279.3 mg/ml solution for injection & solution for injection in a pre-filled syringe
gadoteridol
What ProHance is and what it is used for
ProHance is a contrast agent for magnetic resonance imaging.
You have had it prescribed for examination of the brain, bone marrow, and surrounding tissue or the whole body.
This product is for diagnostic use only.
What you need to know before you are given ProHance
Do not use ProHance
- if you are allergic to gadoteridol or any of the other ingredients of this medicine (listed in section 6).
- for children under 2 years.
Warnings and cautions
Tell your doctor about:
- your kidneys are not functioning normally
- you have recently undergone, or will soon undergo, a liver transplant
- Your doctor may decide to take a blood test to check how well your kidneys are working before deciding to use ProHance, especially if you are 65 years of age or older.
- you have or have had allergies are
- you have or have had epilepsy or brain damage
Talk to your doctor if any of the above warnings apply to you, or have previously been agreed with you.
Children
ProHance should not be used on children under 2 years of age.
Other medicines and ProHance
To date, no interaction with other drugs has been detected.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you think you are or will become pregnant as ProHance should not be used during pregnancy unless necessary.
Breast-feeding
Tell your doctor if you are breastfeeding or about to start breastfeeding. Your doctor will discuss with you whether you should continue breastfeeding or stop breastfeeding for 24 hours after receiving ProHance.
Driving and using machines
There is no information on the effects of ProHance on the ability to drive. If you feel unwell after the examination, such as nausea, do not drive or use machines.
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.
ProHance contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”
How to be given ProHance
Dosage
- adults’ most common dose for examining the brain and spinal cord is 0.2 ml/kg body weight. In some cases, such as in the case of invisible lesions in adults, the dose may be increased to 0.6 ml/kg body weight. The most common dose for examination of the whole body is 0.2 ml/kg body weight.
Use for children
- Children (2 years and older)The most common dose for examining the brain and spinal cord is 0.2 ml/kg body weight.
The safety and efficacy of doses higher than 0.2 ml/kg body weight and repeated administration during the same study or within a short period are not known.
Dosage for special patient groups
The use of ProHance is not recommended for patients with severe kidney problems and patients who have recently undergone, or will soon undergo, a liver transplant. If use is necessary, you should only receive a dose of ProHance during an examination and you should not receive an additional injection for at least 7 days.
Elderly
It is not necessary to adjust your dose if you are 65 years of age or older, but you may need a blood test to check how well your kidneys are working.
How to use ProHance
Healthcare professionals will give you ProHance as an injection into a blood vessel ( intravenously ).
If you use more ProHance than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The safety precautions and procedures to be followed when using MRI must be considered when administering ProHance for contrast enhancement.
Common (may affect up to 1 in 10 people)
- Nausea
Uncommon (may affect up to 1 in 100 people)
- Hypersensitivity reactions (commonly reported symptoms include throat tightness, throat irritation, difficulty breathing, chest discomfort, feeling hot, difficulty swallowing, burning sensation, swelling in the throat, and low blood pressure )
- Headache, changes in sensations, drowsiness, taste changes
- Increased tear formation
- Hot flashes, low blood pressure
- Dry mouth, vomiting
- Itching, rash, hives
- Injection site pain
- Reaction at the injection site
- Increased heart rate
- Feeling weak
Rare (may affect up to 1 in 1,000 people)
- Anxiety
- Confusion, abnormal coordination of movements, seizures
- Tinnitus
- Changes in heart rhythm
- Sore throat, shortness of breath, runny nose, cough, shortness of breath, wheezing
- Stomach pain, swelling of the tongue, itching in the mouth, inflammation of the gums, loose stools
- Facial swelling
- Stiff muscles
- Chest pain, fever
Has been reported (occurs in an unknown number of users)
- Loss of consciousness
- Coma
- Cardiac arrest
- Respiratory arrest, fluid in the lungs
- Kidney failure
- Vasovagal reaction (common symptoms include nausea, dizziness, and profuse sweating. In severe cases, symptoms may include pallor, profuse sweating, slow heart rate, and possible loss of consciousness. Other symptoms may include worry or anxiety, restlessness, weakness, and increased salivation).
Isolated cases of nephrogenic systemic fibrosis (which causes hardening of the skin and may also affect soft tissue and internal organs) have been reported with the use of ProHance, most of which occurred in patients receiving concomitant gadolinium-containing contrast agents.
How to store ProHance
Keep the vial/syringe in the outer carton. Sensitive to light.
Keep this medicine out of the sight and reach of children.
Expiry date: Use before the expiry date which is stated on the label / outer carton after “EXP”. The first 2 digits indicate the month and the last digits the year. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is gadoteridol.
- The other ingredients are calteridol calcium, tromethamine, hydrochloric acid, sodium hydroxide, and water for injections.
What the medicine looks like and the contents of the pack
ProHance is a clear and colorless or yellowish solution.
Vials :
ProHance vials contain 5, 10, 15, 20 or 50 ml solution.
Pack sizes: 5 x 5 ml, 10 x 5 ml, 5 x 10 ml, 10 x 10 ml, 5 x 15 ml, 10 x 15 ml,
5 x 20 ml, 10 x 20 ml, 1 x 50 ml, 5 x 50 ml and 10 x 50 ml.
Pre-filled syringes:
ProHance pre-filled syringe contains 10, 15 or 17 ml solution.
Pack sizes: 1 x 10 ml, 1 x 15 ml and 1 x 17 ml.
Marketing Authorisation Holder
Bracco International BV
Strawinskylaan 3051
NL-1077 ZX Amsterdam
The Netherlands
Manufacturer
BIPSO GmbH, Robert-Gerwig-Strasse 4, 78224 Singen, Germany
Bracco Imaging SPA, Bioindustry Park, Via Ribes, 5, 10010 Colleretto Giacosa (TO), Italy