250 mgl/ml, 300 mgl/ml, 350 mgl/ml Solution for
What does Xenetix contain?
– The active ingredient is jobitridol.
One ml contains jobitridol corresponding to 250 mg iodine, 300 mg iodine, and 350 mg iodine respectively.
– Other ingredients are sodium calcium edetate anhydrous, trometamol hydrochloride, trometamol, hydrochloric acid or sodium hydroxide, water for injections
Marketing Authorisation Holder
GUERBET
BP 57400
F-95943 Roissy CdG Cedex
Manufacturer
GUERBET
BP 57400
F-95943 Roissy CdG Cedex
What Xenetix is and what it is used for
The appearance of the drug:
Genetics is a clear, colorless, or yellowish jobitridol solution for injection that contains iodine. Iodine is a dye that can be seen on X-rays, and which easily shows the changes in your body. The preparation is given as an injection into the bloodstream just before the X-ray examination so that the radiologist can better diagnose the problems in your body.
Genetics belongs to the drug group contrast agents.
Genetics is for diagnostic use only.
Drug group
Genetics belongs to the drug group contrast agents.
What is Xenetix used for?
The preparation is given as an injection into the bloodstream just before the X-ray examination so that the radiologist can better diagnose the problems in your body. Genetics is for diagnostic use only.
What you need to know before using Xenetix
Do not use Xenetix
- if you have previously had a severe skin rash or peeling skin, blisters, and/or mouth sores after receiving Xenetix
- if you are allergic to the active substance (jobitridol) or any other ingredient in this medicine (listed in section 6).
- if you have previously had a severe skin reaction to medicines containing the same active substance (iobitridol)
- if you have high levels of thyroid hormone in your blood ( thyrotoxicosis ).
- if you are pregnant, or if you think you are pregnant, and you are scheduled for an examination of the uterus and fallopian tubes (hysterosalpingography).
Warnings and precautions
Talk to your doctor or pharmacist before using Xenetix. As with all iodine-containing contrast media, regardless of the route of administration and dosage, there is a risk of allergic reactions when receiving Xenetix. These can be mild, but can also be life-threatening. The reactions may occur within an hour of administration or, less commonly, as much as seven days later. They are often unpredictable, but the risk is greater if you have reacted to the previous administration of an iodinated contrast agent.
Other medicines and Xenetix:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Pregnancy
X-ray examination of the uterus and ovaries with Xenetix should not be performed during pregnancy.
If this medicine has been given to a woman during pregnancy, or to a newborn baby, doctors should check the function of the baby’s thyroid gland because these babies may have a temporarily underactive thyroid gland ( hypothyroidism ).
Breast-feeding
Genetics can be excreted in breast milk. You should not breastfeed for at least 24 hours after receiving Xenetix.
Before the examination, you should inform your doctor if any of the following apply to you:
- You have previously reacted to an iodinated contrast agent during an examination.
- You have previously had a severe skin rash or peeling skin, blisters, and mouth sores after receiving Xenetix or any other iodinated contrast medium.
- You have impaired kidney function and/or impaired liver function.
- You are dehydrated (e.g. after severe vomiting or diarrhea or if you use diuretics ).
- You have heart failure or any other disease of the heart or blood vessels.
- You have had a heart attack, stroke, cerebral hemorrhage, or fluid accumulation in the brain.
- You have diabetes.
- You have asthma and have had an asthma attack within eight days before the examination.
- You have epilepsy.
- You have pheochromocytoma (a disease of the adrenal medulla).
- You have myasthenia gravis (a muscle disease).
- You have or have had thyroid disease.
- You are scheduled for a thyroid examination or treatment with radioactive iodine.
- You have a bone marrow disease (eg myeloma, multiple myeloma, or Waldenström ‘s macroglobulinemia)
- You experience anxiety, nervousness, or if you have pain ( side effects may increase).
- You regularly drink large amounts of alcohol or use drugs.
- Do you have any other illness?
Take special care with Xenetix:
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis ( Lyell’s syndrome or TEN), and acute exanthematous pustulosis (AGEP), which may be life-threatening, have been reported with the use of Xenetix.
If you develop a severe rash or any of these skin symptoms, contact your doctor or seek medical attention immediately.
Use of other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Xenetix contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. it is almost “sodium-free”.
How to use Xenetix
Dosage instructions
Injection is given by an experienced person. You must carefully follow this person’s instructions. If you are unsure about something, you should ask the person caring for you. The amount of preparation given to you depends on your weight and the part of the body to be examined.
