Amerika Serikat - Inggris - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, susceptibil

Amerika Serikat - Inggris - NLM (National Library of Medicine)

remedyrepack inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir 200 mg - reyataz ® (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 3 months and older weighing at least 5 kg. limitations of use: - reyataz is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - use of reyataz/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . reyataz is contraindicated:reyataz is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (eg, stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of reyataz capsules or reyataz oral powder [see warnings and precautions (5.2)] . - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or lif

Amerika Serikat - Inggris - NLM (National Library of Medicine)

dispensing solutions, inc. - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. the following points should be considered when initiating therapy with kaletra: - the use of other active agents with kaletra is associated with a greater likelihood of treatment response [see clinical pharmacology (12.4) and clinical studies (14)] . - genotypic or phenotypic testing and/or treatment history should guide the use of kaletra [see clinical pharmacology (12.4)] . the number of baseline lopinavir resistance-associated substitutions affects the virologic response to kaletra [see clinical pharmacology (12.4)] . - once daily administration of kaletra is not recommended for any pediatric patients. - kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir. - co-administration of kaletra is contraindicated with drugs tha

Amerika Serikat - Inggris - NLM (National Library of Medicine)

remedyrepack inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - reyataz ® (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 3 months and older weighing at least 5 kg. limitations of use: - reyataz is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - use of reyataz/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . reyataz is contraindicated:reyataz is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (eg, stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of reyataz capsules or reyataz oral powder [see warnings and precautions (5.2)] . - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or lif

Amerika Serikat - Inggris - NLM (National Library of Medicine)

