Patient leaflet - SCANLUX 370 MG I/ML SOLUTION FOR INJECTION
Package leaflet: Information for the user
Iopamidol
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or nurse.
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– 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.
- if you get any side effects, talk to your doctor or nurse. this includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
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1. What Scanlux Injection is and what it is used for
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2. What you need to know before you are given Scanlux Injection
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3. How Scanlux Injection is given
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4. Possible side effects
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5. How to store Scanlux Injection
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6. Contents of the pack and other information
1. what scanlux injection is and what it is used for
Scanlux is one of a group of medicines called X-ray contrast media. It contains the active substance Iopamidol, which comprises about 49% iodine.
You will be given Scanlux Injection before or during your X-ray examination. 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 Scanlux:
- Examinations of the blood vessels
- Examinations of the heart and its blood vessels
- Brain or whole body scanning
- Examination of the bladder and urinary tract.
2. what you need to know before you are given scanlux injection you are allergic to iopamidol or any of the other ingredients of this medicine (listed in section 6).
- you have an overactive thyroid gland
Warnings and precautions
Take special care with Scanlux Injection:
Before you are given Scanlux Injection, you should tell the doctor or radiographer if any of the following apply to you:
- you ever had an allergic reaction to any other contrast medium
- you have any other allergies
- you are pregnant or think you might be pregnant
- you have asthma, epilepsy, or diabetes
- you have a brain disease or brain tumour
- you have problems with your heart, lungs, liver, or kidneys
- you have a condition called ‘myasthenia gravis’ (causing severe muscle weakness)
- you have a tumour near the kidney
- you have any blood or bone marrow disorders
- you have previously been treated for an overactive thyroid gland
- you have high levels of calcium in your blood
- you have a disease of the blood vessels, especially the arteries that supply the brain
- you have high blood pressure
- you have homocystinuria (an inherited condition affecting the muscles, nervous system and heart)
- you suffer from alcoholism
- you are going to have a blood test (as Scanlux may affect the results)
- If you ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking
Scanlux or other iodinated contast media
Take special care with Scanlux:
Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (Lyell’s syndrome or TEN) and acute generalised exanthematous pustulosis (AGEP), have been reported in association with the use of Scanlux.
Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Before being given Scanlux Injection
- It is important that you drink plenty of non-alcoholic fluids the day before your examination with
Scanlux and also after the procedure.
- If you need to have a thyroid function test in the next weeks after your examination with Scanlux,
please tell the doctor before the test.
Particular care should be taken in children under 1 year of age and in the elderly. These groups might be susceptible to adverse side effects.
Other medicines and Scanlux Injection
Before you are given Scanlux Injection, please tell your doctor or radiographer if you have taken, or been treated recently with any of the following:
- Other X-ray contrast media
- Papaverine
- Medicines for diabetes such as metformin
- Interleukin-2 (used to treat certain cancers)
- Beta-blockers and/or ACE-inhibitors and/or diuretics (for high blood pressure or angina)
- Medicines which change heart rhythm e.g. amiodarone, cisapride, haloperidol.
You should stop taking the following medicines 48 hours before being given Scanlux Injection. You should start taking them again 24 hours after your X-ray examination:
- Medicines for epilepsy
- Medicines for depression such as tricyclic antidepressants or monoamine oxidase inhibitors.
- Medicines for treating mental illnesses
Please tell your doctor or radiographer if you are taking or have recently taken, any other medicines including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you are pregnant, or you are breast-feeding, you should tell your doctor or radiographer before you are given this medicine.
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).
Driving and using machines
After being given this medicine, you should not drive or use machinery for at least one hour – longer if you don’t feel well enough.
3. How Scanlux Injection is given
You will be given Scanlux before or during your X-ray examination. The doctor or nurse will inject the medicine onto a vein or artery.
After your examination, you will probably be asked to rest quietly for about 30 minutes.
Dosage:
The amount injected depends on where the medicine is being injected and which investigation it is being used for.
