Canadá - inglês - Health Canada

sandoz canada incorporated - fluvastatin (fluvastatin sodium) - capsule - 40mg - fluvastatin (fluvastatin sodium) 40mg - hmg-coa reductase inhibitors

Canadá - inglês - Health Canada

accel pharma inc - mycophenolate mofetil - tablet - 500mg - mycophenolate mofetil 500mg - immunosuppressive agents

Canadá - inglês - Health Canada

accel pharma inc - mycophenolate mofetil - capsule - 250mg - mycophenolate mofetil 250mg - immunosuppressive agents

Estados Unidos - inglês - NLM (National Library of Medicine)

avpak - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus 1 mg - sirolimus tablets are 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that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration (2.2)].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 sirolimus tablets 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 sirolimus tablets 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 sirolimus tablets 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 sirolimus tablets 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 sirolimus tablets in maintenance renal transplant patients have not been established [see clinical studies (14.4)]. sirolimus is contraindicated in patients with a hypersensitivity to sirolimus [see warnings and precautions (5.4) ]. pregnancy category c: sirolimus was embryo/fetotoxic in rats when given in doses approximately 0.2 to 0.5 the human doses (adjusted for body surface area). embryo/fetotoxicity was manifested as mortality and reduced fetal weights (with associated delays in skeletal ossification). however, no teratogenesis was evident. in combination with cyclosporine, rats had increased embryo/feto mortality compared with sirolimus alone. there were no effects on rabbit development at a maternally toxic dosage approximately 0.3 to 0.8 times the human doses (adjusted for body surface area). there are no adequate and well-controlled studies in pregnant women. effective contraception must be initiated before sirolimus therapy, during sirolimus therapy, and for 12 weeks after sirolimus therapy has been stopped. sirolimus is excreted in trace amounts in milk of lactating rats. it is not known whether sirolimus is excreted in human milk. the pharmacokinetic and safety profiles of sirolimus in infants are not known. because many drugs are excreted in human milk, and because of the potential for adverse reactions in nursing infants from sirolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. renal transplant the safety and efficacy of sirolimus in pediatric patients < 13 years have not been established.   the safety and efficacy of sirolimus oral solution and sirolimus 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 sirolimus oral solution and sirolimus tablets in this subpopulation of children ≥ 13 years is supported by evidence from adequate and well-controlled trials of sirolimus 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 sirolimus 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) ]. clinical studies of sirolimus 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 sirolimus 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) ].

Canadá - inglês - Health Canada

vanc pharmaceuticals inc - mycophenolate mofetil - tablet - 500mg - mycophenolate mofetil 500mg - immunosuppressive agents

Canadá - inglês - Health Canada

vanc pharmaceuticals inc - mycophenolate mofetil - capsule - 250mg - mycophenolate mofetil 250mg - immunosuppressive agents

Canadá - inglês - Health Canada

sandoz canada incorporated - fluvastatin (fluvastatin sodium) - tablet (extended-release) - 80mg - fluvastatin (fluvastatin sodium) 80mg - hmg-coa reductase inhibitors

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

bristol laboratories limited - furosemide - tablet - 20 milligram(s) - sulfonamides, plain; furosemide

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

bristol laboratories limited - furosemide - tablet - 40 milligram(s) - sulfonamides, plain; furosemide

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

brillpharma (ireland) limited - furosemide - tablet - 20 milligram(s) - sulfonamides, plain; furosemide