- Home
- Automated
- List of product information
- SOOLANTRA CREAM 10MG/G [SIN15197P]
SOOLANTRA CREAM 10MG/G [SIN15197P]
Active ingredients: SOOLANTRA CREAM 10MG/G
On this page
Product Info
SOOLANTRA CREAM 10MG/G
[SIN15197P]
Product information
Active Ingredient and Strength | IVERMECTIN - 10 MG/G |
Dosage Form | CREAM |
Manufacturer and Country | LABORATOIRES GALDERMA - FRANCE |
Registration Number | SIN15197P |
Licence Holder | GALDERMA SINGAPORE PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | D11AX22 |
4.1 Therapeutic indications
Soolantra is indicated for the topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients.
4.2 Posology and method of administration
Posology
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.
Special population
Renal impairment
No dosage adjustment is necessary.
Hepatic impairment
Caution should be exercised in patients with severe hepatic impairment.
Elderly patients
No dosage adjustment is necessary in the geriatric population (see also section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population
The safety and efficacy of Soolantra in children and adolescents aged less than 18 years have not been established. No data are available.
Method of administration
Cutaneous use only.
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.
Soolantra should be applied only to the face.
Hands should be washed after applying the medicinal product.
Cosmetics may be applied after the medicinal product has dried.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
