মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

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 moderately to severely active rheumatoid arthritis (ra). inflectra is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (as). inflectra is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (psa). inflectra is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. inflectra should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see boxed warning, warnings and precautions (5)] . the use of inflectra at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see warnings and precautions (5.5) and adverse reactions (6.1)]. inflectra is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of inflectra or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see warnings and precautions (5.7) and adverse reactions (6.1)]. risk summary available observational studies in pregnant women exposed to infliximab products showed no increased risk of major malformations among live births as compared to those exposed to non-biologics. however, findings on other birth and maternal outcomes were not consistent across studies of different study design and conduct (see data) . monoclonal antibodies such as infliximab products are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations). because infliximab products do not cross-react with tnfα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with infliximab products. in a developmental study conducted in mice using an analogous antibody, no evidence of maternal toxicity or fetal harm was observed (see data) . all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk published data suggest that there is an increased risk of adverse pregnancy outcomes in women with inflammatory bowel disease or rheumatoid arthritis associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) and small for gestational age at birth. fetal/neonatal adverse reactions as with other igg antibodies, infliximab products cross the placenta. infliximab products have been detected in the serum of infants up to 6 months following birth. consequently, these infants may be at increased risk of infection, including disseminated infection which can become fatal. at least a six month waiting period following birth is recommended before the administration of live vaccines (e.g., bcg vaccine or other live vaccines, such as the rotavirus vaccine) to these infants [see warnings and precautions (5.13)] . cases of agranulocytosis in infants exposed in utero have also been reported [see adverse reactions (6.3)] . data human data two prospective cohort studies were conducted assessing birth outcomes as well as the health status of infants up to the age of one year in women exposed to infliximab compared to non-biologic comparators including methotrexate, azathioprine, 6-mercaptopurine and systemic corticosteroids used for the treatment of similar diseases. the first study was conducted in an ibd pregnancy registry in the united states and assessed pregnancy outcomes in 294 women with inflammatory bowel disease exposed to infliximab during pregnancy compared with 515 women on a non-biologic treatment. infliximab exposure was not associated with increased rates of major congenital malformations, miscarriage/stillbirth, infants of low birth weight, small for gestational age, or infection in the first year of life. the second study among ibd and non-ibd patients in sweden, finland, and denmark compared 97, 7, and 166 women exposed to infliximab to 2,693, 2,499 and 1,268 women on non-biologic systemic therapy, respectively. in this study, comparing pooled data across the three countries, exposure to infliximab was not associated with increased rates of congenital anomalies or infant death. infliximab in combination with immunosuppressants (mainly systemic corticosteroids and azathioprine) was associated with increased rates of preterm birth, small for gestational age, low birth weight, and infant hospitalization for infection compared with non-biologic systemic treatment. although the study did not show any associations with infliximab monotherapy, the analyses could have been underpowered to detect an association. there were additional methodological limitations with these studies that may account for the study findings in both studies: the concomitant use of other medications or treatments was not controlled and disease severity was not assessed; in the u.s. study, patient reported outcomes were collected without clinical validation. these methodological limitations hinder interpretation of the study results. animal data because infliximab products do not cross-react with tnfα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with infliximab products. an embryofetal development study was conducted in pregnant mice using cv1q anti-mouse tnfα, an analogous antibody that selectively inhibits the functional activity of mouse tnfα. this antibody administered in mice, during the period of organogenesis on gestation days (gds) 6 and 12, at iv doses up to 40 mg/kg produced no evidence of maternal toxicity, fetal mortality, or structural abnormalities. doses of 10 to 15 mg/kg in pharmacodynamic animal models with the anti-tnf analogous antibody produced maximal pharmacologic effectiveness. analyses of fetal samples on gd 14 indicated placental transfer of the antibody and exposure of the fetuses during organogenesis. in a peri-and post-natal development study in mice, no maternal toxicity or adverse developmental effects in offspring were observed when dams were administered iv doses of 10 or 40 mg/kg of the analogous antibody on gds 6, 12 and 18 and lactation days 3, 9 and 15. risk summary published literature show that infliximab is present at low levels in human milk. systemic exposure in a breastfed infant is expected to be low because infliximab products are largely degraded in the gastrointestinal tract. a u.s. multi-center study of 168 women treated with infliximab for inflammatory bowel disease (breast milk samples obtained, n=29) showed that infants exposed to infliximab through breast milk had no increase in rates of infections and developed normally. there are no data on the effects of infliximab products on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for inflectra and any potential adverse effects on the breastfed child from inflectra or from the underlying maternal condition. the safety and effectiveness of infliximab products have been established in pediatric patients 6 to 17 years of age for induction and maintenance treatment of cd and uc. [see dosage and administration (2.2, 2.4) and adverse reactions (6.1)] . however, the safety and effectiveness of infliximab products in pediatric patients <6 years of age with cd or uc have not been established. the safety and effectiveness of infliximab products in the