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

alembic pharmaceuticals limited - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. teratogenic effects: pregnancy category c . reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects: because of the known effects of p

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

armas pharmaceuticals inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (cl

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

bausch & lomb americas inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the systemic exposure predicted from the recommended human ophthalmic dose [rhod] assuming the human systemic concentration is at the limit of quantification) and rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic exposure) produced no treatment-related malformations in reproduction studies. however, embryofetal lethality and maternal toxicity were produced in rats and rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. in rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human exposure), and caused dystocia, increased neonatal mortality, and reduced postnatal growth at 0.9 mg/kg/day. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. caution should be exercised when bromfenac ophthalmic solution is administered to a nursing woman. safety and efficacy in pediatric patients below the age of 18 years have not been established. there is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 70 years of age and older compared to younger adult patients.

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

sun pharmaceutical industries, inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. none risk summary there are no adequate and well-controlled studies in pregnant women to inform any drug associated risks. treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses. clinical considerations because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. data animal data treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m2 basis, assuming 100% absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose on a mg/m2 basis) produced no structural teratogenicity in reproduction studies. however, embryo-fetal lethality, neonatal mortality and reduced postnatal growth were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was produced in rabbits at 7.5 mg/kg/day. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no data on the presence of bromfenac in human milk, the effects on the breastfed infant, or the effects on milk production; however, systemic exposure to bromfenac from ocular administration is low [see clinical pharmacology (12.3)]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bromfenac and any potential adverse effects on the breast-fed child from bromfenac or from the underlying maternal condition. safety and efficacy in pediatric patients below the age of 18 years have not been established. there is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 65 years of age and older compared to younger adult patients. bromfenac (brom' fe nak) ophthalmic solution 0.075% read this instructions for use before you start using bromfenac ophthalmic solution and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. information about bromfenac ophthalmic solution: •do not let the bromfenac ophthalmic solution applicator tip touch your eye, fingers, or any other surfaces. •if you are using bromfenac ophthalmic solution with other eye (ophthalmic) medicines, you should wait at least 5 minutes after using the other medicine to give your bromfenac ophthalmic solution dose. •you should not wear contact lenses while using bromfenac ophthalmic solution. •put the gray cap back on the bromfenac ophthalmic solution after each use. before you use bromfenac ophthalmic solution for the first time: •tear open the foil pouch using the perforated notch and remove the bromfenac ophthalmic solution bottle. throw away the foil pouch. •remove the white cap by turning it in the clockwise direction (see figure a) . throw away the white cap. •hold the bottle upright. remove the gray cap by turning it in the counterclockwise direction (see figure b) . •replace the gray cap on the bottle and close tightly. follow steps 1 to 5 each time you use bromfenac ophthalmic solution. step 1. wash your hands well. step 2. turn the closed bottle upside down (see figure c). step 3. flick bottle firmly 1 time before each use to move the medicine into the tip of the bottle (see figure d). step 4. keep the bottle upside down and remove the gray cap by turning it in the clockwise direction (see figure e). step 5. tilt your head back. gently squeeze the bottle to place 1 drop into the affected eye (see figure f) . replace the gray cap on the bottle and close tightly. how do i store bromfenac ophthalmic solution? •store at 15°c to 25°c (59°f to 77°f). after opening, bromfenac ophthalmic solution can be used until the expiration date on the bottle. •throw away the bromfenac ophthalmic solution bottle after your treatment is finished. this instructions for use has been approved by the u.s. food and drug administration. distributed by: sun pharmaceutical industries, inc. cranbury, nj 08512 us patent no. 8,778,999 © 2022 sun pharmaceutical industries, inc. all rights reserved. rev.: 03/2023

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

lupin pharmaceuticals, inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution, 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. none. risk summary there are no adequate and well-controlled studies in pregnant women to inform any drug associated risks.  treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses. clinical considerations because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. data animal data treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m2 basis, assuming 100% absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose on a mg/m2 basis) produced no structural teratogenicity in reproduction studies. however, embryo-fetal lethality, neonatal mortality and reduced postnatal growth were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was produced in rabbits at 7.5 mg/kg/day. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no data on the presence of bromfenac in human milk, the effects on the breastfed infant, or the effects on milk production; however, systemic exposure to bromfenac from ocular administration is low [see clinical pharmacology (12.3)]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bromfenac and any potential adverse effects on the breast-fed child from bromfenac or from the underlying maternal condition. safety and efficacy in pediatric patients below the age of 18 years have not been established. there is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 65 years of age and older compared to younger adult patients. instructions for use bromfenac (brome' fen ak ) ophthalmic solution 0.075% read this instructions for use before you start using bromfenac ophthalmic solution and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. information about bromfenac ophthalmic solution: - do not let the bromfenac ophthalmic solution nozzle touch your eye, fingers, or any other surfaces. - if you are using bromfenac ophthalmic solution with other eye (ophthalmic) medicines, you should wait at least 5 minutes after using the other medicine to give your bromfenac ophthalmic solution dose. - you should not wear contact lenses while using bromfenac ophthalmic solution. - put the gray cap back on the bromfenac ophthalmic solution after each use. before you use bromfenac ophthalmic solution for the first time: - break the tamper evident ring by turning cap in counterclockwise direction (see figure a ). - hold the bottle upright. remove the gray cap by turning it in the counterclockwise direction (see figure b ). - replace the gray cap on the bottle and close tightly (see figure c ). follow steps 1 to 5 each time you use bromfenac ophthalmic solution. step 1. wash your hands well. step 2. turn the closed bottle upside down (see figure d). step 3. flick bottle firmly 1 time before each use to move the medicine into the tip of the bottle (see figure e). step 4. keep the bottle upside down and remove the gray cap by turning it in clockwise direction (see  figure f ). step 5. tilt your head back. gently squeeze the bottle to place 1 drop into the affected eye (see figure g). replace the gray cap on the bottle and close tightly. how do i store bromfenac ophthalmic solution? - store bromfenac ophthalmic solution at 15°c to 25°c (59°f to 77°f). after opening, bromfenac ophthalmic solution can be used until the expiration date on the bottle. - throw away the bromfenac ophthalmic solution bottle after your treatment is finished. this instructions for use has been approved by the u.s. food and drug administration. manufactured for: lupin pharmaceuticals, inc. baltimore, maryland 21202 united states manufactured by: lupin limited pithampur (m.p.) - 454 775 india revised: august 2023

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

herbs of gold pty ltd - bromelains, quantity: 18 million pu - capsule, hard - excipient ingredients: purified water; rice bran; medium chain triglycerides; maltodextrin; hypromellose - anti-inflammatory/relieve inflammation ; aid/assist in the healing of minor body tissue injuries ; relieve mild tissue oedema ; decrease/reduce/relieve symptoms of soft tissue trauma (linked indication:analgesic/anodyne/relieve pain; relieve mild tissue oedema); maintain/support healthy digestion ; aid/assist/helps digestion of (state nutrient)

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

imprimisrx nj - bromfenac (unii: 864p0921dw) (bromfenac - unii:864p0921dw), prednisolone acetate (unii: 8b2807733d) (prednisolone - unii:9phq9y1olm) - bromfenac 0.75 mg in 1 ml

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

bromelain (corresponding to 56.25 - 95mg of bromelain) -

Canada - English - Health Canada

vita health products inc - bromelain; papain - tablet - 75mg; 35mg - bromelain 75mg; papain 35mg - digestants

Canada - English - Health Canada

albi naturals - bromelain - capsule - 500mg - bromelain 500mg - enzymes