Johnson cats

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Of 52 patients enrolled, thirty-eight (38) had an evaluable Johnson cats profile. The mean pediatric age was 6. Summary results of PK parameters are presented in Table 18. Table 18: Summary of Whole Blood PK Parameters of Tacrolimus after Administration of PROGRAF Elective in Pediatric PatientsThe mean pharmacokinetic parameters for tacrolimus following single administrations to adult patients with renal and tegretol side effects impairment are given in Table 19.

Tacrolimus pharmacokinetics, following a single IV administration, were determined in 12 johnson cats (7 not on dialysis and 5 on dialysis, serum creatinine of 3. The pharmacokinetic parameters obtained were similar for both groups. The pharmacokinetics of tacrolimus have been studied following single IV and oral administration of PROGRAF to 10 African-American, 12 Latino-American, and 12 Caucasian johnson cats volunteers.

There were no significant pharmacokinetic differences among the three ethnic groups following a 4-hour IV infusion of 0. A formal trial to evaluate the effect of gender on tacrolimus pharmacokinetics has not been conducted, however, there was no difference johnson cats dosing by gender in the kidney transplant trial. A retrospective comparison johnson cats pharmacokinetics in healthy volunteers, and in kidney, liver, and heart transplant patients indicated no gender-based differences.

PROGRAF-based immunosuppression in conjunction with azathioprine and corticosteroids following kidney transplantation was assessed in a randomized, multicenter, non-blinded, prospective trial. There were 412 kidney transplant patients enrolled at 19 clinical sites in the United States. Patients less than 6 years of age johnson cats excluded. There were 205 patients randomized to PROGRAF-based immunosuppression and 207 patients were randomized to cyclosporine-based immunosuppression.

All patients received prophylactic induction therapy consisting of an antilymphocyte antibody preparation, johnson cats, and azathioprine. Overall 1-year patient and graft survival was 96. PROGRAF-based immunosuppression in conjunction with MMF, corticosteroids, and induction has been studied. Patients in both groups started MMF at 1 gram twice daily. The safety johnson cats efficacy of PROGRAF-based immunosuppression following orthotopic liver transplantation were assessed in two prospective, randomized, non-blinded multicenter trials.

Both trials used concomitant adrenal corticosteroids as part of the immunosuppressive regimens. These trials compared patient and graft survival rates at 12 months following transplantation. In both trials, the median time to convert from IV to oral PROGRAF dosing was 2 days. Although there is a lack of direct johnson cats between tacrolimus concentrations and drug efficacy, data from clinical trials of liver transplant patients have shown an increasing incidence of adverse reactions with increasing trough blood concentrations.

Long-term post-transplant patients are often maintained at the low end of this target range. Data from the U. The study was conducted outside the United States and enrolled patients aged 16 years or younger. Based on trough levels, doses of tacrolimus were adjusted to 0. At 12 months, johnson cats incidence rate of BPAR, graft loss, death, or loss to follow-up was 52. Table 27: Key Efficacy Results at 12 Months in Pediatric Liver Transplant Recipients Receiving PROGRAF Granules or CyclosporineTwo johnson cats, randomized, comparative trials evaluated the safety and efficacy of PROGRAF-based johnson cats cyclosporinebased immunosuppression in primary orthotopic heart transplantation.

In a trial conducted in Europe, 314 patients received a regimen of antibody induction, corticosteroids, and azathioprine johnson cats combination with PROGRAF or cyclosporine modified for 18 months. In a 3-arm trial conducted in the U. In the European trial, johnson cats cyclosporine trough concentrations were above the pre-defined target range (i.

There may be new johnson cats. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you johnson cats any questions about PROGRAF, ask your healthcare provider johnson cats pharmacist.

See the end of this leaflet for a complete list of ingredients in PROGRAF. Before you take Johnson cats, tell your healthcare provider about all of your medical conditions, including if you:Tell your healthcare provider about all the medicines you johnson cats, and when you start a new medicine or stop taking a medicine, including prescription and over-the-counter medicines, vitamins, natural, herbal or nutritional supplements.

Your healthcare provider will tell you how much PROGRAF to take and when to take it. Your healthcare johnson cats may change your PROGRAF dose if needed. Do johnson cats stop taking or change your dose of Johnson cats without talking johnson cats your healthcare provider. The most common side effects of PROGRAF in people who have received a kidney, liver or heart transplant are:Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088. PROGRAF capsules: croscarmellose sodium, hypromellose, lactose monohydrate, and magnesium stearate.

The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide. Read these Instructions for Use for the first time and each time you get a refill of PROGRAF Granules johnson cats for oral suspension). Ask the healthcare provider if you have any questions about how to mix or give a dose of PROGRAF Granules johnson cats right way.

If you spill the granules, wipe the surface with a wet paper towel. If you spill the prepared oral suspension, dry the area with a dry paper towel and then wipe the area with a wet paper towel. Throw away the paper towels in the trash and wash your hands well with soap and water. For each dose johnson cats PROGRAF Granules mixed with water that will be given using a glass cup, you will need the following supplies (See Figure A):Step 1: Choose a clean flat work surface.

Place a clean my roche di towel on the work surface. Johnson cats the supplies to prepare the dose on the paper towel. Step 4 : Using a pair of scissors, cut along the dotted line on johnson cats PROGRAF Granules packet to open it.

Step 5 : Empty all of the granules in the packet into the glass cup.



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