FrancophonIA/ELRC3.0 huggingface dataset:
English: After repeated cutaneous application of Mirvaso on facial skin, no drug accumulation in plasma was observed throughout the treatment duration: the highest mean (± standard deviation) plasma maximum concentration (Cmax) and area under the concentration-time curve from 0 to 24 hours (AUC0-24hr) were 46 ± 62 pg/mL and 417 ± 264 pg.hr/mL respectively.
Croatian: Nakon ponovljene kutane primjene gela Mirvaso na kožu lica nije primijećeno nakupljanje lijeka u plazmi za vrijeme liječenja: najviše srednje vrijednosti (± standardna devijacija) maksimalne koncentracije u plazmi (Cmax) i površine ispod krivulje koncentracija-vrijeme od 0 do 24 sata (AUC0-24h) iznosile su 46 ± 62 pg/ml odnosno 417 ± 264 pg.h/ml.
English: Do not apply any other skin medicines or cosmetics immediately before the daily application of Mirvaso.
Croatian: Ne nanosite nikakve druge lijekove za kožu ili kozmetičke proizvode prije dnevne primjene lijeka Mirvaso.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2014
Croatian: Datum prvog odobrenja: 21. veljače 2014.
English: If you do not experience worsening of redness or burning, continue with the usual treatment (see section 3).
Croatian: Ako se pogoršanje crvenila ili žarenja ne pojavi, nastavite s uobičajenim liječenjem (vidjeti dio 3.).
English: No adverse reactions had an increase in frequency over time, and there was no evidence that long-term use of Mirvaso conveyed an increased risk of occurrence of any specific type of adverse reaction.
Croatian: Ni kod jedne nuspojave nije se povećala učestalost tijekom vremena i nije bilo dokaza da dugotrajna primjena lijeka Mirvaso donosi povećani rizik od nastanka određene vrste nuspojave.
English: As a precautionary measure, it is preferable to avoid the use of Mirvaso during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu gela Mirvaso tijekom trudnoće.
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).
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): - hipotenzija (sniženi krvni tlak) - smanjena brzina srčanih otkucaja (usporen puls, poznat kao bradikardija).
English: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes: EU/1/13/904/004
Croatian: Višeslojne tube od polietilena (PE)/kopolimera/aluminija (Al)/kopolimera/polietilena (PE): EU/1/13/904/004
English: If you develop contact allergy (e.g. allergic reaction, rash) or rare angioedema (a serious allergic reaction see rarely usually with swelling of the face, mouth or tongue), stop using Mirvaso and seek prompt medical advice.
Croatian: Ako opazite kontaktnu alergiju (npr. alergijsku reakciju, osip) ili rijetko angioedem (ozbiljnu alergijsku reakciju koja se rijetko pojavljuje, a obično se očituje oticanjem lica, usta ili jezika) prekinite s primjenom gela Mirvaso i odmah zatražite liječničku pomoć.
English: In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued.
Croatian: U slučaju pojave teške nadraženosti ili kontaktne alergije, liječenje ovim lijekom mora se odmah prekinuti.
English: The overall frequencies of adverse reactions in this study are reflected in Table 1 above, with the highest rates occurring in the first 29 days of use.
Croatian: Ukupna učestalost nuspojava u ovom ispitivanju prikazana je u Tablici 1., a najviše stope pojavile su se u prvih 29 dana primjene.
English: Note: when the cap is removed, the pump is not child-resistant.
Croatian: Napomena: nakon skidanja zatvarača, pumpica više nije sigurna za djecu.
English: It is unknown whether brimonidine/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se brimonidin/metaboliti u majčino mlijeko.
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data) and were reported with Mirvaso either in clinical studies, or during the post-marketing experience (identified by an asterix (*) in Table 1).
Croatian: Nuspojave su prikazane prema MedDRA-inoj klasifikaciji organskih sustava i prema učestalosti, uz sljedeće odrednice: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka), a zabilježene su kod gela Mirvaso u kliničkim ispitivanjima ili tijekom razdoblja nakon stavljanja lijeka na tržište (označeno zvjezdicom (*) u Tablici 1).
