Examples of using Envarsus in English and their translations into German
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Colloquial
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Official
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Ecclesiastic
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Medicine
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
How does Envarsus work?
Envarsus contains lactose.
If you forget to take Envarsus.
Envarsus is used in adults.
Other medicines and Envarsus.
Envarsus doses are usually reduced in the post-transplant period.
Therefore, you should not breast-feed whilst taking Envarsus.
Tacrolimus, the active substance in Envarsus, is an immunosuppressive medicine.
Therefore, you may bemore prone to infections while you are taking Envarsus.
The use of Envarsus is not recommended in children and adolescents under 18 years.
Benign andmalignant tumours have been reported following Envarsus treatment.
Envarsus 0.75 mg prolonged-release tablets Envarsus 1 mg prolonged-release tablets Envarsus 4 mg prolonged-release tablets.
Treatment failure occurred in 18.3% patients treated with Envarsus(49 out of 268), and 19.6% given Prograf 54 out of 275.
You will need to take Envarsus every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Failure rates were2.5% in both groups 4 of 162 patients treated with Envarsus, and 4 of 162 treated with Prograf.
Envarsus 0.75 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with“0.75” on one side and“TCS” on the other side.
Prograf capsules or from Advagraf prolonged-release capsules to Envarsus, trough levels should be measured prior to conversion and within two weeks after conversion.
Envarsus is not interchangeable with other existing tacrolimus containing medicines(immediate release or prolonged release) on an equal dose by dose basis.
The relationship between tacrolimus trough levels and systemic exposure(AUC0-24)is well correlated and is similar between the immediate-release formulation and Envarsus.
Envarsus is taken once daily and is not interchangeable with other existing medicines containing tacrolimus(immediate release or prolonged release) on an equal dose by dose basis.
The event rate of biopsy-confirmed acute rejection within the 360day study period was not significantly different between the Envarsus group and the tacrolimus immediate-release group.
Envarsus can also be used to treat organ rejection in adult patients when other immunosuppressive medicines(medicines that reduce the activity of the immune system) are not effective.
The Marketing Authorisation Holder should ensure that, at launch,all Healthcare Professionals who are expected to prescribe or dispense Envarsus are provided with an Educational pack.
Envarsus can only be obtained with a prescription and should only be prescribed by doctors experienced in immunosuppressive medicines and in the management of transplant patients.
Higher Cavg(~50%), reduced peak trough fluctuation(Cmax/Cmin)and a longer Tmax were seen for Envarsus when compared with both, tacrolimus immediate-release formulation(Prograf) and a tacrolimus once daily formulation Advagraf.
In addition, the company that markets Envarsus will provide educational material for healthcare professionals who are likely to prescribe or dispense Envarsus, reminding them of its authorised uses and dosage, and the need for care if switching patients between different forms of tacrolimus.
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.
Because tacrolimus is absorbed into the body differently from Envarsus than from other tacrolimus medicines, when switching patients who are already being treated with any other formulation of tacrolimus they should be given a dose of Envarsus 30% less than their existing dose.
Herbal preparations containing St. John's Wort(Hypericum perforatum)should be avoided when taking Envarsus due to the risk of interactions that lead to a decrease in both blood concentrations and the therapeutic effect of tacrolimus see section 4.5.
In stable patients converted from tacrolimus immediate-release products(twice daily) to Envarsus(once daily) on a 1:0.7(mg:mg) total daily dose basis, the mean systemic exposure to tacrolimus(AUC0-24) was similar to that of immediate-release tacrolimus.