Iomeron 150 mg I / ml solution for injection, Iomeron 200 mg I / ml solution for injection, Iomeron 250 mg I / ml solution for injection, Iomeron 300 mg I / ml solution for injection, Iomeron 350 mg I / ml solution for injection, Iomerone 400 mg I / ml solution for injection
jomeprol
1. What Iomeron is and what it is used for
Iomerone is an X-ray contrast agent that contains iodine. The iodine blocks the X-rays so that blood vessels and internal organs that are supplied with blood become visible and the image becomes clearer.
Iomerone is given before an X-ray examination of, for example, blood vessels, spine, urinary tract, reproductive organs, joints, body cavities, or certain glands such as the pancreas.
This medicine is for diagnostic use only. It is used as an aid in disease determination and not in connection with treatment.
2. What you need to know before you are given Iomeron
Do not use Iomeron:
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
- if you have a serious thyroid disease.
- if it is to be given in the spinal fluid in the spine if you are taking corticosteroids (medicines for inflammation ) given in the spine at the same time
Injection into the spine should not be repeated immediately.
Warnings and cautions
Talk to your doctor or nurse before using Iomeron if you have any of the following conditions:
- Have or have had problems with allergies or asthma or if you have had problems in previous examinations similar to this
- If you are taking blood pressure lowering medicines (beta blockers)
- Blood clots, circulatory problems, inflamed veins
- Infection
- Diabetes
- Sickle cell anemia (your body forms abnormally shaped red blood cells , leading to anemia )
- Heart disease
- Kidney or liver problems
- Overactive or enlarged thyroid gland
- Myasthenia gravis (a disease that causes weak muscles)
- stroke , mini- stroke ( TIA ), brain tumor or other brain diseases
- Have or have had problems with epilepsy
- Alcoholism
- Drug addiction
- Pheochromocytoma (a tumor of the adrenal gland)
- Multiple myeloma (a tumor in white blood cells )
- Waldenström’s paraproteinemia (abnormal protein is in the blood)
- You have strong tension, anxiety and pain
During or a short time after the X-ray procedure, you may experience a short-term brain disorder called encephalopathy. Tell your doctor immediately if you experience any of the symptoms associated with this condition as described in section 4.
Good control of salt and fluid balance and special care is important in infants, children, and the elderly before and after the Iomerone test. These groups may be particularly sensitive to side effects.
Tell your doctor if you have ever had a thyroid function test.
Other medicines and Iomeron
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking the following medicines:
- corticosteroids (medicines for inflammation ) given in the spine
- metformin (a treatment for diabetes ).
- neuroleptics (medicines for the treatment of mental illness) and antidepressants.
Tell your doctor if you are taking the following medicines, as they may increase the risk of side effects:
- treatments for high blood pressure or heart problems ( diuretics , ACE inhibitors and beta blockers)
- antiviral molecules used in cancer or autoimmune diseases (immune modulators such as interleukin-2 and interferon )
It may still be right for you to get Iomeron and your doctor will be able to assess what is right for you.
Tell your doctor if you are going to take laboratory tests as Iomeron may affect certain laboratory tests, such as iron, calcium, protein, and measurement of thyroid function.
Iomeron with food and drink
If you do not receive other instructions from your doctor, you can eat and drink as usual before the examination.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine. Experience with the use of Iomerone during pregnancy is limited. The examination and use of Iomeron will only be carried out if your doctor considers the benefit to be greater than the risk to both you and the baby.
Iomerone passes into breast milk but is not considered to have any effect on the baby at the doses you use. It is not necessary to stop breastfeeding.
Driving and using machines
There is no known effect on the ability to drive or use machines after using Iomeron.
However, it is not recommended that you drive or use machines within 24 hours after injection into the spine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Iomeron
Iomeron will be given to you in a hospital by a qualified healthcare professional.
Dosage
Your doctor will decide on a dose based on your needs, your weight, age, and which part of your body to examine. It will be injected into an artery or vein, or into the spinal fluid of the spine. The drug can also be given in body cavities.
Adults and children:
Dose a given as a single dose, but may be repeated if necessary depending on the type of examination.
The dose for another child is determined by age and weight.
If you have any further questions on the use of this product, ask your doctor or nurse.