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.
Croatian: Prije nego što nastavite liječenje nakon privremenog prekida zbog pogoršanja eritema ili navale crvenila, testirajte primjenu gela na malom području lica barem jedan dan prije nastavka ponovne primjene na cijelom licu.
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).
Croatian: Odmah se obratite svom liječniku ili odmah idite na hitni prijem u bolnicu ako Vi ili dijete ili bilo tko drugi proguta ovaj lijek te ako ima bilo koji od ovih simptoma: omaglicu zbog niskog krvnog tlaka, povraćanje, umor ili omamljenost, smanjene ili nepravilne otkucaje srca, male zjenice (sužene zjenice), otežano ili sporo disanje, mlohavost, nisku tjelesnu temperaturu i konvulzije (napadaje).
English: Mirvaso has no or negligible influence on the ability to drive and use machines.
Croatian: Mirvaso ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Caution, however, is advised in patients taking substances which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine.
Croatian: Međutim, preporučuje se oprez u bolesnika koji uzimaju tvari koje mogu utjecati na metabolizam i apsorpciju cirkulirajućih amina poput klorprozamina, metilfenidata, rezerpina.
English: Mirvaso should be applied only to the face.
Croatian: Mirvaso se primjenjuje samo na lice.
English: It is important to start treatment with a small amount of gel, increase the dose gradually but do not exceed the maximum dose of 1 gram (approximately 5 pea sized amounts).
Croatian: Važno je započeti liječenje s malom količinom gela i postupno povećavati dozu, ali ne prekoračiti maksimalnu dozu od 1 grama (približno količina veličine pet zrna graška).
English: In case of worsening or unexpected redness, discontinue the treatment and contact your doctor.
Croatian: U slučaju pogoršanja ili neočekivanog crvenila, prekinite liječenje i javite se svom liječniku.
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).
Croatian: Osim toga, za ukupnu populaciju, Mirvaso se pokazao statistički superiorniji (p<0,001) od podloge gela u pogledu brzog nastupanja klinički značajnog učinka (kompozitna 1-stupanjska uspješnost za CEA i PSA) nakon prve primjene u 30 minuta na Dan 1. (sekundarni ishod 27,9% naspram 6,9% za Ispitivanje 1., 28,4% naspram 4,8% za Ispitivanje 2.), i postizanja klinički značajnog učinka (kompozitna 1-stupanjska uspješnost za CEA i PSA) na Dan 29. (tercijarni ishod, vidjeti Tablicu 4.).
English: Keep Mirvaso gel away from children.
Croatian: Čuvajte Mirvaso gel dalje od dohvata djece.
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).
Croatian: Preporučuje se oprez pri istodobnom uvođenju (ili mijenjanju doze) tvari sa sistemskim učinkom (neovisno o farmaceutskom obliku) koja može djelovati u interakciji s agonistima alfa-adrenergičkih receptora ili interferirati njihovu aktivnost, tj. agonisti ili antagonisti adrenergičkih receptora (npr. izoprenalin, prazosin).
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).
Croatian: Međutim, u dugotrajnom otvorenom ispitivanju, na djelotvornost i sigurnost lijeka Mirvaso, kao što je prije opisano, nije utjecala istodobna primjena drugih kozmetičkih proizvoda ili lijekova (npr. topikalni metronidazol, topikalna azelatna kiselina i peroralni tetraciklini uključujući nisko dozirani doksiciklin) za liječenje upalnih lezija rozaceje u toj subpopulaciji (131/449 bolesnika u ispitivanju istodobno je koristilo lijek za rozaceju).
English: White to light yellow opaque aqueous gel.
Croatian: Bijeli do svijetložuti neprozirni vodeni gel.
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').
