- Approval Id
- 399723596366d66a
- Drug Name
- PENTAGLOBIN INJECTION 50 MG/ML
- Product Name
- PENTAGLOBIN INJECTION 50 MG/ML
- Approval Number
- SIN11205P
- Approval Date
- 1999-10-29
- Registrant
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Licence Holder
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Dosage instructions and method of administration</strong><br>
The dosage is dependent on the patient's immune status and on the severity of the disease. Dose based on body weight may require adjustment in underweight or overweight patients. The following dosage suggestions may be used as reference:</p>
<p><strong>Bacterial infections</strong><br>
<strong>Neonates, infants, children and adults:</strong><br>
The recommended dose is 5 ml (0.25 g)/kg body weight (bw) daily on 3 consecutive days.<br>
Further infusions may be required depending on the clinical course.</p>
<p><strong>Immunoglobulin replacement therapy</strong><br>
<strong>Children and adults:</strong><br>
The recommended dose is 3 – 5 ml (0.15 – 0.25 g)/kg body weight (bw). Repetition at weekly intervals, if necessary.</p>
<p>The dosage recommendations are summarized in the following:</p>
<img src="/TGIF/Pentaglobin-Table1_100325.png" alt="Pentaglobin Dosage Table 1" /><br><br>
<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 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><strong>Method of administration</strong><br>
Intravenous use.<br>
Pentaglobin should only be mixed with normal saline.<br>
Pentaglobin should be brought to room or body temperature before use and should be infused intravenously at the following infusion rates:</p>
<img src="/TGIF/Pentaglobin-Table2.png" alt="Pentaglobin Dosage Table 2" /><br><br>
<p>In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.</p>
<img src="/TGIF/Pentaglobin-Table3.png" alt="Pentaglobin Dosage Table 3" /><br><br>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Indications</strong><br>
Adjuvant therapy of severe bacterial infections additional to antibiotic therapy.<br>
Product is only intended for use in high risk patients with proven bacterial sepsis and who are unlikely to have underlying IgA deficiency.<br>
Immunoglobulin substitution in immunocompromised patients.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<ul>
<li>Hypersensitivity to the active substance (human immunoglobulins) 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
- J06BA02
- Atc Item Name
- immunoglobulins, normal human, for intravascular adm.
- Pharma Manufacturer Name
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Company Detail Path
- /organization/grifols-asia-pacific-pte-ltd
