140 mg I / ml, 180 mg I / ml, 200 mg I / ml, 240 mg I / ml, 300 mg I / ml, 350 mg I / ml solution for injection
johexol
What Omnipaque is and what it is used for
This medicine is for diagnostic use only. It is used as an aid in disease determination and not in connection with treatment.
Omnipaque is a contrast agent. It is given before an X-ray examination to make the X-ray image clearer.
- It can help your doctor distinguish between normal and abnormal appearance and shape of certain organs in the body.
- It is used in X-ray examinations of the urinary tract, spinal cord and blood vessels including blood vessels in the heart. Can also be used in some mammography examinations.
- Some people get this medicine before or during a scan of the head or body with a so-called “computed tomography” (also called CT scan). This type of imaging uses X-rays.
- It is also used to examine the salivary glands, gastrointestinal tract or to look in body cavities (body cavities) such as the joints or uterine and ovarian tubes.
Your doctor will tell you which part of your body to examine.
What you need to know before you are given Omnipaque
Do not use Omnipaque
- If you have severe thyroid problems.
- If you are allergic (hypersensitive) to johexol or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before receiving Omnipaque if you:
- previously had an allergic reaction after receiving another contrast agent.
- have thyroid problems
- have had any allergies or asthma
- have diabetes
- have any brain disease (including epilepsy ) or tumor er
- have had serious heart disease (eg heart failure , angina, previous heart attack). You then have an increased risk of having heart side effects.
- have kidney problems and / or liver problems
- has 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 secretion of the amino acid cysteine in the urine)
- have an autoimmune disease
- have been addicted to alcohol or drugs, this may increase the risk of seizures
- have pulmonary hypertension (high blood pressure in the pulmonary arteries)
- have paraproteinemia (sharply elevated levels of protein in the blood)
- should have their thyroid examined within the next few weeks. Omnipaque may affect the results of certain samples taken during such an examination, even after several weeks.
- should submit urine or blood samples on the same day as Omnipaque may affect the results.
If you are not sure if any of the above applies to you, contact your doctor or nurse before receiving Omnipaque.
During or shortly after the X-ray examination, you may experience a short-term disturbance in brain function called encephalopathy. Tell your doctor immediately if you notice any of the symptoms of this condition as described in section 4.
Be sure to drink plenty before and after the test. This is especially true for children and elderly patients as well as patients with multiple myeloma (a form of bone marrow cancer), diabetes or kidney problems, and patients in poor general condition.
Children and young people
Be sure to drink plenty before and after the examination. This is especially true for infants and toddlers. Medicines that can damage the kidneys should not be taken at the same time as Omnipaque. Thyroid function in newborns should be checked during the first week of life if the mother has received Omnipaque during pregnancy.
Infants (<1 year) and especially newborns are particularly susceptible to disturbances in the salt and mineral balance in the blood and changes in blood circulation.
Omnipaque contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free’.
Other medicines and Omnipaque
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Tell your doctor especially if you
- taking metformin for diabetes
- treated with interleukin -2 , or interferons (drugs used to treat immune system diseases), e.g. in connection with transplantation.
- take medicines for cardiovascular diseases such as beta- blockers (atenolol, metoprolol ), medicines that affect the blood vessels ( adrenaline , dobutamine , etc.), ACE inhibitors (ramipril, enalapril ) or angiotensin receptor blockers (valsartan, losartan ). Beta-blockers may increase your risk of having difficulty breathing and may interfere with the treatment of severe allergic reactions, which is a risk with Omnipaque.
- taking tricyclic antidepressants or neuroleptics (medicines used to treat mental illness).
You should do this because some medicines may affect the way Omnipaque works 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 performed if your doctor considers the benefit to be greater than the risk to both you and the child.
If you have received Omnipaque during pregnancy, your newborn’s thyroid function should be tested in the first week after birth and also at 2 to 6 weeks of age, especially if your baby was born prematurely or had a low birth weight.
Breast-feeding may continue as usual after examination with Omnipaque.
Driving and using machines
You should not drive or use machines one hour after the last injection one or 24 hours if you have received Omnipaque in the spinal cord. This is because you may feel dizzy or have other symptoms afterward.
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 use Omnipaque
Omnipaque will always be given to you by qualified and qualified hospital staff.
The recommended dose is:
Your doctor will decide which dose is best for you. You will receive Omnipaque as an injection. Alternatively, you may be asked to drink the medicine.
Omnipaque can be given in many different ways, a description of the most common uses can be found below:
Injection into an artery or vein
Omnipaque is most often injected into a vein in the arm or leg. Sometimes it is given through a thin plastic tube ( catheter ) that is inserted into an artery, usually in the arm or groin.
