Ablavar (previously Vasovist) - Patient leaflet, side effects, dosage

WHAT ABLAVAR IS AND WHAT IT IS USED FOR

Do not use Ablavar

You 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 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

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. You will consider this with you. This medicine must not be used in pregnant w 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

3. HOW TO USE ABL

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

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 doct radiologist or MRI-centre personnel.

4. 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 d

Ablavar can be associated with allergy-like reactions (an 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 (afturs to days) may occur.

Below are listed the reported/expe­rienced side effects by frequency): Very common: affects more than 1 user in 10 affe0 users in 100

affe0 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.

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 throat

Feeling 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

Geni 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.

ve 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 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:

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

Detailed information on this medicine is available on the European Medicines Agency web site:

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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 m). 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 There is no evidence to support the initiation of haemodialysis for prevention or treatment of NS patients not already undergoing haemodialysis.

Ablavar should not be used during pregnancy unless the clinical condition of the wom of gadofosveset.

Continuing breast feeding or discontinuing Ablavar for a period of 24 hours a 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 Contrast media should not be used in case of severe disco 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. product should be used immediately.

ination must be discarded.

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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.