Article Contents
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
-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 | |
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1. | What Ablavar is and what it is used for |
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2. | Before you are given Ablavar |
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3. | How to use Ablavar |
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4. | Possible side effects |
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5. | How to store Ablavar |
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6. | Further information |
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1. | WHAT ABLAVAR IS AND WHAT IT IS USED FOR |
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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. | no |
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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
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
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 |
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Please tell your doctor if you are taking or have recently taken any other medicines, including | |
medicines obtained without a prescription. | authorised |
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Your doctor will advise you what to do. |
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Pregnancy and
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
Driving and using machines |
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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 | no | longer | |
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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. |
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3. | HOW TO USE ABLAVAR |
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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 | authorised |
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If you have any further questions on the use of this medicine, please consult your doctor, the radiologist or
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: |
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Ablavar can be associated with | |||||
characterised by:- |
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skin reactions, (cutaneous reactions) |
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breathing difficulties and/or heart/ | |||||
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. |
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Below are listed the reported/experienced side effects by frequency): Very common: | affects more | ||||
than 1 user in 10 |
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Common: | affects 1 to 10 users in 100 |
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Uncommon: | affects 1 to 10 users in 1,000 |
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Rare: | ffects 1 to 10 users in 10,000 |
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Very rare: | affects less than 1 user in 10,000 |
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Not known: | frequency cannot be estimated from the available data. |
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The following is | list of |
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Common: |
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Headache |
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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
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 |
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Cough |
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Indigestion |
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Vomiting |
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Attempting to vomit |
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Diarrhoea |
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Stomach discomfort |
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Stomach pain |
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Pain in the throat |
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Dry mouth |
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Wind | product |
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Muscle cramps |
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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
- Optimark - V08CA06
- Teslascan - V08CA05
Prescription drugs listed. ATC Code: "V08CA"
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
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Low calcium levels in the blood
Unusual amount of salt in the body.
Rare: |
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Inflammation of the skin |
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Urinary tract infection |
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Abnormal dreams |
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Seeing, feeling or hearing things that is not there |
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Appetite decreased |
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Eyesight disorders |
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Abnormal eye sensation |
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Ear pain |
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Heartbeat irregularity/disturbed | ||||
problems with the electrical rhythm of the heart (ST segment/T wave abnormalities) | ||||
Chest pain |
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Slow heart beat |
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Palpitations |
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Thickening of the arteries due to cholesterol deposits |
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Low blood pressure |
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Shallow breathing |
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Face swelling |
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Sweatiness |
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Muscle tightness |
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Sensation of heaviness |
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Urge to pass urine |
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Kidney pain |
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Passing urine frequently |
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Lower abdominal pain |
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Fever |
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Shivering | product |
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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
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
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 | |
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aluminium seal, in individual cartons. The co te ts f the packs are: | |
product |
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1, 5 or 10 injection vials with 10 ml solution for injection (in |
1, 5 or 10 injection vials with 15 ml solution for injection (in
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
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
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
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
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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