treatment of pediatric patients with ps and juvenile rheumatoid arthritis (jra) have not been established. pediatric crohn's disease the safety and effectiveness of infliximab products have been established 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. the use of infliximab for this indication is supported by evidence from a randomized, open-label pediatric cd study in 112 pediatric patients aged 6 years and older [see clinical studies (14.2)] . infliximab has been studied only in combination with conventional immunosuppressive therapy in pediatric cd. the longer term (greater than 1 year) safety and effectiveness of infliximab products in pediatric cd patients have not been established in clinical trials. postmarketing cases of hstcl have been reported in pediatric patients treated with tnf blockers including infliximab products. due to the risk of hstcl, a careful risk-benefit assessment should be made when inflectra is used in combination with other immunosuppressants in pediatric cd patients [see boxed warning, warnings and precautions (5.2)] . pediatric ulcerative colitis the safety and effectiveness of infliximab products for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients aged 6 years and older with moderately to severely active uc who have had an inadequate response to conventional therapy have been established. the use of infliximab for this indication is supported by evidence from adequate and well-controlled studies of infliximab in adults with additional safety and pharmacokinetic data from an open-label pediatric uc study in 60 pediatric patients aged 6 years and older [see dosage and administration (2.4), adverse reactions (6.1), and clinical studies (14.4)] . the effectiveness of infliximab in inducing and maintaining mucosal healing in pediatric uc was not established. although 41 patients had a mayo endoscopy subscore of 0 or 1 at the week 8 endoscopy, the induction phase was open-label and lacked a control group. only 9 patients had an optional endoscopy at week 54. approximately half of the patients were on concomitant immunomodulators (aza, 6-mp, mtx) at study start. due to the risk of hstcl, a careful risk-benefit assessment should be made when inflectra is used in combination with other immunosuppressants in pediatric uc patients [see boxed warning and warnings and precautions (5.2)]. the longer term (greater than 1 year) safety and effectiveness of infliximab products in pediatric uc patients have not been established in clinical trials. juvenile rheumatoid arthritis (jra) the safety and effectiveness of infliximab products in the treatment of pediatric patients with juvenile rheumatoid arthritis (jra) have not been established. the safety and efficacy of infliximab in patients with jra were evaluated in a multicenter, randomized, placebo-controlled, double-blind study for 14 weeks, followed by a double-blind, all-active treatment extension, for a maximum of 44 weeks. patients with active jra between the ages of 4 and 17 years who had been treated with mtx for at least 3 months were enrolled. concurrent use of folic acid, oral corticosteroids (≤0.2 mg/kg/day of prednisone or equivalent), nsaids, and/or disease modifying antirheumatic drugs (dmards) was permitted. doses of 3 mg/kg of infliximab or placebo were administered intravenously at weeks 0, 2 and 6. patients randomized to placebo crossed-over to receive 6 mg/kg of infliximab at weeks 14, 16, and 20, and then every 8 weeks through week 44. patients who completed the study continued to receive open-label treatment with infliximab for up to 2 years in a companion extension study. the study failed to establish the efficacy of infliximab in the treatment of jra. key observations in the study included a high placebo response rate and a higher rate of immunogenicity than what has been observed in adults. additionally, a higher rate of clearance of infliximab was observed than had been observed in adults. population pharmacokinetic analysis showed that in pediatric patients with jra with a body weight of up to 35 kg receiving 6 mg/kg infliximab and pediatric patients with jra with body weight greater than 35 kg up to adult body weight receiving 3 mg/kg infliximab, the steady state area under the concentration curve (aucss) was similar to that observed in adults receiving 3 mg/kg of infliximab. a total of 60 patients with jra were treated with doses of 3 mg/kg and 57 patients were treated with doses of 6 mg/kg. the proportion of patients with infusion reactions who received 3 mg/kg infliximab was 35% (21/60) over 52 weeks compared with 18% (10/57) in patients who received 6 mg/kg over 38 weeks. the most common infusion reactions reported were vomiting, fever, headache, and hypotension. in the 3 mg/kg infliximab group, 4 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions). in the 6 mg/kg infliximab group, 2 patients had a serious infusion reaction, 1 of whom had a possible anaphylactic reaction. two of the 6 patients who experienced serious infusion reactions received infliximab by rapid infusion (duration of less than 2 hours). antibodies to infliximab developed in 38% (20/53) of patients who received 3 mg/kg infliximab compared with 12% (6/49) of patients who received 6 mg/kg. a total of 68% (41/60) of patients who received 3 mg/kg of infliximab in combination with mtx experienced an infection over 52 weeks compared with 65% (37/57) of patients who received 6 mg/kg of infliximab in combination with mtx over 38 weeks. the most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was pneumonia. other notable infections included primary varicella infection in 1 patient and herpes zoster in 1 patient. of the total number of infliximab-treated patients in ra and ps clinical studies, 256 (9.6%) were 65 years old and over, while 17 (0.6%) were 75 years old and over. in these trials, no overall differences in safety or effectiveness were observed between geriatric patients (patients ≥65 years old) and younger adult patients (patients 18 to 65 years old). however, the incidence of serious adverse reactions in geriatric patients was higher in both infliximab and control groups compared to younger adult patients. of the total number of infliximab-treated patients in cd, uc, as, and psa clinical studies, 76 (3.2%) were 65 years old and over, while 9 (0.4%) were 75 years old and over. in the cd, uc, as, and psa studies, there were insufficient numbers of geriatric patients to determine whether they respond differently from younger adults. the incidence of serious infections in infliximab-treated geriatric patients was greater than in infliximab-treated younger adult patients; therefore close monitoring of geriatric patients for the development of serious infections is recommended [see warnings and precautions (5.1), and adverse reactions (6.1)] .

