or blood vessel (cardiovascular) disease
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if you have bronchial asthma
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if you have diabetes mellitus
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if you have a seizure disorder
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if you have advanced arteriosclerosis (hardening) of arteries supplying the brain
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if you have had an acute stroke
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during acute bleeding in the brain or in conditions accompanied by damage to the blood-brain
barrier and swelling of the brain
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if you are in poor overall health or have a fluid deficit (dehydration)
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if you have an abnormality with the proteins or antibodies in your blood such as
dysproteinaemia or paraproteinaemia (e.g. in multiple myeloma/plasmocytoma)
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if you have high blood pressure due to a tumour near the kidney (phaeochromocytoma).
Precautions to be considered while using Iopamigita
The patient should hydrate himself/herself sufficiently.
As with all iodine-containing contrast media, dose-independent allergic-like side effects may occur
after you have been given Iopamigita.
Usually these reactions result in minor symptoms. If such reactions happen, contact your doctor
immediately.
Allergic reactions are more common in patients with allergies and/or asthma and also in patients
with known allergy to contrast media. If you have a history of allergies or bronchial asthma, you
may be given antihistamines and/or corticosteroids before the X-ray investigation.
Iodine-containing contrast media can effect thyroid function. This may induce overactivity of the
thyroid gland or even thyreotoxic crisis (over active thyroid gland function) in patients with thyroid
disease. If you are potentially at risk, then your thyroid function has to be assessed prior to the Xray examination.
Patients with heart and circulation problems, especially those with cardiac weakness, severe
coronary heart disease, unstable angina pectoris, diseases of the heart valves, previous heart
attack, heart bypass and high blood pressure, are at higher risk for serious reactions of the heart.
This is especially applicable following intracoronary, left and right ventricular application of the
contrast media.
Patients with diseases of the brain vessels (cerebrovascular diseases), who have had a previous
stroke or short term blood vessel constriction or blockage, brain tumour or a wasting or
inflammation of the brain are at an increased risk of complications. The presence of brain tumours
and epilepsy may lead to an increased risk of seizures. Short or long term alcoholism may cause
contrast medium induced reactions of the central nervous system.

Other medicines and Iopamigita
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Iodine containing x-ray contrast media can reduce the ability of the thyroid gland to take up radioisotopes used in the diagnosis and treatment of thyroid disease for 2-6 weeks.
The application of X-ray contrast media may induce temporary kidney function impairment which
may cause lactate acidosis in patients with diabetes mellitus treated with metformin. Therefore use
of metformin must be stopped for a certain period of time before and after the examination. For
safety precautions see Precautions to be considered while using Iopamigita.
In patients taking beta-receptor blockers (for heart problems and high blood pressure),
hypersensitivity reactions may occur more frequently and, above all, more intensely.
Medicines that reduce the seizure threshold (e.g. phenothiazine derivatives, analeptics, tricyclic
antidepressants, monoamine oxidase inhibitors, antipsychotics) may facilitate seizures especially in
patients with epilepsy or focal brain damage. If medically acceptable, treatment with such
medicines should be suspended for 48 hours before and up to 24 hours after cerebral
angiography in such patients.
In patients who have been treated with interferons and interleukins, known contrast medium
reactions such as skin redness, fever and/or flu-like symptoms may occur more frequently and,
above all, with a time lag. No cause has been identified.
Arterial thrombosis has been reported when iopamidol was given following papaverine.
The administration of vasopressors strongly potentiates the neurological effect of the intra-arterial
contrast media.
When renal scintigraphy using an injection of radiopharmaceutical secreted by the renal tubule is
planned, it should preferably be performed before injection of the contrast agent.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you are pregnant.
Safe use of iopamidol in pregnant women has not been established. When a pregnant woman
has an x-ray examination, the child in her womb will also be exposed to radiation. For this reason
alone, the benefit of any x-ray examination, with or without a contrast medium, must be carefully
considered. Apart from trying to avoid foetal radiation exposure wherever possible, the benefit-risk
assessment of the use of iodine containing contrast media should also take account of the iodine
sensitivity of the foetal thyroid gland.
Breast feeding

The symptoms of myasthenia gravis may be increased by iodinated contrast media.

Low amounts of iodinated contrast agents are secreted into the breast milk. Occasional
administration to the mother is associated with a low risk of adverse effects for the infant.
However, as a precautionary measure, it is preferable to suspend breast feeding for 24 hours
after administration of a iodinated contrast agent.

The following information is intended for medical or healthcare professionals only:

Intravenous or intraarterial use (injection or infusion).

Field of application

The contrast medium should be brought to body temperature before administration. Experience
has shown that a warmed contrast medium is tolerated better.

