- Approval Id
- 4212a32068dfd146
- Drug Name
- MESNA STADA® CONCENTRATE SOLUTION FOR INJECTION 400MG/4ML
- Product Name
- MESNA STADA® CONCENTRATE SOLUTION FOR INJECTION 400MG/4ML
- Approval Number
- SIN14991P
- Approval Date
- 2016-04-25
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DCH AURIGA SINGAPORE
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Dosage
- <p><strong>Posology and method of administration</strong></p>
<p>IV: Unless prescribed otherwise, MESNA Stada is normally administered intravenously to adults at a dose of 20% of the oxazaphosphorine dose at time zero (the time of administration of the oxazaphosphorine), and then at 4 and 8 hours.</p>
<img src="/TGIF/MesnaStada-Table1.png" alt="MesnaStada Dosage Table 1" /><br><br>
<p>Clinical experience with children has shown that it is beneficial in individual cases to give MESNA Stada at shorter intervals (e.g., every 3 hrs, total MESNA Stada dose = 60% of oxazaphosphorine dose). With very high-dose oxazaphosphorine cytostatic therapy (e.g., before bone marrow transplantation), the total MESNA Stada dose can be increased to between 120% and 160% of the oxazaphosphorine dose. It is recommended that after administration of 20% MESNA Stada (related to the total dose of oxazaphosphorine) at time 0, the remaining calculated dose should be given continuously IV over a period of 24 hrs with a perfusor. Alternatively, an intermittent bolus injection is possible: For adults 3 x 40% (at times 0, 4, 8 hrs) or 4 x 40% (at times 0, 3, 6, 9 hrs), respectively. For children due to more frequent micturition, the bolus injections should always be given in 3-hr intervals (e.g., 20% at times 0, 1, 3, 6, 9, 12 hrs). Instead of a bolus injection, short infusions of 15-min duration are possible. With a continuous infusion of ifosfamide (Holoxan), it has been shown to be of benefit to give MESNA Stada at time zero following the initial 20% bolus injection (start of infusion, time 0), followed by infusion to up to 100% of the ifosfamide dose, and to continue uroprotection for a further 6 to 12 hours after termination of the ifosfamide infusion.</p>
<img src="/TGIF/MesnaStada-Table2.png" alt="MesnaStada Dosage Table 2" /><br><br>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Therapeutic indications</strong></p>
<p>Prevention of urinary tract toxicity of oxazaphosphorines (e.g., ifosfamide, cyclophosphamide or trofosfamide).</p>
<p>In the case of a tumour therapy with ifosfamide MESNA Stada must always be given. In the case of a tumour therapy with cyclophosphamide or trofosfamide, MESNA Stada must always be given when dosages above 10 mg/kg are used and in patients at risk. Risks are in particular: previous radiation therapy in the area of the true pelvis, cystitis following previous therapy with ifosfamide, cyclophosphamide or trofosfamide and a history of uropathy.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Known hypersensitivity to mesna, other thiol compounds or to any of the excipients.</p>
<p>As mesna is only indicated in combination with oxazaphosphorines, the contraindications which apply to cyclophosphamide, ifosfamide and trofosfamide should also be observed.</p>
- Atc Code
- V03AF01
- Atc Item Name
- mesna
- Pharma Manufacturer Name
- DCH AURIGA SINGAPORE
