Соединенные Штаты - английский - NLM (National Library of Medicine)

bausch & lomb incorporated - timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - preservative-free timoptic in ocudose is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. preservative-free timoptic in ocudose may be used when a patient is sensitive to the preservative in timoptic (timolol maleate ophthalmic solution), benzalkonium chloride, or when use of a preservative-free topical medication is advisable. preservative-free timoptic in ocudose is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see warnings); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see warnings); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

Соединенные Штаты - английский - NLM (National Library of Medicine)

bausch & lomb incorporated - brinzolamide (unii: 9451z89515) (brinzolamide - unii:9451z89515) - brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma. brinzolamide ophthalmic suspension is contraindicated in patients who are hypersensitive to any component of this product. risk summary there are no adequate and well-controlled studies in pregnant women to inform drug-associated risk. in reproductive toxicity studies, brinzolamide administered orally to rats induced fetal toxicity at 375 times the recommended human ophthalmic dose (rhod) based on mg/kg. in rabbits, no fetal toxicity was observed following oral administration (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4%, and of miscarriage is 15% to 20%, of clinically recognized pregnancies. data animal data embryo-fetal studies were conducted in pregnant rats administered 0, 2, 6, or 18 mg/kg/day brinzolamide by oral gavage on gestation days 6 to 17, to target the period of organogenesis. decreased fetal body weight with reduced skeletal ossification were observed at 18 mg/kg/day (375 times the rhod based on mg/kg). the no-observed-adverse-effect-level (noael) for fetal toxicity was 6 mg/kg/day (125 times the rhod). decreased maternal weight gain was observed at 18 mg/kg/day. the noael for maternal toxicity was 6 mg/kg/day (125 times the rhod). embryo-fetal studies were conducted in pregnant rabbits administered 0, 1, 3, or 6 mg/kg/day of brinzolamide by oral gavage on gestation days 6 to 18, to target the period of organogenesis. no treatment-related fetal effects were observed at any dose. the noael for fetal toxicity was 6 mg/kg/day (125 times the rhod based on mg/kg). maternal weight loss during pregnancy was observed at 3 mg/kg/day (63 times the rhod) and above. the noael for maternal toxicity was 1 mg/kg/day (21 times the rhod). a peri-/postnatal study was conducted in rats administered brinzolamide by oral gavage from gestation day 16 through lactation day 20. decreased pup body weight was observed at 15 mg/kg/day (313 times the rhod based on mg/kg). the noael for developmental toxicity was 5 mg/kg/day (104 times the rhod). following oral administration of 14 c-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood. risk summary there are no data on the presence of brinzolamide in human milk, the effects on the breastfed infant, or the effects on milk production. brinzolamide has been detected in the milk of lactating rats. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for brinzolamide ophthalmic suspension and any potential adverse effects on the breastfed child from brinzolamide ophthalmic suspension. a 3-month controlled clinical study was conducted in which brinzolamide ophthalmic suspension was dosed only twice a day in pediatric patients 4 weeks to 5 years of age. patients were not required to discontinue their iop-lowering medication(s) until initiation of monotherapy with brinzolamide ophthalmic suspension. iop-lowering efficacy was not demonstrated in this study in which the mean decrease in elevated iop was between 0 mmhg and 2 mmhg. five out of 32 patients demonstrated an increase in corneal diameter of one millimeter. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Канада - английский - Health Canada

vertex pharmaceuticals (canada) incorporated - tezacaftor; ivacaftor; ivacaftor; elexacaftor - tablet - 25mg; 37.5mg; 75mg; 50mg - tezacaftor 25mg; ivacaftor 37.5mg; ivacaftor 75mg; elexacaftor 50mg

Соединенные Штаты - английский - NLM (National Library of Medicine)

bausch & lomb incorporated - perfluorohexyloctane (unii: 7vyx4elwqm) (perfluorohexyloctane - unii:7vyx4elwqm) - miebo® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease (ded). none. risk summary there are no adequate and well controlled studies with miebo in pregnant women. in animal reproduction studies with oral administration of perfluorohexyloctane during the period of organogenesis, no adverse maternal or developmental effects were observed in rats at doses up to 162 times the recommended human ophthalmic dose (rhod) (see data ). maternal toxicity, miscarriages and reduced fetal weights were observed in rabbits at all doses tested, with the lowest dose as 41 times the rhod. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. data animal data an embryofetal study was conducted in pregnant rabbits administered perfluorohexyloctane by oral gavage on gestation days 6 to 19, to target the period of organogenesis. perfluorohexyloctane produced maternal toxicity, characterized by reduced body weight gain and food consumption, and miscarriages at all doses tested, with the lowest dose as ≥ 250 mg/kg/day (41 times the rhod based on body surface area). reduced fetal weights were also observed at ≥ 250 mg/kg/day but no fetal mortality or malformations. a no observed adverse effect level (noael) for maternal toxicity was not established in rabbits. an embryofetal study was conducted in pregnant rats administered perfluorohexyloctane by oral gavage on gestation days 6 to 17, to target the period of organogenesis. there was no evidence of embryofetal toxicity or teratogenicity at doses up to 2,000 mg/kg/day (162 times the rhod). there are no data on the presence of perfluorohexyloctane in human milk, the effects on the breastfed infant, or the effects on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of miebo to an infant during lactation; however, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for miebo. the safety and effectiveness of miebo in pediatric patients below the age of 18 years have not been established. no overall differences in safety and effectiveness have been observed between elderly and younger patients.

