Primovist 0.25 mmol/ml, solution for injection, prefilled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor giving you Primovist.

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

• if you are allergic to gadoxetate disodium or any of the other ingredients of this medicine (listed in section 6)

Talk to your doctor before you are given Primovist if you have:

• or have had asthma or an allergy such as hay fever, nettle rash
• had a previous reaction to contrast media
• reduced kidney function.
  The use of some gadolinium-containing contrast agents in patients with these conditions has been associated with a disease called Nephrogenic Systemic Fibrosis (NSF). NSF is a disease involving thickening of the skin and connective tissues. NSF may result in debilitating joint immobility, muscle weakness or impairment of the function of internal organs which may potentially be life threatening.
• a serious disease of the heart and blood vessels
• low potassium levels
• or someone in your family, has had problems with the electrical rhythm of the heart called long QT syndrome
• had heart rhythm changes after taking medicines
• a heart pacemaker or if there are any implants or clips containing iron in your body

Allergy-like reactions may occur after use of Primovist with delayed reactions after hours or days. See section 4.

Tell your doctor if:

• your kidneys do not work properly
• you have recently had, or soon expect to have, a liver transplant

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:

• betablockers, medicines to treat high blood pressure or other heart conditions
• medicines that change the rhythm or rate of your heartbeat such as amiodarone, sotalol
• rifampicin, medicine to treat tuberculosis or certain other infections

Pregnancy

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.

Breast-feeding

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.

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.

Elderly

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.

• low blood pressure
• swelling in the tongue, throat, or face
• runny nose, sneezing, cough
• red, watery and itchy eyes
• stomach pain
• nettle rash
• reduced feeling or sensitivity in the skin, itching, pale skin

The following further side effects may occur:

Common: may affect up to 1 in 10 people

• headache
• nausea

Uncommon: may affect up to 1 in 100 people

• dizziness
• numbness and tingling
• problems with sense of taste or smell
• flushing
• high blood pressure
• breathing difficulties
• vomiting
• dry mouth
• skin rash
• severe itching, affecting the whole body or the eye
• back pain, chest pain
• injection site reactions, such as
  • burning, coldness, irritation, pain
• feeling hot
• chills
• tiredness
• feeling abnormal

Rare: may affect up to 1 in 1000 people

• incapability to sit or stand still
• uncontrollable shaking
• feeling of increased heart rate
• irregular heartbeat (signs of heart block)
• discomfort of the mouth
• increased production of saliva
• red skin rash with pimples or spots
• increased sweating
• feeling of discomfort, generally feeling unwell

Not known: frequency cannot be estimated from the available data

• fast heartbeat
• restlessness

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.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

• The active substance is gadoxetate disodium. Each ml of solution for injection contains 0.25 mmol gadoxetate disodium (equivalent to 181.43 mg gadoxetate disodium)
• The other ingredients are caloxetate trisodium, trometamol, sodium hydroxide and hydrochloric acid (both for pH adjustment), water for injections.

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.