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

clinect pty ltd - fluorescein sodium, quantity: 100 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections - fluorescein angiography of the fundus and of the iris vasculature. this medicinal product is for diagnostic use only.

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

phebra pty ltd - fluorescein sodium, quantity: 100 mg/ml - injection - excipient ingredients: hydrochloric acid; water for injections; sodium hydroxide - diagnostic: intravenous injection of sodium fluorescein dye followed by multiframe photography (angiography) or opthalmoscopic evaluation (angioscopy). used in evaluation of wide range of retinal and choroidal diseases. less commonly used to evaluate abnormalities of the optic nerve and iris. may be used in the diagnosis and management of macular and vascular (including diabetic) diseases.

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

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

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)

phebra pty ltd - fluorescein sodium, quantity: 250 mg/ml - injection, intravenous infusion - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - indications as at 01 january 1991 : diagnostic - intravenous injection of sodium fluorescein dye followed by multiframe photography (angiography) or ophthalmoscopic evaluation (angioscopy). used in evaluation of wide range of retinal and choroidal diseases. less commonly used to evaluate abnormalities of the optic nerve and iris. may be used in diagnosis and management of macular and vascular (including diabetes) diseases.

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

phebra pty ltd - fluorescein sodium, quantity: 100 mg/ml - injection, intravenous infusion - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - indications as at 01 january 1991 : diagnostic - intravenous injection of sodium fluorescein dye followed by multiframe photography (angiography) or ophthalmoscopic evaluation (angioscopy). used in evaluation of wide range of retinal and choroidal diseases. less commonly used to evaluate abnormalities of the optic nerve and iris. may be used in diagnosis and management of macular and vascular (including diabetes) diseases.

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

altaire pharmaceuticals inc. - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir), proparacaine hydrochloride (unii: u96ol57goy) (proparacaine - unii:b4ob0jhi1x) - known hypersensitivity to any component of this product.

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

ocusoft, inc. - fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir), benoxinate hydrochloride (unii: 0ve4u49k15) (benoxinate - unii:axq0jym303) - flourescein sodium and benoxinate hydrochloride opthalmic solution usp, 0.25%/0.4% is a disclosing agent with rapid anesthetic action of short duration. fluorescein sodium is represented by the following structural formula: chemical name: spiro  [isobenzofuran-1  (3h ),9'-[9h ]  xanthene]-3-one,  3',6'  dihydroxy, disodium salt. benoxinate hydrochloride is represented by the following structural formula: chemical name: 2-(diethylamino) ethyl 4-amino-3butoxybenzoate monohydrochloride. for procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures. known hypersensitivity to any component of this product.