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pfizer laboratories div pfizer inc - oxaprozin (unii: mhj80w9lrb) (oxaprozin - unii:mhj80w9lrb) - oxaprozin 600 mg - daypro is indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis - for relief of the signs and symptoms of juvenile rheumatoid arthritis daypro is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin 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 nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of cabg surgery [see warnings and precautions (5.1) ] risk summary use of nsaids, including daypro, 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 daypro use b

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pfizer laboratories div pfizer inc - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - feldene is indicated: feldene is contraindicated in the following patients: risk summary use of nsaids, including feldene, 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 feldene use between about 20 and 30 weeks of gestation, and avoid feldene 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 feldene, 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 other potential embryofetal risks of n

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pfizer laboratories div pfizer inc - epoetin (unii: 64fs3bfh5w) (erythropoietin - unii:64fs3bfh5w) - retacrit is indicated for the treatment of anemia due to chronic kidney disease (ckd), including patients on dialysis and not on dialysis to decrease the need for red blood cell (rbc) transfusion. retacrit is indicated for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in patients with hiv-infection with endogenous serum erythropoietin levels of ≤ 500 munits/ml. retacrit is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. retacrit is indicated to reduce the need for allogeneic rbc transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dl who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. retacrit is not indicated for patients who are willing to donate autologous blood pre-operatively. retacrit has not been shown to improv