Adults:
You may be given an injection of up to 100ml of Scanlux depending on the type of examination you are undergoing. In some cases, you may be given a second injection.
Children:
Children may be given up to 2.5ml per kg of their bodyweight depending on the type of examination.
If you think you have been given too much of this medicine
This is unlikely to happen but if it does, the doctor will treat any symptoms that follow.
4. possible side effects
Like all medicines, Scanlux can cause side effects, although not everybody gets them.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). These are signs of an allergic reaction which can be serious and might require medical treatment.
Seek medical attention immediately if you notice any of the following symptoms:
- reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flulike symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
- A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).
The frequency of these side-effects is not known.
Allergic reactions may develop up to several days after you are given Scanlux. If you develop such reactions please consult a physician.
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface-toxic epidermal necrolysis) might occur. Further, skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme) might appear.
The following side effects have been reported following injection of Iopamidol, solution for injection
- headache
- feeling sick (nausea)
- feeling hot
Uncommon: (more than 1 out 1,000 persons and less than 1 out of 100 persons)
dizziness,problems with sense of tastechanges in heart rhythmlow and high blood pressureflushingvomitingdiarrhoeaabdominal paindry mouthitching; skin rash, urge to itch, rednesss of the skin- increased sweating
- kidney failure
- chest pain, injection site pain
Rare: (more than 1 out 10,000 persons and less than1 out of 1,000 persons)
confusion,sensation of tingling, pricking or numbness- slow heart beat
- pulmonary oedema (difficulty breathing, coughing, accelerated breathing)
Not known: (cannot be estimated).
reduced blood platelet count (this can be detected by a test carried out by a doctor),allergic reactioncomamini-strokefainting, low level of consciousness, loss of consciousnesstemporary loss of vision, vision difficulties, inflamed eyes, excessive sensitivity to light, watery/itchy eyesheart attack, heart failure, the cessation of normal circulation of the blood due to failure of the heart to contract effectively, increased heart ratefailure of the blood circulationstopped breathing, respiratory failure, acute respiratory distress syndrome (a severe lung disease), abnormal breathing, suspension of breathing, shortness of breathswelling of the throat, swelling of the face, swollen salivary glandsincreased salivation- pain in the bones, muscles, ligaments, tendons and /or nerves
- pain, feeling of general discomfort or uneasiness
- abnormal electrocardiogram (this can be detected by a test carried out by a doctor)
- abnormalities in blood tests
- memory loss
- paresis, paralysis, tremor (shivering), seizures, muscular rigidity
- effects on hearing including difficulty or loss of hearing, or hearing echos
- loss of appetite, retching and choking
- transient changes in renal function test, changed frequency of urination, incontinence, pain, blood in urine
- changes in blood flow
- inability to move one side of the body
- heart attack caused by an allergic reaction
The following side effects have occurred mainly after examinations of the heart and its blood vessels:
- fast or slow heartbeat
- low or high blood pressure
- heart attack, heart failure or collapse due to very low blood pressure
- stroke
- changes in heart rhythm
- swelling and tenderness along a vein
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website:. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store scanlux injection
Keep this medicine out of the sight and reach of children.
Do not use Scanlux after the expiry date which is printed on the label and carton.
Protect the solution from light and X-rays. Do not store above 25°C. Store in the original package.
Your doctor, pharmacist or nurse will know how to store Scanlux Injection properly.
6. contents of the pack and other information- the active substance is iopamidol (equivalent to 300 or 370mg iodine/ml)
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– The other ingredients are trometamol, sodium calcium edetate, hydrochloric acid and water for
What Scanlux Injection looks like and contents of the pack
Scanlux Injection is a clear, colourless to pale yellow solution.
It is available in 50 ml, 75 ml, 100 ml and 200 ml glass bottles.
Marketing Authorisation Holder and Manufacturer
Sanochemia Pharmazeutika GmbH
Landegger StraBe 7
2491 Neufeld an der Leitha
Austria
This leaflet was last revised in March 2021.
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