- Approval Id
- 4523dc7e9803006c
- Drug Name
- SOOLANTRA CREAM 10MG/G
- Product Name
- SOOLANTRA CREAM 10MG/G
- Approval Number
- SIN15197P
- Approval Date
- 2017-03-23
- Registrant
- GALDERMA SINGAPORE PRIVATE LIMITED
- Licence Holder
- GALDERMA SINGAPORE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CREAM
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u><br>
One application a day for up to 4 months. Soolantra should be applied daily over the treatment course. The treatment course may be repeated. In case of no improvement after 3 months, the treatment should be discontinued.</p>
<p><em>Special population</em></p>
<p><em>Renal impairment</em><br>
No dosage adjustment is necessary.</p>
<p><em>Hepatic impairment</em><br>
Caution should be exercised in patients with severe hepatic impairment.</p>
<p><em>Elderly patients</em><br>
No dosage adjustment is necessary in the geriatric population (see also section 4.8 – <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 Soolantra in children and adolescents aged less than 18 years have not been established. No data are available.</p>
<p><u>Method of administration</u><br>
Cutaneous use only.<br>
Cutaneous application of a pea-size amount of medicinal product to each of the five areas of the face: forehead, chin, nose, and each cheek. The medicinal product should be spread as a thin layer across the entire face, avoiding the eyes, lips and mucosa.<br>
Soolantra should be applied only to the face.<br>
Hands should be washed after applying the medicinal product.<br>
Cosmetics may be applied after the medicinal product has dried.</p>
- Route Of Administration
- TOPICAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Soolantra is indicated for the topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance 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
- D11AX22
- Atc Item Name
- ivermectin
- Pharma Manufacturer Name
- GALDERMA SINGAPORE PRIVATE LIMITED