The following applies to the 500 ml bottle/bag: Xenetix is given with an auto-injector. A sterile device (for example, a liquid transfer device that has a valve that prevents backflow) that is approved for repeated use when transferring contrast medium from the vial to the syringe is used.
Information for the hospital staff :
The hospital staff must prepare the patient for using Xenetix and ensure the patient’s suitability for using thihelpontrast medium.
The hose between the injector and the patient must always be changed after each patient. The remaining contrast agent in the bottle/bag, the fluid transfer equipment, and other used materials must be discarded at the end of the day (within 8 hours at the most). Other instructions from the manufacturer must always be followed. The venous connection must be kept open throughout the examination in case of an allergic reaction.
If you are given too much Xenetix:
Because you receive the injection in a hospital by a trained person, it is very unlikely that you will get overdose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you develop any of the following signs of serious side effects:
- angioedema (rare) and allergic shock reaction (very rare)
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
- fever and drop in blood pressure
- Toxic epidermal necrolysis ( Lyell’s syndrome or TEN) and Stevens-Johnson syndrome: (very rare)
- red-violet target-like or round spots with central blistering, often symmetrically distributed, on the trunk
- sores in the mouth, throat, nose, genitals, or eye inflammation (red and swollen eyes)
- the skin reactions, which can be life-threatening, are often followed by flu-like symptoms. The rash can develop into blisters over large areas or skin peeling.
- Acute generalized exanthematous pustulosis, DRESS or drug hypersensitivity syndrome: (very rare)
- red, scaly widespread skin rash with nodules under the skin and blisters associated with fever at the start of treatment ( acute generalized exanthematous pustulosis ) or widespread skin rash, high body temperature, elevated liver enzyme levels, blood abnormalities ( eosinophilia ), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms also known as DRESS or drug hypersensitivity syndrome). See also section 2.
Overall, the following side effects have been described for Xenetix
Common (may affect up to 1 in 10 users):
– Feeling of warmth
– Nausea
Rare (may affect up to 1 in 1,000 users):
– Fainting, tremors, abnormal sensations such as tingling
– Dizziness
– Increased or decreased heart rate
– Low blood pressure
– Difficulty breathing, coughing, tightness in the throat, sneezing
– Vomiting
– Swelling of the skin and mucous membranes, especially on the face, hives (severely itchy red spots on the skin), redness of the skin, itching
– Sickness, chills, and pain at the injection site
Very rare (may affect up to 1 in 10,000 users):
– Influence on thyroid function
– Coma, convulsions, confusion, visual disturbances, memory loss, aversion to light, temporary blindness, drowsiness, restlessness, headache
– Hearing loss
– Cardiac arrest, heart attack, heart rhythm disturbances, angina attacks (severe chest pain radiating to the left arm)
– Circulatory collapse
– Respiratory arrest, breathing difficulties caused by spasms in the airways ( bronchi ) or water in the lungs such as wheezing, swelling in the throat, spasm in the larynx
– Abdominal pains
– Severe allergic skin reactions with blisters and redness of the skin, eczema
– Acute kidney damage, cessation of urine production
– Reactions at the injection site with swelling, inflammation, local redness, and tissue damage if Xenetix is accidentally introduced next to the blood vessels.
– Increased creatinine levels in the blood
Has been reported (occurring in an unknown number of treated patients)
– Severe heart rhythm disorder ( torsades de pointes ), discomfort or pain caused by temporary spasm (narrowing) of one or more of the coronary arteries of the heart.
– High blood pressure
– Temporary underactive thyroid gland ( hypothyroidism ) in newborns
How to store Xenetix
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label. The expiration date is the last day of the specified month.
Store the bottle in the outer carton. Light sensitive. Must be protected from X-rays. Store at a maximum of 30°C.
Do not use this medicine if the solution is discolored or contains particles.
Medicines should not be thrown down the drain. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active ingredient is jobitridol.
- One ml contains jobitridol corresponding to 250 mg iodine, 300 mg iodine, and 350 mg iodine respectively.
- Other ingredients are sodium calcium edetate anhydrous, trometamol hydrochloride, trometamol, hydrochloric acid or sodium hydroxide, water for injections
Marketing Authorization Holder and Manufacturer:
GUERBET
BP 57400
F-95943 Roissy CdG cedex
FRANCE
Further information about this medicine can be obtained from the national representative of Guerbet:
GOTHIA MEDICAL AB
Bolshedens Industriväg 20
42750 BRIDAL