Ablavar (Vasovist) (gadofosveset trisodium) – Package leaflet - V08CA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ablavar 0.25 mmol/ml solution for injection

Gadofosveset

Read all of this leaflet carefully before you are given this medicine.

-Keep this leaflet. You may need to read it again.

-If you have further questions, please ask the doctor giving you Ablavar (the radiologist) or the hospital/MRI-centre personnel

-If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or radiologist.

Ablavar is an injectable contrast medium for making a diag ostic image of the body's blood vessels in the abdomen or limb clearer. It is for use in adults only.

If you have any questions or a e n sure about something, ask the doctor or MRI-centre personnel.

through the vessels by brighteningproductthe blood for an extended period. This medicine is used together with an imaging technique called magnetic resonance imaging (MRI).

2.MedicinalBEFORE YOU ARE GIVEN ABLAVAR

Do not use Ablavar

You must not be given Ablavar if you are allergic (hypersensitive) to gadofosveset or any of the other ingre ients of this medicine (see section 6 of this leaflet).

Take sp cial care with Ablavar

You will need special medical attention if allergy-like reactions occur. Tell your doctor immediately if you notice itching, a feeling of mild swelling in your throat or tongue, which might be a first sign of some allergy-like reaction. Your doctor will be mindful of other signs as well.

Tell your doctor if:

you have a cardiac pacemaker or any ferromagnetic implant or a metallic stent in your body

you suffer from allergy (e.g. hay fever, hives) or asthma

you had any reactions to previous injections of contrast media

your kidneys do not work properly

you have recently had, or soon expect to have, a liver transplant

The use of this medicine 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 this medicine 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.

If you receive more Ablavar than you should have received:

If you think you may have had an overdose talk to your doctor immediately. Your doctor will treat you

If you have any further questions on the use of this medicine, please consult your doctor, the radiologist or MRI-centre personnel.

4. POSSIBLE SIDE EFFECTS

Tingling or numbness of the hands or feet

Change of taste in mouth

Burning sensation

Warm feeling (vasodilatation) including flushing

Nausea

Itching

Feeling cold.

Uncommon:

Low calcium levels in the blood

Unusual amount of salt in the body.

Weakness

Chest pressure sensation

Injection site blood clot

Injection site bruising

Injection site inflammation

Injection site burning

Fluid escaping from injection site into the surrounding tissue

Sensation of pressure

InjectionMedicinalsite bleeding

Injection site itching

Phantom pain the arms or legs

Low or h gh potassium levels in the blood

High so ium levels the blood.

Th re 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or radiologist.

5.HOW TO STORE ABLAVAR

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of the month.

Keep the injection vial in its outer carton in order to protect from light.

After first opening, the medicine should be used immediately.

Do not use this medicine if you notice severe discolouration, the occurrence of particulate matter or a defective container.

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.

6. FURTHER INFORMATION

What Ablavar contains

- The active substance is gadofosveset. 1 ml contains 227 mg gadofosveset equivalent to 244 mg/ml (0.25 mmol/millilitre) gadofosveset trisodium.

10 ml solution contains 2.27 g, 15 ml solution contains 3.41g and 20 ml solution contains 4.54 g

- The other ingredients are fosveset, sodium hydroxide,longerhydrochloric acid, and water for injections.

1, 5 or 10 injection vials with 15 ml solution for injection (in 20-ml glass vial) 1, 5 or 10 injection vials with 20 ml sol tion for injection (in 20-ml glass vial) Not all pack sizes may be marketed.

Marketing Authorisation H lder and Manufacturer

This afl t was last approved in

TMCMedicinalPharma Services Ltd., Finchampstead, Berkshire RG40 4LJ , UK

Tel:01252 842255

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu <--------------------------------------------------------------------------------------------------------------------------

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The following information is intended for medical or healthcare professionals only:

Prior to administration of Ablavar it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR< 30 ml/min /1.73 m2). Patients undergoing liver transplantation are at particular risk since the

incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with Ablavar, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI. If use of Ablavar cannot be avoided, the dose should not exceed 0.03 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Ablavar injections should not be repeated unless the interval between injections is at least 7 days.

As the renal clearance of gadofosveset may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

Ablavar should not be used during pregnancy unless the clinical condition of the woman equires use of gadofosveset.

Haemodialysis shortly after Ablavar administration may be useful at removing Ablavar from the body. There is no evidence to support the initiation of haemodialysis for preventionauthorisedtreatment of NSF in patients not already undergoing haemodialysis.

Continuing breast feeding or discontinuing Ablavar for a period of 24 hours af er administration, should be at the discretion of the doctor and lactating mother.

Ablavar is supplied ready to use as a clear, colourless to pale yellow aqueous solution.

The peel-off tracking label included on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent usedlonger. The dose us d should also be recorded.

Contrast media should not be used in case of severe disc uratio , the occurrence of particulate matter, or defective container.

Vials containing Ablavar are not intended for thenowithdrawal of multiple doses. The rubber stopper

should never be pierced more than once. After withdrawal of the solution from the vial, this medicinal

product should be used immediately.product

Any remaining solution not used in one examination must be discarded.

Medicinal