Канада - английский - Health Canada

vertex pharmaceuticals (canada) incorporated - lumacaftor; ivacaftor - granules - 75mg; 94mg - lumacaftor 75mg; ivacaftor 94mg

Соединенные Штаты - английский - NLM (National Library of Medicine)

bausch & lomb incorporated - lifitegrast (unii: 038e5l962w) (lifitegrast - unii:038e5l962w) - xiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (ded). xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation [see adverse reactions (6.2)]. risk summary there are no available data on xiidra use in pregnant women to inform any drug-associated risks. intravenous (iv) administration of lifitegrast to pregnant rats, from premating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [rhod], based on the area under the curve [auc] level). since human systemic exposure to lifitegrast following ocular administration of xiidra at the rhod is low, the applicability of animal findings to the risk of xiidra use in humans during pregnancy is unclear [see clinical pharmacology (12.3)] data animal data lifitegrast administered daily by iv injection to rats, from premating through gestation day 17, caused an increase in mean pre-implantation loss and an increased incidence of several minor skeletal anomalies at 30 mg/kg/day, representing 5,400-fold the human plasma exposure at the rhod of xiidra, based on auc. no teratogenicity was observed in the rat at 10 mg/kg/day (460-fold the human plasma exposure at the rhod, based on auc). in the rabbit, an increased incidence of omphalocele was observed at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the rhod, based on auc), when administered by iv injection daily from gestation days 7 through 19. a fetal no observed adverse effect level (noael) was not identified in the rabbit. risk summary there are no data on the presence of lifitegrast in human milk, the effects on the breastfed infant, or the effects on milk production. however, systemic exposure to lifitegrast 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 xiidra and any potential adverse effects on the breastfed child from xiidra. safety and efficacy in pediatric patients below the age of 17 years have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger adult patients. instructions for use xiidra ® [zye-druh] (lifitegrast ophthalmic solution) 5% for topical ophthalmic use read this instructions for use before you start using xiidra and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your doctor about your medical condition or your treatment. important information you need to know before using xiidra: - xiidra is for use in the eye. - wash your hands before each use to make sure you do not infect your eyes while using xiidra. - if you wear contact lenses, remove them before using xiidra. - xiidra single‑use containers are packaged in a foil pouch. do not remove from the foil pouch until you are ready to use xiidra. - do not let the tip of the xiidra single-use container touch your eye or any other surfaces. - use one drop of xiidra in each eye two times each day (one drop in the morning and one drop in the evening, approximately 12 hours apart). each single‑use container of xiidra will give you enough medicine to treat both of your eyes, one time. there is some extra xiidra in each single‑use container in case you miss getting a drop into your eye. after you have applied the drops, throw away the single‑use container and any unused xiidra. do not save any unused xiidra. follow steps 1 to 9 each time you use xiidra. step 1. take a foil pouch out of the xiidra box. open the pouch and remove the strip of single‑use containers (see figure a ). - pull off one single‑use container from the strip (see figure b ). - figure a - figure b step 2. put the remaining strip of single‑use containers back in the pouch (see figure c ). - figure c - fold the edge to close the pouch (see figure d ). - figure d step 3. hold the xiidra container upright (see figure e ). - tap the top of the container until all of the solution is in the bottom part of the container (see figure f ). figure e figure f step 4. open the xiidra single‑use container by twisting off the tab. make sure that the tip of the single‑use container does not touch anything, to avoid contamination (see figure g ). figure g step 5. tilt your head backwards. if you are not able to tilt your head, lie down. step 6. gently pull your lower eyelid downwards and look up. step 7. place the tip of the xiidra single‑use container close to your eye, but be careful not to touch your eye with it. step 8. gently squeeze the single‑use container and let one drop of xiidra fall into the space between your lower eyelid and your eye. if a drop misses your eye, try again ( see figure h ). figure h step 9. repeat steps 5 to 8 for your other eye. there is enough xiidra in one single‑use container for both eyes. - once you have applied a drop to both eyes, throw away the opened single‑use container with any remaining solution. - if you use contact lenses, wait for at least 15 minutes before placing them back in your eyes. distributed by: bausch & lomb americas inc., bridgewater, nj 08807 usa patented. see https://patents.bausch.comfor us patent information. xiidra is a trademark of bausch & lomb incorporated or its affiliates. © 2023 bausch & lomb incorporated or its affiliates this instructions for use has been approved by the u.s. food and drug administration. revised: december 2023 9800800

Канада - английский - Health Canada

vertex pharmaceuticals (canada) incorporated - ivacaftor; ivacaftor; elexacaftor; tezacaftor - granules - 75mg; 75mg; 100mg; 50mg - ivacaftor 75mg; ivacaftor 75mg; elexacaftor 100mg; tezacaftor 50mg

Канада - английский - Health Canada

vertex pharmaceuticals (canada) incorporated - ivacaftor; ivacaftor; elexacaftor; tezacaftor - granules - 60mg; 59.5mg; 80mg; 40mg - ivacaftor 60mg; ivacaftor 59.5mg; elexacaftor 80mg; tezacaftor 40mg

Филиппины - английский - FDA (Food And Drug Administration)

n/a; importer: dreamax incorporated :; distributor: dreamax incorporated : - piperacillin (as sodium) , tazobactam (as sodium) , wfi - powder for injection (iv) - 4g / 500 mg

Филиппины - английский - FDA (Food And Drug Administration)

n/a; importer: dreamax incorporated :; distributor: dreamax incorporated : - piperacillin (as sodium) , tazobactam (as sodium) - powder for injection (iv) - 2g / 250 mg