Injection into the spinal cord
Omnipaque is injected into the area around the spinal cord to see your spinal canal. You are then asked to follow the advice below:
- to rest your head and body in an upright position for an hour or six hours if you rest in bed and
- to walk carefully and to avoid bending down for six hours, and
- not to be completely alone for the first 24 hours after receiving Omnipaque, if you are an outpatient and have ever had a seizure.
The above advice only applies if you have had Omnipaque injected into your spine. If you are not sure, talk to your doctor.
Use in body cavities (body cavities) or joints
Body cavities are, for example, uterus, blood vessels, and bladder. How and where Omnipaque is given varies.
Oral use as a beverage
When examining the esophagus, stomach/stomach, or small intestine, Omnipaque is given as a drink and can be diluted with water.
After receiving Omnipaque
You should drink plenty of fluids to facilitate the excretion of the drug from the body.
All patients who have received Omnipaque are advised to stay in the ward where they have had their X-ray examination for at least 30 minutes and in the clinic or hospital for one hour.
If you get any side effects during this time, contact your doctor immediately (see section 4 “Possible side effects”). There may also be delayed reactions. If you are not sure about any of the above, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (occurs in an unknown number of users)
If you get an allergic reaction when you are examined at the hospital, tell your doctor or nurse immediately. Symptoms of an allergic reaction can be:
- Wheezing, difficulty breathing, pressure or pain in the chest
- Skin rash, lumps, itchy areas, blisters on skin and mouth, red / itchy eyes, cough, runny nose, sneezing
- Swelling of the face
- Dizziness or fainting (caused by low blood pressure )
The above reactions may occur several hours or days after you receive Omnipaque.
If this happens after you have left the hospital, you should contact the nearest emergency department immediately.
If you get any of the following very rare syndromes, contact your doctor immediately.
Stevens-Johnson syndrome:
An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals
Lyell’s syndrome ( toxic epidermal necrolysis ):
Severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes)
Other side effects that you may experience are listed below. These depend on how or why you received Omnipaque. If you are not sure how to get Omnipaque to see a doctor.
General
(applies to all use of Omnipaque)
Common ( may affect up to 1 in 10 people ):
- Feeling of warmth
Uncommon ( may affect up to 1 in 100 people ):
- Nausea
- Increased / abnormal sweating, cold feeling, dizziness / fainting
Rare ( may affect up to 1 in 1,000 people ):
- Allergic reactions (hypersensitivity; eg rash, itching and difficulty breathing)
- Slow heart rate
- Headache, vomiting, fever
Very rare ( may affect up to 1 in 10,000 users including single reports ):
- Temporary taste changes ( dysgeusia )
- High or low blood pressure , chills
- Diarrhea, abdominal pain
No known frequency ( can not be calculated from the available data ):
- Allergic reaction , including severe allergic reaction leading to shock and collapse, see section “Allergic reactions” for other symptoms.
- Iodism (sharply elevated levels / amounts of iodine in the body) resulting in swollen and sore (painful) salivary glands
After injection into an artery or vein
Common: ( may affect up to 1 in 10 people )
- short-term changes in respiratory rate
Uncommon ( may affect up to 1 in 100 people ):
- Pain and discomfort
Rare ( may affect up to 1 in 1,000 people ):
- Dizziness, feeling weak, muscle weakness
- Light sensitivity
- Feeling of abnormal fatigue
- Diarrhea
- Irregular heartbeat, including slow or fast heart rate
- Impaired renal function
- Cough, shortness of breath, fever, general discomfort
- Skin rash and itching , reddening of the skin
- Impaired vision
Very rare ( may affect up to 1 in 10,000 users including single reports ):
- Seizures, disturbed consciousness, stroke , sensory disturbances (such as touch), tremors
- Hemorrhoids
- Breathing difficulties
- Myocardial infarction
No known frequency ( can not be calculated from the available data ):
- Confusion, disorientation, feeling of agitation, restlessness or anxiety
- Overactive thyroid gland ( thyrotoxicosis ), temporary underactive thyroid gland (transient hypothyroidism)
- Transient difficulty moving
- Transient blindness (hours to a few days), transient hearing loss
- Chest pain, including heart failure , cardiac arrest, arterial spasm and cyanosis (blue to purple color on the skin due to reduced oxygen)
- Chest pressure or difficulty breathing, including swelling of the lungs, spasm of the airways
- Exacerbation of inflammation of the pancreas (an organ behind the stomach)
- Pain and swelling in your veins, blood clots ( thrombosis ), decreased number of blood cells
- Joint pain, muscle spasms, back pain
- Injection site reactions
- Severe skin reactions including severe rash, blistering and peeling of the skin
- Inflammatory psoriasis
- Speech difficulties including aphasia (inability to speak), dysarthria (difficulty pronouncing words)
- Disorientation, edema / swelling of the brain
- Asthma attack
- Iodism (large amounts of iodine in the body) which results in swelling and tenderness (pain) of your salivary glands
- Short-term disturbance in brain function ( encephalopathy ) that can cause confusion, hallucinations, visual impairment, vision loss, seizures, loss of coordination, paralysis in one side of the body, speech difficulties, unconsciousness, coma and stupor (decreased level of consciousness). Also transient memory loss and retrograde amnesia (memory loss).
