Patient leaflet - Xenetix 300 (300 Mgi/ml) solution for injection)
1. WHAT XENETIX IS AND WHAT IT IS USED FOR
Xenetix is a diagnostic agent. It belongs to the group of contrast agents used for radiological examinations.
Xenetix is used to enhance the contrast of the images obtained during radiological examinations. This contrast enhancement improves the visualisation and outline of certain body parts.
This medicine is for diagnostic use only.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE XENETIX
You should read the information in this section carefully.
You and your doctor should consider this information before you are given Xenetix.
Do not use Xenetix if:
- you have previously developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Xenetix
- you are allergic to iobitridol or any of the other ingredients of Xenetix (listed in section 6)
- you have already had an allergic reaction following the injection of iobitridol (see section 4: possible side effects)
- you have excess thyroid hormones (these are hormones that affect your energy level)
- you are pregnant or think you are pregnant and are due to undergo hysterosalpingography (examination of the uterus and fallopian tubes)
Warnings and precautions
Inform your doctor if the following applies to you:
- you have previously had an allergic reaction to a contrast agent during an examination
- you have previously developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Xenetix or other iodinated contrast media
- you are asthmatic and have had an asthma attack within the 8 days preceeding the examination
- you have a history of allergic reaction to anything
- you have sickle cell disease (an inherited blood disorder that affects red blood cells)
- you have any condition that could cause a water or electrolyte imbalance (for example dehydration, increase of sodium in your blood, which may change the amount of certain body salts, eg calcium, potassium, sodium… in your body) • you are being treated with a beta-blocker (medicine for heart and blood pressure disorders)
- you have kidney problems
- you have liver disease
- you have pancreatitis
- you have a disease affecting your heart or your blood vessels
- you have had convulsions or you are being treated for epilepsy
- you have heart failure (your heart is not pumping well)
- you have diabetes
- you have had a stroke or recent history of intracranial haemorrhage (bleeding inside the skull)
- you have myasthenia gravis
- you have thyroid disorders or a history of thyroid disease
- you have a phaeochromocytoma (tumour of the adrenal gland)
- you have bone-marrow disease (monoclonal gammapathy: multiple myeloma or Waldenström’s disease)
- you are due to undergo a thyroid examination in the near future or treatment with radioactive iodine
- you regularly drink large amounts of alcohol or you use drugs
- you have anxiety, nervousness or pain, as possible side-effects may be intensified
- you have or have ever had inflammation in the pelvis affecting your womb, tubes or ovaries
In all these cases, your doctor will only give you Xenetix if the benefits outweigh the risks. If you are given Xenetix, your doctor will take the precautions necessary and the administration of Xenetix will be carefully monitored.
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 can be life-threatening, have been reported with the use of Xenetix.
If you develop a serious rash or another of these skin symptoms, contact your doctor or seek medical attention immediately.
During or shortly after the imaging procedure you may experience a short-term brain disorder called encephalopathy. Seek medical attention immediately if you notice any of the symptoms related to this condition described in section 4.
Other medicines and Xenetix
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, please inform your doctor or pharmacist if:
you are taking or have recently taken medicines for:
- heart and blood pressure disorders such as beta-blockers or diuretics
- diabetes (metformin)
- you have recently received interleukin-2 (a drug for treating cancer)
Xenetix with food and drink
There are no known interactions between Xenetix and food and drinks. However, please check with your doctor or pharmacist if it is required not to eat or drink before the examination.
You should inform your doctor if you regularly drink large quantities of alcohol (see section 2: Warnings and precautions).
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.
Xenetix may pass into your breast milk.
If this medicine has been given to a woman during pregnancy, or to a newborn baby, doctors should check the baby’s thyroid gland function, as these babies may temporarily have an underactive thyroid gland (hypothyroidism).
The thyroid function of a newborn baby should be closely monitored if the iodinated contrast agent was administered to the mother during pregnancy.
Driving and using machines
Xenetix is unlikely to affect your ability to drive or use machines. If you feel unwell after the examination, you should not drive or use machines.
Xenetix contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mL, i.e. is essentially “sodium-free”.
3. HOW TO USE XENETIX
Xenetix will be administered to you by injection.
During the examination, you will be under the supervision of a doctor. A plastic needle will be left in your vein; this will allow the doctor to inject you with appropriate emergency drugs if necessary. If you experience an allergic reaction, the administration of Xenetix will be stopped.
The procedure will be carried out in a hospital, clinic or private practice. The attending staff know what precautions have to be taken for the examination. They are also aware of any possible complications that can occur.
Dosage
Your doctor will determine the dose you will receive and supervise the injection.
If too much Xenetix has been administered to you
It is highly unlikely that you will be given an overdose. You will be given Xenetix in a medical setting by a trained person. In a real case of overdose, Xenetix can be removed from the body by haemodialysis (blood cleaning).
Speak to your doctor if you are unsure or worried.
If you have any further questions on the use of this product ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Xenetix can cause side effects, although not everybody gets them.
Most side effects occur during the injection or within the first hour following administration. Some effects can occur up to several days after Xenetix injection.
Side effects of Xenetix are generally mild to moderate and are temporary.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please also tell your doctor or pharmacist as soon as possible.
