- Approval Id
- 33c21f79628ba052
- Drug Name
- SALOFALK 500 SUPPOSITORIES 500 MG
- Product Name
- SALOFALK 500 SUPPOSITORIES 500 MG
- Approval Number
- SIN09296P
- Approval Date
- 1997-04-16
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DCH AURIGA SINGAPORE
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SUPPOSITORY
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p><u>Adults and elderly</u><br>
<em>For the treatment of acute episodes of ulcerative colitis</em><br>
One Salofalk 500 mg suppository is inserted into the rectum three times daily (equivalent to 1500 mg mesalazine daily), according to the individual clinical requirement.</p>
<p><u>Children and adolescents</u><br>
There is little experience and only limited documentation for an effect in children.</p>
<p><u>Method of administration</u><br>
When used three times daily, Salofalk 500 mg suppositories should be inserted into the rectum in the morning, at midday and at bedtime.</p>
<p>Treatment with Salofalk suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved.</p>
<p>An acute episode of ulcerative colitis generally subsides within 8 – 12 weeks. The duration of use is determined by the physician.</p>
- Route Of Administration
- RECTAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Treatment of acute episodes of ulcerative colitis that is limited to the rectum.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Salofalk suppositories are contraindicated in patients with</p>
<ul class="dash">
<li>known hypersensitivity to the active substance, salicylates 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></li>
<li>severe impairment of hepatic or renal function</li>
</ul>
- Atc Code
- A07EC02
- Atc Item Name
- mesalazine
- Pharma Manufacturer Name
- DCH AURIGA SINGAPORE
