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

cadila healthcare limited - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 250 mg - mycophenolate mofetil capsules and mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. mycophenolate mofetil capsules and/or tablets should be used concomitantly with cyclosporine and corticosteroids. mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, mycophenolate mofetil tablets and oral suspension. mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. allergic reactions to mycophenolate mofetil capsules and mycophenolate mofetil tablets have been observed; therefore, mycophenolate mofetil capsules and mycophenolate mofetil tablets are contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any com

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

h.j. harkins company, inc. - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride 250 mg - mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax . there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae . -  note: patients with acute p. vivax malaria, treated with mefloquine hydrochloride tablets, are at high risk of relapse because mefloquine hydrochloride tablets do not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). mefloquine hydrochloride tablets are indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparum . use of mefloquine hydrochloride tablets is contraindicated in patients

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

rebel distributors corp - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax . there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae . -  note: patients with acute p. vivax malaria, treated with mefloquine hydrochloride tablets, are at high risk of relapse because mefloquine hydrochloride tablets do not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). mefloquine hydrochloride tablets are indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparum . use of mefloquine hydrochloride tablets is contraindicated in patients

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

torrent pharmaceuticals limited - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii – iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%). tadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the lst dose of tadalafil. tadalafil potentiates the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cgmp pathway [see clinical pharmacology ( 12.2)] . coadministration of gc stimulators, such as riociguat with tadalafil is contraindicated. tadalafil may potentiate the hypotensive effects of gc stimulators. tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets). hypersensitivity reactions have been reported, including stevens-johnson syndrome and exfoliative dermatitis [see adverse reactions ( 6.2)] . risk summary limited data from case series with tadalafil use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day based on auc (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. data animal data tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day during organogenesis based on auc. in one of two perinatal/postnatal developmental studies in rats, a reduction of postnatal pup survival was observed at dose levels of 60, 200 and 1,000 mg/kg. the no-observed effect-level (noel) for developmental toxicity was 30 mg/kg, which provided maternal exposure to unbound tadalafil concentrations approximately 5 times the exposure at the mrhd based on auc. signs of maternal toxicity occurred at doses greater than 200 mg/kg/day, which produced aucs greater than 8 times the exposure at the mrhd. surviving offspring had normal development and reproductive performance. risk summary there are no data on the presence of tadalafil and/or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-times that found in the plasma. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tadalafil tablets and any potential adverse effects on the breastfed child from tadalafil tablets or from the underlying maternal condition. infertility males based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. this effect was not seen in the study of 20 mg tadalafil taken for 6 months. there was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. the clinical significance of the decreased sperm concentrations in the two studies is unknown. there have been no studies evaluating the effect of tadalafil on fertility in men or women [see clinical pharmacology ( 12.2)] . safety and effectiveness of tadalafil tablets in pediatric patients have not been established. of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over. no overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age. no dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered. [see clinical pharmacology ( 12.3)] . for patients with mild or moderate renal impairment, start tadalafil tablets at 20 mg once daily. increase the dose to 40 mg once daily based upon individual tolerability [see dosage and administration ( 2.2), and clinical pharmacology ( 12.3)] . in patients with severe renal impairment, avoid use of tadalafil tablets because of increased tadalafil exposure (auc), limited clinical experience, and the lack of ability to influence clearance by dialysis  [see clinical pharmacology ( 12.3)] . because of limited clinical experience in patients with mild to moderate hepatic cirrhosis (child-pugh class a or b), consider a starting dose of tadalafil tablets 20 mg once daily. patients with severe hepatic cirrhosis (child-pugh class c) have not been studied, thus avoid use of tadalafil tablets in such patients [see dosage and administration ( 2.3), and clinical pharmacology ( 12.3)] .

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

concord biotech limited - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in recipients 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 tablets have been observed; therefore, mycophenolate mofetil tablets are 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 firs

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

amneal pharmaceuticals ny llc - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil tablets are 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 tablets have been observed; therefore, mycophenolate mofetil tablets are 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 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 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 tablets. 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 tablets 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 tablets 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 tablets 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)

solco healthcare us, llc - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii – iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%). tadalafil tablets are contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the last dose of tadalafil tablets. tadalafil tablets potentiate the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil tablets on the nitric oxide/cgmp pathway [see clinical pharmacology (12.2)] . coadministration of gc stimulators such as riociguat with tadalafil tablets are contraindicated. tadalafil tablets may potentiate the hypotensive effects of gc stimulators. tadalafil tablets are contraindicated in patients with a k

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

remedyrepack inc. - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii – iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%). tadalafil tablets are contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the last dose of tadalafil tablets. tadalafil tablets potentiate the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil tablets on the nitric oxide/cgmp pathway [see clinical pharmacology ( 12.2)] . coadministration of gc stimulators such as riociguat with tadalafil tablets are contraindicated. tadalafil tablets may potentiate the hypotensive effects of gc stimulators. tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or cialis). hypersensitivity reactions have been reported, including stevens-johnson syndrome and exfoliative dermatitis [see adverse reactions ( 6.2)] . risk summary limited data from case series with tadalafil use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day based on auc (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the 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 pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. data animal data tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day during organogenesis based on auc. in one of two perinatal/postnatal developmental studies in rats, a reduction of postnatal pup survival was observed at dose levels of 60, 200 and 1000 mg/kg. the no-observed-effect-level (noel) for developmental toxicity was 30 mg/kg, which provided maternal exposure to unbound tadalafil concentrations approximately 5 times the exposure at the mrhd based on auc. signs of maternal toxicity occurred at doses greater than 200 mg/kg/day, which produced aucs greater than 8 times the exposure at the mrhd. surviving offspring had normal development and reproductive performance. risk summary there are no data on the presence of tadalafil and/or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-times that found in the plasma. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tadalafil tablets and any potential adverse effects on the breastfed child from tadalafil tablets or from the underlying maternal condition. infertility males based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. this effect was not seen in the study of 20 mg tadalafil taken for 6 months. there was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. the clinical significance of the decreased sperm concentrations in the two studies is unknown. there have been no studies evaluating the effect of tadalafil on fertility in men or women [see clinical pharmacology (12.2)] . safety and effectiveness of tadalafil tablets in pediatric patients have not been established. of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over. no overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age. no dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered. [see clinical pharmacology ( 12.3)] . for patients with mild or moderate renal impairment, start tadalafil tablets at 20 mg once daily. increase the dose to 40 mg once daily based upon individual tolerability [see dosage and administration ( 2.2) and clinical pharmacology ( 12.3)] . in patients with severe renal impairment, avoid use of tadalafil tablets because of increased tadalafil exposure (auc), limited clinical experience, and the lack of ability to influence clearance by dialysis [see clinical pharmacology ( 12.3)] . because of limited clinical experience in patients with mild to moderate hepatic cirrhosis (child-pugh class a or b), consider a starting dose of tadalafil tablets 20 mg once daily. patients with severe hepatic cirrhosis (child-pugh class c) have not been studied, thus avoid use of tadalafil tablets in such patients [see dosage and administration ( 2.3) and clinical pharmacology ( 12.3)] .

Kanada - Inggris - Health Canada

janssen inc - darunavir (darunavir ethanolate) - tablet - 300mg - darunavir (darunavir ethanolate) 300mg - hiv protease inhibitors

Kanada - Inggris - Health Canada

janssen inc - darunavir (darunavir ethanolate) - tablet - 400mg - darunavir (darunavir ethanolate) 400mg - hiv protease inhibitors