Croatian: Nemojte uzimati Mirvaso uz selegilin, moklobemid, imipramin, mianserin ili maprotilin (lijekove koji se mogu koristiti kod depresije ili Parkinsonove bolesti) jer bi oni mogli prouzročiti promjenu u učinkovitosti lijeka Mirvaso ili bi mogli povećati vjerojatnost od nuspojava poput pada krvnog tlaka (pogledajte „Nemojte primjenjivati Mirvaso“).
English: Distribution The protein binding of brimonidine has not been studied.
Croatian: Nije ispitivano vezanje brimonidina na proteine.
English: SPECIAL STORAGE CONDITIONS Do not freeze.
Croatian: POSEBNE MJERE ČUVANJA Ne zamrzavati.
English: Tube of 10 g and 30g
Croatian: Tuba od 10 g i 30 g
English: Galderma Italia S.p.A. Tel: + 39 039 63 4691
Croatian: Tel: + 39 039 63 4691
English: One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55 mg propylene glycol (E1520).
Croatian: Jedan gram gela sadrži 1 mg metilparahidroksibenzoata (E218) i 55 mg propilenglikola (E1520).
English: Mirvaso can be used in conjunction with other cutaneous medicinal products for the treatment of inflammatory lesions of rosacea and with cosmetics.
Croatian: Mirvaso se može primjenjivati u kombinaciji s drugim lijekovima za kožu za liječenje upalnih lezija rozaceje i s kozmetičkim proizvodima.
English: Do not use this medicine after the expiry date which is stated on the carton, tube and pump after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, tubi i pumpici iza oznake „Rok valjanosti“ ili „EXP“.
English: Talk to your doctor or pharmacist, before using Mirvaso especially if: - the skin of your face is irritated or has open wounds.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Mirvaso, pogotovo: - ako Vam je koža lica nadražena ili ako ima otvorene rane - ako imate problema sa srcem ili cirkulacijom
English: Driving and using machines Mirvaso has no significant influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Mirvaso ne utječe značajno na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Umjereni do teški eritem lica definiran je stupnjem 3 ili višim kako na skali liječničke procjene eritema (engl. clinician erythema assessment, CEA) tako i na skali samoprocjene bolesnika (engl. patient self-assessment, PSA).
English: No data on the level of circulating catecholamines after Mirvaso administration are available.
Croatian: Nisu dostupni podaci o razini cirkulirajućih kateholamina nakon primjene gela Mirvaso.
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).
Croatian: Rezultati oba klinička ispitivanja pokazali su da je Mirvaso značajno učinkovitiji (p<0,001) u smanjenju eritema lica uzrokovanog rozacejom nego podloga gela kada se primjenjuje jednom dnevno tijekom 29 dana (primarni ishod, vidjeti Tablicu 2.).
English: INFORMATION IN BRAILLE Mirvaso
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Mirvaso
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).
Croatian: Nemojte primjenjivati Mirvaso više od jednom dnevno i nemojte prekoračiti maksimalnu dnevnu dozu od 1grama (približno količina veličine pet zrna graška).
English: Concomitant use of Mirvaso with other medicinal products for the treatment of inflammatory lesions of rosacea has not been systematically investigated.
Croatian: Istodobna primjena lijeka Mirvaso s drugim lijekovima za liječenje upalnih lezija rozaceje nije sustavno ispitana.
English: Redness of the face due to rosacea is caused by high levels of blood flow in the facial skin, which is the result of enlargement (dilation) of the small blood vessels of the skin.
Croatian: Crvenilo kože lica zbog rozaceje uzrokovano je većim dotokom krvi u kožu lica zbog povećanja (proširenja) malih krvnih žila u koži.
English: It is important not to exceed the maximum daily dose of 1gram (5 pea sized amounts applied to the whole face).
Croatian: Važno je ne prekoračiti maksimalnu dnevnu dozu od 1grama (količina veličine 5 zrna graška primijenjena na cijelo lice).
English: How to open the tube with a child-resistant cap To avoid spilling, do not squeeze the tube while opening or closing.
