FrancophonIA/ELRC3.0 huggingface dataset:
English: Contact your doctor immediately or go to a hospital emergency department right away if you, a child, or anyone else swallows this medicine and has any of these symptoms: feeling dizzy from low blood pressure, vomiting, tiredness or drowsiness, decreased or irregular heartbeats, small pupils (constricted pupils), difficult or slow breathing, floppiness, low body temperature and convulsions (fits).
Slovenian: Takoj se posvetujte z zdravnikom ali nemudoma pojdite na urgentni oddelek bolnišnice, če vi sami, otrok ali kdor koli drugi zaužije to zdravilo in ima katerega od naslednjih simptomov: omotičnost zaradi nizkega krvnega tlaka, bruhanje, utrujenost ali zaspanost, zmanjšan ali nereden srčni utrip, majhne zenice (zožitev zenic), oteženo ali počasno dihanje, ohlapnost mišičja, nizka telesna temperatura in konvulzije (napadi).
English: 92927 La Défense Cedex France
Slovenian: La Défense Cedex 92927
English: How to use Mirvaso Mirvaso is recommended to be applied to the face once a day only.
Slovenian: Kako uporabljati zdravilo Mirvaso Priporočamo, da zdravilo Mirvaso nanesete na obraz le enkrat na dan.
English: These products should not be applied immediately before the daily application of Mirvaso; they may be used only after the applied Mirvaso has dried.
Slovenian: Teh izdelkov se ne sme nanašati tik pred dnevnim nanosom zdravila Mirvaso; uporabiti jih je dovoljeno le, ko se naneseno zdravilo Mirvaso osuši.
English: Rare side effects (may affect up to 1 in 1000 people): - hypotension (blood pressure decreased) - heart rate decrease (slow heart rate, known as bradycardia).
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - hipotenzija (znižanje krvnega tlaka) - znižanje srčne frekvence (počasen srčni utrip, znan kot bradikardija).
English: Do not apply Mirvaso more than once a day and do not exceed the maximum daily dose of 1gram (approximately 5 pea sized amounts).
Slovenian: Zdravila Mirvaso ne nanašajte več kot enkrat na dan in ne presezite največjega dnevnega odmerka, tj. 1 gram (približno 5 grahovih zrn).
English: Mirvaso with alcohol
Slovenian: Zdravilo Mirvaso skupaj z alkoholom
English: Pay attention when opening the tube / pump for the first time, not to spill a larger quantity of gel than what is needed.
Slovenian: Ob prvem odpiranju tube/črpalke pazite, da ne izlijete več gela, kot ga potrebujete.
English: It is applied to the skin of the face to treat redness due to rosacea in adult patients.
Slovenian: Nanese se na kožo obraza za zdravljenje rdečine zaradi rozacee pri odraslih bolnikih.
English: Mirvaso has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Mirvaso nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: No data on the level of circulating catecholamines after Mirvaso administration are available.
Slovenian: Podatki o ravni cirkulirajočih kateholaminov po uporabi zdravila Mirvaso niso na voljo.
English: If you forget to use Mirvaso
Slovenian: Če ste pozabili uporabiti zdravilo Mirvaso
English: If you do not experience worsening of redness or burning, continue with the usual treatment (see section 3).
Slovenian: Če se pordelost ali pekoč občutek na koži ne pojavita, lahko nadaljujete z običajnim zdravljenjem (glejte poglavje 3).
English: 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.
Slovenian: Tanko plast zdravila Mirvaso je treba nanesti gladko in enakomerno čez cel obraz (na čelo, brado, nos in vsako lice), pri čemer se je treba izogibati predelu oči, vek, ustnic, ust in nosne sluznice.
English: Concomitant use of other systemic alpha adrenergic receptor agonists The concomitant use of other systemic alpha adrenergic receptor agonists may potentiate the undesirable effects of this class of medicinal products in patients: - with severe or unstable or uncontrolled cardiovascular disease; - with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren's syndrome.
