Ablavar (previously Vasovist)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

gadofosveset trisodium

Available from:

TMC Pharma Services Ltd.

ATC code:

V08CA

INN (International Name):

gadofosveset trisodium

Therapeutic group:

Contrast media

Therapeutic area:

Magnetic Resonance Angiography

Therapeutic indications:

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.

Product summary:

Revision: 10

Authorization status:

Withdrawn

Authorization date:

2005-10-03

Patient Information leaflet

B. PACKAGE LEAFLET
21
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
:
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 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 oth

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Ablavar 0.25 mmol/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
1 ml Ablavar solution for injection contains 244 mg (0.25 mmol)
gadofosveset trisodium equivalent to
227 mg gadofosveset.
Each vial of 10 ml solution contains a total of 2.44 g (2.50 mmol) of
gadofosveset trisodium
equivalent to 2.27 g of gadofosveset
Each vial of 15 ml solution contains a total of 3.66 g (3.75 mmol) of
gadofosveset trisodium
equivalent to 3.41g of gadofosveset.
Each vial of 20 ml solution contains a total of 4.88 g (5.00 mmol) of
gadofosveset trisodium
equivalent to 4.54g of gadofosveset.
Excipient
This medicinal product contains 6.3 mmol sodium (or 145 mg) per dose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should only be used by physicians experienced
in the field of diagnostic
imaging.
Posology
Adults: 0.12 ml/kg body weight (equivalent to 0.03 mmol/kg)
Imaging time points
Dynamic imaging begins immediately upon injection. Steady state
imaging can begin after the
dynamic scan has been completed. In clinical trials, imaging was
completed up to approximately one
hour following injection.
No clinical information is available about repeated use of this
medicinal product.
Special populations
Elderly (aged 65 years and above)
2
Medicinal product no longer authorised
No dose adjustment is considered necessary. Caution should be
exercised in elderly patients (see
section 4.4).
Renal impairment
Use of Ablavar should be avoided in patients with severe