United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir) - ak-fluor® 10% (100 mg/ml) and 25% (250 mg/ml) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. 4.1 hypersensitivity ak-fluor® is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. rare cases of death due to anaphylaxis have been reported [see warnings and precautions (5.1) and adverse reactions (6.2)]. 8.1 pregnancy pregnancy category c. adequate animal reproduction studies have not been conducted with fluorescein sodium. it is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. fluorescein sodium should be given to a pregnant woman only if clearly needed. 8.3 nursing mothers fluorescein sodium has been demonstrated to be excreted in human milk. caution should be exercised when fluorescein sodium is administered to a nursing woman. 8.4 pediatric use pediatric patients have been included in clinical studies. no overall differences in sa

United States - English - NLM (National Library of Medicine)

nomax inc. - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir) - fluorescein 0.12 mg - for testing tear film stability by determining the fluorescein break-up time (fbut). hypersensitivity to components or mercury-containing compounds.

United States - English - NLM (National Library of Medicine)

hub pharmaceuticals, inc. - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir) - fluorescein sodium 1 mg in 1 mg - for staining the anterior segment of the eye when fitting contact lenses, in disclosing corneal injury and in applanation tonometry.

Israel - English - Ministry of Health

tradis gat ltd - fluorescein sodium - solution for injection - fluorescein sodium 10 g / 100 ml - fluorescein - for examination of the retina by fluorescent angiography.

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - fluorescein 100 mg/ml (as fluorescein sodium formed in process from fluorescein and sodium hydroxide);   - solution for injection - 500 mg/5ml - active: fluorescein 100 mg/ml (as fluorescein sodium formed in process from fluorescein and sodium hydroxide)   excipient: sodium hydroxide water for injection - fluorescein is indicated for angiography of the fundus and of the iris vasculature. this medicinal product is for diagnostic use only.

Ireland - English - HPRA (Health Products Regulatory Authority)

pharmargus limited - fluorescein sodium - solution for injection - 100 milligram(s)/millilitre - fluorescein

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

bausch + lomb ireland - fluorescein sodium 20 mg/ml - eye drops, solution - 20 mg/ml - fluorescein sodium 10 mg - fluorescein

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - fluorescein sodium - solution for injection - fluorescein sodium 100 mg/ml - ophthalmologicals

United States - English - NLM (National Library of Medicine)

altaire pharmaceuticals inc. - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir), benoxinate hydrochloride (unii: 0ve4u49k15) (benoxinate - unii:axq0jym303) - altafluor benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. altafluor benox is contraindicated in patients with known hypersensitivity to any component of this product. risk summary   there are no available data on the use of altafluor benox in pregnant women to inform any drug associated risk. adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. altafluor benox should be given to a pregnant woman only if clearly needed. risk summary    there are no data on the presence of fluorescein sodium or benoxinate hydrochloride in human milk after ocular administration of altafluor benox, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for altafluor benox a

United States - English - NLM (National Library of Medicine)

alcon, inc. - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir) - fluorescite® injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. fluorescite® injection 10% is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. rare cases of death due to anaphylaxis have been reported. [see warnings and precautions (5.1) and adverse reactions (6)]. fluorescein sodium can induce serious intolerance reactions. these reactions of intolerance are always unpredictable but they are more frequent in patients who have previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and vomiting) or in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis. detailed questioning of each patient is recommended before the angiography to evaluate any prior history of allergy. adequate animal reproduction studies have not been conducted with fluorescein sodium.  it is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. fluorescein sodium should be given to a pregnant woman only if clearly needed. fluorescein sodium injection has been demonstrated to be excreted in human milk for up to 4 days.  following fluorescein angiography, breast-feeding should therefore be discontinued for at least 4 days and the milk should be pumped off and discarded during this period. pediatric patients have been included in clinical studies.  no overall differences in safety or effectiveness have been observed between pediatric and adult patients. no overall differences in safety or effectiveness have been observed between elderly and other adult patients.