What Ablavar contains
- The active substance is gadofosveset equivalent to 244 mg/ml gadofosveset trisodium corresponding to 0.25 mmol/millilitre. 10 ml solution contains 2.44 g, 15 ml solution contains 3.66 g and 20 ml solution contains 4.88 g of gadofosveset trisodium 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
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 2). 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 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.