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - arthrotec is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing nsaid-induced gastric and duodenal ulcers and their complications. for a list of factors that may increase the risk of nsaid-induced gastric and duodenal ulcers and their complications [see warnings and precautions (5.3)] . arthrotec is contraindicated in the following patients: risk summary arthrotec is contraindicated in pregnant women [see contraindications (4)]. if a woman becomes pregnant while taking arthrotec, discontinue the drug and advise the woman of the potential risks to her and to a fetus. there are no adequate and well-controlled studies of arthrotec in pregnant women; however, there is information available about the active drug components of arthrotec, diclofenac sodium and misoprostol. administration of misoprostol to pregnant women can cause uterine rupture, abortion, premature birth, or birth defects [see warnings and precautions (5.1)] . co

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

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

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

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

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

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

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus 1 mg in 1 ml - rapamune (sirolimus) is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. in patients at low-to moderate-immunologic risk , it is recommended that rapamune be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration (2.2) ]. in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra; peak pra level >80%]), it is recommended that rapamune be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration (2.3) , clinical studies (14.3) ]. cyclosporine withdrawal has not been studied in patients with banff grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those with serum creatinine >4.5 mg/dl, black patients, patients of multi-organ transplants, secondary transplants, or those with high levels of panel-reactive antibodies [see clinical studies (14.2) ]. in patients at high-immunologic risk , the safety and efficacy of rapamune used in combination with cyclosporine and corticosteroids has not been studied beyond one year; therefore after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient [see clinical studies (14.3) ]. in pediatric patients , the safety and efficacy of rapamune have not been established in patients <13 years old, or in pediatric (<18 years) renal transplant patients considered at high-immunologic risk [see adverse reactions (6.5), clinical studies (14.6) ]. the safety and efficacy of de novo use of rapamune without cyclosporine have not been established in renal transplant patients [see warnings and precautions (5.12) ]. the safety and efficacy of conversion from calcineurin inhibitors to rapamune in maintenance renal transplant patients have not been established [see clinical studies (14.4) ]. rapamune (sirolimus) is indicated for the treatment of patients with lymphangioleiomyomatosis (lam). rapamune is contraindicated in patients with a hypersensitivity to rapamune [see warnings and precautions (5.4) ]. risk summary based on animal studies and the mechanism of action, rapamune can cause fetal harm when administered to a pregnant woman [see data, clinical pharmacology (12.1) ]. there are limited data on the use of sirolimus during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal studies, sirolimus was embryo/fetotoxic in rats at sub-therapeutic doses [see data ]. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data sirolimus crossed the placenta and was toxic to the conceptus. in rat embryo-fetal development studies, pregnant rats were administered sirolimus orally during the period of organogenesis (gestational day 6–15). sirolimus produced embryo-fetal lethality at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg, on a body surface area basis) and reduced fetal weight at 1 mg/kg (5-fold the clinical dose of 2 mg). the no observed adverse effect level (noael) for fetal toxicity in rats was 0.1 mg/kg (0.5-fold the clinical dose of 2 mg). maternal toxicity (weight loss) was observed at 2 mg/kg (10-fold the clinical dose of 2 mg). the noael for maternal toxicity was 1 mg/kg. in combination with cyclosporine, rats had increased embryo-fetal mortality compared with sirolimus alone. in rabbit embryo-fetal development studies, pregnant rabbits were administered sirolimus orally during the period of organogenesis (gestational day 6–18). there were no effects on embryo-fetal development at doses up to 0.05 mg/kg (0.5-fold the clinical dose of 2 mg, on a body surface area basis); however, at doses of 0.05 mg/kg and above, the ability to sustain a successful pregnancy was impaired (i.e., embryo-fetal abortion or early resorption). maternal toxicity (decreased body weight) was observed at 0.05 mg/kg. the noael for maternal toxicity was 0.025 mg/kg (0.25-fold the clinical dose of 2 mg). in a pre- and post-natal development study in rats, pregnant females were dosed during gestation and lactation (gestational day 6 through lactation day 20). an increased incidence of dead pups, resulting in reduced