Exemple de utilizare a Prograf în Engleză și traducerile lor în Română
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Advagraf and Prograf are not interchangeable.
Treatment emergent fatal adverse events occurred in 1.2% of Envarsus patients and 0.6% of Prograf patients.
Prograf and Advagraf both contain the active substance, tacrolimus.
The percentages were 15% in the patients treated with Prograf/ Prograft, and 17% in those treated with ciclosporin.
The relationship between tacrolimus trough levels(C24) and systemic exposure(AUC 0-24)is similar between the two formulations Advagraf and Prograf.
Example: Total daily dose Prograf capsules given as 1 mg in the morning and 0.5 mg in the evening.
Patients were either switched to treatment with Envarsus once daily or continued Prograf treatment twice daily.
The second study compared Envarsus with Prograf as part of standard treatment in 543 patients with a newly transplanted kidney.
The first study involved 326 patients who had already had a kidney transplant andwere being treated with Prograf and other immunosuppressants to prevent rejection.
These studies compared Envarsus with Prograf, a widely used and well-established tacrolimus medicine that releases tacrolimus more quickly.
Results of a single dose bioequivalence study with adult healthy volunteers showed that Modigraf granules were approximately 20% more bioavailable than the Prograf capsules.
When converting from Prograf capsules to Advagraf tacrolimus trough levels should be measured prior to conversion and within two weeks after conversion.
The relationship between tacrolimus trough levels(C12) and systemic exposure(AUC0-12)is similar between the 2 formulations Modigraf granules and Prograf capsules.
The efficacy and safety of Advagraf and Prograf, both in combination with corticosteroids, was compared in 471 de novo liver transplant recipients.
In healthy subjects thesystemic exposure to tacrolimus(AUC) for Modigraf was approximately 18% higher than that for Prograf capsules when administered as single doses.
If equal doses are not possible,the total daily dose of Prograf should be rounded-up to the nearest amount possible, with the higher dose given in the morning and the lower dose in the evening.
In de novo kidney and liver transplant patients AUC0-24 of tacrolimus for Advagraf on Day 1 was 30% and50% lower respectively, when compared with that for Prograf at equivalent doses.
Kidney transplantation The efficacy andsafety of Advagraf and Prograf, both in combination with mycophenolate mofetil(MMF) and corticosteroids, was compared in 667 de novo kidney transplant recipients.
The event rate of biopsy confirmed acute rejection within the first 24 weeks after transplantationwas 32.6% in the Advagraf group(N=237) and 29.3% in the Prograf group(N=234).
In stable patients converted from Prograf(twice daily) to Advagraf(once daily) on a 1:1(mg: mg) total daily dose basis the systemic exposure to tacrolimus(AUC0-24) for Advagraf was approximately 10% lower than that for Prograf.
The Agency's Committee for Medicinal Products for Human Use(CHMP) decided that the approved doses of Envarsus have been shown to have a comparable quality, safety andeffectiveness to Advagraf and Prograf.
Blood trough levels of tacrolimus should also be monitored following conversion from Prograf to Advagraf, dose adjustment, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations(see section 4.5).
No studies have been conducted with conversion of patients from Advagraf to Envarsus; however,data from healthy volunteers would suggest that the same conversion rate is applicable as with the conversion from Prograf to Envarsus.
Results from clinical trials performed with once-daily tacrolimus Advagraf Liver transplantation The efficacy andsafety of Advagraf and Prograf, both in combination with corticosteroids, was compared in 471 de novo liver transplant recipients.
The percentage of patients with one or greater than one episodes of clinically-suspected and treated rejections during the 360-day study was 13.8% for the Envarsus group(N=268)and 15.6% for the Prograf group(N=275).
Results from published data of tacrolimus administered twice daily as Prograf capsules in other primary organ transplantation Prograf has evolved into an accepted treatment as primary immunosuppressive medicinal product following pancreas, lung and intestinal transplantation.
The efficacy failure rate as measured by the composite endpoint of death, graft loss, locally read BPAR andloss to follow-up was 2.5% in both the Envarsus and Prograf groups.
Blood trough levels of tacrolimus should also be closely monitored following conversion from Prograf to Advagraf, dose adjustments, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations(see section 4.5).
The treatment failure rate using the same composite end-point with centrally read BPAR was 1.9% in the Envarsus group and 3.7% in the Prograf group(95% confidence interval[-6.51%, 2.31%]).
Blood trough levels of tacrolimus should also be closely monitored when clinical signs of toxicity or acute rejection are observed,following conversion between Modigraf granules to Prograf capsules, dose adjustments, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations(see section 4.5).