Tma 07 ema

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Tma 07 ema

This information is intended for use by health professionals 1. Name of the medicinal product Rapamune 0. Qualitative and quantitative composition Rapamune 0.

Introducing : The Intermittent Student

Rapamune 1 mg coated tablets Each coated tablet contains 1 mg sirolimus. Rapamune 2 mg coated tablets Each coated tablet contains 2 mg sirolimus.

Each 60 mL bottle contains 60 mg sirolimus. Excipients with known effect Rapamune 0. Rapamune 1 mg coated tablets Each tablet contains Rapamune 2 mg coated tablets Each tablet contains Oral Solution Each mL contains 20 mg of ethanol and 20 mg of soya oil.

For the full list of excipients, see section 6. Pharmaceutical form Rapamune 0.

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Pale yellow to yellow solution. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months.

Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued see sections 4.

Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function see sections 4. Posology Prophylaxis of organ rejection Initial therapy 2 to 3 months post-transplantation The usual dose regimen for Rapamune is a 6 mg single oral loading dose, administered as soon as possible after transplantation, followed by 2 mg once daily until results of therapeutic monitoring of the medicinal product are available see Therapeutic monitoring of the medicinal product and dose adjustment.

Rapamune therapy should be optimised with a tapering regimen of steroids and ciclosporin microemulsion. To minimise variability, Rapamune should be taken at the same time in relation to ciclosporin, 4 hours after the ciclosporin dose, and consistently either with or without food see section 5.

Rapamune should be given with corticosteroids. In patients for whom ciclosporin withdrawal is either unsuccessful or cannot be attempted, the combination of ciclosporin and Rapamune should not be maintained for more than 3 months post-transplantation.

In such patients, when clinically appropriate, Rapamune should be discontinued and an alternative immunosuppressive regimen instituted. Therapeutic monitoring of the medicinal product and dose adjustment Whole blood sirolimus levels should be closely monitored in the following populations: Therapeutic monitoring of the medicinal product should not be the sole basis for adjusting sirolimus therapy.

Optimal therapy requires therapeutic concentration monitoring of the medicinal product in all patients. Optimally, adjustments in Rapamune dose should be based on more than a single trough level obtained more than 5 days after a previous dosing change.

Patients can be switched from Rapamune oral solution to the tablet formulation on a mg per mg basis.TMA30 EMA. Download. after completing the PTSD quiz I realised I needed to re-read the section on treatment before commencing the TMA. I particularly found the online quiz on ‘referencing’ a beneficial way to recap my knowledge before commencing the TMA / .

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Tma 07 ema
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