Volume
Sheet Film Angiography

Digital Subtraction Angiography

Adults: Maximum of 250 ml. The
volume of the single injection
depends on the vascular region to
be examined.

Adults: 30 – 40 ml. Maximum of
250 ml. The volume of the single
injection depends on the vascular
region to be examined.

Arteriography
Others, non-cerebral

Angiocardiography

Coronary angiography

Children: depending on body
Children: depending on body
weight and age.
weight and age.
Adults: Maximum of 250 ml. The volume of the single injection depends
on the vascular region to be examined.
Children: depending on body weight and age.
4 – 10 ml/artery, to be repeated if required

Adults: 30 – 40 ml, to be repeated if required
Intravenous digital
subtraction angiography
Children: depending on body weight and age.
(i.v. DSA)
general
Computer tomography (CT) Adults: 1 – 2 ml/kg body weight
Children: depending on body weight and age.
The maximum dose for Iopamigita 370 mg /ml is 1.5 ml/kg bodyweight.

Iodine-containing contrast media should only be used under the precondition that treatment of
emergencies is possible. This includes availability of the necessary technical and medicinal
equipment. Following application, the patient shall be monitored for at least ½ hour, as from
experience the majority of all serious incidents occur within this timeframe.

Do not use Iopamigita if you notice that the solution is not clear.
Contrast media should normally not be drawn up into a syringe until immediately before use. To
minimise the risk of thrombo-embolism associated with the examination, the contact time between
blood and contrast medium in syringes and catheters should be kept as short as possible.
Attention should also be paid to careful angiographic technique and frequent flushing of catheters
with sodium chloride 9 mg/ml (0,9%) solution for injection (adding heparin if necessary). Contrast
medium not completely used up during an examination must be discarded.
The contrast medium should be administered to the recumbent patient if at all possible. Immediate
repositioning must be possible. To enable emergency management if necessary, a secured venous
access should be in place before starting the examination. Like all iodine containing x-ray contrast
media, Iopamigita should be used with any diagnostic technique only if resuscitative equipment
and emergency medication are available.
After the examination, patients should be monitored for at least 30 minutes because experience
shows that most severe adverse reactions to contrast media occur during this time. All medical and
nursing staff must be informed of adverse reactions as well as general and pharmacological
emergency measures.
In patients with impaired renal function, cardio-circulatory insufficiency as well as bad general
condition, the dosage of contrast media should be kept as low as possible. Kidney function should
be monitored at least three days following the examination.
Pretesting using a low dose of contrast medium for hypersensitivity is not recommended, as this not
meaningful and occasionally resulted in serious hypersensitivity reactions.
As the intravascular administration of iopamidol can lead to renal failure, metformin must be
discontinued prior to, or at the time of the test and not be reinstituted until 48 hours afterwards,
and only after renal function has been re-evaluated and found to be normal.
The patient must be kept sufficiently hydrated before and after the examination. Any fluid and
electrolyte imbalance should be corrected. In patients with dysproteinaemia or paraproteinaemia
(multiple myeloma/plasmacytoma), diabetes mellitus, polyuria or oliguria, gout, as well as in
young children, old patients and patients in poor general condition, fluid intake must never be

Driving and using machines
The effects on the ability to drive and use machines have not been investigated.
Iopamigita contains sodium
This medicinal product contains approximately 0.059 mg of sodium per milliliter (ml). To be taken
into consideration by patients on a controlled sodium diet.
3.How to use Iopamigita
The medicine will be given to you by a doctor. You should check with your doctor or pharmacist if
you are not clear about anything. Unless prescribed otherwise by your doctor, the dose will
depend on the type of examination to be performed on you, your age, weight, heart function and
general state of health, and the type of examination that is being used. Usually the same iodine
concentrations and volumes are used as with other non-ionic iodine containing x-ray contrast
media. The lowest dose necessary to obtain the desired diagnostic information should be used.

Not known
Frequency cannot be estimated from the available data
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Altered thyroid gland function or a severe form of overactive thyroid (thyrotoxic crisis)
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Blockage of a blood vessel by a blood clot that results in a stroke
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Temporary complications such as dizziness and headache
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Injection site reactions: if the injection does not go directly into the blood vessel; local pain and
swelling (oedemas)
Delayed reactions can occur, if you are concerned you should contact your doctor.
If you get any side effects, talk to your doctor or the X-ray department staff/radiologist. This
includes any possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

The dose recommendations given at the end of this leaflet are based on general experience with
non-ionic x-ray contrast media as well as clinical studies performed with iopamidol. The total
volume administered should not exceed 250 ml.

