- Approval Id
- 463c865333ef78ab
- Drug Name
- MEGALOTECT CP SOLUTION FOR INFUSION 100 U/ML
- Product Name
- MEGALOTECT CP SOLUTION FOR INFUSION 100 U/ML
- Approval Number
- SIN14452P
- Approval Date
- 2013-12-04
- Registrant
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Licence Holder
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Posology and method of administration</strong></p>
<p><u>Posology</u><br>
The single dose is 1 ml per kg body weight. Administration should be initiated on the day of transplantation. In case of bone marrow transplantation an initiation of prophylaxis up to 10 days before transplantation can also be envisaged, particularly in CMV zero-positive patients. A total of at least 6 single doses at 2 to 3 weeks' intervals should be given.</p>
<p><em><u>Hepatic impairment</u></em><br>
No evidence is available to require a dose adjustment.</p>
<p><em><u>Renal impairment</u></em><br>
No dose adjustment unless clinically warranted, see section ‘Special warnings and precautions for use’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><em><u>Elderly</u></em><br>
No dose adjustment unless clinically warranted, see section "special warings and precautions for use" – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><strong>Method of administration</strong></p>
<p><u>Intravenous use</u><br>
Megalotect CP should be infused intravenously at an initial rate of 0.08 ml/kg BW/hr for the first 10 minutes. See section <strong>Special warnings and precautions for use</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.8 ml/kg BW/hr for the remainder of the infusion.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Indications</strong></p>
<p>Prophylaxis of clinical manifestations of cytomegalovirus infection in patients receiving immunosuppressive therapy, particularly in transplant recipients.</p>
<p>The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<ul>
<li>Hypersensitivity to the active substance (human cytomegalovirus immunoglobulin) or to any of the excipients listed above – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA-containing product can result in anaphylaxis.</li>
</ul>
- Atc Code
- J06BB09
- Atc Item Name
- cytomegalovirus immunoglobulin
- Pharma Manufacturer Name
- GRIFOLS ASIA PACIFIC PTE. LTD.
