ANATERA Solution for injection Ref.[9468] Active ingredients: Fluorescein

Posology

Adults, including elderly

Inject 5 ml of Anatera 100 mg/ml solution for injection rapidly into the antecubital vein after taking precautions to avoid extravasation. In cases when highly sensitive imaging systems e.g., scanning laser ophthalmoscope are used, the dose of this product should be reduced to 2 ml of Anatera 100 mg/ml solution for injection.

Paediatric population

Anatera 100 mg/ml solution for injection has not been studied in children and dose-adaptation data are not available. Therefore, Anatera 100 mg/ml solution for injection should not be used in patients below 18 years as efficacy and safety in this group have not been established.

Patients with renal insufficiency (glomerular filtration rate below 20 ml/min)

Limited experience in renally impaired subjects (glomerular filtration rate below 20 ml/min) suggests that, in general, no dose adjustment is required although a longer excretion rate in patients with renal impairment is possible (see section 5.2).

Dialysed patients: Reduce dose to 2.5 ml (half a vial).

Method of administration and fluorescence angiography

Anatera 100 mg/ml solution for injection should be used exclusively by qualified physicians with technical expertise in performing and interpreting fluorescence angiography.

This product should only be administered intravenously.

Flush intravenous cannulas with sterile sodium chloride solution (0.9%) before and after medicinal products are injected to avoid physical incompatibility reactions. The injection should be administered rapidly (1 ml per second is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation using a 23 gauge butterfly needle for injection. Luminescence usually appears in the retina and choroidal vessels in 7 to 14 seconds.

For further instructions on the correct administration/use of the medicinal product, see sections 6.2 and 6.6.

No toxic effects are expected given the minimal risk of overdose with Anatera 100 mg/ml solution for Injection.

3 years.

Do not store above 25°C.

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Glass (type I) vial with grey chlorobutyl coated rubber stopper and aluminum seal with polypropylene flip-off cap.

Pack containing 12 vials of 5 ml injection solution.

The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles. For single use only. Any unused product or waste material should be disposed of in accordance with local requirements. Do not use Anatera 100 mg/ml solution for injection if the vial is cracked or damaged in any way.