What is it and how is it used?

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

Ablavar is for diagnostic use only. It is used to help detect changes in the blood vessels which are known or suspected to be abnormal. The diagnosis can be made with greater accuracy than without using this medicine.

This medicine, a contrast agent with magnetic properties, helps to visualise the passage of blood through the vessels by brightening the blood for an extended period. This medicine is used together with an imaging technique called magnetic resonance imaging (MRI).

If you have any questions or are not sure about something, ask the doctor or MRI-centre personnel.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use AblavarYou must not be given Ablavar if you are allergic (hypersensitive) to gadofosveset or any of the other ingredients of this medicine (see section 6 of this leaflet).

Take special care with AblavarYou will need special medical attention ifallergy-like reactionsoccur. 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 implantor 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

If any of these apply to you, your doctor will decide whether the intended examination is possible or not.

Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use this medicine, especially if you are 65 years of age or older.

Children or adolescents under 18 years

This medicine should not be used in children or adolescents under 18 year of age.

Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Your doctor will advise you what to do.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.
You must tell your doctor if you think you are or might become pregnant.
It has not been proven that this medicine is safe to use during pregnancy. Your doctor or radiologist will consider this with you. This medicine must not be used in pregnant women 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 this medicine.

Driving and using machines

There are no studies on the effects on the ability to drive and use machines.
This medicine can uncommonly cause dizziness or vision problems. If you get these effects you should not drive or use machines

Important information about some of the ingredients of Ablavar

This medicine contains 6.3 mmol sodium (or 145 mg) per dose. To be taken into consideration by patients on a controlled sodium diet.

How is it used?

You will be asked to lie down on the MRI scanning bed. Scanning may start immediately after the Ablavar injection. After the injection you will be observed in case there might be any initial side effects.

The usual dose

The dose of this medicine varies depending on your weight. The doctor will decide how much medicine is needed for your examination. The dose is: 0.12 ml/kg body weight (equivalent to 0.03 mmol/kg of body weight).
Further information regarding the administration and handling of this medicine is given at the end of the leaflet.

Method of administration
This medicine is given as a rapid injection into a vein by a medical professional only. The usual injection site is the back of your hand or just in front of your elbow.

Dose in special patient groups

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 should overdose occur. If necessary, this medicine can be removed from the body by haemodialysis using high-flux filters.

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

What are possible side effects?

Like all medicines, Ablavar can cause side effects, although not everybody gets them.

If you have any of the following symptoms you should tell a doctor immediately:

Ablavar can be associated with allergy-like reactions (anaphylactoid / hypersensitivity reactions) characterised by:-
- skin reactions, (cutaneous reactions)
- breathing difficulties and/or heart/ pulse-rate/ blood pressure disturbances which may lead to consciousness disorders respiratory reactions, and /or cardiovascular manifestations which may lead to shock).

Most of the side effects were mild to moderate in intensity. Most of the side effects (80%) occurred within 2 hours. Delayed effects (after hours to days) may occur.

Below are listed the reportedexperienced side effects by frequency Very common affects more than 1 user in 10 Common Uncommon Rare Very rare Not known affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data.

The following is a list of side-effects observed in clinical trials:

Common:

Headache
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:

Runny nose
Sore throatFeeling anxious
Confusion
Allergy-like reaction
Impairment of taste
Dizziness
Shaking
Decreased feeling or sensitivity (especially of the skin) Sense of smell distortion
Involuntary muscle contractions
Abnormal vision
Tear secretion increased
Disturbed nerve signals in the heart (first degree) Fast heart beat
Problems with the electrical rhythm of the heart (long QT) High blood pressure
Swelling and clotting in a vein
Coldness in the fingers and toes
Shortness of breath
Cough
Vomiting
Attempting to vomit
Diarrhoea
Stomach discomfort
Stomach pain
Pain in the throat
Indigestion
Dry mouth
Wind
Decreased feeling or sensitivity of the lips
Increased production of saliva
Anal itching
Hives
Reddening of the skin
Rash
Sweating increased
Muscle cramps
Muscle spasms
Neck pain
Pain in arms or legs
Genital itching
Genital burning sensation
Pain
Chest pain
Tiredness
Feeling abnormal
Groin pain
Feeling hot
Injection site pain
Injection site coldness
Reddening of skin at the injection site
Blood in the urine
Proteins in the urine
Sugar in the urine

High sugar levels in the blood
Low calcium levels in the blood
Unusual amount of salt in the body.

Rare:

Inflammation of the skin
Urinary tract infection
Abnormal dreams
Seeing, feeling or hearing things that is not there
Appetite decreased
Eyesight disorders
Abnormal eye sensation
Ear pain
Heartbeat irregularity/disturbed heart-chamber contractions (cardiac flutter, atrial fibrillation) problems with the electrical rhythm of the heart (ST segment/T wave abnormalities) Chest pain
Slow heart beat
Palpitations
Thickening of the arteries due to cholesterol deposits
Low blood pressure
Shallow breathing
Face swelling
Sweatiness
Muscle tightness
Sensation of heaviness
Urge to pass urine
Kidney pain
Passing urine frequently
Lower abdominal pain
Fever
Shivering
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
Injection site bleeding
Injection site itching
Sensation of pressure
Phantom pain in the arms or legs
Low or high potassium levels in the blood
High sodium levels in the blood.

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 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.

How should it be stored?

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 toprotect from light .

After first opening, the medicine should be used immediately.

Do not use this medicine if you notice severediscolouration, 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.

Further information

What Ablavar contains

  • The active substance is gadofosveset equivalent to 244 mg/ml gadofosveset trisodium corresponding to 0.25 mmol/millilitre. 10 ml solution contains 2.44 g, 15 ml solution contains 3.66 g and 20 ml solution contains 4.88 g of gadofosveset trisodium in a vial.
  • The other ingredients are fosveset, sodium hydroxide, hydrochloric acid, and water for injections.
What Ablavar looks like and contents of the pack

Ablavar is a clear, colourless to pale yellow liquid supplied in a rubber stoppered glass vial, with an aluminium seal, in individual cartons. The contents of the packs are:

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

Marketing Authorisation Holder and Manufacturer

TMC Pharma Services Ltd., Finchampstead, Berkshire RG40 4LJ , UK
Tel:01252 842255

This leaflet was last approved in

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 m 2). 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.

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 prevention or treatment of NSF in patients not already undergoing haemodialysis.

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

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

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 used. The dose used should also be recorded.

Ablavar is supplied ready to use as a clear, colourless to pale yellow aqueous solution. Contrast media should not be used in case of severe discolouration, the occurrence of particulate matter, or defective container.

Vials containing Ablavar are not intended for the withdrawal 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.

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

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