- Approval Id
- f2a581b079fa3c57
- Drug Name
- MOFECON 500 FILM-COATED TABLETS 500 MG
- Product Name
- MOFECON 500 FILM-COATED TABLETS 500 MG
- Approval Number
- SIN16010P
- Approval Date
- 2020-09-18
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
Please refer to full prescribing information for corticosteroids and either ciclosporin or tacrolimus, which are used in combination with Mofecon.</p>
<p><u>Standard Dosage for prophylaxis of renal rejection</u><br>
A dose of 1 g administered orally or intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2 g) is recommended for use in renal transplant patients.</p>
<p>Although a dose of 1.5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients. Patients receiving 2 g per day of Mofecon demonstrated an overall better safety profile compared to patients receiving 3 f per day of Mofecon.</p>
<p><u>Standard Dosage for prophylaxis of cardiac rejection</u><br>
A dose of 1.5g administered orally or intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 3g) is recommended for use in cardiac transplant patients.</p>
<p><u>Standard Dosage for prophylaxis of hepatic rejection</u><br>
A dose of 1.0g administered intravenousely (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2g) or 1.5g orally twice a day (daily dose of 3g) is recommended for use in hepatic transplant patients.</p>
<p><u>Standard dosage for treatment of refractory renal rejection</u><br>
A dose of 1.5 g administered twice a day (daily dose of 3g) is recommended for management of refractory rejection.<br>
The initial dose of Mofecon should be given as soon as possible following renal, cardiac or hepatic transplantation.</p>
<p><strong>Special dosage instructions</strong><br>
Patients with neutropenia: If neutropenia develops (absolute neutrophil count <1.3 x 103/ml), dosing with Mofecon should be interrupted or the dose should be reduced and the patient carefully observed.</p>
<p>For dosage instructions in special population, please refer to sections Special Populations – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong><br>
Mofecon is indicated for:</p>
<ul>
<li>prophylaxis of acute organ rejection and treatment of refractory organ rejection in patients receiving allogeneic renal transplants.</li>
<li>prophylaxis of acute organ rejection and increased graft and patient survival in patients receiving allogeneic cardiac transplants.</li>
<li>prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants.</li>
</ul>
<p>Mofecon should be used concomitantly with cyclosporin and corticosteroids.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Mofecon should not be given to:</p>
<ul>
<li>Patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients shown above – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Women of childbearing potential who are not using highly effective contraception.</li>
<li>Women of childbearing potential without providing a pregnancy test result to rule out unintended use in pregnancy.</li>
<li>During pregnancy due to its mutagenic and teratogenic potential.</li>
<li>Women who are breastfeeding.</li>
</ul>
- Atc Code
- L04AA06
- Atc Item Name
- mycophenolic acid
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