live litter size, occurred at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg/kg on a body surface area basis). at 0.1 mg/kg (0.5-fold the clinical dose of 2 mg), there were no adverse effects on offspring. sirolimus did not cause maternal toxicity or affect developmental parameters in the surviving offspring (morphological development, motor activity, learning, or fertility assessment) at 0.5 mg/kg, the highest dose tested. risk summary it is not known whether sirolimus is present in human milk. there are no data on its effects on the breastfed infant or milk production. the pharmacokinetic and safety profiles of sirolimus in infants are not known. sirolimus is present in the milk of lactating rats. there is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action [see clinical pharmacology (12.1)]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for rapamune and any potential adverse effects on the breastfed child from rapamune. contraception females should not be pregnant or become pregnant while receiving rapamune. advise females of reproductive potential that animal studies have been shown rapamune to be harmful to the developing fetus. females of reproductive potential are recommended to use highly effective contraceptive method. effective contraception must be initiated before rapamune therapy, during rapamune therapy, and for 12 weeks after rapamune therapy has been stopped [see warnings and precautions (5.15), use in specific populations (8.1) ]. infertility based on clinical findings and findings in animals, male and female fertility may be compromised by the treatment with rapamune [see adverse reactions (6.7), nonclinical toxicology (13.1) ]. ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of rapamune. azoospermia has been reported in males with the use of rapamune and has been reversible upon discontinuation of rapamune in most cases. renal transplant the safety and efficacy of rapamune in pediatric patients <13 years have not been established. the safety and efficacy of rapamune oral solution and rapamune tablets have been established for prophylaxis of organ rejection in renal transplantation in children ≥13 years judged to be at low- to moderate-immunologic risk. use of rapamune oral solution and rapamune tablets in this subpopulation of children ≥ 13 years is supported by evidence from adequate and well-controlled trials of rapamune oral solution in adults with additional pharmacokinetic data in pediatric renal transplantation patients [see clinical pharmacology (12.3) ]. safety and efficacy information from a controlled clinical trial in pediatric and adolescent (< 18 years of age) renal transplant patients judged to be at high-immunologic risk, defined as a history of one or more acute rejection episodes and/or the presence of chronic allograft nephropathy, do not support the chronic use of rapamune oral solution or tablets in combination with calcineurin inhibitors and corticosteroids, due to the higher incidence of lipid abnormalities and deterioration of renal function associated with these immunosuppressive regimens compared to calcineurin inhibitors, without increased benefit with respect to acute rejection, graft survival, or patient survival [see clinical studies (14.6) ]. lymphangioleiomyomatosis the safety and efficacy of rapamune in pediatric patients <18 years have not been established. clinical studies of rapamune oral solution or tablets did not include sufficient numbers of patients ≥65 years to determine whether they respond differently from younger patients. data pertaining to sirolimus trough concentrations suggest that dose adjustments based upon age in geriatric renal patients are not necessary. differences in responses between the elderly and younger patients have not been identified. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, or cardiac function, and of concomitant disease or other drug therapy. the maintenance dose of rapamune should be reduced in patients with hepatic impairment [see dosage and administration (2.7), clinical pharmacology (12.3) ]. dosage adjustment is not required in patients with renal impairment [see dosage and administration (2.8), clinical pharmacology (12.3) ]. rapamune / raap-a-mune/ (sirolimus) oral solution be sure that you read and understand the following instructions for the correct way to dilute and take rapamune oral solution. ask your pharmacist or doctor if you are not sure. important: each rapamune oral solution carton contains: you will also need: figure 1: opening the bottle 1. open the solution bottle. figure 2: inserting adapter 2. the first time you use a bottle of rapamune oral solution: figure 3: inserting syringe 3. use a new disposable amber oral syringe for each dose of rapamune oral solution. figure 4: withdrawing solution 4. withdraw the prescribed amount of rapamune oral solution: figure 5: capping syringe 5. if your doctor tells you to carry your medicine with you: figure 6: placing syringe in carrying case figure 7: emptying syringe into glass 6. taking a dose of rapamune oral solution: 7. always store the bottles of medication in the refrigerator. how should i store rapamune? keep rapamune and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. lab-0579-6.0 revised: august 2022

