- Approval Id
- f0fd237c0e6961b9
- Drug Name
- PANTOPRAZOLE KALCEKS POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL
- Product Name
- PANTOPRAZOLE KALCEKS POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL
- Approval Number
- SIN17236P
- Approval Date
- 2025-05-15
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>This medicine should be administered by a healthcare professional and under appropriate medical supervision.</p>
<p>Intravenous administration of pantoprazole is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, intravenous treatment with pantoprazole should be discontinued and 40 mg of pantoprazole should be administered orally instead.</p>
<p><u>Posology</u></p>
<p><em>Gastric and duodenal ulcer, moderate and severe reflux oesophagitis</em><br>
The recommended dose is 40 mg pantoprazole daily.</p>
<p><u>Special populations</u></p>
<p><em>Patients with hepatic impairment</em><br>
A daily dose of 20 mg pantoprazole 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><em>Patients with renal impairment</em><br>
No dose adjustment is necessary in patients with impaired renal function (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Elderly</em><br>
No dose adjustment is necessary in the elderly (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Paediatric population</em><br>
The safety and efficacy of intravenous pantoprazole in children aged under 18 years of age have not been established. Therefore, this medicine is not recommended in children under 18 years of age. The currently available data are described in section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>. However, no dose recommendation can be made based on these data.</p>
<p><u>Method of administration</u></p>
<p>Intravenous use.</p>
<p>This medicinal product should be reconstituted, or reconstituted and diluted, before use. It should be administered intravenously over 2–15 minutes.</p>
<p>For instructions on reconstitution, or reconstitution and dilution of the medicinal product before administration, see section 6.7 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Pantoprazole is indicated for short-term use in adults for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:</p>
<ul>
<li>Moderate and severe reflux oesophagitis</li>
<li>Gastric and duodenal ulcer</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- A02BC02
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