remedyrepack inc. - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil (mmf) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies ( 14.1)], heart [see clinical studies ( 14.2)] or liver transplants [see clinical studies ( 14.3)] , in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. mycophenolate mofetil intravenous is contraindicated in patients who are allergic to polysorbate 80 (tween). pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary use of mycophenolate mofetil (mmf) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see human data] . oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05  times the recommended clinical doses in kidney and heart transplant patients) [see animal data]. consider alternative immunosuppressants with less potential for embryofetal toxicity. risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman. the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data a spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in mmf exposed pregnancies, based on published data from pregnancy registries. malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following mmf exposure. animal data in animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. oral administration of mmf to pregnant rats from gestational day 7 to day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to  0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. oral administration of mmf to pregnant rabbits from gestational day 7 to day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa.  risk summary there are no data on the presence of mycophenolate in human milk, or the effects on milk production. there are limited data in the national transplantation pregnancy registry on the effects of mycophenolate on a breastfed child [see data] . studies in rats treated with mmf have shown mycophenolic acid (mpa) to be present in milk. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil or from the underlying maternal condition. data limited information is available from the national transplantation pregnancy registry. of seven infants reported by the national transplantation pregnancy registry to have been breastfed while the mother was taking mycophenolate, all were born at 34-40 weeks gestation, and breastfed for up to 14 months. no adverse events were reported. females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. pregnancy planning for patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. risks and benefits of mycophenolate mofetil should be discussed with the patient. pregnancy testing to prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 miu/ml immediately before starting mycophenolate mofetil. another pregnancy test with the same sensitivity should be done 8 to 10 days later. repeat pregnancy tests should be performed during routine follow-up visits. results of all pregnancy tests should be discussed with the patient. in the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. contraception female patients females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see table 9  for acceptable contraception methods). patients must use acceptable birth control during the entire mycophenolate mofetil therapy, and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence. patients should be aware that mycophenolate mofetil reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness [see drug interactions ( 7.2)]. table 9    acceptable contraception methods for females of reproductive potential  pick from the following birth control options: - intrauterine devices (iuds) - tubal sterilization - patient’s partner vasectomy or - o ral  contraceptive pill - transdermal patch -   vaginal ring - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom or - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom male patients genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 1.25 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolate mofetil and for at least 90 days after cessation of treatment [see use in special populations ( 8.1), nonclinical toxicology ( 13.1), patient counseling information ( 17.9)] . safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants. kidney transplant use of mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant (100 patients, 3 months to 18 years of age) [see dosage and administration ( 2.2), adverse reactions ( 6.1), clinical pharmacology ( 12.3), clinical studies ( 14.1)]. heart transplant and liver transplant use of mycophenolate mofetil in pediatric heart transplant and liver transplant patients is supported by adequate and well controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [see dosage and administration ( 2.3, 2.4), adverse reactions ( 6.1), clinical pharmacology ( 12.3), clinical studies ( 14.1)]. clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between geriatric and younger patients. in general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies  [see adverse reactions ( 6.1), drug interactions ( 7)]. patients with kidney transplant no dosage adjustments are needed in kidney transplant patients experiencing delayed graft function postoperatively but patients should be carefully monitored [see clinical pharmacology ( 12.3)]. in kidney transplant patients with severe chronic impairment of the graft (gfr less than 25 ml/min/1.73 m 2 ), no dose adjustments are necessary; however, doses greater than 1 g administered twice a day should be avoided. patients with heart and liver transplant no data are available for heart or liver transplant patients with severe chronic renal impairment. mycophenolate mofetil may be used for heart or liver transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks. patients with kidney transplant no dosage adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. however, it is not known whether dosage adjustments are needed for hepatic disease with other etiologies [see clinical pharmacology ( 12.3)]. patients with heart transplant no data are available for heart transplant patients with severe hepatic parenchymal disease.