Slovenian: Sočasna uporaba drugih sistemskih agonistov alfa adrenergičnih receptorjev Sočasna uporaba drugih sistemskih agonistov alfa adrenergičnih receptorjev lahko poveča neželene učinke tega razreda zdravil pri bolnikih: - s hudo ali nestabilno ali nekontrolirano kardiovaskularno boleznijo; - z depresijo, cerebralno ali koronarno insuficienco, Raynaudovim fenomenom, ortostatsko hipotenzijo, obliterantnim trombangiitisom, sklerodermo ali Sjögrenovim sindromom.
English: See also instructions ‘How to use Mirvaso'.
Slovenian: Glejte tudi navodila »Kako uporabljati zdravilo Mirvaso«.
English: No meaningful differences in the safety profiles were observed between the elderly subject population and subjects 18 to 65 years of age.
Slovenian: Med starejšimi osebami in osebami, starimi od 18 do 65 let, niso opazili pomembnih razlik v profilu varnosti.
English: Mirvaso is contraindicated in children aged less than 2 years because of serious systemic safety risk (see section 4.3).
Slovenian: Zdravilo Mirvaso je zaradi resnih sistemskih tveganj za zdravje kontraindicirano pri otrocih, starih manj kot 2 leti (glejte poglavje 4.3).
English: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes: EU/1/13/904/004
Slovenian: Tube z večplastno folijo iz polietilena (PE)/kopolimera/aluminija (Al)/kopolimera/polietilena (PE): EU/1/13/904/004
English: No dose adjustment is necessary.
Slovenian: Odmerka ni potrebno prilagajati.
English: INFORMATION IN BRAILLE Mirvaso
Slovenian: PODATKI V BRAILLOVI PISAVI Mirvaso
English: Across all clinical studies, 16% of patients receiving Mirvaso experienced an event of symptom exacerbation.
Slovenian: V vseh kliničnih študijah so se simptomi poslabšali pri 16 % bolnikov, ki so prejemali zdravilo Mirvaso.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC: SN:
English: Caution is advised when initiating (or changing the dose of) a concomitant systemic substance (irrespective of pharmaceutical form) which may interact with alpha adrenergic receptor agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor e.g. (isoprenaline, prazosin).
Slovenian: Previdnost se priporoča pri uvedbi (ali spremembi odmerka) sočasne sistemske učinkovine (neodvisno od farmacevtske oblike), ki lahko vpliva na agoniste alfa adrenergičnih receptorjev ali vpliva na njihovo aktivnost, tj. agonisti ali antagonisti adrenergičnih receptorjev (npr. izoprenalin, prazosin).
English: Multidose container with airless pump system with child resistant closure.
Slovenian: Večodmerni vsebnik s sistemom z brezzračno črpalko in za otroke varno zaporko.
English: As a precautionary measure, it is preferable to avoid the use of Mirvaso during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Mirvaso bolje izogibati.
English: Mirvaso can be used in conjunction with other cutaneous medicinal products for the treatment of inflammatory lesions of rosacea and with cosmetics.
Slovenian: Zdravilo Mirvaso se lahko uporablja skupaj z drugimi dermatološkimi zdravili za zdravljenje vnetnih lezij rozacee in s kozmetičnimi izdelki.
English: What Mirvaso contains - The active substance is brimonidine.
Slovenian: Kaj vsebuje zdravilo Mirvaso - Učinkovina je brimonidin.
English: The onset of flushing relative to application of Mirvaso topical gel varied, ranging from approximately 30 minutes to several hours (see section 4.8).
Slovenian: Čas od nanosa zdravila Mirvaso topikalni gel do pojava vročinskih oblivov je bil različen, in sicer od približno 30 minut do več ur (glejte poglavje 4.8).
English: Montdésir 74540 Alby-sur-Chéran France or
Slovenian: Montdésir 74540 Alby-sur-Chéran Francija ali
English: These levels are significantly lower (2-fold) than those observed following single-day ocular administration of a 0.2% eye drops solution of brimonidine.
