Patient Medication Information: uses, side effects, how to take - Ultravist 300
What is ULTRAVIST used for?
- ULTRAVIST is a contrast medium that can be used for X-rays of your veins and arteries and also your urinary system, kindey, brain, spine, heart, joints and body cavities.
- ULTRAVIST can also be used before or during a scan of your head or body using “computed tomography” (also called a CT scan). This type of scan uses X-rays.
- ULTRAVIST is for diagnostic use only. It is only used to help identify an illness. It is not used for treatment.
- Your healthcare professional will explain which part of your body will be scanned.
How does ULTRAVIST work?
ULTRAVIST is a contrast media that contains iodine. X-rays are absorbed by iodine. This makes the areas of your body where ULTRAVIST has been injected visible during X-rays or CT scans. This helps your healthcare professional see any problems or irregularities in your body.
What are the ingredients in ULTRAVIST?
Medicinal ingredients: iopromide
Non-medicinal ingredients: calcium disodium edetate (EDTA), hydrochloric acid and tromethamine.
ULTRAVIST comes in the following dosage forms:
ULTRAVIST is a solution for injection that is supplied in two strengths:
ULTRAVIST® 300: 62% w/v, 300 mg I / mL
ULTRAVIST® 370: 77% w/v, 370 mg I / mL
Do not use ULTRAVIST if:
- you are allergic (hypersensitive) to iopromide or any of the non-medicinal ingredients in ULTRAVIST or a component of the container (see What are the ingredients in ULTRAVIST?)
- you need imaging or treatment of the spinal cord, the ventricles of the brain or the fluid in the spinal cord and brain (cerebral spinal fluid)
- you have an overactive thyroid gland (hyperthyroidism)
- the patient is an infant or young child and they have been fasting, had their liquid restricted or have recently been given a laxative
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ULTRAVIST. Talk about any health conditions or problems you may have, including if you:
- have had a previous reaction to contrast media or have an allergy to iodine
- have allergies (eg, seafood allergy, hay fever, hives) or asthma
- have kidney or liver problems
- are taking medicine that affects your kidneys
- have had a kidney transplant
- are very dehydrated
- have diabetes
- have heart disease or problems with your circulation
- have a vascular condition in which you have clotting of some small blood vessels in the hands or feet (Buerger's disease or thromboangiitis obliterans)
- have high blood pressure
- have a tumour of the adrenal gland (pheochromocytoma)
- had or have a history of thyroid problems
- have problems with your brain, including problems with blood circulation or increased pressure inside your skull
- have a history of seizures or other nervous system problems
- have multiple myeloma (cancer of the blood cells)
- have a condition where your body overproduces certain proteins (paraproteinemia)
- have homocystinuria, a genetic condition that causes a buildup of homocysteine in your body
- have sickle cell disease (not enough healthy red blood cells to carry oxygen throughout your body)
- have a breathing condition called chronic obstructive pulmonay disease (COPD)
- have myasthenia gravis, a diease that causes progressive muscle weakness
are pregnant. ULTRAVIST should only be used in pregnancy if the benefit to the mother outweighs the risk to the baby.
- are breastfeeding. You must not breastfeed for 48 hours after you have been given ULTRAVIST.
- need to have imaging of your gallbladder
Other warnings you should know about:
Thyroid Problems
Contrast media containing iodine, such as ULTRAVIST, may cause thyroid problems in some patients, both in adults and infants. This may cause:
hypothyroidism (i.e. too little thyroid hormones in the blood)
or
- hyperthyroidism (i.e. too much thyroid hormones in the blood)
Thyroid Problems in Infants
Contrast media containing iodine may cause hypothyroidism in infants, especially infants born too soon, that:
- can continue for several weeks to a month after treatment
- can harm growth and development
- can harm mental growth
- may require treatment
can cause symptoms such as:
- fatigue, shortness of breath, low heart rate
- reduced appetite, feeling cold, weight gain
- muscle stiffness
Tell your healthcare professional if these symptoms happen to your infant.
Your healthcare professional may order blood tests for your infant after treatment to follow thyroid hormone levels in the blood.
Tell your healthcare professional if your infant or young child has been fasting, had their fluid restricted or have recently been given a laxative, as these may lead to dehydration. If your infant or young child is dehydrated before they are given ULTRAVIST, this can increase their risk for kidney injury.
