270 mg I/ml, 320 mg I/ml solution
What Visipaque is and what it is used for
Visipaque is a contrast agent and is intended for diagnostic use only. It is used as an aid in disease determination.
It is given before an X-ray examination to make the X-ray image clearer.
- Visipaque can help your doctor distinguish between the normal and abnormal appearance and shape of certain organs in the body.
- Visipaque is used in X-ray examinations of the urinary tract, spinal cord, and blood vessels, including blood vessels in the heart.
- Some patients receive this medicine before or during imaging of the head or body with a so-called computed tomography (also called a CT scan).
- Visipaque is also used to examine the gullet (esophagus), and the gastrointestinal tract or to look into body cavities (body cavities) such as the joints or uterus and ovaries.
Your doctor will tell you which part of your body will be examined.
What you need to know before you are given Visipaque
Do not use Visipaque
- If you have serious thyroid problems.
- If you are allergic (hypersensitive) to iodixanol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before receiving Visipaque if you:
- have previously had an allergic reaction after receiving another contrast medium.
- have thyroid problems
- have had any allergies or asthma, because an attack can be induced
- have diabetes
- have kidney problems and or liver problems
- have epilepsy, blood clots in the brain, stroke, or a brain tumor
- have a heart or lung disease
- have the disease myasthenia gravis, a condition that causes severe muscle weakness
- have pheochromocytoma (high blood pressure due to a rare tumor in your adrenal gland )
- have homocystinuria (a condition with increased excretion of the amino acid cysteine in the urine)
- have paraproteinemia (severely elevated levels of protein in the blood)
- have been/are addicted to alcohol or medication/drugs, this can increase the risk of convulsions
- should have the thyroid checked within the next few weeks. Visipaque can affect the results of some samples taken during such an examination, even after several weeks
- must provide a urine or blood sample on the same day when Visipaque can affect the results
You may experience a short-term disturbance in brain function called encephalopathy during or shortly after the contrast medium examination. Tell your doctor straight away if you notice any of the symptoms associated with this condition described in section 4.
If you are not sure if any of the above apply to you, talk to your doctor or nurse before you are given Visipaque.
Other medicines and Visipaque
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you
- taking metformin for diabetes
- if you are being treated or have recently (within 2 weeks before the examination) been treated with interleukin -2, e.g. in connection with transplantation.
- taking medicines to lower blood pressure et ( beta blockers )
You should do this because certain medicines can affect the effect of Visipaque and increase the risk of side effects.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant, if you think you may be pregnant or if you are trying to become pregnant. The examination will only be carried out if your doctor judges that the benefit is greater than the risk for both you and the child. If you have received Visipaque during pregnancy, it is recommended that the thyroid function of the newborn baby be monitored.
The amount of Visipaque excreted in breast milk is small and is not considered harmful to the baby. Breastfeeding can continue as usual after examination with Visipaque.
Driving ability and use of machinery
You should not drive or use machines for 24 hours after a brain scan ( intrathecal use of Visipaque). You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or healthcare professional if you are unsure.
How Visipaque is used
Visipaque will always be given to you by a specially trained and qualified healthcare professional.
- Visipaque will be given in a hospital or clinic.
- Your doctor will tell you what you need to know for safe use.
The recommended dose is:
Visipaque is injected into a blood vessel before or during an X-ray or you may be asked to drink it. For children, Visipaque can be given via the rectum. The amount injected varies depending on the type of examination, user technique, and your age and weight.
After you have received Visipaque
- Drink plenty of fluids to facilitate the excretion of the medicine from the body.
- Stay in the department where you had your X-ray examination for at least 30 minutes and in the clinic or hospital for an hour.
If you experience side effects during this time, contact your doctor immediately (see section 4 “Possible side effects”). This advice applies to all patients who have received Visipaque. If you are unsure about any of the above, ask your doctor.
Visipaque can be given in many different ways, a description of the most common ways of administration can be found below:
Injection into an artery or vein
Visipaque is usually injected into a vein in the arm or leg. Sometimes it is given via a thin plastic tube ( catheter ), inserted into an artery usually in the arm or groin.
Injection into the spinal cord
Visipaque is injected into the area around the spinal cord to see the spinal canal. You are then asked to follow the advice below:
- Resting the head and body in an upright position for one hour or six hours if you rest in bed, and
- To walk carefully and avoid bending down for six hours, and
- Not to be completely alone for the first 24 hours after receiving Visipaque, if you are an outpatient and have ever had a seizure.
The above advice only applies if you have received Visipaque injected into the spine. If you are unsure, consult your doctor.
Use in body cavities (body cavities) or joints
Body cavities are, for example, the uterus, blood vessels, and bladder. How and where Visipaqe is given varies.
Oral use as a drink
When examining the esophagus, stomach/stomach, or small intestine, Visipaque is given as a drink that can be diluted with water.
If you receive too many Visipaque
As you will be given Visipaque by trained healthcare professionals, overdose is unlikely.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction while being examined at the hospital, tell your doctor or nurse immediately. Signs of an allergic reaction may include:
- Wheezing, difficulty breathing, pressure, or pain in the chest
- Skin rashes, lumps, itchy spots, blisters on the skin and in the mouth, or other allergic symptoms
- Swelling in the face
- Dizziness or fainting (caused by low blood pressure )
The above reactions may occur several hours or days after you receive Visipaque.
If it happens after you have left the hospital, go straight to the nearest emergency department. Serious allergic reactions may occur in an unknown number of users. Less serious allergic reactions may occur in up to 1 in 100 users.