After injection in the spine
Very common ( may affect more than 1 user in 10 ):
- Headache (may be severe and persistent)
Common ( may affect up to 1 in 10 people ):
- Nausea, vomiting
- Nerve pain
Uncommon ( may affect up to 1 in 100 people ):
- Meningitis ( inflammation of the membrane surrounding the brain and spinal cord)
Rare ( may affect up to 1 in 1,000 people ):
- Cramps, dizziness, pain in arms, legs, neck or back
No known frequency ( can not be calculated from the available data ):
- Feeling of agitation
- Abnormal electrical activity in the brain that is shown in a so-called electroencephalography examination
- Photosensitivity, neck stiffness
- Transient difficulty moving, confusion
- Sensory disturbances (sensory disturbances), transient blindness (hours to a few days), transient hearing loss
- Tingling, muscle cramps, injection site reaction
- Short-term disturbance in brain function ( encephalopathy ) that can cause confusion, hallucinations, visual impairment, vision loss, seizures, loss of coordination, paralysis in one side of the body, speech difficulties, unconsciousness, coma and stupor (decreased level of consciousness). Also transient memory loss and retrograde amnesia (memory loss).
- Speech difficulties including aphasia (inability to speak), dysarthria (difficulty pronouncing words)
After use in body cavities
(such as the uterus, blood vessels, bladder, blood vessels)
Very common ( may affect more than 1 user in 10 ):
- Stomach pain
Common ( may affect up to 1 in 10 people ):
- Inflammation of the pancreas ( pancreatitis )
- Elevated blood amylase (seen in blood tests)
No known frequency : ( can not be calculated from available data ):
- Pain
After injection into the conductor
Very common ( may affect more than 1 user in 10 ):
- Pain
No known frequency : ( can not be calculated from available data ):
- Inflammation of the joints
After oral use as a beverage
Very common ( may affect more than 1 user in 10 ):
- Diarrhea
Common ( may affect up to 1 in 10 people ):
- Nausea, vomiting
Uncommon ( may affect up to 1 in 100 people ):
- Stomach pain
Additional side effects in children and adolescents
A short-term thyroid dysfunction that later returns to normal (transient hypothyroidism) has been reported in premature infants, newborns, and other children after receiving Omnipaque. Normally, no symptoms are seen. Premature babies are especially sensitive to the effects of iodine.
How to store Omnipaque
Like all medicines injected, Omnipaque should be inspected visually before use. The solution should be particle-free, colorless to pale yellow, and the bottle intact.
- Keep out of sight and reach of children.
- Do not use Omnipaque after the expiry date which is stated on the label. The expiration date is the last day of the specified month.
- Store in the outer carton. Sensitive to light. Omnipaque must not be frozen. Can be stored in a heating cabinet at 37 ° C for up to one month before use.
Contents of the pack and other information
Content declaration
The active substance is iohexol.
Excipients are: trometamol, sodium calcium edetate, hydrochloric acid (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
Omipaque comes in clear, colorless to pale yellow, sterile solution for injection .
| 140 mg I / ml | 180 mg I / ml | 200 mg I / ml | 240 mg I / ml | 300 mg I / ml | 350 mg I / ml |
|---|---|---|---|---|---|
| 10 x 50 ml6 x 200 ml | 10 x 10 ml10 x 50 ml | 10 x 50 ml10 x 100 ml | 25 x 20 ml10 x 50 ml6 x 200 ml6 x 500 ml | 10 x 10 ml10 x 40 ml25 x 20 ml10 x 40 ml10 x 50 ml10 x 75 ml10 x 100 ml6 x 200 ml6 x 500 ml | 25 x 20 ml10 x 50 ml10 x 100 ml6 x 200 ml6 x 500 ml |
| 140 mg I / ml | 180 mg I / ml | 200 mg I / ml | 240 mg I / ml | 300 mg I / ml | 350 mg I / ml |
|---|---|---|---|---|---|
| 10 x 50 ml10 x 100 ml10 x 200 ml | 10 x 50 ml | 10 x 50 ml10 x 100 ml | 10 x 50 ml10 x 100 ml10 x 200 ml6 x 500 ml | 10 x 40 ml10 x 50 ml10 x 75 ml10 x100 ml10 x 150 ml10 x 175 ml10 x 200 ml6 x 500 ml4 x 700 ml4 x 1000 ml | 10 x 50 ml10 x 75 ml10 x 100 ml10 x 150 ml10 x 175 ml10 x 200 ml6 x 500 ml4 x 700 ml4 x 1000 ml |
Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
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