- Approval Id
- 9b62248d6187cc5e
- Drug Name
- FORTRANS FOR ORAL SOLUTION
- Product Name
- FORTRANS FOR ORAL SOLUTION
- Approval Number
- SIN09234P
- Approval Date
- 1997-03-03
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PHARMACY ONLY MEDICINES
- Dosage Form
- GRANULE, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
<strong>Posology</strong><br>
FOR USE IN ADULTS ONLY<br>
Oral route.<br>
Each sachet must be dissolved in one litre of water.<br>
Stir until complete dissolution of the powder.<br>
The dosage is approximately one litre of the solution for 15 to 20 kg of body weight, which corresponds to an average dosage of 3 to 4 litres.</p>
<p><strong>Method of administration</strong><br>
It is possible to ingest the preparation as a single dose or as divided doses, providing that the total amount of the reconstituted solution is always fully ingested (average of 3 to 4 litres of solution according to the patient’s body weight):</p>
<ul class="dash">
<li>In divided doses: either 2 litres ingested in the evening before the procedure and 1 to 2 litres in the morning of the procedure, the last glass being ingested 3 to 4 hours before the procedure, or 3 litres ingested the night before and 1 litre on the morning of the procedure, the last glass being ingested at the latest 3 to 4 hours before the procedure.</li>
<li>In a single dose: 3 to 4 litres in the evening before the procedure, possibly with a break of one hour after the first 2 litres.</li>
</ul>
<p>The recommended ingestion rate is 1 to 1.5 litres an hour (i.e. 250 ml every 10 to 15 minutes).<br>
The doctor may adjust the recommended rate according to the patient clinical condition and to potential comorbidities.</p>
<ul class="circle">
<li><em>Patients with renal impairment</em><br>
Insufficient data are available for this population (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li><em>Paediatric population</em>.<br>
The safety and efficacy of Fortrans in children aged <18 years has not been established.</li>
</ul>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
Colon lavage in the preparation of patients prior to :</p>
<ul class="dash">
<li>endoscopic or radiological investigations,</li>
<li>colon surgery.</li>
</ul>
<p>Fortrans is indicated in adults only.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Hypersensitivity to the active substances or to one of the excipients referred to in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Severe heart failure</li>
<li>Serious deteriorations in general health such as dehydration</li>
<li>Advanced carcinoma or any other colonic pathology causing excessive mucosal fragility</li>
<li>Acute phases of intestinal tract inflammation including Crohn's disease and ulcerative colitis;</li>
<li>Gastrointestinal perforation or risk of perforation;</li>
<li>Toxic colitis or toxic megacolon</li>
<li>Patients likely to have or who already have an ileus</li>
<li>Patients likely to have or who already have a gastrointestinal obstruction or stenosis</li>
<li>Gastric emptying disorders (e.g.: gastroparesis, gastric stasis)</li>
</ul>
- Atc Code
- A06AX
- Atc Item Name
- 其它治疗便秘的药物
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
