Šalis: Armėnija
kalba: anglų
Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
brimonidine (brimonidine tartrate)
Laboratoires Galderma Z.I. Montdesir
D11AX21
brimonidine (brimonidine tartrate)
3,3mg/g
gel
2g, 10g and 30g laminated or polyfoil plastic tube
Prescription
Registered
2015-12-02
B. PACKAGE LEAFLET GALDERMA SA Av. Gratta-Paille 2 CH - 1018 Lausanne Package leaflet: Information for the patient Mirvaso 3 mglg gel brimonidine Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even iftheir signs ofillness are the same as yours. - Ifyou get any side effects, talk to your doctor. This hcludes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Mirvaso is and what it is used for 2. What you need to know before you use Mirvaso 3. How to use Mirvaso 4. Possible side effects 5. How to store Mirvaso 6. Contents ofthe pack and other information 1. What Mirvaso is and what it is used for Mirvaso contains the active substance brimonidine which belongs to a group of medicines commonly referred to as "alpha agonists". It is applied to the skin ofthe face to treat redness due to rosacea in adult patients. Redness of the face due to rosacea is caused by high Ievels of blood flow in the facial skin. which is the result of enlargement (dilation) ofthe small blood vessels ofthe skin. When applied, Mirvaso acts to narrow these blood vessels again which reduces the excess blood flow and redness. 2. What you need to know before you use Mirvaso Do not use Mirvaso: - ifyou are allergic to brimonidine or any ofthe other ingredients ofthis medicine (listed in section 6). - in children below 2 years of age, who may be at greater risk of side effects from any of the medicine absorbed through the skin. - ifyou are taking certain medicines used for depression or Parkinson's disease including so-called monoamine oxidase (MAO) inhibitors (for example selegiline or moclobemide) or tricyclic antidepressants (such as imipramine) or tetracyclic antidepressants (such as maprotiline, mianserin or mirtazapin). Perskaitykite visą dokumentą
A}INEX I SIJMMARY OF PRODUCT CHARACTERISTICS GALDERMA SA Av. Gratta-Paille 2 CH - 1018 Lausanne 1. NAMEOFTHEMEDICINALPRODUCT Mirvaso 3 mglg gel 2. QUALITATIVE AND QUANTITATN'E COMPOSITION One gram ofgel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate. Excipient(s) with known effect: One gram ofgel contains I mg methylparahydroxltenzoate @218) and 55 mg propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICALFORM Gel. White to iight yellow opaque aqueous gel. 4. CLINICALPARTICT]LARS 4.1 Therapeuticindications Mirvaso is indicated for the rymptomatic treatment of facial erythema of rosacea in adult patients. 4.2 Posology and method of administration Posoloev One application per 24 hours, at any time suitable for the patient, for as long as facial erlthema is present. The maximum daily recommended dose is 1 g ofgel in total weight, divided into five pea size amounts. Soecial populations Elderly patients The experience ofuse of Mirvaso in patients aged above.65 years is limited (see also section 4.8). Paediatic 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 concems related to the systemic absorption of brimonidine have also been identifred 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. GALDERMA SA Av. Gratta-Paille 2 CH - 1018 Lausanne Method of administration Cutaneous use only. Cutaneous application ofa small pea size amount of medicinal product to each ofthe five areas ofthe 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 ofthe inner nose. Mirvaso should be applied only to the face. Hands should be washed immediately after applyin Perskaitykite visą dokumentą