DAIVOBET GEL 50MCG/G + 0.5MG/G

LEO PHARMA A/S - DENMARKLEO LABORATORIES LTD (IRELAND)🇸🇬 Health Sciences Authority

Approval Date: Mar 1, 2013
Approval ID: d353c80aeffa05a7
Company: LEO PHARMA A/S - DENMARKLEO LABORATORIES LTD (IRELAND)
Type: Therapeutic

Approval Details

Approval Id: d353c80aeffa05a7
Drug Name: DAIVOBET GEL 50MCG/G + 0.5MG/G
Product Name: DAIVOBET GEL 50MCG/G + 0.5MG/G
Approval Number: SIN14318P
Approval Date: 2013-03-01
Registrant: DKSH SINGAPORE PTE. LTD.
Licence Holder: DKSH SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: GEL
Dosage: Posology and method of administration Posology Daivobet® Gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks for scalp areas and 8 weeks for “non-scalp” areas. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision. When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g, and the maximum weekly dose should not exceed 100 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30%. If used on the scalp All the affected scalp areas may be treated with Daivobet® Gel. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon). Special Populations Renal and hepatic impairment The safety and efficacy of Daivobet® Gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Paediatric population The safety and efficacy of Daivobet® Gel in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in sections Undesirable effects and Pharmacodynamics properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, but no recommendation on a posology can be made. Method of administration Daivobet® Gel should not be applied directly to the face or eyes. In order to achieve optimal effect, it is not recommended to take a shower or bath, or to wash the hair in case of scalp application, immediately after application of Daivobet® Gel. Daivobet® Gel should remain on the skin during the night or during the day. When using the bottle The bottle should be shaken before use and Daivobet® Gel applied to the affected area. The hands should be washed after use.
Route Of Administration: TOPICAL
Indication Info: Indications Topical treatment of scalp psoriasis. Topical treatment of “non-scalp” plaque psoriasis vulgaris.
Contraindications: Contraindications Hypersensitivity to the active substances or to any of the excipients. Due to the content of calcipotriol, Daivobet® Gel is contraindicated in patients with known disorders of calcium metabolism. Due to the content of corticosteroid, Daivobet® Gel is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds and perianal and genital pruritus. Daivobet® Gel is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Atc Code: D05AX52
Atc Item Name: calcipotriol, combinations
Pharma Manufacturer Name: DKSH SINGAPORE PTE. LTD.

Active Ingredients

Calcipotriol monohydrate 52.2 mcg/g eqv calcipotriol

0.05 mg/g

Betamethasone dipropionate 0.643mg eqv betamethasone (micronized)

0.5 mg/g

Betamethasone dipropionate 0.643mg eqv betamethasone (micronized)

0.5 mg/g

Calcipotriol monohydrate 52.2 mcg/g eqv calcipotriol

0.05 mg/g

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 1, 2013

Approval ID

d353c80aeffa05a7

Type

Therapeutic

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