ANATERA Solution for injection (2022)
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Περιεχόμενα
Name of the medicinal product
Anatera 100 mg/ml solution for injection.
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 ...
Pharmaceutical form
Solution for injection. Clear, red-orange solution.
Therapeutic indications
This medicinal product is for diagnostic use only. For fluorescein angiography of the ocular fundus.
Posology and method of administration
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Anatera 100 mg/ml solution for injection should not be injected intrathecally or intra-arterially.
Special warnings and precautions for use
Fluorescein sodium can induce serious intolerance reactions. In the event of serious intolerance reactions during a first angiography, the benefit of an additional fluorescein angiography should be balanced ...
Interaction with other medicinal products and other forms of interaction
Fluorescein is a relatively inert dye and specific drug interaction studies have not been reported. There are few case reports on potential interactions with organic anion transporters and interference ...
Pregnancy and lactation
Pregnancy There are no or limited data available concerning the use of Anatera 100 mg/ml solution for injection in pregnancy. Animal studies do not indicate teratogenic effects (see section 5.3). As a ...
Effects on ability to drive and use machines
If mydriasis is necessary for the examination with fluorescence angiography visual acuity is influenced and thus affects the ability to react in traffic or use machinery. The patient must be made aware ...
Undesirable effects
Summary of safety profile The most frequently reported treatment related undesirable effects were nausea, vomiting, syncope and pruritus. Less frequent but more severe adverse reactions have been reported ...
Overdose
No toxic effects are expected given the minimal risk of overdose with Anatera 100 mg/ml solution for Injection.
Pharmacodynamic properties
Pharmacotherapeutic group: DIAGNOSTIC AGENTS, Colouring agents ATC code: S01JA01 Fluorescein sodium is a fluorochrome used in medicine as a diagnostic stain. Fluorescein is used to make the blood vessels ...
Pharmacokinetic properties
Distribution Within 7 to 14 seconds after intravenous administration into antecubital vein, fluorescein usually appears in the central artery of the eye. Within a few minutes of intravenous administration ...
Preclinical safety data
Non-clinical data for sodium fluorescein reveal no special hazard for humans based on studies of single dose toxicity. Fluorescein did not show teratogenic effects in rats and rabbits. Fluorescein crosses ...
List of excipients
Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. To avoid physical incompatibilities, this product must not be administered simultaneously ...
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.
Nature and contents of container
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.
Special precautions for disposal and other handling
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 ...
Marketing authorization holder
Alcon Eye Care UK Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Marketing authorization number(s)
PL 41809/0001
Date of first authorization / renewal of the authorization
25/04/2012
Date of revision of the text
04 March 2022
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