Slovenian: Te ravni so značilno nižje (2-kratno) kot ravni, ki so jih opazili po enodnevni okularni uporabi 0,2 % raztopine brimonidina v obliki kapljic za oko.
English: Mirvaso contains: - Methylparahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Slovenian: Zdravilo Mirvaso vsebuje: - metilparahidroksibenzoat (E218), ki lahko povzroči alergijske reakcije (lahko zapoznele).
English: Moderate to severe erythema was defined as a grade 3 or greater on both the Clinician Erythema Assessment (CEA) scale and Patient Self-Assessment (PSA) scale.
Slovenian: Zmeren do hud eritem je bil označen s stopnjo 3 ali višjo tako glede na lestvico za zdravnikovo oceno eritema (CEA - Clinician Erythema Assessment) kot lestvico za bolnikovo samooceno (PSA - Patient Self-Assessment).
English: Galderma Italia S.p.A. Tel: + 39 039 63 4691
Slovenian: Tel: + 39 039 63 4691
English: Exacerbation of rosacea symptoms is very common in patients treated with Mirvaso.
Slovenian: Poslabšanje simptomov rozacee je pri bolnikih, ki se zdravijo z zdravilom Mirvaso, zelo pogosto.
English: Angioedema*
Slovenian: redki angioedem*
English: The efficacy of Mirvaso in the treatment of moderate to severe facial erythema of rosacea has been demonstrated in two randomised, vehicle controlled blinded clinical trials, which were identical in design.
Slovenian: Učinkovitost zdravila Mirvaso pri zdravljenju zmernega do hudega obraznega eritema zaradi rozacee je bila dokazana v dveh randomiziranih, z vehiklom kontroliranih slepih kliničnih preskušanjih, ki sta bili po zasnovi identični.
English: This medicine does not require any special storage condition.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila.
English: METHOD OF ADMINISTRATION Do not swallow.
Slovenian: POSTOPEK UPORABE Ne pogoltnite.
English: If your symptoms worsen during treatment with Mirvaso (increased redness, or burning), stop treatment and make an appointment to see your doctor - see also section 2 under `Warnings and precautions'.
Slovenian: Če se simptomi med zdravljenjem z zdravilom Mirvaso poslabšajo (povečana pordelost ali pekoč občutek na koži), prekinite zdravljenje in se naročite pri zdravniku - glejte tudi poglavje 2 Opozorila in previdnostni ukrepi).
English: One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55 mg propylene glycol (E1520).
Slovenian: En gram gela vsebuje 1 mg metilparahidroksibenzoata (E218) in 55 mg propilenglikola (E1520).
English: Driving and using machines Mirvaso has no significant influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Mirvaso nima pomembnega vpliva na sposobnost vožnje ali upravljanja s stroji.
English: Concomitant use of Mirvaso with other medicinal products for the treatment of inflammatory lesions of rosacea has not been systematically investigated.
Slovenian: Sočasna uporaba z drugimi zdravili za zdravljenje vnetnih lezij zaradi rozacee ni bila sistemsko raziskana.
English: What Mirvaso is and what it is used for What you need to know before you use Mirvaso How to use Mirvaso
Slovenian: Kaj je zdravilo Mirvaso in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Mirvaso Kako uporabljati zdravilo Mirvaso Možni neželeni učinki
English: How to use Mirvaso
Slovenian: Kako uporabljati zdravilo Mirvaso
English: Continue to press down the pump to get the number of pea sizes you need according to your doctor's prescription (but no more than 5 pea sizes in total).
Slovenian: Nadaljujte s pritiskanjem črpalke, dokler ne dobite količine, ustrezne številu grahovih zrn, ki vam jih je predpisal vaš zdravnik (vendar ne več kot skupno 5 grahovih zrn).
English: - if you 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).
