- Approval Id
- 1f8aa7671dc339cd
- Drug Name
- PANTOPRAZOLE-AFT POWDER FOR INJECTION 40MG/VIAL
- Product Name
- PANTOPRAZOLE-AFT POWDER FOR INJECTION 40MG/VIAL
- Approval Number
- SIN16905P
- Approval Date
- 2023-12-06
- Registrant
- APEX PHARMA MARKETING PTE. LTD.
- Licence Holder
- APEX PHARMA MARKETING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- <p><strong>4.2 POSOLOGY AND METHOD OF ADMINISTRATION</strong></p>
<p>The intravenous administration of pantoprazole is recommended only if oral application is not appropriate.</p>
<img src="/TGIF/Pantoprazole-AFT_Table1.png" alt="Pantoprazole-AFT Dosage Table 1" /><br><br>
<p><strong>Special patient population</strong></p>
<p><strong><em>Paediatric patients</em></strong></p>
<p>The experience in children is limited. Pantoprazole-AFT powder for solution for injection is not recommended for use in patients below 18 years of age.</p>
<p><strong><em>Impaired hepatic function</em></strong></p>
<p>A daily dose of pantoprazole 20 mg should not be exceeded in patients with severe liver impairment (See section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong><em>Impaired renal function</em></strong></p>
<p>No dose adjustment is necessary in those with impaired renal function.</p>
<p><strong><em>Elderly patients</em></strong></p>
<p>Generally, no dose adjustment is necessary in elderly patients. However, the daily dose of 40 mg should not be exceeded in treatment of gastric or duodenal ulcer.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 THERAPEUTIC INDICATIONS</strong></p>
<p>Short term use for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:</p>
<ul>
<li><p>Duodenal ulcer</p></li>
<li><p>Gastric ulcer</p></li>
<li><p>Moderate and severe reflux esophagitis</p></li>
</ul>
- Contraindications
- <p><strong>4.3 CONTRAINDICATIONS</strong></p>
<p>Pantoprazole-AFT should not be used in cases of known hypersensitivity to any of the constituents.</p>
- Atc Code
- A02BC02
- Atc Item Name
- pantoprazole
- Pharma Manufacturer Name
- APEX PHARMA MARKETING PTE. LTD.
