The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00010/0555.
Primovist 0.25 mmol/ml, solution for injection, prefilled syringe
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Primovist 0.25 mmol/ml, solution for injection, pre-filled syringe
If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Primovist is and what it is used for
2. What you need to know before you are given Primovist
3. How to use Primovist
4. Possible side effects
5. How to store Primovist
6. Contents of the pack and other information
Primovist is a contrast medium for magnetic resonance imaging (MRI) of the liver. It is used to help detect and diagnose changes that may be found in the liver. Abnormal signs within the liver can be better evaluated as to number, size, and distribution. Primovist can also help the doctor determine the nature of any abnormalities, thereby increasing the confidence in the diagnosis.
It is provided as a solution for intravenous injection. This medicine is for diagnostic use only.
MRI is a form of medical diagnostic imaging that forms pictures after water molecules have been detected in normal and abnormal tissues. This is done using a complex system of magnets and radio waves.
Talk to your doctor before you are given Primovist if you have:
Allergy-like reactions may occur after use of Primovist with delayed reactions after hours or days. See section 4.
Tell your doctor if:
Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use Primovist, especially if you are 65 years of age or older.
Primovist works because it contains a metal called gadolinium. Studies have shown that small amounts of gadolinium can remain in the body, including the brain. No side effects have been seen due to gadolinium remaining in the brain.
The safety and efficacy of Primovist have not been established in patients under 18 years as there is limited experience on its use. Further information is given at the end of the leaflet.
Tell your doctor if you are taking, have recently taken or might take any other medicines. These include especially:
You must tell your doctor if you think you are or might become pregnant, as Primovist should not be used during pregnancy unless strictly necessary.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive Primovist.
Primovist has no influence on the ability to drive and use machines.
This medicine contains 82 mg sodium (main component of cooking/table salt) in each dose based on the amount given to a 70 kg person. This is equivalent to 4.1 % of the recommended maximum daily dietary intake of sodium for an adult.
Primovist is injected via a small needle into a vein. Primovist will be administered immediately before your MRI examination.
After the injection you will be observed for at least 30 minutes.
0.1 ml Primovist per kg body weight.
Dosage in special patient groups
The use of Primovist is not recommended in patients with severe kidney problems and patients who have recently had, or soon expect to have, a liver transplant. However if use is required you should only receive one dose of Primovist during a scan and you should not receive a second injection for at least 7 days.
It is not necessary to adjust your dose if you are 65 years of age or older but you may have a blood test to check how well your kidneys are working.
Overdosing is unlikely. If it does happen, the doctor will treat any symptoms that follow.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects are mild to moderate.
If you get any side effects, talk to your doctor.
As with other contrast media, in rare cases allergy-like reactions may occur. Delayed reactions hours to days after the administration of Primovist may occur.
The most serious side effect in patients receiving Primovist is anaphylactoid shock (a severe allergy-like reaction).
The following further side effects may occur:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1000 people
Not known: frequency cannot be estimated from the available data
Changed laboratory values may occur shortly after you have been given Primovist. Inform your healthcare professional if you have recently been administered Primovist if giving blood or urine samples.
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) associated with use of other gadolinium-containing contrast agents.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).
By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the syringe and outer carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
This medicine should be used immediately after opening.
It should be visually inspected before use. This medicine should not be used in case of severe discoloration, the occurrence of particulate matter or a defective container.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
1 pre-filled syringe with 5.0 ml contains 907 mg gadoxetate disodium.
1 pre-filled syringe with 7.5 ml contains 1361 mg gadoxetate disodium [glass syringe only],
1 pre-filled syringe with 10.0 ml contains 1814 mg gadoxetate disodium.
Primovist is a clear, colourless to pale yellow solution free from visible particles. The contents of the packs are 1, 5 or 10 pre-filled syringes with
5.0 ml solution for injection (in 10-ml glass/plastic prefilled syringes)
7.5 ml solution for injection (in 10-ml glass prefilled syringes) [glass syringe only]
10.0 ml solution for injection (in 10-ml glass/plastic prefilled syringes)
Not all pack sizes may be marketed.
This leaflet was last revised in October 2019.