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - sunitinib malate (unii: lvx8n1ut73) (sunitinib - unii:v99t50803m) - sunitinib 12.5 mg - sutent is indicated for the treatment of adult patients with gastrointestinal stromal tumor (gist) after disease progression on or intolerance to imatinib mesylate. sutent is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc). sutent is indicated for the adjuvant treatment of adult patients at high risk of recurrent rcc following nephrectomy. sutent is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pnet) in adult patients with unresectable locally advanced or metastatic disease. none. risk summary based on animal reproduction studies and its mechanism of action, sutent can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform a drug-associated risk. in animal developmental and reproductive toxicology studies, oral administration of sunitinib to pregnant rats and rabbits throughout organogenesis resulted in teratogenicity (embryolet

ইস্রায়েল - ইংরেজি - Ministry of Health

pfizer pharmaceuticals israel ltd - fesoterodine fumarate - tablets sustained release - fesoterodine fumarate 4 mg - fesoterodine - fesoterodine - treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome.

ইস্রায়েল - ইংরেজি - Ministry of Health

pfizer pharmaceuticals israel ltd - fesoterodine fumarate - tablets sustained release - fesoterodine fumarate 8 mg - fesoterodine - fesoterodine - treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - sodium chloride, quantity: 900 mg - injection, intravenous infusion - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - for the restoration and maintenance of salt and extracellular fluid levels or as a vehicle for the administration of parenteral drugs.