OMNIPAQUE 240 mg Roztwór Do Wstrzykiwań

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1. Omnipaque 240 mg I/ml injectable solution, 300 mg I/ml injectable solution, 350 mg l/ml injectable solution
   1. What is Omnipaque and what it is used for
   2. What you need to know before using Omnipaque
   3. How to use Omnipaque
   4. Possible side effects
   5. How to store Omnipaque
   6. Contents of the pack and other information

Omnipaque 240 mg I/ml injectable solution, 300 mg I/ml injectable solution, 350 mg l/ml injectable solution

Ioexol

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What is Omnipaque and what it is used for

This medicine is for diagnostic use only. It is only used to help identify a disease.
Omnipaque is a “contrast agent”. It is administered before X-rays, to make the image clearer for the doctor.

• Once injected, it can help the doctor distinguish between normal and abnormal appearance and shape of some organs in your body.
• It can be used for X-rays of your urinary system, spine, or blood vessels, including the blood vessels of your heart.
• Some people are given this medicine before or during a scan of their head or body, using a “Computed Tomography” (also called a CT scan). This type of scan uses X-rays
• It can also be used to examine your salivary glands, stomach and intestines, or to examine body cavities, such as your joints, uterus and fallopian tubes.
• This medicine is also indicated in adults to identify a known or suspected lesion of the breast, using a system known as “spectral mammography enhancement” (CESM), in patients with dense breasts, for whom there are absolute or relative contraindications to performing magnetic resonance imaging.

The doctor will explain which part of your body will be scanned.

2. What you need to know before using Omnipaque

Do not use Omnipaque

• if you suffer from severe thyroid problems
• if you are allergic (hypersensitive) to iohexol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before usingOmnipaque:

• if you have had an allergic reaction after taking a medicine similar to Omnipaque, called a “contrast agent”.
• if you have thyroid problems (hyperthyroidism).
• if you have had allergies.
• if you have asthma.
• if you have diabetes.
• if you have brain disorders (including migraine) or tumors.
• if you have or have had serious heart or lung problems.
• if you have kidney or kidney and liver problems
• if you have high blood pressure
• if you have a disease called “myasthenia gravis”, a condition that causes severe muscle weakness.
• if you have “pheochromocytoma” (constantly high blood pressure or spikes in high blood pressure due to a rare tumor of the adrenal glands).
• if you have homocystinuria (a condition characterized by increased excretion of the amino acid cysteine in the urine)
• if you have a disease of the immune system
• if you have suffered from alcohol or drug addiction.
• if you have epilepsy, blood clots in the brain, or stroke.
• if you are going to undergo thyroid function tests in the coming weeks.
• if you suffer from paraproteinemia (a group of conditions characterized by the presence in circulation of high quantities of particular proteins (paraproteins) or from dysproteinemia (alteration of the quantity and quality of blood proteins).
• if you have a blood disease called sickle cell anemia.

A temporary brain disorder may occur during or shortly after the imaging procedure
called encephalopathy. Tell your doctor immediately if you notice any of the symptoms related to this
condition described in section 4.
Tell your doctor before using Omnipaque if you are not sure whether the above cases apply to you.

Othermedicines and Omnipaque
Tell your doctor if you are taking a medicine containing metformin, if you are being treated with ß-
blockers, vasoactive substances, ACE enzyme inhibitors or angiotensin antagonists (medicines used for
the treatment of high blood pressure) or if you have recently been given interleukin-2, for
example following a transplant, or interferons (medicines used in the treatment of diseases of the
immune system), antidepressants (medicines used for the treatment of mental disorders, such as
depression) or if you are using, have recently used or may use any other medicine, including those
available over the counter.
This is because some medicines may interfere with Omnipaque.
Beta-blockers may increase the risk of breathing difficulties and may interfere with the treatment
of severe allergic reactions, which represents a risk of Omnipaque.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine. The safety of use of
OMNIPAQUE in pregnant women has not been evaluated. Therefore, your doctor will only administer Omnipaque if he/she considers
that the benefit of its use outweighs the risk to the mother and the baby. If Omnipaque has been
administered to the mother during pregnancy, the thyroid function of the newborn should be
tested in the first week of life and from 2 to 6 weeks of age in premature infants and infants
with low birth weight.