Slovenian: - če uporabljate nekatera zdravila, ki se uporabljajo pri depresiji ali Parkinsonovi bolezni, vključno s tako imenovanimi zaviralci monoamin oksidaze (MAO) (npr. selegilin ali moklobemid), tricikličnimi antidepresivi (kot je imipramin) ali tetracikličnimi antidepresivi (kot so maprotilin, mianserin ali mirtazapin).
English: Do not use this medicine after the expiry date which is stated on the carton, tube and pump after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, tubi in črpalki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: even if their signs of illness are the same as yours.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni podobne vašim.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not swallow.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Ne pogoltnite.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/904/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/904/006
English: The maximum daily recommended dose is 1 g of gel in total weight, which corresponds to approximately five pea sized amounts.
Slovenian: Največji dnevni priporočeni odmerek je 1 g skupne mase gela, kar ustreza približno petim delom v velikosti grahovega zrna.
English: Do not take Mirvaso with selegiline, moclobemide, imipramine, mianserin, or maprotiline, which are medicines that can be used for depression or Parkinson's disease, as this could lead to a change in the effectiveness of Mirvaso or could increase the chances for side effects such as a fall in blood pressure (see under ‘Do not use Mirvaso').
Slovenian: Zdravila Mirvaso ne uporabljajte skupaj s selegininom, moklobemidom, imipraminom, mianserinom ali maprotilinom, tj. zdravili za zdravljenje depresije ali Parkinsonove bolezni, saj lahko spremenijo učinkovitost zdravila Mirvaso ali povečajo verjetnost neželenih učinkov, kot je padec krvnega tlaka (glejte poglavje „Ne uporabljajte zdravila Mirvaso“).
English: Mirvaso should not be used during breast-feeding.
Slovenian: Zdravilo Mirvaso se med dojenjem ne sme uporabljati.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 30 G TUBE / MULTIDOSE CONTAINER WITH AIRLESS PUMP
Slovenian: PODATKI NA PRIMARNI OVOJNINI 30 g TUBA/VEČODMERNI VSEBNIK Z BREZZRAČNO ČRPALKO
English: If you develop uncommon side effects of severe skin irritation or inflammation, skin rash, skin pain or discomfort, dry skin, warm skin sensation, tingling or sensation of pins and needles or swelling of the face or common side effects like worsening of rosacea, discontinue the treatment and talk to your doctor since this medicine may not be suitable for you.
Slovenian: Če se pojavijo občasni neželeni učinki hudo draženje kože ali vnetje, kožni izpuščaj, bolečine ali nelagodje na koži, suha koža, topel občutek na koži, ščemenje ali mravljinčenje, oteklost obraza ali pogosti neželeni učinek poslabšanje rozacee , prenehajte z zdravljenjem in se takoj posvetujte z zdravnikom, ker morda to zdravilo ni primerno za vas.
English: All enrolled subjects received a single-day ocular administration of a 0.2% eye drops solution of brimonidine followed by a once daily cutaneous application of Mirvaso for 29 days (intra-individual comparison of systemic exposure).
Slovenian: Vse vključene osebe so 29 dni enkrat na dan okularno prejemale 0,2 % kapljice za oko, raztopino brimonidina, nato pa je sledil dermalni nanos zdravila Mirvaso enkrat na dan (primerjava sistemske izpostavljenosti med posamezniki).
English: PSA: Patient Self-Assessment: 0=No redness, 1=Very mild redness, 2=Mild redness, 3=Moderate redness and 4=Severe redness
Slovenian: PSA: Bolnikova samoocena: 0=Ni rdečine, 1=Zelo blaga rdečina, 2=Blaga rdečina, 3=Zmerna rdečina in 4=Huda rdečina
English: Caution, however, is advised in patients taking substances which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine.
Slovenian: Vendar je potrebna pozornost pri bolnikih, ki jemljejo učinkovine, ki lahko vplivajo na presnovo in privzem cirkulirajočih aminov, npr. klorpromazin, metilfenidat, reserpin.