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil for oral suspension is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)] , heart [see clinical studies (14.2)]  or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants.  allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil for oral suspension is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product.  pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-­617-8191.  risk summary  use of mycophenolate mofetil (mmf) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see human data] . oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients) [see animal data] .  consider alternative immunosuppressants with less potential for embryofetal toxicity. risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman.  the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.  data  a spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23% to 27% of live births in mmf exposed pregnancies, based on published data from pregnancy registries. malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.  based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45% to 49% following mmf exposure.  in animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. oral administration of mmf to pregnant rats from gestational day 7 to day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. oral administration of mmf to pregnant rabbits from gestational day 7 to day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa.  risk summary  there are no data on the presence of mycophenolate in human milk, or the effects on milk production. there are limited data in the national transplantation pregnancy registry on the effects of mycophenolate on a breastfed child [see data] . studies in rats treated with mmf have shown mycophenolic acid (mpa) to be present in milk. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil or from the underlying maternal condition.  limited information is available from the national transplantation pregnancy registry. of seven infants reported by the national transplantation pregnancy registry to have been breastfed while the mother was taking mycophenolate, all were born at 34 to 40 weeks gestation, and breastfed for up to 14 months. no adverse events were reported.  females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.  pregnancy planning  for patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. risks and benefits of mycophenolate mofetil should be discussed with the patient.  pregnancy testing  to prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 miu/ml immediately before starting mycophenolate mofetil. another pregnancy test with the same sensitivity should be done 8 to 10 days later. repeat pregnancy tests should be performed during routine follow-up visits. results of all pregnancy tests should be discussed with the patient. in the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible.  contraception  female patients  females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see table 9  for acceptable contraception methods). patients must use acceptable birth control during the entire mycophenolate mofetil therapy, and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence.  patients should be aware that mycophenolate mofetil reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness [see drug interactions (7.2)] .  table 9 acceptable contraception methods for females of reproductive potential pick from the following birth control options: option 1 methods to use alone - intrauterine devices (iuds) - tubal sterilization - patient’s partner vasectomy or option 2 hormone methods choose 1 barrier methods choose 1 choose one hormone method  and  one barrier method estrogen and progesterone - oral contraceptive pill - transdermal patch - vaginal ring progesterone-only - injection - implant and - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom or option 3 barrier methods choose 1 barrier methods choose 1 choose one barrier method from each column  (must choose two methods) - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge and - male condom - female condom male patients  genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 1.25 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolate mofetil and for at least 90 days after cessation of treatment [see use in special populations (8.1), nonclinical toxicology (13.1), patient counseling information (17.9)] .  safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogeneic kidney, heart or liver transplants. kidney transplant use of mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant (100 patients, 3 months to 18 years of age) [see dosage and administration (2.2), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] .  heart transplant and liver transplant use of mycophenolate mofetil in pediatric heart transplant and liver transplant patients is supported by adequate and well- controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [ see dosage and administration (2.3, 2.4), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] . clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between geriatric and younger patients. in general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies [see adverse reactions (6.1), drug interactions (7)] . patients with kidney transplant  no dosage adjustments are needed in kidney transplant patients experiencing delayed graft function postoperatively but patients should be carefully monitored [see clinical pharmacology (12.3)] . in kidney transplant patients with severe chronic impairment of the graft  (gfr <25 ml/min/1.73 m2 ), no dose adjustments are necessary; however, doses greater than 1 g administered twice a day should be avoided.  