Ablavar (previously Vasovist)

Основна информация

  • Търговско наименование:
  • Ablavar (previously Vasovist)
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Ablavar (previously Vasovist)
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • CONTRAST MEDIA
  • Терапевтична област:
  • Magnetic Resonance Angiography
  • Терапевтични показания:
  • This medicinal product is for diagnostic use only.Ablavar is indicated for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease.
  • Каталог на резюме:
  • Revision: 10

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Withdrawn
  • Номер на разрешението:
  • EMEA/H/C/000601
  • Дата Оторизация:
  • 03-10-2005
  • EMEA код:
  • EMEA/H/C/000601
  • Последна актуализация:
  • 19-01-2019

Доклад обществена оценка

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

EMA/CHMP/54085/2011

EMEA/H/C/000601

EPAR summary for the public

Ablavar

gadofosveset trisodium

This document is a summary of the European public assessment report (EPAR) for Ablavar. It explains

how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its

opinion in favour of granting a marketing authorisation and its recommendations on the conditions of

use for Ablavar.

What is Ablavar?

Ablavar is a solution for injection that contains the active substance gadofosveset trisodium.

What is Ablavar used for?

Ablavar is for diagnostic use. It is used in patients who are undergoing magnetic resonance

angiography (MRA), a procedure where pictures of the flow of the blood in the body are taken using a

scan called magnetic resonance imaging (MRI). Ablavar is used to obtain a clearer scan in patients who

have suspected or known problems with blood vessels in the abdomen (tummy) or limbs.

The medicine can only be obtained with a prescription.

How is Ablavar used?

Ablavar should only be used by doctors who have experience in diagnostic imaging.

Ablavar is given as an injection into a vein lasting about 30 seconds. Imaging can start immediately

after the injection, and can continue for up to one hour after Ablavar is injected.

Doctors should avoid using Ablavar in patients who have severe kidney problems or who have recently

had or are about to have a liver transplant. If Ablavar is essential, these patients should receive no

Previously known as Vasovist.

Medicinal product no longer authorised

more than one dose during each MRI scan, and there should be a gap of at least a week between each

Ablavar injection.

How does Ablavar work?

The active substance in Ablavar, gadofosveset trisodium, contains gadolinium, a ‘rare-earth’ metal

element. Gadolinium is used as a ‘contrast enhancer’ to help obtain better pictures with MRI scanners.

MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the

body. Once injected, gadolinium interacts with the water molecules. As a result of this interaction, the

water molecules give a stronger signal, and this helps to obtain a brighter picture. In Ablavar, the

gadolinium is attached to another chemical so that the metal is not released in the body, and prepared

so that it attaches to proteins in the blood. This means that the gadolinium stays in the blood long

enough for a good scan to be obtained.

How has Ablavar been studied?

Ablavar was studied in four studies involving 693 patients. Patients were having scans because of

potential problems with the blood vessels that supply blood to the legs, the kidneys or the feet. All of

the patients first had a scan using the standard X-ray method (angiography), followed by MRI scans

without or with Ablavar used as a contrast enhancer. The measure of effectiveness was based on the

improvement in the detection of stenoses (narrowing of the blood vessels) that reduced the width of

the vessel by 50% or more.

What benefit has Ablavar shown during the studies?

Using Ablavar as an enhancer improved the performance of the scans. The sensitivity was improved by

between 6 and 42%, which means that between 6 and 42% more stenoses were detected when

Ablavar was used than when it was not used. Ablavar also improved the accuracy and specificity of the

diagnosis.

What is the risk associated with Ablavar?

The most common side effects with Ablavar (seen in more than 1 patient in 100) are headache,

paraesthesia (unusual sensations like pins and needles), dysgeusia (taste disturbances), a burning

sensation, vasodilatation (widening of the blood vessels, including reddening of the skin), nausea

(feeling sick), pruritus (itching) and feeling cold. For the full list of all side effects reported with

Ablavar, see the package leaflet.

Ablavar should not be used in people who may be hypersensitive (allergic) to gadofosveset trisodium

or any of the other ingredients.

Why has Ablavar been approved?

The CHMP decided that Ablavar’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

Other information about Ablavar:

The European Commission granted a marketing authorisation valid throughout the European Union for

Vasovist on 3 October 2005. The name of the medicine was changed to Ablavar on 10 January 2011.

AblavarF

EMA/CHMP/54085/2011

Page 2/3

Medicinal product no longer authorised

AblavarF

EMA/CHMP/54085/2011

Page 3/3

The marketing authorisation holder is TMC Pharma Services Ltd. The marketing authorisation is valid

for an unlimited period. The full EPAR for Ablavar can be found here

. For more information about

treatment with Ablavar, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

This summary was last updated in 01-2011.

Medicinal product no longer authorised

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

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

What Ablavar is and what it is used for

Before you are given Ablavar

How to use Ablavar

Possible side effects

How to store Ablavar

Further information

1.

WHAT ABLAVAR IS AND WHAT IT IS USED FOR

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.

2.

BEFORE 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 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

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

Medicinal product no longer authorised

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 y

ou should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after

you receive this m

edicine.

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.

3.

HOW TO USE ABLAVAR

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

Medicinal product no longer authorised

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.

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 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 reported/experienced side effects by frequency): Very common:

affects more

than 1 user in 10

Common:

affects 1 to 10 users in 100

Uncommon:

affects 1 to 10 users in 1,000

Rare:

affects 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 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:

Medicinal product no longer authorised

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

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

Medicinal product no longer 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

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.

5.

HOW TO STORE ABLAVAR

Keep out of the reach and sight of children.

Medicinal product no longer authorised

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.

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

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

http://www.ema.europa.eu

<--------------------------------------------------------------------------------------------------------------------------

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

Medicinal product no longer authorised

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.

Medicinal product no longer authorised