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pfizer laboratories div pfizer inc - rituximab (unii: 4f4x42syq6) (rituximab - unii:4f4x42syq6) - ruxience is indicated for the treatment of adult patients with: ruxience, in combination with fludarabine and cyclophosphamide (fc), is indicated for the treatment of adult patients with previously untreated and previously treated cd20-positive cll. ruxience, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to severely-active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (tnf) antagonist therapies. ruxience, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener's granulomatosis) and microscopic polyangiitis (mpa). none. risk summary based on human data, rituximab products can cause adverse developmental outcomes including b-cell lymphocytopenia in infants exposed in-utero (see clinical considerations) . in animal reproduction studies, intravenous administration of rituximab to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid b-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on auc) of those achieved following a dose of 2 grams in humans. advise pregnant women of the risk to a fetus. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the background risk of major birth defects and miscarriage for the indicated populations is unknown. the estimated background risk in the u.s. general population of major birth defects is 2%–4% and of miscarriage is 15%–20% of clinically recognized pregnancies. clinical considerations fetal/neonatal adverse reactions observe newborns and infants for signs of infection and manage accordingly. data human data postmarketing data indicate that b-cell lymphocytopenia generally lasting less than six months can occur in infants exposed to rituximab in-utero. rituximab was detected postnatally in the serum of infants exposed in-utero. animal data an embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. pregnant animals received rituximab via the intravenous route during early gestation (organogenesis period; post coitum days 20 through 50). rituximab was administered as loading doses on post coitum (pc) days 20, 21, and 22, at 15, 37.5, or 75 mg/kg/day, and then weekly on pc days 29, 36, 43, and 50, at 20, 50, or 100 mg/kg/week. the 100 mg/kg/week dose resulted in 80% of the exposure (based on auc) of those achieved following a dose of 2 grams in humans. rituximab crosses the monkey placenta. exposed offspring did not exhibit any teratogenic effects but did have decreased lymphoid tissue b cells. a subsequent pre- and postnatal reproductive toxicity study in cynomolgus monkeys was completed to assess developmental effects including the recovery of b cells and immune function in infants exposed to rituximab in-utero. animals were treated with a loading dose of 0, 15, or 75 mg/kg every day for 3 days, followed by weekly dosing with 0, 20, or 100 mg/kg dose. subsets of pregnant females were treated from pc day 20 through postpartum day 78, pc day 76 through pc day 134, and from pc day 132 through delivery and postpartum day 28. regardless of the timing of treatment, decreased b cells and immunosuppression were noted in the offspring of rituximab-treated pregnant animals. the b-cell counts returned to normal levels, and immunologic function was restored within 6 months postpartum. there are limited data on the presence of rituximab in human milk, and the effect on the breastfed child, and there are no data on the effect on milk production. rituximab is detected in the milk of lactating cynomolgus monkeys, and maternal igg is present in human breast milk. rituximab has also been reported to be excreted at low concentrations in human breast milk. given that the clinical significance of this finding for children is not known, advise women not to breastfeed during treatment with ruxience and for 6 months after the last dose due to the potential of serious adverse reactions in breastfed children. rituximab products can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating ruxience. contraception females advise females of reproductive potential to use effective contraception during treatment with ruxience and for 12 months after the last dose. the safety and effectiveness of ruxience have not been established in pediatric patients with nhl, cll or ra. rituximab was not studied in pediatric patients with polyarticular juvenile idiopathic arthritis (pjia) due to concerns regarding the potential for prolonged immunosuppression as a result of b-cell depletion in the developing juvenile immune system. diffuse large b-cell nhl among patients with dlbcl evaluated in three randomized, active-controlled trials, 927 patients received rituximab in combination with chemotherapy. of these, 396 (43%) were age 65 or greater and 123 (13%) were age 75 or greater. no overall differences in effectiveness were observed between these patients and younger patients. cardiac adverse reactions, mostly supraventricular arrhythmias, occurred more frequently among elderly patients. serious pulmonary adverse reactions were also more common among the elderly, including pneumonia and pneumonitis. low-grade or follicular non-hodgkin's lymphoma patients with previously untreated follicular nhl evaluated in nhl study 5 were randomized to rituximab as single-agent maintenance therapy (n=505) or observation (n=513) after achieving a response to rituximab in combination with chemotherapy. of these, 123 (24%) patients in the rituximab arm were age 65 or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. other clinical studies of rituximab in low-grade or follicular, cd20-positive, b-cell nhl did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. chronic lymphocytic leukemia among patients with cll evaluated in two randomized active-controlled trials, 243 of 676 rituximab-treated patients (36%) were 65 years of age or older; of these, 100 rituximab-treated patients (15%) were 70 years of age or older. in exploratory analyses defined by age, there was no observed benefit from the addition of rituximab to fludarabine and cyclophosphamide among patients 70 years of age or older in cll study 1 or in cll study 2; there was also no observed benefit from the addition of rituximab to fludarabine and cyclophosphamide among patients 65 years of age or older in cll study 2 [see clinical studies (14.5)] . patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of rituximab. in cll study 1, the dose intensity of rituximab was similar in older and younger patients, however in cll study 2 older patients received a lower dose intensity of rituximab. the incidence of grade 3 and 4 adverse reactions was higher among patients receiving r-fc who were 70 years or older compared to younger patients for neutropenia [44% vs. 31% (cll study 1); 56% vs. 39% (cll study 2)], febrile neutropenia [16% vs. 6% (nhl study 10 (nct00719472))], anemia [5% vs. 2% (cll study 1); 21% vs. 10% (cll study 2)], thrombocytopenia [19% vs. 8% (cll study 2)], pancytopenia [7% vs. 2% (cll study 1); 7% vs. 2% (cll study 2)], and infections [30% vs. 14% (cll study 2)]. rheumatoid arthritis among the 2,578 patients in global ra studies completed to date, 12% were 65–75 years old and 2% were 75 years old and older. the incidences of adverse reactions were similar between older and younger patients. the rates of serious adverse reactions, including serious infections, malignancies, and cardiovascular events were higher in older patients. granulomatosis with polyangiitis (gpa) (wegener's granulomatosis) and microscopic polyangiitis of the 99 rituximab-treated gpa and mpa patients in gpa/mpa study 1, 36 (36%) were 65 years old and over, while 8 (8%) were 75 years and over. no overall differences in efficacy were observed between patients that were 65 years old and over and younger patients. the overall incidence and rate of all serious adverse events was higher in patients 65 years old and over. the clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. in gpa/mpa study 2, 30 (26%) of the enrolled patients were at least 65 years old, of which 12 patients were exposed to non-u.s.-licensed rituximab and 18 were exposed to azathioprine. the clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects.