There is a small risk (rare) that you may have an allergic reaction to Xenetix. Such reactions can be severe and may exceptionally result in shock (very rare case of allergic reaction that could put your life in danger). An allergy can be recognised by the following effects:
- reactions that appear very rapidly (often within an hour) with pimples on the skin, redness (erythema) and itching (localised or extensive hives), sudden swelling of the face and neck (angioneurotic edema)
reactions that appear later on the skin, i.e. red pimples (macular or papular eruptions) and in exceptional cases, serious extensive skin lesions with the appearance of blisters on the body (Lyell's or Stevens-Johnson syndrome) red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis) or widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also Section 2.
• respiratory effects: cough, nasal inflammation (rhinitis), tightness in the throat, breathing difficulties, swollen throat (laryngeal oedema), breathing difficulties combined with coughing (bronchial spasm), respiratory collapse
- effects on the heart and blood vessels: low blood pressure (hypotension), vertigo, dizziness, malaise, heart rhythm disorders, cyanosis (low blood oxygen levels and blue lips and skin), cardiac arrest
- gastrointestinal effects: nausea, vomiting, abdominal pains
If you experience any of these effects during or after injection of Xenetix, you should immediately inform your doctor.
Overall, the following side effects have been described for Xenetix
Uncommon side effects (affecting 1 to 10 out of every 1,000 patients treated)
- sensation of warmth • nausea
Rare side effects (affecting 1 to 10 out of every 10,000 patients treated)
- swelling of various parts of the body including the face
- tightness sensation in the throat
- hypotension (low blood pressure)
- hypertension (high blood pressure)
- breathing difficulties
- wheezy breathing
- coughing
- sneezing
- eye irritation
- vertigo (feeling of spinning or dizziness)
malaise (feeling of discomfort or being unwell)
- vomiting
- effects on the heart and blood vessels, including increased or decreased heart rate
- urticaria (patches of red skin, severe itching)
- other skin reaction
- injection site pain
- chill
- tremor
- presyncope (lightheaded)
- paresthesia (feeling of pins and needles in a limb)
Very rare side effects (affecting fewer than 1 in 10,000 patients treated)
- thyroid disorder
- coma*
- convulsions (fits)*
- confusion*
- visual disorders*
- memory loss*
- photophobia (fear of light)*
- transient blindness*
- drowsiness*
- agitation*
- restlessness*
- headache
- hearing difficulties
- cardiac arrest
- blood creatinine increased
changes to heart rate, angina or heart attack (heavy chest pain radiating up left arm)
- heart and blood vessels fail to work properly
- severe heart rhythm disorder (torsades de pointes)
- temporary discomfort or pain caused by a temporary spasm (narrowing) of one or more of the coronary arteries of your heart
- abdominal pain
- kidney disorders
- breathing difficulties caused by tightening of the muscles in your airways or water in the lungs
- swelling of throat
- eczema
- severe allergic skin reaction including reaction with blister like lesions
If Xenetix is accidentally injected outside the vein, pain can occur around the site of injection with swelling, inflammation, local reddening or necrosis.
* if Xenetix concentration in cerebral arterial blood is high.
Other side effects (frequency not known: based on available data the frequency cannot be defined):
- joint pain (when Xenetix is administered into joints)
- pelvic pain (when Xenetix is administered into the uterus and fallopian tubes)
- babies may temporarily have an underactive thyroid gland (transient neonatal hypothyroidism)
- young children (0 to 3 years) may have an underactive thyroid gland (hypothyroidism)
- dizziness (more often reported in association with an allergic reaction)
- cyanosis (low blood oxygen levels and blue lips and skin) – (more often reported in association with a severe allergic reaction)
- short term brain disorders (encephalopathy) which can cause headache, confusion, difficulties with vision, loss of vision, seizures, loss of coordination, weakness on one side of the body, problems with speech and loss of consciousness.
an allergic skin reaction that may include round or oval patches of redness and swelling of the skin, blistering, and itching (fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur.
Fixed drug eruption usually reoccurs at the same site(s) if the medication is used again.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE XENETIX
Keep this medicine out of the sight and reach of children.
Vial: Keep the container in the outer carton. Do not store above 30°C Bags: Keep the container in the outer carton
Do not use Xenetix after the expiry date which is stated on the vial or the bag and on the carton, after the abbreviation “Exp”. The expiry date refers to the last day of that month.
Do not use Xenetix if you notice visible signs of deterioration of the product.
- It is unlikely that you will be asked to dispose of any left over Xenetix. If this happens ask your pharmacist what you should do. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Xenetix contains
The active substance is iobitridol. 100 millilitres (mLs) of solution for injection of:
Xenetix 300 contains 65.81 g of iobitridol, corresponding to a quantity of 30g of iodine. Xenetix 350 contains 76.78 g of iobitridol, corresponding to a quantity of 35g of iodine.
- The other ingredients are: Sodium calcium edetate, trometamol, trometamol hydrochloride, water for injection, sodium hydroxide or hydrochloric acid (for pH adjustment).
What Xenetix looks like and contents of the pack
Xenetix is a clear, colourless or slightly yellow solution for injection.
The solution for injection of Xenetix 300 and Xenetix 350 is presented in the following containers sizes: 20 mL filled in 20 or 30 mL vial, 50 mL filled in 60 mL vial, 60 mL filled in 60 mL vial, 75 mL filled in 100 or 125 mL vial, 100 mL filled in 100 or 125 mL vial, 150 mL filled in 250 mL vial, 200 mL filled in 250 mL vial and 500 mL filled in 500 mL vial, and in 100 mL, 150 mL, 200 mL or 500 mL bags.
Not all pack sizes may be marketed.
Marketing Authorisation Holder/Manufacturer:
Guerbet BP 57400
95943 Roissy CdG cedex France