patients with heart and liver transplant  no data are available for heart or liver transplant patients with severe chronic renal impairment. mycophenolate mofetil may be used for heart or liver transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.  patients with kidney transplant  no dosage adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. however, it is not known whether dosage adjustments are needed for hepatic disease with other etiologies [see clinical pharmacology (12.3)] .  patients with heart transplant  no data are available for heart transplant patients with severe hepatic parenchymal disease.  mycophenolate mofetil (mye " koe fen ' oh late moe ' fe til) for oral suspension, usp read this instructions for use before you take or give mycophenolate mofetil for oral suspension for the first time and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important: - always use the oral dispenser provided with mycophenolate mofetil for oral suspension to make sure you measure the right amount of medicine. if your mycophenolate mofetil for oral suspension does not come with the oral dispenser, contact your pharmacist. - call your pharmacist if your oral dispenser is lost or damaged. - your pharmacist will write the expiration date on your mycophenolate mofetil for oral suspension bottle label. do not use after the expiration date. - ask your doctor or pharmacist if you have any questions or are unsure about how to take or give the right amount of medicine. - the mycophenolate mofetil for oral suspension should not be mixed with any type of liquids before taking or giving the dose. - do not let the mycophenolate mofetil for oral suspension come in contact with the skin. if this happens, wash the skin well with soap and water. if the mycophenolate mofetil for oral suspension gets in the eyes, rinse the eyes with plain water. - if you spill any mycophenolate mofetil for oral suspension, wipe it up using paper towels wet with water. put the child-resistant bottle cap back on the bottle and wipe the outside of the bottle with wet paper towels. supplies needed to take or give a dose of mycophenolate mofetil for oral suspension : to take or give a dose of mycophenolate mofetil for oral suspension, you will need the bottle of medicine and the oral dispenser provided with the medicine (see figure 1 ). your pharmacist will insert the bottle adapter in the mycophenolate mofetil for oral suspension bottle. do not remove the bottle adapter from the bottle. taking or giving a dose of mycophenolate mofetil for oral suspension: step 1:   with the child-resistant cap on the bottle, shake the bottle well for about 5 seconds before each use. step 2:   open the bottle by firmly pressing down on the child-resistant bottle cap and turning it to the left (counter-clockwise). do not throw away the child-resistant bottle cap. step 3:   place the bottle on a flat surface. before inserting the tip of the oral dispenser into the bottle adapter, push the plunger completely down toward the tip of the oral dispenser. use 1 hand to hold the bottle upright. insert the oral dispenser tip firmly into the opening of the bottle adapter. step 4:   carefully turn the bottle upside down with the oral dispenser tip in place. slowly pull the plunger down to withdraw your prescribed dose. do not pull the plunger out of the oral dispenser (see figure 2 ). step 5:   leave the oral dispenser tip in the bottle and turn the bottle to an upright position. slowly remove the oral dispenser tip from the bottle.                if there are air bubbles in the oral dispenser or if you have withdrawn the wrong dose, insert the oral dispenser tip back into the bottle adapter while the bottle is in an upright position. push the plunger gently all the way up so the mycophenolate mofetil for oral suspension flows back into the bottle. repeat step 4 . step 6:   place the tip of the oral dispenser in the mouth directed towards the cheek and slowly push the plunger down until the oral dispenser is empty. step 7:   put the child-resistant bottle cap back on the bottle and turn the cap to the right (clockwise) to close the bottle. keep the bottle tightly closed after each use. step 8:   rinse the oral dispenser under running tap water after each use: - remove the plunger from the oral dispenser. - rinse the oral dispenser and plunger with water only and let them air dry on a paper towel. - when the oral dispenser and plunger are dry, put the plunger back in the oral dispenser for the next use. do not throw away the oral dispenser. store the oral dispenser in a clean, dry place. - do not boil the oral dispenser. do not use solvent-containing wipes to clean the oral dispenser. do not use cloths or wipes to dry the oral dispenser. how should i store mycophenolate mofetil for oral suspension? - store the mycophenolate mofetil for oral suspension at room temperature between 59°f to 86°f (15°c to 30°c), for up to 60 days. you can also store mycophenolate mofetil for oral suspension in the refrigerator between 36°f to 46°f (2°c to 8°c). - do not freeze. keep mycophenolate mofetil for oral suspension and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. distributed by:  amneal pharmaceuticals llc bridgewater, nj  08807 rev. 12-2022-04

