Clariscan™

Stability refers to how tightly the gadolinium ion is bound to the chelating molecule and how likely it is to dissociate. Gadoteric acid is the only macrocyclic, ionic molecule across all gadoliunium-based contrast agents. In vitro data suggest that combining a macrocyclic structure for high kinetic stability, with ionicity for thermodynamic stability, may help to reduce the potential risk of gadolinium dissociation.¹

Clariscan is indicated for diagnostic contrast enhancement in³:

• MRI of the CNS including the brain, spine and surrounding tissue
• Whole body MRI including the major organs, pelvis, breast and musculoskeletal system (not recommended for children below 6 months)
• MR angiography including lesions or stenoses of the non-coronary arteries (adults only)

Clariscan should be used when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI).

 

Gadoteric acid must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions (e.g. coma, encephalopathy, seizures), have been reported with intrathecal use. For intravenous injection only.

Clariscan offers a range of packaging:

• Glass vials: 5, 10, 15, and 20 mL
• Clear plastic prefilled syringes: 10, 15, and 20 mL
• +PLUS PAK polymer bottles: 50 and 100 mL

Our unique +

PLUS

PAK packaging reduces hazard and downtime:

• No more broken bottles, glass or ring-pull injuries ⁴

It also reduces cost and environmental impact:

• Less storage space, lower disposal cost, reduced environmental impact ^4-6

GE HealthCare has invested more than $370 million since 2019 to increase our manufacturing capacity and capability to meet growing demand for our contrast agents⁷. All our manufacturing sites are cGMP accredited.

There are no signals to suggest that the safety profile of Clariscan is different to that established for the reference product, Dotarem®.²

 

Hypersensitivity reactions: As with other intravenous contrast agents, gadoteric acid can be associated with anaphylactoid / hypersensitivity or other idiosyncratic reactions, characterised by cardiovascular, respiratory or cutaneous manifestations, and ranging to severe reactions including shock. In general, patients with cardiovascular disease are more susceptible to serious or even fatal outcomes of severe hypersensitivity reactions. The risk of hypersensitivity reactions may be higher in case of:

• previous reaction to contrast media
• history of bronchial asthma
• history of allergic disorders

In patients with an allergic disposition the decision to use Clariscan must be made after particularly careful evaluation of the risk-benefit ratio. Most of these reactions occur within half an hour of administration. Therefore, post-procedure observation of the patient is recommended. Medication for the treatment of hypersensitivity reactions as well as preparedness for institution of emergency measures are necessary. Delayed reactions (after hours up to several days) have been rarely observed.

 

Impaired renal function: Prior to administration of Clariscan, 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/1.73m²). Patients undergoing liver transplantation are at particularly high risk since the incidence of acute renal failure is high in this group

 

Elderly: As the renal clearance of gadoteric acid may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

 

Neonates and infants: Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Clariscan should only be used in these patients after careful consideration.

 

Cardiovascular disease: In patients with severe cardiovascular disease Clariscan should only be administered after careful benefit assessment because only limited data are available so far.

 

For full safety information, including information on use in pregnancy and breast-feeding women, please consult the Clariscan SmPC.