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

bausch & lomb incorporated - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir), benoxinate hydrochloride (unii: 0ve4u49k15) (benoxinate - unii:axq0jym303) - fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product. risk summary there are no available data on the use of fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% in pregnant women to inform any drug associated risk. adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% 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 fluorescein sodium and beno

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

oceanside pharmaceuticals - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir), benoxinate hydrochloride (unii: 0ve4u49k15) (benoxinate - unii:axq0jym303) - fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product. risk summary there are no available data on the use of fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% in pregnant women to inform any drug associated risk. adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% 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 fluorescein sodium and beno

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch + lomb ireland limited - fluorescein sodium - eye drops, solution - colouring agents; fluorescein

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch + lomb ireland limited - fluorescein sodium - eye drops, solution - colouring agents; fluorescein

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch + lomb ireland limited - fluorescein sodium; lidocaine hydrochloride - eye drops, solution - colouring agents; fluorescein, combinations

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

bausch & lomb americas inc. - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir), benoxinate hydrochloride (unii: 0ve4u49k15) (benoxinate - unii:axq0jym303) - fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product. risk summary there are no available data on the use of fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% in pregnant women to inform any drug associated risk. adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. fluorescein sodium and benoxinate hydrochloride ophthalmic solution, 0.3%/0.4% 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 fluorescein sodium and beno

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - fluorescein sodium -

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch & lomb uk limited - fluorescein sodium - eye drops solution - 1 %w/v - fluorescein

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch & lomb uk limited - fluorescein sodium - eye drops solution - 2.0 %w/v - fluorescein

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

akorn - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir) - fluorescein sodium 100 mg in 1 ml - 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. 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) ]. 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. fluorescein sodium has been demonstrated to be excreted in human milk. caution should be exercised when fluorescein sodium is administered to a nursing woman. pediatric patients have been included in clinical studies. no overall differences in safety or effectiveness have been observed between pediatric and adult patient