MIRVASO GEL 3MG/G [SIN14828P]

Product Info

MIRVASO GEL 3MG/G

[SIN14828P]

4.1 Therapeutic indications
Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.

4.2 Posology and method of administration

Posology
One application per 24 hours, at any time suitable for the patient, for as long as facial erythema is present.
The maximum daily recommended dose is 1 g of gel in total weight, divided into five pea size amounts.

Special populations
Elderly patients
The experience of use of Mirvaso in patients aged above 65 years is limited (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 Mirvaso in children and adolescents aged less than 18 years have not been established. No data are available.

Mirvaso is contraindicated in children aged less than 2 years because of serious systemic safety risk (see section 4.3). Safety concerns related to the systemic absorption of brimonidine have also been identified for the age group 2 to 12 years (see section 4.9 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Mirvaso should not be used in children or adolescents aged 2 to 18 years.

Method of administration
Cutaneous use only.
Cutaneous application of a small pea size amount of medicinal product to each of the five areas of the face: forehead, chin, nose, each cheek.

Mirvaso should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes, eyelids, lips, mouth and membrane of the inner nose. Mirvaso should be applied only to the face.

Hands should be washed immediately after applying the medicinal product.

Mirvaso can be used in conjunction with other cutaneous medicinal products for the treatment of inflammatory lesions of rosacea and with cosmetics. These products should not be applied immediately before the daily application of Mirvaso; they may be used only after the applied Mirvaso 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.

Children aged less than 2 years.

Patients receiving monoamine oxidase (MAO) inhibitor therapy (for example selegiline or moclobemide) and patients on tricyclic (such as imipramine) or tetracyclic (such as maprotiline, mianserin or mirtazapine) antidepressants which affect noradrenergic transmission.