Blood Tests: Before you are given ULTRAVIST your healthcare professional will do blood tests to check the health of your kidneys.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ULTRAVIST:
- beta-blockers (medicines used to treat high blood pressure or other heart conditions)
- biguanides (such as, metformin - a medicine used to treat diabetes)
- interleukins, used to treat inflammatory conditions such as rheumatoid arthrits
- radioactive substances used for imaging of the thyroid gland
- Some medical tests (eg, thyroid function tests, blood tests for clotting or blood clot breakdown or tests for certain proteins involved in immunity and inflammation) may be affected by the use of ULTRAVIST. Tell your healthcare professional if you have any of these tests scheduled.
How to take ULTRAVIST:
- ULTRAVIST will be given to you in a hospital or clinic by a healthcare professional who is experienced in the use of contrast media. It will be injected directly into a vein, joint or body cavity.
- You may be given an enema or laxative on the evening before your X-ray or CT scan. Follow the instructions given to you by your healthcare professional. Talk to your healthcare professional if you are unsure.
Usual dose:
- Your healthcare professional will decide on the dose of ULTRAVIST that is right for you depending on your age, body weight and the type of scan that is being done.
Overdose:
| If you think you, or a person you are caring for, have been given too much ULTRAVIST, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
What are possible side effects from using ULTRAVIST?
These are not all the possible side effects you may feel when taking ULTRAVIST. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- sensation of warmth
- sensation of pain
- feeling sick (nausea), vomiting, diarrhea
- restlessness/anxiety, agitation
- sensation of whirling/dizziness (vertigo)
- abnormal taste
- headache
- numbness
- sore throat
- hearing problems
- discomfort in bright light, pressure over the eyes
- swelling of salivary glands
- change in body temperature, chills, shivers, sweating
- tight muscles
- decreased sensation
- tremor
- rash, itching, redness
The side effects in the table below may happen several hours or days after ULTRAVIST is given. If any of these side effects happen after you leave the hospital or clinic, go straight to the emergency department of your nearest hospital.
Serious side effects and what to do about them
| Symptom/ Effect | Talk to your healthcare professional | ||||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| UNCOMMON | |||||
| Loss of consciousness | ✓ | ||||
| Low blood pressure or high blood pressure | ✓ | ||||
| Allergic reactions: rash, hives, itching, swelling of the throat, face, tongue, lips, difficulty swallowing, difficulty in breathing, coughing, sneezing, redness of the eyes, blurred/disturbed vision, tearing | ✓ | ||||
| Swelling or pain around the knee | ✓ | ||||
| UNKNOWN | |||||
Blood clot or inflammation of a vein: Leg or arm: swelling, pain, redness, warmth Lung: shortness of breath, chest pain that is worse with breathing, dizziness, coughing up blood, fainting | ✓ | ||||
| Heart attack: pressure, tightness, pain or a squeezing or aching sensation in your chest or arms that may spread to your neck, jaw or back, nausea, shortness of breath, cold sweat, lightheadedness or sudden dizziness | ✓ | ||||
| Heart stopped (cardiac arrest) | ✓ | ||||
| Inflammation, redness or swelling where ULTRAVIST was injected | ✓ | ||||
| Lips turning blue | ✓ | ||||
| Memory loss | ✓ | ||||
| Muscle weakness, partial paralysis, paralysis | ✓ | ||||
Serious side effects and what to do about them
| Symptom/ Effect | Talk to your healthcare professional |
|---|
| Only if severe | In all cases | |
|---|---|---|
| Heart problems: rapid or slow heartbeat, palpitations, irregular heartbeat | ✓ | |
| Seizure (fits) | ✓ | |
| Serious skin reactions [Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP)]: redness, pain swelling, peeling or blistering of the skin (around the mouth, nose, eyes and genitals), red, scaly rash with small pus-filled blisters, fever, liver problems (yellowing of the skin or eyes, dark urine, pale stool, abdominal pain, nausea, vomiting, loss of appetite), swollen lymph nodes, cough, shortness of breath | ✓ | |
| Stroke: sudden onset headache and/or weakness, difficulty speaking, blurred vision, sleepiness, confusion | ✓ | |
| Vision problems: short-term blindness (hours to a few days) | ✓ | |
| Breathing problems (due to breathing foreign material into lungs) | ✓ | |
| Compartment syndrome: pressure in muscles, pain, hardness, swelling, “pins and needles” feeling | ✓ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
ULTRAVIST will be stored by your healthcare professional.
If you want more information about ULTRAVIST:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.bayer.ca), or by calling Bayer Medical Information at 1-800-265-7382 or canada.medinfo@bayer.com.
Bayer Inc. 2920 Matheson Blvd East, Mississauga, Ontario L4W 5R6 Canada |
Last Revised: MAR 24, 2022
© 2022, Bayer Inc.
® TM see www.bayer.ca/tm-mc
Bayer
 |