Amerika Serikat - Inggris - NLM (National Library of Medicine)

teva pharmaceuticals, inc. - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil for oral suspension is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)] , heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid (mpa) or any component of the drug product. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil for oral suspension treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary use of mycophenolate mofetil during pregnan

Amerika Serikat - Inggris - NLM (National Library of Medicine)

catalyst pharmaceuticals, inc. - perampanel (unii: h821664npk) (perampanel - unii:h821664npk) - fycompa is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. fycompa is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as fycompa, during pregnancy. encourage women who are taking fycompa during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no adequate data on the developmental risk associated with use in pregnant women.  in animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses [see data] . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rats throughout organogenesis resulted in an increase in visceral abnormalities (diverticulum of the intestine) at all doses tested; maternal toxicity was observed at the mid and high doses. in a dose-ranging study at higher oral doses (10, 30, or 60 mg/kg/day), embryo lethality and reduced fetal body weight were observed at the mid and high doses tested. the lowest dose tested (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m2 ). upon oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rabbits throughout organogenesis, embryo lethality and maternal toxicity were observed at the mid and high doses tested; the no-effect dose for embryo-fetal developmental toxicity in rabbit (1 mg/kg/day) is approximately 2 times a human dose of 8 mg/day based on body surface area (mg/m2 ). oral administration of perampanel (1, 3, or 10 mg/kg/day) to rats throughout gestation and lactation resulted in fetal and pup deaths at the mid and high doses (associated with maternal toxicity) and delayed sexual maturation in males and females at the highest dose tested. no effects were observed on measures of neurobehavioral or reproductive function in the offspring. the no-effect dose for pre- and postnatal developmental toxicity in rat (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m2 ). risk summary there are no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.  perampanel and/or its metabolites are present in rat milk, and are detected at concentrations higher than that in maternal plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fycompa and any potential adverse effects on the breastfed child from fycompa or from the underlying maternal condition. contraception use of fycompa may reduce the efficacy of hormonal contraceptives containing levonorgestrel. advise women taking fycompa who are using a levonorgestrel-containing contraceptive to use an additional non-hormonal form of contraception while using fycompa and for a month after discontinuation [see drug interactions (7.1), clinical pharmacology (12.3)]. safety and effectiveness of fycompa for the treatment of partial-onset seizures have been established in pediatric patients 4 years of age and older. the safety and effectiveness of fycompa in patients 12 years of age and older was established by three randomized double-blind, placebo-controlled, multicenter studies, which included 72 pediatric patients between 12 and 16 years of age exposed to fycompa [see clinical pharmacology (12.3) and clinical studies (14.1)] .  use of fycompa for the treatment of partial-onset seizures in pediatric patients 4 years to less than 12 years of age is supported by evidence from adequate and well-controlled studies of fycompa in patients 12 years of age and older with partial onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 225 pediatric patients 4 years to less than 12 years of age treated with fycompa [see adverse reactions (6.1) and clinical pharmacology (12.3)] . the safety and efficacy of fycompa for the adjunctive therapy of primary generalized tonic-clonic seizures in pediatric patients 12 years of age and older was established in a single randomized double-blind, placebo-controlled, multicenter trial (n=164), which included 11 pediatric patients 12 to 16 years of age exposed to fycompa; an additional 6 patients were treated with fycompa in the open-label extension of the study [see clinical studies (14.2)] . the safety and effectiveness of fycompa for the treatment of partial-onset seizures in pediatric patients less than 4 years of age or for the treatment of primary generalized tonic-clonic seizures in pediatric patients less than 12 years of age have not been established. juvenile animal data oral administration of perampanel (1, 3, 3/10/30 mg/kg/day; high dose increased on postnatal days [pnd] 28 and 56) to young rats for 12 weeks starting on pnd 7 resulted in reduced body weight, reduced growth, neurobehavioral impairment (water maze performance and auditory startle habituation) at the mid and high doses, and delayed sexual maturation at the high doses. cns signs (reduced activity, incoordination, excessive grooming/scratching), pup death, decreased hindlimb splay, and decreased hindlimb grip strength were observed at all doses. effects on pup body weight, pup growth, hindlimb splay, impairment in the water maze performance, and auditory startle persisted after dosing was stopped. a no-effect dose for postnatal developmental toxicity was not identified in this study. oral administration of perampanel (1, 5, 5/10 mg/kg/day; high dose increased on pnd 56) to juvenile dogs for 33 weeks, starting on pnd 42, resulted in cns signs (incoordination, excessive grooming/licking/scratching, spatial disorientation, and/or ataxic gait) at all doses tested. clinical studies of fycompa did not include sufficient numbers of patients aged 65 and over to determine the safety and efficacy of fycompa in the elderly population. because of increased likelihood for adverse reactions in the elderly, dosing titration should proceed slowly in patients aged 65 years and older [see dosage and administration (2.5)] . use of fycompa in patients with severe hepatic impairment is not recommended, and dosage adjustments are recommended in patients with mild or moderate hepatic impairment [see dosage and administration (2.4), clinical pharmacology (12.3)] . dose adjustment is not required in patients with mild renal impairment. fycompa should be used with caution in patients with moderate renal impairment, and slower titration may be considered. use in patients with severe renal impairment or patients undergoing hemodialysis is not recommended [see  dosage and administration (2.5), clinical