MIRVASO Gel Ref.[6613] Active ingredients: Brimonidine

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, which corresponds to approximately five pea sized amounts.

Treatment should be initiated with a smaller amount of gel (less than the maximum) for at least one week. The amount of gel can then be increased gradually based on tolerability and patient response.

Special populations

Elderly patients

The experience of use of Mirvaso in patients aged above 65 years is limited (see also section 4.8). No dose adjustment is necessary.

Hepatic and renal impairment

Mirvaso has not been studied in patients with hepatic and renal impairment.

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). Mirvaso should not be used in children or adolescents aged 2 to 18 years.

Method of administration

Cutaneous use only.

Mirvaso should be applied smoothly and evenly as a thin layer across the entire face (forehead, chin, nose and both cheeks) 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.

Overdoses after oral use of other alpha₂-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.

Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

Paediatric population

Serious adverse reactions following inadvertent ingestion of Mirvaso by two young children of one clinical study subject have been reported. The children experienced symptoms consistent with previously reported oral overdoses of alpha₂-agonist in young children. Both children were reported to have made a full recovery within 24 hours.

2 years.

This medicinal product does not require any special storage condition.

Store below 30°C and do not freeze.

Tube of 2g:

Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polyethylene (PE) child resistant closure

Tube of 10 g and 30g:

Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure.

And

Polyethylene (PE)/ Polyethylene (PE)/Copolymer/Aluminium (Al)/Polyethylene (PE)/Polyethylene high density (PEHD) and Linear low density polyethylene (LLDPE) polyfoil tubes with polypropylene (PP) child resistant closure.

Pump of 30 g:

Multidose container with airless pump system with child resistant closure.

Polypropylene (PP)/Thermoplastic Polyolefin (TPO)/high density polyethylene (HDPE) and polypropylene (PP) child resistant closure.

Pack sizes: 1 tube of 2 g,10 g or 30 g; 1 pump of 30 g.

Not all pack sizes may be marketed.

No special requirements.