After receiving Iomeron, you will be kept under medical supervision. The time period depends on how you received Iomeron and the type of examination you went through.
If you take more Iomeron than you should
The hospital or clinic where you are given Iomeron is well equipped to treat any effects of an overdose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate and do not linger. However, serious and life-threatening reactions have been reported, sometimes fatal. After injection into a vein or artery, most reactions occur within a few minutes, and after injection into body cavities or the spine, most reactions occur within a few hours or more.
Contact a doctor or nurse immediately if you experience any of the following rare reactions (may affect up to 1 in 1,000 people) :
Allergic reaction:
- wheezing and wheezing, difficulty breathing,
- swelling of eyelids, face or lips,
- skin rash or itching (especially if it affects the whole body)
Stevens-Johnson syndrome:
An extremely severe allergic reaction with skin rash is usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals.
Lyellas syndrome ( toxic epidermal necrolysis ):
Severe skin damage (skin detachment of the epidermis and superficial mucous membranes).
Contact a doctor or nurse immediately if you experience any of the following reactions (affects an unknown number of users):
Acute generalized exanthematous pustulosis (AGEP):
- if you get a severe skin reaction: red, scaly rash with bumps under the skin and blisters
Other side effects that may occur:
When injecting into a blood vessel
Common (may affect up to 1 in 10 people):
- feeling of warmth
Uncommon (may affect up to 1 in 100 people):
- dizziness, headache
- increased blood pressure
- respiratory distress
- nausea, vomiting
- flushing redness , hives , itching
- chest pain, feeling of heat and pain at the injection site
Rare (may affect up to 1 in 1,000 people):
- severe allergic reactions that cause difficulty breathing or dizziness
- lost appetite
- anxiety, confusion
- fainting sensation
- slow or fast pulse , extra beats
- low blood pressure
- rash
- back pain
- weakness, stiffness, fever
- increased level of creatinine in the blood
- reduction in the number of platelets (which increases the risk of bleeding and bruising)
- coma , mini- stroke ( TIA ), diseases of the blood vessels of the brain, brain disease, fluid accumulation ( edema ) in the brain, paralysis, fainting, convulsions, unconsciousness, speech disorder, affected feeling (eg ant crawling), memory loss, drowsiness, taste disorders
- transient blindness, visual disturbances, eye inflammation, increased tear flow, flicker vision
- cardiac arrest, heart attack, heart failure , angina, heart fibrillation , disorders of the cardiac conduction system ( AV block ), extra beats in the heart, palpitations, blue discoloration of skin and mucous membranes, blood clots in the coronary arteries of the heart
- circulatory collapse or shock (rapid drop in blood pressure, pallor, restlessness, weak fast pulse , cold sweaty skin, impaired consciousness), hot flashes, pallor
- respiratory arrest, acute respiratory distress, fluid accumulation ( edema ) in the lungs, fluid accumulation in the pharynx, sudden contraction of the airways ( bronchospasm ), asthma , cough, shallow and rapid breathing (hyperventilation), discomfort in the throat and throat, runny nose, hoarseness
- acute inflammation of the pancreas, intestinal upset, diarrhea, stomach pain, severe salivation, difficulty swallowing, enlarged salivary gland
- severe allergic reactions such as swelling of the face or throat, cold sweats, increased sweat production, development of round skin blisters (usually paler in the middle) (erythema multiforme), possibly with ulceration and blistering of the mucous membranes (especially in the mouth, lips, eyes and genitals) and high fever ( Stevens-Johnson syndrome ), with skin waste in the most severe cases ( toxic epidermal necrolysis ( Lyell’s disease))
- joint pain,
- kidney failure
- injection site reactions such as pain, swelling, malaise, fatigue, spotty cold, thirst
- abnormal electrocardiogram ( ECG )
- abnormal liver and blood values
Has been reported (occurs in an unknown number of users):
- severe skin reaction: red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis ).
- hemolytic anemia (abnormal breakdown of red blood cells , which can cause fatigue, increased heart rate and shortness of breath)
- brain disorder ( encephalopathy ) with symptoms include headache, vision problems, visual loss, confusion, seizures, loss of coordination, paralysis of one half of the body, problems with speech or unconsciousness.
