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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Alcon Eye Care UK Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Product name and form

Anatera 100 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, red-orange solution.

Qualitative and quantitative composition

1 ml solution contains 100 mg fluorescein (as 113.2 mg fluorescein sodium).

One 5 ml vial contains 500 mg fluorescein (as 566 mg fluorescein sodium).

Contains sodium (from fluorescein sodium and sodium hydroxide) at amounts up to 1.45% (approximately 3.15 mmol) per dose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluorescein

Fluorescein is a fluorochrome used in medicine as a diagnostic stain. Fluorescein is used to make the blood vessels of the ocular fundus visible (angiography of the retina and choroid).

List of Excipients

Sodium hydroxide (for pH-adjustment)
Hydrochloric acid (for pH-adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Alcon Eye Care UK Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Marketing authorization dates and numbers

PL 41809/0001

25/04/2012

Drugs

Drug Countries
ANATERA United Kingdom

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