Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Guerbet, 15, rue des Vanesses, 93420, Villepinte, France
This medicinal product is for diagnostic use only.
Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualization and helps with the characterization of focal lesions and abnormal structures in the CNS and liver in adult patients and in children of two years and older with known or highly suspected pathology.
Optimark should only be administered by physicians experienced in clinical MRI practice. To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/ adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.
The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/kg (100 micromol/kg) body weight. To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9%) solution for injection. The imaging procedure should be completed within 1 hour of administration of the contrast medium.
In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast-enhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
The safety of repeat doses has not been established in children and adolescents (2 years and older), in patients with renal impairment, or the elderly. The repeat dose is not recommended in these populations.
Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of the dose of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.
No dose adjustment is considered necessary in children more than 2 years of age.
Optimark is contraindicated in neonates up to 4 weeks of age (see section 4.3).
Use of Optimark is not recommended in children less than 2 years of age because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
No dose adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4).
Optimark is contraindicated in patients with severe renal impairment (GFR <30 ml/min/1.73m²) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3). Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73m²) at a dose not exceeding 100 micromol/kg body weight (see section 4.4). More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Optimark injections should not be repeated unless the interval between injections is at least 7 days.
The agent should be administered as a bolus peripheral intravenous injection. To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9%) solution for injection. Insertion of a flexible in-dwelling venous catheter is recommended, see section 4.4. Optimark must not be administered with an autoinjector to children of 2 to 11 years (see section 4.4).
The container and the solution should be inspected prior to use as described in section 6.6.
Gadoversetamide has been tested in humans in doses up to 700 micromol/kg (seven times the standard dose). Clinical consequences of an overdose have not been reported. Acute toxicity symptoms are unlikely to occur in patients with normal renal function. Optimark can be removed by haemodialysis. However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
3 years.
Chemical and physical in-use stability has been demonstrated for 24 hours at up to 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Pre-filled syringe: Keep the syringe in the outer carton in order to protect from light.
Vial: Keep the vial in the outer carton in order to protect from light.
Do not refrigerate or freeze.
For storage conditions after first opening of the medicinal product, see section 6.3.
Optimark is filled in pre-filled syringes made of polypropylene. Syringe tip cap and piston are made of bromobutyl rubber.
Pack sizes:
1 × 10 ml 10 × 10 ml
1 × 15 ml 10 × 15 ml
1 × 20 ml 10 × 20 ml
1 × 30 ml 10 × 30 ml
Not all pack-sizes may be marketed.
Optimark is filled in vials made of colourless highly resistant borosilicate glass (EP Type I). The vials are fitted with bromobutyl rubber closures, aluminium cap seals, and plastic flip caps.
Pack sizes:
1 × 10 ml 10 × 10 ml
1 × 15 ml 10 × 15 ml
1 × 20 ml 10 × 20 ml
Not all pack-sizes may be marketed.
Optimark is intended for single use only; any unused portions should be discarded.
Do not use the solution if it is discoloured or particulate matter is present. If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
Inspect the syringe for signs of leakage. Do not use if leakage is observed.
After screwing the push rod into the syringe piston, it is important to turn the push rod an additional ½ turn so that the grey piston rotates freely.
Prior to using the syringe, twist off grey tip cap and discard. Syringe is now ready for needle or infusion tubing attachment.
Discard syringe and unused portion of the solution after use.
Any unused product or waste material should be disposed of in accordance with local requirements. The peel-off tracking label on the pre-filled syringes should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded.
If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.
Optimark should be drawn into the syringe and used immediately.
The product must be examined before use to confirm that all solids are dissolved and that the container and closure are undamaged. If solids remain, the vial must be discarded.
Discard syringe and unused portion of the solution after use. Any unused product or waste material should be disposed of in accordance with local requirements.
The peel-off tracking label 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. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record
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