Breastfeeding
Breastfeeding can be continued normally after the examination with Omnipaque.
However, to avoid any risk to the infant, it is advisable to stop breastfeeding before using
Omnipaque and do not resume it for at least 24 hours. The milk produced during this period must be discarded.

Driving and operating machinery
It is not advisable to drive vehicles or use machinery from the last injection of Omnipaque for:

• 24 hours, if the medicine has been administered into your spine, or
• for one hour in all other cases.

This is because you may feel dizzy or have other symptoms of a delayed reaction.

Children and adolescents
Adequate hydration must be ensured before and after the administration of OMNIPAQUE,
especially in neonates and young children.

3. How to use Omnipaque

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor.

Dosage and administration
Omnipaque will always be administered by a suitably trained and qualified healthcare professional.

• Omnipaque will always be used in hospital or clinic.
• The medical staff will inform you of everything you need to know for the safe use of the medicine.

The doctor will determine the most appropriate dose for you.

The usual dose is:

• A single injection or you may be asked to drink it.

After administration of Omnipaque
You will be asked:

• to drink plenty of fluids, to help eliminate the medicine from your body, and
• to remain in the area where you underwent the scan or X-ray or nearby for at least 30 minutes,
• to remain in the clinic or hospital for one hour.

Immediately inform your doctor if you experience any adverse effects during this period (see section 4
“Possible side effects”).
The above advice applies to all patientswho have been administered Omnipaque. If you are not sure
about the above, ask your doctor.
Omnipaque can be administered in many different ways; below is a description
of how it is usually administered:

Injection into an artery or a vein
Omnipaque will usually be injected into a vein in the arm or leg.
Sometimes it will be administered through a thin plastic tube (catheter), inserted into an artery,
usually in the arm or groin.

Injection into the spinal cord
Omnipaque will be injected into the space around the spinal cord, to see your spinal canal.
If you have been given Omnipaque into the spinal cord, you will subsequently be asked to follow the
following recommendations:

• remain with your head and body raised for one hour, or for six hours, if you are in bed, and
• walk carefully and try not to bend over for six hours, and
• do not be completely alone in the first 24 hours after the administration of Omnipaque, if you are an outpatient and have had seizures.

The above advice applies onlyif Omnipaque has been administered into your spinal cord.
If you are not sure about the above, ask your doctor.

Use in body cavities or joints
Body cavities may be the joints, the uterus and the fallopian tubes. The methods and location of
administration of Omnipaque may vary.

Oral use
Omnipaque is usually given by mouth to examine: throat, stomach and small intestine.
Omnipaque may be diluted with water for these examinations.

If you have been given too much Omnipaque
Since Omnipaque will be administered by a qualified healthcare professional, an overdose is unlikely.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest them.

Allergic reactions
If you have an allergic reaction following the administration of Omnipaque in hospital or clinic, tell your
doctor immediately. Symptoms may include:

• shortness of breath, difficulty breathing, a feeling of tightness or pain in the chest
• severe skin reactions, rashes, swelling, itchy spots, blisters on the skin and in the mouth, redness/itching of the eyes, cough, nasal congestion, sneezing other allergic symptoms
• swelling of the face
• dizziness or fainting (caused by low blood pressure) The side effects described above may also appear several hours or days after you have been given Omnipaque. If any of these side effects occur after you have left hospital or the clinic, go to the emergency room of the nearest hospital immediately. Other side effects may occur as listed below.