Other unwanted effects you may experience are listed below. These depend on how or why you received Visipaque.
After injection into an artery or vein
Uncommon (may affect up to 1 in 100 users):
- Headache
- Bleeding
- Nausea, vomiting
- Kidney damage
- Feeling of warmth
- Chest pain
Rare (may affect up to 1 in 1,000 users) :
- Dizziness
- Changed sensations (including changes in taste, changes in sense of smell, tingling, numbness, or burning sensation in the skin)
- Irregular heartbeats
- Low blood pressure
- Myocardial infarction
- Cough
- Sneezing
- Chills
- Fever
- Feeling cold
- Pain and local reactions (at the injection site), Discomfort
Very rare (may affect up to 1 in 10,000 users, including isolated cases) :
- Feeling of outrage
- Anxiety
- Stroke
- Fainting
- Tremors (which are transient)
- Decreased sensation in the skin
- High blood pressure
- Difficulty breathing
- Swelling in the throat
- Transient blindness
- Transient visual impairment (including double vision, blurred vision)
- Swollen eyelids
- Stomach pain, diarrhea/discomfort
- Palpitation
- Cardiac arrest
- Short-term memory loss
- Weakness, exhaustion
- Back pain
- Swelling of the face or swelling at the injection site
- Excessive sweating
- Muscle spasms
Has been reported (may occur in an unknown number of users ) :
- Confusion
- Coma
- Cramps
- Blood clots ( thrombosis )
- Spasms in the arteries including the coronary arteries
- Shock
- The decreased pumping capacity of the heart
- Pain and swelling in your veins
- Severe breathing difficulties (due to fluid in the lungs, spasm of the trachea, respiratory arrest)
- Problems with the pancreas ( acute or worsening inflammation of the pancreas)
- Enlarged salivary glands
- Overactive thyroid gland ( hyperthyroidism )
- Underactive thyroid ( hypothyroidism ), which may be transient
- Pain in joints
- Short-term disturbances in brain function ( encephalopathy ) include memory loss, hallucinations, visual disturbances, vision loss, seizures, loss of coordination, hemiplegia, speech difficulties, and unconsciousness. Confusion.
- The increased amount of creatinine in the blood (which may indicate impaired kidney function)
- Iodism
After injection into the spine
Uncommon (may affect up to 1 in 100 users) :
- Headache (can be severe and last for hours)
- Vomiting
Has been reported (may occur in an unknown number of users):
- Dizziness
- Nausea
- Chills
- Pain at the injection site
- Short-term disturbances in brain function ( encephalopathy ) include confusion, memory loss, hallucinations, vision problems, vision loss, seizures, loss of coordination, hemiplegia, speech difficulties, and unconsciousness.
- Muscle spasms
After use in body cavities (such as the uterus and fallopian tubes)
Very common (may affect more than 1 in 10 users) :
- Pain in the stomach area
- Vaginal bleeding
Common (may affect up to 1 in 10 users) :
- Headache
- Feeling sick (nausea)
- Increase in body temperature
Has been reported (may occur in an unknown number of users):
- Vomiting
- Chills
- Local reactions (at the injection site)
After injection into joints
Common (may affect up to 1 in 10 users) :
- Pain at the injection site
Has been reported (may occur in an unknown number of users):
- Chills
After oral use as a drink
Common (may affect up to 1 in 10 users) :
- Diarrhea
- Feeling sick (nausea)
- Stomach pain
Uncommon (may affect up to 1 in 100 users) :
- Vomiting
Has been reported (may occur in an unknown number of users):
- Chills
Reporting side effects If you experience side effects, talk to a doctor or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can contribute to increasing information about drug safety.
How to store Visipaque
Store out of sight and reach of children.
Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
Visipaque must not be frozen. Store in the outer carton. Light sensitive.
Can be heated and stored in a warming cabinet at 37°C for up to one month before use.
Contents of the packaging and other information
Contents declaration
The active substance is iodixanol. Other ingredients are trometamol, sodium chloride, calcium chloride dihydrate, anhydrous sodium calcium edetate, hydrochloric acid ( pH regulation), and water for injections.
Visipaque 270 mg I/ml contains 550 mg iodixanol per ml (equivalent to 270 mg iodine per ml).
Visipaque 320 mg I/ml contains 652 mg iodixanol per ml (equivalent to 320 mg iodine per ml).
Appearance and package sizes of the medicine
Visipaque is a solution for injection. The product is a clear, colorless slightly yellow aqueous solution.
Visipaque is supplied as:
270 mg I/ml solution for injection
Glass bottle: 10×20 ml, 10×50 ml, 10×75 ml, 10×100 ml, 6×200 ml and 6×500 ml
Polypropylene bottle (USB ): 10×50 ml, 10×75 ml, 10×100 ml, 10×150 ml, 10×175 ml, 10×200 ml and 6×500 ml.
320 mg I/ml solution for injection
Glass bottle : 10×20 ml, 10×50 ml, 10×100 ml, 6×200 ml and 6×500 ml
Polypropylene bottle (USB): 10×50 ml, 10×75 ml, 10×100 ml, 10×150 ml, 10×175 ml, 10×200 ml, and 6×500 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
GE Healthcare AS
PO Box 4220 Nydalen
NO-0401 Oslo
Norway
Manufacturer:
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway
or
GE Healthcare Ireland Limited
IDA Business Park
Carrigtohill
Co. Cork
Ireland