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pfizer laboratories div pfizer inc - abrocitinib (unii: 73sm5sf3or) (abrocitinib - unii:73sm5sf3or) - cibinqo is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. limitations of use cibinqo is not recommended for use in combination with other jak inhibitors, biologic immunomodulators, or other immunosuppressants. cibinqo is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment [see warnings and precautions (5.6), drug interactions (7.2), and clinical pharmacology (12.2)].             pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to cibinqo during pregnancy. pregnant women exposed to cibinqo and health care providers are encouraged to call 1-877-311-3770. risk summary available data from pregnancies reported in clinical trials with cibinqo are not sufficient to establish a drug‑associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of abrocitinib to pregnant rats and rabbits during organogenesis at exposure 11 or 4 times the maximum recommended human dose (mrhd) based on auc comparison, respectively, resulted in maternal dystocia and skeletal variations in rats and no adverse effects in rabbits (see data ). the background risks of major birth defects and miscarriage for the indicated population are unknown. all pregnancies carry some risk of birth defects, loss, or other adverse outcomes. the background risks in the u.s. general population of major birth defects and miscarriages are 2–4% and 15–20% of clinically recognized pregnancies, respectively. data animal data in an embryofetal development study, abrocitinib was administered orally to pregnant rats at doses of 10, 30, or 60 mg/kg/day during the period of organogenesis. no fetal malformations were observed. abrocitinib increased the incidence of skeletal variations of short 13th ribs at 30 mg/kg/day (11 times the mrhd based on auc comparison). increased embryofetal lethality and additional skeletal variations (cervical arches with reduced ventral processes, thickened ribs, and unossified metatarsals) were noted at 60 mg/kg/day (17 times the mrhd based on auc comparison). in an embryofetal development study, abrocitinib was administered orally to pregnant rabbits at doses of 10, 30, or 75 mg/kg/day during the period of organogenesis. no abrocitinib-related maternal or developmental toxicity was noted at doses up to 75 mg/kg/day (4 times the mrhd based on auc comparison). in a prenatal and postnatal development study, abrocitinib was administered orally to pregnant rats at doses of 10, 30, and 60 mg/kg/day beginning on gestation day 6 and continuing through lactation day 20. dystocia with prolonged parturition and reduced offspring body weights were noted at 30 mg/kg/day (11 times the mrhd based on auc comparison). postnatal survival was markedly decreased at 60 mg/kg/day (17 times the mrhd based on auc comparison). no maternal toxicity was observed at 10 mg/kg/day (2.4 times the mrhd based on auc comparison). no abrocitinib-related effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring was noted at doses up to 30 mg/kg/day (11 times the mrhd based on auc comparison). risk summary there are no data on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. abrocitinib was secreted in milk of lactating rats (see data ). when a drug is present in animal milk, it is likely that the drug will be present in human milk. because of the serious adverse findings in adults, including risks of serious infections, malignancy, and thrombosis, advise women not to breastfeed during treatment with cibinqo and for one day after the last dose (approximately 5–6 elimination half-lives). data animal data lactating female rats were orally administered a single dose of 10 mg/kg abrocitinib on lactation day 12. abrocitinib auc was approximately 5 times greater in milk than in plasma.       infertility females based on the findings in rats, oral administration of cibinqo may impair female fertility. impaired fertility in female rats was reversible 1 month after cessation of abrocitinib oral administration [see nonclinical toxicology (13.1)] . the safety and effectiveness of cibinqo in pediatric patients 12 years of age and older with atopic dermatitis have been established. in trials trial-ad-1 and trial-ad-2, 124 pediatric subjects 12 to less than 18 years old weighing 25 kg or more with moderate-to-severe atopic dermatitis were enrolled and randomized to receive either cibinqo 100 mg (n=51), 200 mg (n=48), or matching placebo (n=25) in monotherapy. additional 284 pediatric subjects 12 to less than 18 years of age weighing 25 kg or more with moderate-to-severe atopic dermatitis, were enrolled and randomized to receive either cibinqo 100 mg (n=95) or 200 mg (n=94) or matching placebo (n=95) in combination with topical corticosteroids in trial-ad-4. efficacy and adverse reaction profile were comparable between the pediatric patients and adults [see clinical studies (14) and adverse reactions (6.1)] . the safety and effectiveness of cibinqo have not been established in pediatric patients below 12 years of age. juvenile animal toxicity data in a juvenile animal toxicity study, abrocitinib was administered orally to juvenile rats at doses of 5, 25, and 75 mg/kg/day from postnatal day 10 (approximately equivalent to a human infant) through postnatal day 63 (approximately equivalent to an adolescent). abrocitinib caused a reversible, dose‑related decrease in the primary spongiosa in the metaphysis of the proximal tibia and distal femur and adverse effects on bone development at all dose levels. abrocitinib caused irreversible dose-related small or misshapen femoral heads at doses ≥5 mg/kg/day (0.8 times the mrhd based on auc comparison); irreversibly decreased femur size and caused paw malrotation and limb impairment at doses ≥25 mg/kg/day (7.2 times the mrhd based on auc comparison); and fractures at 75 mg/kg/day (27 times the mrhd based on auc comparison). in a follow-up study, abrocitinib (25 mg/kg/day, at least 4.5 times the mrhd based on auc comparison) was orally administered to juvenile rats from postnatal day (pnd) 10, 15, 21, or 30 through pnd day 63. administration beginning pnd 10 caused adverse macroscopic and microscopic bone findings consistent with the previous juvenile animal study. however, administration beginning pnd 15 (approximately equivalent to a 6- to 12-month old infant) caused non-adverse reversible microscopic bone findings. no bone findings were noted when administration began on pnd 21 or 30 (approximately equivalent to 2- and 6-year old children, respectively). a total of 145 (4.6%) subjects 65 years of age and older, while 25 (0.8%) were 75 years of age and older, were enrolled in cibinqo clinical trials. clinical trials of cibinqo did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. a higher proportion of subjects 65 years of age and older discontinued from clinical trials compared to younger subjects. among all subjects exposed to cibinqo, including the long-term extension trial, confirmed alc <500/mm3 occurred only in subjects 65 years of age and older. a higher proportion of subjects 65 years of age and older had platelet counts <75,000/mm3 . the incidence rate of herpes zoster in subjects 65 years of age and older treated with cibinqo (7.40 per 100 patient-years) was higher than that of subjects 18 to less than 65 years of age (3.44 per 100 patient-years). in patients with severe (egfr <30 ml/min) and moderate (egfr 30–59 ml/min) renal impairment, the combined exposure (aucinf,u ) of abrocitinib and its two active metabolites, m1 and m2, is increased compared to patients with normal renal function (egfr ≥90 ml/min) [see clinical pharmacology (12.3)]. this may increase the risk of adverse reactions such as infections. cibinqo is not recommended for use in patients with severe renal impairment and esrd including those on renal replacement therapy [see dosage and administration (2.3)]. a dosage reduction in patients with moderate renal impairment is recommended. no dosage adjustment is required in patients with mild renal impairment (egfr 60–89 ml/min) [see dosage and administration (2.3)] . cibinqo has not been studied in subjects on renal replacement therapy. in phase 3 clinical trials, cibinqo was not evaluated in subjects with atopic dermatitis with baseline creatinine clearance values less than 40 ml/min. avoid use of cibinqo in patients with severe (child pugh c) hepatic impairment. in clinical trials, cibinqo was not evaluated in subjects with severe (child pugh c) hepatic impairment. dosage adjustment is not required in patients with mild (child pugh a) or moderate (child pugh b) hepatic impairment based on similar combined exposure (aucinf,u ) of abrocitinib and its two active metabolites, m1 and m2 compared to patients with normal hepatic function [see clinical pharmacology (12.3)] . in patients who are cyp2c19 poor metabolizers, the auc of abrocitinib is increased compared to cyp2c19 normal metabolizers due to reduced metabolic clearance. dosage reduction of cibinqo is recommended in patients who are known or suspected to be cyp2c19 poor metabolizers based on genotype or previous history/experience with other cyp2c19 substrates [see dosage and administration (2.4) and clinical pharmacology (12.5)] .