English: When applied, Mirvaso acts to narrow these blood vessels again which reduces the excess blood flow and redness.
Slovenian: Pri nanosu zdravilo Mirvaso deluje tako, da te žilice zoži, kar zmanjša čezmerni pretok krvi in rdečino.
English: The results from both clinical studies demonstrated that Mirvaso was significantly more effective (p<0.001) in the reduction of facial erythema of rosacea than vehicle gel when applied once daily for 29 days (primary endpoint, see Table 2).
Slovenian: Rezultati obeh kliničnih študij so pokazali, da je bilo zdravilo Mirvaso, naneseno enkrat na dan 29 dni, značilno učinkovitejše (p < 0,001) pri zmanjšanju obraznega eritema zaradi rozacee kot vehikel (primarni opazovani dogodek, glejte preglednico 2).
English: It is important not to exceed the maximum daily dose of 1gram (5 pea sized amounts applied to the whole face).
Slovenian: Pomembno je, da ne presežete največjega dnevnega odmerka, tj. 1 g (5 grahovih zrn), ki ga nanesete na celoten obraz.
English: Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission (see section 4.3).
Slovenian: Zdravilo Mirvaso je kontraindicirano pri bolnikih, ki se zdravijo z zaviralci monoamin oksidaze (MAO) in bolniki, ki se zdravijo s tricikličnimi ali tetracikličnimi antidepresivi, ki vplivajo na noradrenergično transmisijo (glejte poglavje 4.3).
English: In addition, for the overall population, Mirvaso demonstrated statistical superiority (p<0.001) over vehicle gel with respect to rapid initial onset of a clinically meaningful effect (1-Grade Composite Success for CEA and PSA) after the first application at 30 minutes on Day 1(secondary endpoint 27.9% vs. 6.9% for Study 1, 28.4% vs. 4.8% for Study 2), and to achievement of a clinically meaningful effect (1-Grade Composite Success for CEA and PSA) on Day 29 (tertiary endpoint, see Table 4).
Slovenian: (p < 0,001) kot gel z vehiklom glede hitrega začetka klinično pomembnega učinka (1-stopenjski sestavljeni uspeh za CEA in PSA) po prvem nanosu pri 30. minutah na 1. dan (sekundarni opazovani dogodek 27,9 % v primerjavi s 6,9% za študijo 1 in 28,4 % v primerjavi s 4,8 % za študijo 2) in za doseganje klinično pomembnega učinka (1-stopenjski sestavljeni uspeh za CEA in PSA) na 29. dan (terciarni opazovani dogodek; glejte preglednico 4).
English: The primary endpoint was expressed in terms of composite success i.e. subjects responding with a 2-grade reduction on both baseline CEA score and baseline PSA score on Day 29.
Slovenian: Primarni opazovani dogodek je bil izražen kot sestavljeni uspeh, tj. osebe, ki so se odzvale z 2-stopenjskim izboljšanjem glede na izhodiščno vrednost CEA in PSA na 29. dan.
English: - Propylene glycol (E1520) which may cause skin irritation.
Slovenian: - Propilenglikol (E1520), ki lahko povzroči draženje kože.
English: - you have kidney or liver problems or have had them in the past.
Slovenian: - imate ali ste imeli težave z ledvicami ali jetri.
English: How to open the tube with a child-resistant cap To avoid spilling, do not squeeze the tube while opening or closing.
Slovenian: Da preprečite razlitje, tube med odpiranjem in zapiranjem ne stiskajte.
English: However, in the long term open label study, the efficacy and safety of Mirvaso, as described above, was not affected by the concomitant use of cosmetics or other medicinal products (e.g. topical metronidazole, topical azelaic acid, and oral tetracyclines including low dose doxycycline) for the treatment of inflammatory lesions of rosacea in the concerned subpopulation (131/449 patients in the study used concomitant rosacea medicinal product).