Croatian: Kako biste izbjegli prolijevanje, ne tiskajte tubu pri otvaranju ili zatvaranju.
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.
Croatian: Te su razine značajno niže (dvostruko) od razina primijećenih nakon jednodnevne okularne primjene 0,2% otopine kapi za oko s brimonidinom.
English: CEA: Clinician Erythema Assessment: 0=Clear skin with no signs of erythema, 1=Almost clear; slight redness, 2=Mild erythema; definite redness, 3=Moderate erythema+ marked redness and 4=Severe erythema+ fiery redness
Croatian: CEA: liječnička procjena eritema: 0=Čista koža bez znakova eritema, 1=Gotovo čista koža, lagano crvenilo, 2=Blagi eritem; jasno crvenilo, 3=Umjereni eritem + značajno crvenilo, 4=Teški eritem + vatreno crvenilo
English: Worsening of skin redness, flushing or burning feeling of the skin Up to 1 in 6 patients experience the return of their redness worse than it was initially.
Croatian: Pogoršanje crvenila kože, navale crvenila ili osjećaja žarenja kože Najviše jednom od 6 bolesnika crvenilo se vrati u gorem obliku od početnog.
English: Post-marketing cases of bradycardia, hypotension (including orthostatic hypotension) and dizziness have been reported, some of which required hospitalisation.
Croatian: Slučajevi bradikardije, hipotenzije (uključujući ortostatsku hipotenziju) i omaglice prijavljeni su nakon stavljanja lijeka u promet.
English: One application per 24 hours, at any time suitable for the patient, for as long as facial erythema is present.
Croatian: Nanosi se jednom u 24 sata kada god to bolesniku odgovara, sve dok je eritem lica prisutan.
English: Mirvaso 3 mg/g gel brimonidine
Croatian: Mirvaso 3 mg/g gel brimonidin
English: The absorption of brimonidine from Mirvaso was evaluated in a clinical study in 24 adult subjects with facial erythema of rosacea.
Croatian: Apsorpcija brimonidina iz gela Mirvaso ispitana je u kliničkom ispitivanju provedenom na 24 odrasla ispitanika s eritemom lica uzrokovanog rozacejom.
English: Pack sizes: 1 tube of 2 g,10 g or 30 g; 1 pump of 30 g. Not all pack sizes may be marketed.
Croatian: Veličine pakiranja: 1 tuba od 2 g, 10 g ili 30 g; 1 pumpica od 30 g.
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).
Croatian: - ako uzimate određene lijekove koji se koriste kod depresije ili Parkinsonove bolesti uključujući takozvane inhibitore monoaminooksidaze (MAO) (na primjer selegilin ili moklobemid), ili triciklične antidepresive (poput imipramina) ili tetraciklične antidepresive (poput maprotilina, mianserina ili mirtazapina).
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).
Croatian: Mirvaso je kontraindiciran u bolesnika koji primaju terapiju inhibitorom monoaminooksidaze (MAO) i u bolesnika koji su na tricikličkim ili tetracikličkim antidepresivima koji utječu na noradrenergičku transmisiju (vidjeti dio 4.3).
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).
Croatian: Trenutak pojave navale crvenila povezan uz primjenu Mirvaso gela za topikalnu primjenu varirao je u rasponu od približno 30 minuta do nekoliko sati (vidjeti dio 4.8).
English: If you experience worsening of redness or burning you should stop using Mirvaso and contact your doctor if needed.
Croatian: Ako se crvenilo ili žarenje pogoršaju, morate prestati primjenjivati Mirvaso i javiti se svom liječniku po potrebi.
English: If you forget to use Mirvaso
Croatian: Ako ste zaboravili primijeniti Mirvaso
English: How to use Mirvaso Mirvaso is recommended to be applied to the face once a day only.
Croatian: Kako primjenjivati Mirvaso Preporučuje se nanošenje lijeka Mirvaso na kožu lica samo jednom dnevno.
