Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

profeng australia pty ltd - fipronil - suspension concentrate - fipronil nitrile active 200.0 g/l - insecticide

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer limited - fluconazole - powder for oral suspension - 40 mg/ml - triazole derivatives

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer limited - fluconazole - powder for oral suspension - 10 mg/ml - triazole derivatives

Canada - English - Health Canada

ratiopharm inc division of teva canada limited - flurbiprofen - tablet - 50mg - flurbiprofen 50mg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

ratiopharm inc division of teva canada limited - flurbiprofen - tablet - 100mg - flurbiprofen 100mg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

nu-pharm inc - flurbiprofen - tablet - 50mg - flurbiprofen 50mg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

nu-pharm inc - flurbiprofen - tablet - 100mg - flurbiprofen 100mg - other nonsteroidal antiimflammatory agents

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

medsource pharmaceuticals - flurbiprofen (unii: 5gro578klp) (flurbiprofen - unii:5gro578klp) - flurbiprofen tablets are indicated: - for relief of the signs and symptoms of rheumatoid arthritis. - for relief of the signs and symptoms of osteoarthritis. - flurbiprofen tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to flurbiprofen or any components of the drug product [ see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nonsteroidal anti-inflammatory drugs have been reported in such patients [ see warnings and precautions ( 5.7, 5.8) ]. - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1) ]. risk summary use of nsaids, including flurbiprofen, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including flurbiprofen, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of flurbiprofen in pregnant women. data from observational studies regarding potential embryo-fetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. in animal reproduction studies, delayed parturition, prolonged labor, stillborn fetuses, and the presence of retained fetuses at necropsy occurred following treatment of pregnant rats treated with oral flurbiprofen throughout gestation until labor at less than 1-time the human dose of 300 mg/day. embryofetal lethality was seen in pregnant rats and rabbits administered oral flurbiprofen during the period of organogenesis at exposures 0.03-times and 0.5 times, respectively, the human dose of 300 mg. no evidence of malformations were noted in rats, rabbits, or mice treated with flurbiprofen during the period of organogenesis at doses that were 0.8-, 0.5-, and 0.2-times the maximum human daily dose [see data]. based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as flurbiprofen, resulted in increased pre- and post-implantation loss. clinical considerations labor or delivery there are no studies on the effects of flurbiprofen during labor or delivery. in animal studies, nsaids, including flurbiprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data animal data pregnant rats were treated with oral doses of 0.05, 1, and 3 mg/kg flurbiprofen 14 days prior to mating through gestation day (gd) 16. embryofetal lethality was seen at 1 mg/kg and above (0.03 times the maximum recommended human dose [mrhd] of 300 mg on a mg/m 2 basis). no maternal toxicity was evident at this dose. no malformations were seen in fetuses from pregnant rats administered flurbiprofen during the period of organogenesis at doses up to 25 mg/kg (0.8 times the mrhd on a mg/m 2 basis). maternal toxicity (uterine hemorrhage, gastric ulcers) was observed at this dose. pregnant rabbits were administered oral doses of 0.675, 2.25, and 7.5 mg/kg flurbiprofen from gd 1 through gd 29. embryofetal lethality, but no evidence of teratogenicity, was seen at 7.5 mg/kg (0.5 times the mrhd of 300 mg on a mg/m 2 basis). maternal toxicity (gastric ulcers and lethality) was observed at this dose. pregnant mice were treated with oral doses of 2, 5, and 12 mg/kg flurbiprofen from gd 3 to 18. an increased incidence of fetal lethality occurred in the 12 mg/kg group (0.2 times the mrhd). all doses were associated with some evidence of maternal toxicity (placental hemorrhage). pregnant rats were treated with oral doses of 0.2, 0.675, 2.25, 7.5, and 25 mg/kg flurbiprofen from gd 1 until labor. delayed delivery, the incidence of stillborn pups, and decreased pup viability, were noted at doses of 2.25 mg/kg and higher (0.07 times the mrhd). these doses were associated with maternal toxicity (uterine hemorrhage, gastrointestinal ulceration, decreased body weight). pregnant rats treated with oral doses of 0.4, 4, and 10 mg/kg flurbiprofen from gd 16 to labor, delayed parturition was seen at 0.4 mg/kg and above and stillborn pups were seen at 4 mg/kg and above (0.01-times and 0.13 times, respectively, the mrhd on mg/m 2 basis). uterine hemorrhage, ulceration, and mortality were noted in dams at 0.4 mg/kg and above. risk summary flurbiprofen is poorly excreted into human milk. the nursing infant dose is predicted to be approximately 0.1 mg/day in the established milk of a woman taking flurbiprofen 200 mg/day. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for flurbiprofen and any potential adverse effects on the breastfed infant from flurbiprofen or from the underlying maternal condition. infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including flurbiprofen, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including flurbiprofen, in women who have difficulties conceiving or who are undergoing investigation of infertility. safety and effectiveness in pediatric patients have not been established. elderly patients, compared to younger patients, are at greater risk for nsaid-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. if the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [ see warnings and precautions ( 5.1, 5.2, 5.3, 5.6, 5.13) ].

