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

Updated on site: 05-Oct-2017

Medication nameAblavar (Vasovist)
ATC CodeV08CA
Substancegadofosveset trisodium
ManufacturerTMC Pharma Services Ltd.
Medicinal product no longer authorised

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.

In this leaflet:

authorised

 

1.

What Ablavar is and what it is used for

 

2.

Before you are given Ablavar

 

3.

How to use Ablavar

 

4.

Possible side effects

 

5.

How to store Ablavar

 

6.

Further information

 

1.

WHAT ABLAVAR IS AND WHAT IT IS USED FOR

 

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.

Ablavar is for diagnostic use only. It is used to help detect changes in the blood vessels which are

 

 

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known or suspected to be abnormal. The diag osis can be made with greater accuracy than without

using this medicine.

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This medicine, a contrast agent with magnetic properties, helps to visualise the passage of blood

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

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.

authorised

 

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 doc or radiologist will consider this with you. This medicine must not be used in pregnant women nless 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-f ding 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 r visi problems. If you get these effects you

should not drive or use machines

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Important information about some of the ingredients of Ablavar

 

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

patients on a controlled sodium diet.

 

 

3.

HOW TO USE ABLAVAR

 

 

MedicinalYou will be asked to ie 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.

authorised

 

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

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

 

 

 

 

 

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

 

Ablavar can be associated with allergy-like reactions (a aphylactoid / hypersensitivity reactions)

characterised by:-

 

 

 

 

skin reactions, (cutaneous reactions)

 

 

 

 

 

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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).

 

 

 

 

 

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Most of the side effects were mild to moderate in intensity. Most of the side effects (80%) occurred

within 2 hours. Delayed effects (after ho rs to days) may occur.

 

Below are listed the reported/experienced side effects by frequency): Very common:

affects more

than 1 user in 10

 

 

 

 

 

Common:

affects 1 to 10 users in 100

 

 

 

Medicinal

 

 

 

 

Uncommon:

affects 1 to 10 users in 1,000

 

 

Rare:

ffects 1 to 10 users in 10,000

 

 

Very rare:

affects less than 1 user in 10,000

 

 

Not known:

frequency cannot be estimated from the available data.

 

The following is

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

 

 

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Indigestion

 

 

Vomiting

 

 

 

Attempting to vomit

 

 

 

Diarrhoea

 

 

 

Stomach discomfort

 

 

 

Stomach pain

 

 

 

Pain in the throat

 

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Dry mouth

 

 

 

 

 

Wind

product

 

 

Muscle cramps

 

 

Decreased feeling or sensitivity of the lips

Increased production of saliva

Anal itching

Hives

Reddening of the skin

Rash

Pain arms or legs

Genital itch ng

Sweating increased

MuscleMedicinalspasms

Neck pain

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

authorised

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

 

 

 

authorised

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

 

 

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Sweatiness

 

 

 

 

 

 

 

Muscle tightness

 

 

 

 

Sensation of heaviness

 

 

 

 

Urge to pass urine

 

 

 

 

Kidney pain

 

 

 

 

Passing urine frequently

 

 

 

 

Lower abdominal pain

 

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Fever

 

 

 

 

 

 

 

Shivering

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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.

What Ablavar looks like and contents of the pack

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

of gadofosveset in a vial.

authorised

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

Ablavar is a clear, colourless to pale yellow liquid supplied in a rubber stoppered glass vial, with an

 

no

aluminium seal, in individual cartons. The co te ts f the packs are:

product

 

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 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

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