Slovenian: V dolgoročni odprti študiji, kot je opisano zgoraj, sočasna uporaba kozmetičnih izdelkov ali drugih zdravil (npr. metronidazol za topikalno uporabo, azelainska kislina za topikalno uporabo in tetraciklini za peroralno uporabo, vključno z nizkim odmerkom doksicilina) za zdravljenje vnetnih lezij zaradi rozacee v zadevni podpopulaciji (131/449 bolnikov je v študiji sočasno uporabljalo zdravilo za rozaceo) ni vplivala na učinkovitost in varnost zdravila Mirvaso.
English: The medicinal product contains methylparahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed), and propylene glycol (E1520) which may cause skin irritation.
Slovenian: To zdravilo vsebuje metilparahidroksibenzoat (E218), ki lahko povzroči alergijske reakcije (lahko zapoznele), in propilenglikol (E1520), ki lahko povzroči draženje kože.
English: Table 3: Percentage of subjects with severe erythema at baseline Day 1 (CEA or PSA grade 4) with 2-grade improvement in both CEA and PSA
Slovenian: Preglednica 3: Odstotek oseb s hudim eritemom ob izhodišču - na 1. dan (CEA ali PSA stopnje 4) z 2-stopenjskim izboljšanjem vrednosti CEA in PSA
English: In case worsening of erythema occurs, Mirvaso topical gel should be discontinued.
Slovenian: Če pride do poslabšanja eritema, je treba prekiniti z uporabo zdravila Mirvaso topikalni gel.
English: 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.
Slovenian: Poročali so, da preveliki peroralni odmerki agonistov alfa2 povzročajo simptome, kot so hipotenzija, astenija, bruhanje, letargija, sedacija, bradikardija, aritmije, mioza, apneja, hipotonija, hipotermija, respiratorna depresija in epileptični napadi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En gram gela vsebuje 3,3 mg brimonidina, kar ustreza 5 mg brimonidinijevega tartrata.
English: A potential consequence of stopping the treatment before finishing the course of treatment is the disease to come back to its initial state.
Slovenian: Če ste prenehali uporabljati zdravilo Mirvaso Bolezen se lahko povrne v prvotno stanje kot potencialna posledica predčasnega prenehanja zdravljenja.
English: Mirvaso contains the active substance brimonidine which belongs to a group of medicines commonly referred to as “alpha agonists”.
Slovenian: Kaj je zdravilo Mirvaso in za kaj ga uporabljamo Zdravilo Mirvaso vsebuje učinkovino brimonidin, ki sodi v skupino zdravil, pogosto označenih kot »agonisti alfa«.
English: Prior to resuming treatment after temporary discontinuation due to aggravated erythema or flushing, perform a test application on a small area of the face for at least one day before full facial application is resumed.
Slovenian: Pred nadaljevanjem zdravljenja po začasni prekinitvi zaradi poslabšanja eritema ali vročinskih oblivov z nanosom na celoten obraz, opravite poskusni nanos na majhnem predelu obraza.
English: If you use more than the maximum daily dose of 1 gram within a 24 hour period, it could lead to skin irritation or other side effects at the application site.
Slovenian: Če ste uporabili večji odmerek zdravila Mirvaso, kot bi smeli Če ste v 24-urnem obdobju uporabili odmerek, večji od največjega dnevnega odmerka, 1 gram, lahko pride do draženja kože in drugih neželenih učinkov na mestu nanosa.
English: One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.
Slovenian: En gram gela vsebuje 3,3 mg brimonidina, kar ustreza 5 mg brimonidinijevega tartrata.
English: - you have depression, decreased blood flow to the brain or the heart, fall in blood pressure on standing up, decreased blood flow to the hands, feet or skin, or Sjögren's syndrome (a chronic disease in which the body's natural defence - the immune system - attacks the moisture-producing glands).
Slovenian: - imate depresijo, zmanjšan pretok krvi v možgane ali srce, padec krvnega tlaka ob vstajanju ali zmanjšan pretok krvi v dlani, stopala ali kožo ali Sjögrenov sindrom (kronična bolezen,