5.How to store Iopamigita

Unless indicated otherwise, the dosage for children depends on their age and body weight, and
should be determined by the attending physician.

Do not use this medicine after the expiry date which is stated on the vial and carton after “EXP”.
The expiry date refers to the last day of that month.

Keep this medicine out of the sight and reach of children.

Do not refrigerate or freeze.
Iopamigita is a diagnostic product for single injection in the intended indications. Multiple
injections or repeated examinations are possible.
How to use Iopamigita
You should have nothing to eat for 2 hours prior to the investigation, in order to reduce the risk of
aspiration, as nausea and vomiting are known possible adverse reactions.
If you use more Iopamigita than you should
In case of accidental overdose or significantly impaired kidney function, iopamidol can be
removed from the body by dialysis.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects you may get after being given a contrast media like Iopamigita are usually mild to
moderate and do not last long.
However, as with similar contrast media, severe reactions and life-threatening reactions can occur,
that require rapid and effective emergency treatment.
If you notice:
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swelling of the face or throat (angioedema)
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itchy or watery eyes (conjunctivitis); coughing; itching; runny or blocked nose; sneezing; nettle
rash
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a massive fall in blood pressure, increased heart rate (tachycardia)
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difficulty in breathing, gagging, feeling of suffocation (anaphylactoid reactions)
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agitation, blue lips, blue or pale skin, cold sweats, clouding or loss of consciousness,
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headache, dizziness, feeling faint.
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the fall in blood pressure may also be connected with decreased heart rate (bradycardia;
vasovagal reaction), from which increased heart rate (tachycardia) usually develops over time.
Tell the radiologist or X-ray staff immediately as these may be the first signs of allergic reaction
or shock. Your investigation will need to be stopped, and you may need further treatment.
Apart from the symptoms listed above, these are the other side effects of Iopamigita, starting with
the more common ones:

Store in the original package in order to protect from light. Protect from x-rays.
Do not use this medicine if you notice that the solution is not clear.
Once opened:
Do not refrigerate or freeze.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, unless the method of opening precludes the risk of microbial
contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of user.
Each vial is for single patient use only.
Discard any unused contents.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
6.Contents of the pack and other information
What Iopamigita contains
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The active substance is iopamidol.

1 ml solution contains 755.2 mg iopamidol, equivalent to 370 mg iodine.
One vial of 20 ml solution contains 15,104 mg Iopamidol, equivalent to 7,400 mg Iodine.
One vial of 50 ml solution contains 37,760 mg Iopamidol equivalent to 18,500 mg Iodine.
One vial of 75 ml solution contains 56,640 mg Iopamidol, equivalent to 27,750 mg Iodine.
One vial of 100 ml solution contains 75,520 mg Iopamidol equivalent to 37,000mg Iodine.
One vial of 200 ml solution contains 151,040 mg Iopamidol, equivalent to 74,000 mg Iodine.
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The other ingredients are trometamol, edetate calcium disodium (dihydrate), hydrochloric acid
36 % (for pH adjustment) and water for injection
What Iopamigita looks like and contents of the pack
Iopamigita is a solution for injection and infusion. Clear, colourless or light yellow solution.
pH

6.5 – 7.5

Osmolality at

37°C

835 [mOsm/kg]

Common (may affect up to 1 in 10 people)

Osmolarity at

37°C

544 [mOsm/l]

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Temporary changes in breathing rate; shortness of breath; difficulty breathing as well as

Osmotic pressure

37°C

2.08 [MPa]

Viscosity

37°C

10.75 [mPa.s]

coughing
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Nausea; vomiting; problems with your sense of taste
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Swelling of the hands, ankles or feet (oedemas); flush; nettle rash; rash; itching; redness of skin
Rare (may affect up to 1 in 1,000 people)
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X-ray procedures of the brain and other procedures in which the contrast media enters the
arterial blood in the brain in a high concentration: agitation; confusion; loss of memory; speech,
sight and hearing disorders; epileptic fits; shaking; weakness causing loss of movement;
paralyses; tingling or numbness of the hands or feet (pins and needles); increased sensitivity to
light; temporary blindness; coma; drowsiness
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Blockage of a blood vessel by a blood clot have been reported during catheter angiographic
examinations, which resulted in heart attack
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Difficulty in breathing or wheezing, swelling or spasm of the voice box (larynx).
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Stomach complaints
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Kidney function disorders extending to acute kidney failure, particularly in patients whose renal
function was already impaired
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Serious life-threatening reactions (including fatalities) that require emergency treatment and are
associated with vital functions of the cardiovascular system, usually in connection with
respiratory and central nervous reactions: Feeling warmth; changes in body temperature (fever);
headache; feeling unwell; sweating; a cold feeling; fainting
Very rare (may affect up to 1 in 10,000 people)