The frequencies of side effects are defined as follows:
Very common :occurs in more than 1 in 10 people
Common: occurs in 1 to 10 people out of 100
Uncommon: occurs in 1 to 10 people out of 1,000
Rare: occurs in 1 to 10 people out of 10,000
Very rare: occurs in less than 1 in 10,000
Not known: the frequency cannot be estimated based on the available data

General
(Applies to all uses of Omnipaque)
Common:

• feeling of warmth Uncommon:
• feeling unwell (nausea)
• increased/abnormal sweating, feeling cold, dizziness/fainting Rare:
• allergic reactions (hypersensitivity)
• slowed heartbeat
• headache, vomiting, fever Very rare:
• temporary alteration of the sense of taste
• high or low blood pressure, tremor (shivering)
• diarrhea, pain in the area around the stomach Not known:
• Allergic reactions, including severe allergic reactions, involving shock and collapse, see “allergic reactions” for other symptoms.
• fainting
• swelling of the salivary glands
• iodine poisoning, acute or chronic

After injection into an artery or a vein

Read the “General” sub-paragraph first. The following describes only the side effects and

frequencies that occur following intravascular use of monomeric, non-ionic contrast agents.
Common:

• feeling of warmth
• short-term changes in respiratory rate, breathing problems Uncommon:
• pain and discomfort Rare:
• dizziness
• partial or complete loss of muscle motility
• intolerance to bright light
• abnormal feeling of fatigue
• diarrhea
• irregular heartbeat
• kidney problems
• cough, general discomfort, respiratory arrest
• skin rash and itching, redness of the skin
• decreased vision Very rare:
• convulsions (seizures), blurred consciousness, stroke, sensory disturbances (e.g. of touch), altered sensitivity of limbs or other parts of the body (paresthesia), tremor
• hot flushes, redness
• difficulty breathing
• transient brain disorders (encephalopathy), including short-term memory loss, coma, disorientation, memory loss for events that occurred before the cause (retrograde amnesia), which can cause confusion, hallucinations, visual disturbances, loss of vision, seizures, loss of coordination, loss of movement on one side of the body, speech problems and loss of consciousness
• myocardial infarction Not known:
• Severe skin reactions of a pustular, exfoliating or blistering type
• Feeling of confusion, disorientation, feeling agitated, restless or anxious
• brain edema/swelling
• Hyperactivity of the thyroid (an excess of thyroid hormones in the blood that causes a variety of symptoms, such as tachycardia, sweating, anxiety), short-term hypoactivity of the thyroid (an abnormality of thyroid function that then returns to normal). Symptoms are not normally observed.
• transient movement difficulties, sensory disturbances (e.g. of touch)
• transient speech disorders including aphasia (inability to speak), dysarthria (difficulty pronouncing words)
• temporary blindness, transient hearing loss
• chest pain, heart problems, including heart failure, cardiac arrest and cyanosis (bluish discoloration of the skin due to a decrease in oxygen).
• feeling of tightness in the chest or difficulty breathing including fluid accumulation in the lungs, worsening of inflammation of the pancreas or acute inflammation of the pancreas.
• shock, arterial spasm, ischemia
• pain and swelling of the vein, blood clots (thrombosis), decreased platelets in the blood
• joint pain, muscle spasm, muscle weakness, reaction at the injection site, back pain
• asthma attack
• Psoriasis flare-up
• bullous dermatitis, Stevens Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized pustulosis, drug rash
• Iodism (excessive amount of iodine in the body) resulting from swelling and pain of its salivary glands.

After injection into the spinal cord

Read the “General” sub-paragraph first. The following describes only the side effects and

frequencies that occur following intrathecal use of monomeric, non-ionic contrast agents.
Very common:

• headache (may be severe and last for hours) Common:
• feeling unwell (nausea), vomiting Uncommon:
• central nervous system disease (aseptic meningitis, including chemical meningitis) Rare:
• convulsions (seizures), dizziness, diarrhea
• pain in the arms or legs, neck pain, back pain, pain in the extremities Not known:
• feeling agitated
• abnormal electrical activity of the brain in an examination called electroencephalography
• irritation of the meninges
• status epilepticus
• intolerance to bright light
• difficulty moving, feeling confused
• sensory disturbances (e.g. of touch), temporary blindness, transient hearing loss
• speech disorders including aphasia (inability to speak), dysarthria (difficulty pronouncing words)
• altered sensitivity of limbs or other parts of the body (paresthesia), decreased sensitivity and relative response to a given stimulus (hypoesthesia)
• feeling of tingling, muscle contractions (spasms), reaction at the injection site
• transient brain disorders (encephalopathy) including short-term memory loss, coma, disorientation, memory loss for events that occurred before the cause (retrograde amnesia), which can cause confusion, hallucinations, visual disturbances, loss of vision, seizures, loss of coordination, loss of movement on one side of the body, speech problems and loss of consciousness.