When injected into the spinal fluid in the spine
Very common (in more than 1 in 10 patients):
- headache
Common (in more than 1 in 100, but less than 1 in 10 patients):
- dizziness
- increased blood pressure
- nausea, vomiting
- back pain, pain in the extremity er
- injection site reactions such as pain, discomfort, feeling hot
Uncommon (in more than 1 in 1,000, but less than 1 in 100 patients):
- unconsciousness, paralysis of the lower extremities , numbness, numbness, drowsiness, epilepsy
- lowered blood pressure , redness
- increased sweating, itching , rash
- muscle stiffness, neck pain
- feeling hot, fever
- severe allergic reaction that causes difficulty breathing or dizziness
- epilepsy
- rash
Has been reported (occurs in an unknown number of users):
- brain disorder ( encephalopathy ) with symptoms include headache, vision problems, visual loss, confusion, seizures, loss of coordination, paralysis of one half of the body, problems with speech or unconsciousness.
When injected into body cavities
Has been reported (occurs in an unknown number of users):
- abnormal blood counts (examination of the pancreas)
- local irritation by arthrography or fistulography (contrast X-ray of joint cavities or fistulas )
- allergic reactions: severe allergic reactions that cause difficulty breathing or drowsiness can not be ruled out
- as with other iodine-containing preparations, abdominal pain and malaise may occur after examination of the cervix, fallopian tubes and ovaries
Iomeprol’s safety profile is similar in children and adults.
If you have any other questions that are not answered in this leaflet, please ask your healthcare provider.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Iomeron
You will not store this medicine yourself, your doctor or hospital pharmacist knows how to store it.
Keep this medicine out of the sight and reach of children. Store in the original package. Sensitive to light. Although Iomerone’s sensitivity is low, it is advisable to keep the product out of the reach of ionizing radiation.
Do not use this medicine after the expiry date which is stated on the label. The expiration date is the last day of the specified month.
Iomerone should be given to you immediately after it has been drawn up into the syringe.
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is iodine.1 ml Iomerone contains:solution for injection 150 mg I / ml: jomeprol 306 mg equivalent to iodine 150 mg.solution for injection 200 mg I / ml: jomeprol 408 mg equivalent to iodine 200 mg.solution for injection 250 mg I / ml: jomeprol 510 mg equivalent to iodine 250 mg.solution for injection 300 mg I / ml: jomeprol 612 mg equivalent to iodine 300 mg.solution for injection 350 mg I / ml: jomeprol 714 mg equivalent to iodine 350 mg.solution for injection 400 mg I / ml: jomeprol 816 mg equivalent to iodine 400 mg.
- The other ingredients are trometamol, hydrochloric acid and water for injections.
What the medicine looks like and contents of the pack
Iomerone is a solution for injection. The product is a clear aqueous solution packaged in glass bottles.
Pack sizes:
Iomerone 150 mg I / ml: 50 ml, 100 ml (cartons of 10 bottles).
Iomerone 200 mg I / ml: 50 ml, 100 ml (cartons of 10 bottles).
Iomerone 250 mg I / ml: 50 ml, 100 ml, 200 ml (cartons of 10 bottles).
Iomerone 300 mg I / ml: 20 ml, 50 ml, 75 ml, 100 ml, 150 ml, 200 ml (cartons of 10 bottles), 500 ml (cartons of 6 bottles).
Iomerone 350 mg I / ml: 20 ml, 50 ml, 100 ml, 150 ml, 200 ml (cartons of 10 bottles), 500 ml (cartons of 6 bottles).
Iomerone 400 mg I / ml: 50 ml, 75 ml, 100 ml, 150 ml (cartons of 10 bottles), 500 ml (cartons of 6 bottles).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Bracco Imaging SpA
Via Egidio Folli 50
20134 Milan, Italy
Information provided by:
Bracco Imaging Scandinavia AB, Drakegatan 6, floor 7, 412 50 Gothenburg
Manufacturer
Patheon Italia SpA
2 ° Trav. SX Via Morolense 5
03013 Ferentino, Italy
BIPSO GmbH
Robert-Gerwig-Strasse 4
78224 Singen, Germany
Bracco Imaging SpA
Bioindustry Park
Via Ribes 5
10010 Colleretto Giacosa (TO), Italy