Your medicinal product comes in a clear glass vial with a rubber stopper and aluminium cap that
is packed into a carton along with this patient information leaflet (package leaflet).
Iopamigita 370 mg/ml is presented in the following packs:
10 vials with 20, 50, 75, 100 and 200 ml solution for injection/infusion
30 vials with 20, 50, 75 and 100 ml solution for injection/infusion
20 vials with 200 ml solution for injection/infusion
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Agfa HealthCare Imaging Agents GmbH
Am Coloneum 4
50829 Köln
Germany
Tel: + 49 221 5717-660
Fax: + 49 221 5717-1051
E-mail: imagingagents@agfa.com

Manufacturer:
Corden Pharma S.p.A.
Viale Dell´Industria 3
20867 Caponago (MB)
Italy

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Clinically relevant disorders of: blood pressure; heart rate; fast, slow or irregular heartbeats;

pain or tightness in the chest; heart failure; heart attack
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Swelling or fluid in the lungs; stopped breathing (respiratory arrest)
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Swelling of salivary glands in and around the mouth (iodide mumps)
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Swelling of the face, skin, tongue, other mucous membranes (e.g. inside nose or mouth) or other

This leaflet was last revised in 11/2015

parts of the body; severe skin disease (red, blistered, bleeding, painful skin, which may affect
the lips, eyes, mouth, nose and genitals too).
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Swelling and redness along a vain which is extremely tender when touched; blood clots of the
veins
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Injection site reactions: inflammation and soft tissue infections

restricted before administering the contrast medium. In patients at risk, the water and electrolyte
balance should be monitored, watching for symptoms of decreasing serum calcium levels.
Reversible kidney failure can occur in rare cases. A history of or existing kidney disease, age over
60 years, fluid imbalance, advanced arteriosclerosis, decompensated heart insufficiency, high
doses of contrast media and multiple injections, direct application of contrast media to the renal
artery, exposition to further medicines which may damage the kidneys, severe and chronic high
blood pressure, hyperuricaemia and paraproteinaemia (e. g. plasmocytoma,
macroglubulinaemia) are predisposing factors.
In patients with impaired kidney function, the use of potentially kidney damaging medicines
should, if at all possible, be avoided until excretion of the contrast medium is complete. Further
contrast medium examinations should be postponed until kidney function has returned to baseline.
Iodine-containing contrast media can be removed from the blood by dialysis.
In patients with phaeochromocytoma, it is recommended to administer alpha-adrenergic receptor
blockers before the examination because severe high blood pressure crises may occur following
intravascular administration of non-ionic contrast media.

Iodinated contrast media can react with metallic surfaces containing copper (e.g. Brass).
Therefore the use of equipment in which the product comes into direct contact with such surfaces,
should be avoided.
What to do in the event of side effects
If an adverse reaction occurs, administration of the contrast medium must be stopped immediately.
Treatment should be in response to the clinical picture. General resuscitative measures and the use
of medicines may be necessary e.g. general treatment (antihistaminic, corticosteroids,
oxygenotherapy), treatment of cardiovascular disorders (vasopressors, plasma, electrolytes),
treatment of convulsions (diazepam), treatment of tetanic crisis (calcic gluconate), Renal function
should be monitored at least the following 3 days after overdose.
It should be borne in mind that the effects of adrenaline and volume replacement are reduced in
patients co-administered β-receptor blockers.

Contrast media may interfere with laboratory tests for bilirubin, proteins or inorganic substances
(eg iron, copper, calcium, phosphate). These substances should not be assayed during the same
day following the administration of contrast media.
Dosage adjustments in specific patient groups is required such as in patients with renal impairment
and hepatic impairment.
Prior to use, the solution has to be inspected visually. Only solutions without visible signs of
deterioration or particles may be used.
Neuroleptics must be absolutely avoided because they lower the seizure threshold. The same
applies to analgesics, antiemetics, antihistamines and sedatives of the phenothiazine group.
Whenever possible, treatment with such drugs should be discontinued at least 48 hours before
administration of the contrast medium and not be resumed less than 24 hours after completion of
the procedure.
Angiography should be avoided whenever possible in patients with homocystinuria due to an
increased risk of thrombosis and embolism.
To avoid sickling in individuals who are homozygous for sickle cell disease appropriate hydration
should be assured and the minimum effective volume should be used.
Contents not used in a patient during one single investigation must be discarded.

230139-97/11-2015/02

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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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