Soolantra 10mg/g cream

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Ivermectin

Mevcut itibaren:

Galderma (UK) Ltd

ATC kodu:

D11AX22

INN (International Adı):

Ivermectin

Doz:

10mg/1gram

Farmasötik formu:

Cutaneous cream

Uygulama yolu:

Cutaneous

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 13060300; GTIN: 05020465201038 05020465202264

Ürün özellikleri

OBJECT 1
SOOLANTRA 10MG/G CREAM
Summary of Product Characteristics Updated 13-Apr-2018 | Galderma
(U.K) Ltd
1. Name of the medicinal product
Soolantra 10 mg/g cream
2. Qualitative and quantitative composition
One gram of cream contains 10 mg of ivermectin.
Excipient(s) with known effect:
One gram of cream contains 35 mg of cetyl alcohol, 25 mg of stearyl
alcohol, 2 mg of methyl
parahydroxybenzoate (E218), 1 mg of propyl parahydroxybenzoate (E216)
and 20 mg of propylene
glycol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Cream.
White to pale yellow hydrophilic cream.
4. Clinical particulars
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).
_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
lis