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

bryant ranch prepack - flurbiprofen (unii: 5gro578klp) (flurbiprofen - unii:5gro578klp) - flurbiprofen tablets are indicated: - for relief of the signs and symptoms of rheumatoid arthritis. - for relief of the signs and symptoms of osteoarthritis. flurbiprofen tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to flurbiprofen or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nonsteroidal anti-inflammatory drugs have been reported in such patients [see warnings and precautions (5.7, 5.8) ]. - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ]. risk summary use of nsaids, including flurbiprofen tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of flurbiprofen tablets use between about 20 and 30 weeks of gestation, and avoid flurbiprofen tablets use at about 30 weeks of gestation and later in pregnancy [see clinical considerations, data ]. premature closure of fetal ductus arteriosus use of nsaids, including flurbiprofen tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. in animal reproduction studies, delayed parturition, prolonged labor, stillborn fetuses, and the presence of retained fetuses at necropsy occurred following treatment of pregnant rats treated with oral flurbiprofen throughout gestation until labor at less than 1-time the human dose of 300 mg/day. embryofetal lethality was seen in pregnant rats and rabbits administered oral flurbiprofen during the period of organogenesis at exposures 0.03-times and 0.5 times, respectively, the human dose of 300 mg. no evidence of malformations were noted in rats, rabbits, or mice treated with flurbiprofen during the period of organogenesis at doses that were 0.8-, 0.5-, and 0.2-times the maximum human daily dose [see data]. based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as flurbiprofen, resulted in increased pre- and post-implantation loss. prostaglandins also have been shown to have an important role in fetal kidney development. in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. clinical considerations fetal/neonatal adverse reactions premature closure of fetal ductus arteriosus: avoid use of nsaids in women at about 30 weeks gestation and later in pregnancy, because nsaids, including flurbiprofen tablets, can cause premature closure of the fetal ductus arteriosus [see data ]. oligohydramnios/neonatal renal impairment if an nsaid is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. if flurbiprofen tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. if oligohydramnios occurs, discontinue flurbiprofen tablets and follow up according to clinical practice [see data ]. data human data premature closure of fetal ductus arteriosus: published literature reports that the use of nsaids at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment: published studies and postmarketing reports describe maternal nsaid use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. these adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after nsaid initiation. in many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. there have been a limited number of case reports of maternal nsaid use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. these limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal nsaid use. because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to nsaids through maternal use is uncertain. animal data pregnant rats were treated with oral doses of 0.05, 1, and 3 mg/kg flurbiprofen 14 days prior to mating through gestation day (gd) 16. embryofetal lethality was seen at 1 mg/kg and above (0.03 times the maximum recommended human dose [mrhd] of 300 mg on a mg/m2 basis). no maternal toxicity was evident at this dose. no malformations were seen in fetuses from pregnant rats administered flurbiprofen during the period of organogenesis at doses up to 25 mg/kg (0.8 times the mrhd on a mg/m2 basis). maternal toxicity (uterine hemorrhage, gastric ulcers) was observed at this dose. pregnant rabbits were administered oral doses of 0.675, 2.25, and 7.5 mg/kg flurbiprofen from gd 1 through gd 29. embryofetal lethality, but no evidence of teratogenicity, was seen at 7.5 mg/kg (0.5 times the mrhd of 300 mg on a mg/m2 basis). maternal toxicity (gastric ulcers and lethality) was observed at this dose. pregnant mice were treated with oral doses of 2, 5, and 12 mg/kg flurbiprofen from gd 3 to 18. an increased incidence of fetal lethality occurred in the 12 mg/kg group (0.2 times the mrhd). all doses were associated with some evidence of maternal toxicity (placental hemorrhage). pregnant rats were treated with oral doses of 0.2, 0.675, 2.25, 7.5, and 25 mg/kg flurbiprofen from gd 1 until labor. delayed delivery, the incidence of stillborn pups, and decreased pup viability, were noted at doses of 2.25 mg/kg and higher (0.07 times the mrhd). these doses were associated with maternal toxicity (uterine hemorrhage, gastrointestinal ulceration, decreased body weight). pregnant rats treated with oral doses of 0.4, 4, and 10 mg/kg flurbiprofen from gd 16 to labor, delayed parturition was seen at 0.4 mg/kg and above and stillborn pups were seen at 4 mg/kg and above (0.01-times and 0.13 times, respectively, the mrhd on mg/m2 basis). uterine hemorrhage, ulceration, and mortality were noted in dams at 0.4 mg/kg and above. labor or delivery there are no studies on the effects of flurbiprofen during labor or delivery. in animal studies, nsaids, including flurbiprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. risk summary flurbiprofen is poorly excreted into human milk. the nursing infant dose is predicted to be approximately 0.1 mg/day in the established milk of a woman taking flurbiprofen 200 mg/day. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for flurbiprofen and any potential adverse effects on the breastfed infant from flurbiprofen or from the underlying maternal condition. infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including flurbiprofen, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including flurbiprofen, in women who have difficulties conceiving or who are undergoing investigation of infertility. safety and effectiveness in pediatric patients have not been established. elderly patients, compared to younger patients, are at greater risk for nsaid-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. if the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see warnings and precautions (5.1, 5.2, 5.3, 5.6, 5.14) ].

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

nucare pharmaceuticals,inc. - flurbiprofen (unii: 5gro578klp) (flurbiprofen - unii:5gro578klp) - flurbiprofen tablets are indicated: - for relief of the signs and symptoms of rheumatoid arthritis. - for relief of the signs and symptoms of osteoarthritis. - flurbiprofen tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to flurbiprofen or any components of the drug product [ see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nonsteroidal anti-inflammatory drugs have been reported in such patients [ see warnings and precautions ( 5.7, 5.8) ]. - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1) ]. risk summary use of nsaids, including flurbiprof