pharmacology (12.3)] . fycompa contains perampanel and is listed as a schedule iii controlled substance. prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see drug abuse and dependence (9.3)] . studies of human abuse potential were performed to evaluate the abuse potential of fycompa (8 mg, 24 mg, and 36 mg) as compared to alprazolam c-iv (1.5 mg and 3 mg), and oral ketamine c-iii (100 mg) in recreational polydrug users. supra-therapeutic doses of fycompa 24 and 36 mg produced responses for “euphoria” that were similar to ketamine 100 mg and alprazolam 3 mg. for “high,” fycompa 24 mg and 36 mg produced responses comparable to ketamine 100 mg and significantly higher than both doses of alprazolam on a visual analog scale (vas). “drug liking,” “overall drug liking,” and “take drug again” for fycompa were each statistically lower than ketamine 100 mg. in addition, for “bad drug effects,” fycompa 24 mg and 36 mg produced responses significantly higher than ketamine 100 mg.  for “sedation,” fycompa 24 and 36 mg produced responses similar to alprazolam 3 mg and higher than ketamine 100 mg.  additionally, on vas measures related to dissociative phenomena such as “floating,” “spaced out,” and “detached,” fycompa at supratherapeutic doses produced responses similar to ketamine 100 mg and greater than both doses of alprazolam tested. of note, due to somnolence a number of subjects had missing data around tmax of fycompa. the above described data might represent an underestimate of fycompa’s effects. the duration of effects of higher doses of fycompa on the majority of measures was much greater than alprazolam 3 mg and ketamine 100 mg. in this study, the incidence of euphoria following fycompa administration 8 mg, 24 mg, and 36 mg was 37%, 46%, 46%, respectively, which was higher than alprazolam 3 mg (13%) but lower than ketamine 100 mg (89%). physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug.  a nonclinical dependence study in rats demonstrated withdrawal symptoms, including hyperreactivity to handling, muscle rigidity, and decreases in food consumption and body weights. fycompa may cause dependence and withdrawal symptoms that may include anxiety, nervousness, irritability, fatigue, lethargy, asthenia, mood swings, and insomnia.    instructions for use fycompa® (fī-com-puh) (perampanel) oral suspension read this instructions for use before you start using fycompa oral suspension and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. prepare the fycompa oral suspension dose you will need the following supplies: see figure a • fycompa oral suspension bottle • bottle adapter • dosing syringe (2 dosing syringes are included in the fycompa oral suspension box) figure a step 1. remove the fycompa oral suspension bottle, bottle adapter, and 2 syringes from the box. see figure a step 2. shake the bottle well before each use. see figure b figure b  step 3. uncap the bottle and insert the bottle adapter into the bottle by pressing downward. see figure c and figure d figure c  figure d after the bottle adapter is in place, it cannot be removed. step 4. check the dose in milliliters (ml) as prescribed by your healthcare provider. find this number on the syringe. see  figure e figure e  step 5.  push the plunger of the syringe all the way down then insert the syringe into the upright bottle through the opening in the bottle adapter. see figure f figure f  step 6. with the syringe in place, turn the bottle upside down. pull the plunger to withdraw the dose prescribed by your healthcare provider (the amount of liquid medicine in step 4).  if you see air bubbles in the oral syringe, fully push in the plunger so that the oral solution flows back into the bottle. then, withdraw the prescribed dose of oral suspension. see  figure g  figure g  measure the mls of medicine from the end of the plunger. step 7. if the dose is more than 20 ml, you can use: • 2 syringes or • 1 syringe, taking 2 steps to draw up the medicine in that same syringe for example: if the dose is 24 ml, draw up 20 ml in the first syringe and the remaining 4 ml in the second syringe. or if the dose is 24 ml, draw up 20 ml in the single syringe and squirt the medicine into the mouth, then draw up the remaining 4 ml in that same syringe. if the dose is more than 20 ml, repeat steps 4 through 6 when drawing up the remaining dose of medicine. step 8. turn the bottle right-side up and remove the syringe from the bottle adapter. see figure h figure h  step 9. slowly squirt the fycompa oral suspension directly into the corner of the mouth until all of the liquid medicine is given. if you need 2 syringes for the dose, slowly squirt the medicine from the first syringe into the mouth, then slowly squirt the medicine from the second syringe into the mouth. see figure i figure i  step 10. rinse the syringe (or syringes) with tap water after each use. see figure j • fill a cup with water • pull back on the plunger and draw the water from the cup into the syringe • push down on the plunger to release the water into the sink figure j  step 11. cap the bottle tightly. the cap will fit over the bottle adapter. see figure k figure k  how should i store fycompa oral suspension? - store fycompa oral suspension below 86°f (30°c).  do not freeze. - replace the cap tightly after opening.  - use fycompa oral suspension within 90 days after the bottle is first opened. - after 90 days safely throw away any fycompa oral suspension that has not been used. this instructions for use has been approved by the u.s. food and drug administration. fycompa® is a registered trademark owned by catalyst pharmaceuticals, inc. marketed by catalyst pharmaceuticals, inc., coral gables, fl 33134 ©2023 catalyst pharmaceuticals, inc. revised: 06/2023

Amerika Serikat - Inggris - NLM (National Library of Medicine)

doh central pharmacy - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir 200 mg - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. the following points should be considered when initiating therapy with kaletra: - the use of other active agents with kaletra is associated with a greater likelihood of treatment response [see clinical pharmacology (12.4) and clinical studies (14)] . - genotypic or phenotypic testing and/or treatment history should guide the use of kaletra [see clinical pharmacology (12.4)] . the number of baseline primary protease inhibitor mutations affects the virologic response to kaletra [see clinical pharmacology (12.4)] . - once daily administration of kaletra is not recommended for therapy-experienced adult patients or any pediatric patients. ● kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir. ●  co-administration of kaletra is contraindicated with drugs t

Irlandia - Inggris - HPRA (Health Products Regulatory Authority)

ciba geigy plc - rifampicin - tablets - 450 milligram