PROHANCE

Posology The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient’s body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section.

2 ml/kg). 6 ml/kg) have been shown to be useful in patients suspected of having cerebral metastases or other poorly enhancing lesions. 2 ml/kg). 2 ml/kg). ProHance has been used in only a limited number of children aged between birth and 2 years.

If an MRI procedure must be performed in this group, particular caution should be exercised. 2 ml/kg) and sequential or repeat procedures have not been established. 4). 2 ml/kg) body weight. More than one dose should not be used during a scan.

Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days. 2 ml/kg) body weight. More than one dose should not be used during a scan.

Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days. Use for whole body MRI is not recommended in children less than 18 years of age.

Elderly (aged 65 years and above) No dosage adjustment is considered necessary. 4). Method of administration To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml normal saline flush. The imaging procedure should be completed within 1 hour after injecting ProHance.

Caution during injection of any contrast media is necessary to avoid extravasation.

The accepted safety considerations and procedures that are required for Magnetic Resonance Imaging are applicable when ProHance is used for contrast enhancement. The following adverse reactions have been reported with ProHance. adverse reactions from clinical trials have been included with an indication of the frequency.

Adverse reactions from spontaneous reporting are included with the frequency “not known”. There were no adverse reactions with an incidence greater than 2%. System Organ Class Adverse Reactions Common (≥1/100 - <1/10) Uncommon (≥1/1000 - <1/100) Rare (≥1/10,000 - <1/1000) Not known ( cannot be estimated from the available data) Immune system disorders Anaphylactic/anaphylactoid reactions*** Psychiatric disorders anxiety Nervous system disorders headache, paraesthesia, dizziness, taste disturbance mental impairment, abnormal coordination, convulsion loss of consciousness, coma, vasovagal reactions* Eye disorders increased lacrimation Ear and labyrinth disorders tinnitus Cardiac disorders nodal arrhythmia cardiac arrest Vascular disorders flushing, hypotension Respiratory, thoracic and mediastinal disorders laryngospasm, dyspnoea, rhinitis, cough, apnea, wheezing respiratory arrest , pulmonary oedema Gastrointestinal disorders nausea dry mouth, vomiting abdominal pain, tongue oedema, oral pruritus, gingivitis, loose stools Skin and subcutaneous tissue disorders pruritus, rash, urticaria oedema face Musculoskeletal and connective tissue disorders musculoskeletal stiffness Renal and urinary system acute renal failure** General disorders and administration site conditions injection site pain, injection site reaction ****, asthenia chest pain, pyrexia Investigations heart rate increased Description of selected adverse reactions *Vasovagal reactions Vasovagal reactions, rarely leading to vasovagal syncope have been reported during or immediately after ProHance administration.

g. needle puncture for IV placement). Symptoms commonly experienced include nausea, dizziness and diaphoresis. In severe cases possibly leading to syncope, patients are usually pale and diaphoretic with altered state of consciousness and bradycardia.

Patients with a history of allergy, drug reactions, or other hypersensitivity-like disorders should be closely observed during the procedure and the contrast medium administration, as well as for the time the physician deems useful given the patient condition.

As with other gadolinium chelates, there have been reports of anaphylactic/anaphylactoid/ hypersensitivity reactions with gadoteridol These reactions manifested with various degrees of severity, including anaphylactic shock or death.

They involved one or more body systems, mostly respiratory, cardiovascular and/or mucocutaneous systems. Anaphylactic shock has been very rarely reported with the use of gadoteridol. Appropriate drugs and instruments for emergency measures must be readily available.

In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased. g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.

Gadoteridol must not be used intrathecally. g. coma, encephalopathy, seizures), have been reported with intrathecal use. Transitory changes in serum iron (within normal range in the majority of cases) have been observed in some patients after administration of ProHance and these changes were shown not to be clinically significant.

Caution during injection of any contrast media is necessary to avoid extravasation. Since Gadoteridol is renally cleared from the body, caution should be exercised in patients with severely impaired renal function. Impaired renal function Prior to administration of ProHance, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.

73m2). 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 ProHance, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI.

1 or to other gadolinium-based contrast.