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pfizer laboratories div pfizer inc - etrasimod arginine (unii: mxe5ema09l) (etrasimod - unii:6wh8495mmh) - velsipity is indicated for the treatment of moderately to severely active ulcerative colitis (uc) in adults. velsipity is contraindicated in patients who:       pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to velsipity during pregnancy. pregnant females exposed to velsipity and healthcare providers are encouraged to contact the pregnancy registry by calling 1-800-616-3791. risk summary based on findings from animal studies, velsipity may cause fetal harm when administered to a pregnant woman. available data from reports of pregnancies from the clinical development program with velsipity are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. there are risks to the mother and the fetus associated with increased disease activity in women with inflammatory bowel disease during pregnancy (see clinical considerations). in animal reproduction studies, administration

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pfizer laboratories div pfizer inc - tofacitinib citrate (unii: o1ff4div0d) (tofacitinib - unii:87la6fu830) - tofacitinib 5 mg - xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (ra) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active psoriatic arthritis (psa) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc), who have an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz oral solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcjia) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more tnf

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pfizer laboratories div pfizer inc - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - neomycin 3.5 mg in 1 g - for the treatment of corticosteroid-responsive dermatoses with secondary infection. it has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment. (see warnings.) not for use in the eyes or in the external ear canal if the eardrum is perforated. this product is contraindicated in tuberculous, fungal, or viral (for example, herpes simplex or varicella zoster) lesions of the skin. this product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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pfizer laboratories div pfizer inc - infliximab (unii: b72hh48flu) (infliximab - unii:b72hh48flu) - infliximab, license holder unspecified 100 mg in 10 ml - inflectra is indicated for: inflectra is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active cd who have had an inadequate response to conventional therapy. inflectra is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response to conventional therapy. inflectra is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active uc who have had an inadequate response to conventional therapy. inflectra, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderatel

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pfizer laboratories div pfizer inc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c), naltrexone hydrochloride (unii: z6375yw9sf) (naltrexone - unii:5s6w795cqm) - morphine sulfate 20 mg - embeda is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)] , reserve embeda for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - embeda is not indicated as an as-needed (prn) analgesic. embeda is contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.6)] - con