English: Tube of 2g
Croatian: Tuba od 2 g
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.
Croatian: Ako opazite manje česte nuspojave kao što su teška nadraženost ili upala kože, kožni osip, bolovi ili neugoda na koži, suha koža, osjećaj topline na koži, trnci ili osjećaj bockanja ili nateknuće lica ili čestu nuspojavu kao što je pogoršanje rozaceje, prekinite s liječenjem i posavjetujte se s liječnikom jer ovaj lijek možda nije prikladan za vas.
English: How to use Mirvaso
Croatian: Kako primjenjivati Mirvaso
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Laboratoires Galderma
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Laboratoires Galderma
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.
Croatian: Djelotvornost gela Mirvaso u liječenju umjerenog do teškog eritema lica uzrokovanog rozacejom dokazana je u dva randomizirana, podlogom kontrolirana slijepa klinička ispitivanja identičnog dizajna.
English: It is important to inform the patient not to exceed the recommended maximum dose (5 pea size amounts) and frequency of application (once daily).
Croatian: Važno je upozoriti bolesnika na to da ne prekorači preporučenu maksimalnu dozu (količina veličine 5 zrna graška) i učestalost primjene (jednom dnevno).
English: How to close the tube with a child-resistant cap Push down and turn clockwise (turn to the right).
Croatian: Kako zatvoriti tubu sa zatvaračem sigurnim za djecu Pritisnite i okrenite u smjeru kazaljke na satu (okrenite udesno).
English: Tel. +356 21461851, +356 21460164 e-mail:info@prohealth.com.mt
Croatian: +356 21461851, +356 21460164 e-mail: info@prohealth.com.mt
English: Day 1 (i.e. subjects with CEA or PSA grade of 4) which represented 26% of the randomised subjects, the results on the primary endpoint on Day 29 were similar to those results observed in the overall population (see Table 3) and were statistically significant for both studies combined (p=0.003).
Croatian: U podskupini populacije bolesnika s teškim eritemom kao početnom vrijednošću na Dan 1. (tj. podskupine sa CEA ili PSA stupnja 4.) koja je predstavljala 26% randomiziranih ispitanika, rezultati primarnog ishoda ispitivanja na Dan 29. bili su slični rezultatima opaženima u ukupnoj populaciji (vidjeti Tablicu 3.) i bili su statistički značajni za oba kombinirana ispitivanja (p= 0,003).
English: Caution is therefore advised when using medicinal products such as anti-hypertensives and/or cardiac glycosides concomitantly with brimonidine.
Croatian: Stoga se savjetuje oprez pri istodobnoj primjeni brimonidina s lijekovima poput antihipertenziva i/ili srčanih glikozida.
English: If you stop using Mirvaso
Croatian: Ako prestanete primjenjivati Mirvaso
English: It is applied to the skin of the face to treat redness due to rosacea in adult patients.
Croatian: Nanosi se na kožu lica radi liječenja crvenila uzrokovanog rozacejom u odraslih.
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.
Croatian: U slučajevima predoziranja nakon peroralne primjene drugih alfa2-agonista zabilježeni su simptomi poput hipotenzije, astenije, povraćanja, letargije, sedacije, bradikardije, aritmije, mioze, apneje, hipotonije, hipotermije, depresije disanja i napadaja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan gram gela sadrži 3,3 mg brimonidina, što odgovara 5 mg brimonidintartarata.
English: Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.
Croatian: Mirvaso je indiciran za simptomatsko liječenje eritema lica uzrokovanog rozacejom u odraslih bolesnika.
English: Multidose container with airless pump system with child resistant closure.
Croatian: Višedozni spremnik sa sistemom zaštitne pumpice i zatvaračem sigurnim za djecu.
English: To apply Mirvaso gel to your face, dispense a pea-sized amount of Mirvaso from the pump onto your fingertip.
Croatian: Za nanošenje Mirvaso gela na lice istisnite na vršak prsta malu količinu Mirvaso gela veličine zrna graška.