After use in body cavities (such as uterus and fallopian tubes, gallbladder, pancreas or hernia)

Read the “General” sub-paragraph first. The following describes only the side effects and

frequencies that occur following the use of monomeric, non-ionic contrast agents in body

cavities.

After endoscopic retrograde cholangiopancreatography (ERCP), an examination required to understand what

obstructs the normal outflow of bile and pancreatic juice into the intestine:
Common:

• inflammation of the pancreas (pancreatitis)
• increased amylase (enzymes) in the blood

After oral use:
Very common:

• diarrhea Common:
• nausea, vomiting Uncommon:
• abdominal pain

After hysterosalpingography (HSG), a radiological technique performed to check the health of

the fallopian tubes (salpinges) and study the morphology of the uterine cavity:
Very common:

• abdominal pain

After a radiograph of a joint (arthrography):
Very common:

• pain Not known:
• arthritis

Herniography:
Not known:

• pain

Further side effects in children and adolescents:
Not known:
Temporarily inactive thyroid in newborns.
Transient hypothyroidism, which fails to produce enough thyroid hormones to make the body function normally, has been reported in premature infants, newborns and in other children after receiving Omnipaque. Premature infants are particularly sensitive to the effect of iodine. Thyroid function should be monitored in newborns during the first week of life, following administration of iodinated contrast agents to the mother during pregnancy.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor. You can also report side effects directly to:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Omnipaque

Keep this medicine out of the sight and reach of children.
Polypropylene bottles: Store at a temperature not exceeding 30°C protected from light.
Glass bottles: Store at a temperature not exceeding 25°C protected from light.
Glass and polypropylene bottles of 50, 75, 100, 200 and 500 ml can be stored for one month at
37°C before use. Polypropylene bottles of 20 ml can be stored for one week at 37°C
before use.
Do not use this medicine after the expiry date which is stated on the label after Exp. The expiry date
refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Store in the carton in order to protect the medicine from light.

6. Contents of the pack and other information

What Omnipaque contains

• The active ingredient is iohexol. Omnipaque 240 mg/ml contains 518 mg of iohexol per ml (equivalent to 240 mg of iodine per ml).

Omnipaque 300 mg/ml contains 647 mg of iohexol per ml (equivalent to 300 mg of iodine per ml).
Omnipaque 350 mg/ml contains 755 mg of iohexol per ml (equivalent to 350 mg of iodine per ml).

• The other ingredients are: trometamol, calcium sodium edetate, hydrochloric acid (pH adjustment) and water for injections.

Description of the appearance of Omnipaque and contents of the pack
Omnipaque is an injectable solution. The medicine presents as a transparent aqueous solution, from
colourless to pale yellow.
Omnipaque is distributed in the following packs:
240 mg I/ml 1 vial of 20 ml
1 vial of 50 ml
300 mg I/ml 1 vial of 20 ml
1 vial of 50 ml
1 vial of 75 ml
1 vial of 100 ml
1 vial of 200 ml
1 vial of 500 ml
1 polypropylene vial of 20 ml
1 pre-break polypropylene vial 50 ml
1 polypropylene vial of 50 ml
1 polypropylene vial of 75 ml
1 polypropylene vial of 100 ml
1 polypropylene vial of 200ml
1 polypropylene vial of 500 ml
350 mg I/ml 1 vial of 50 ml
1 vial of 100 ml
1 vial of 200 ml
1 vial of 500 ml
1 pre-break polypropylene vial 50 ml
1 polypropylene vial of 50 ml
1 polypropylene vial of 100 ml
1 polypropylene vial of 200ml
1 polypropylene vial of 500 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
GE Healthcare S.r.l.
Via Galeno 36,
20126 Milan - Italy

Manufacturers:
GE Healthcare AS
Nycoveien 1
NO 0485 Oslo, Norway
GE Healthcare Ireland
IDA Business Park
Carrigtohill
Co.Cork, Ireland
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The following information is intended for healthcare professionals only: