FrancophonIA/ELRC3.0 huggingface dataset:
English: Of these, 539 completed 29 days of treatment and had data available to be included in the efficacy analysis at Day 29, with the majority being Caucasians between 18 and 65 years of age.
Slovenian: 539 med njimi je v 29 dneh zaključilo zdravljenje in zagotovilo podatke, ki so bili vključeni v analizo učinkovitosti na 29. dan, pri čemer je bila večina belcev, starih med 18 in 65 let.
English: Mirvaso should not be used in children or adolescents aged 2 to 18 years.
Slovenian: Zdravila Mirvaso se ne sme uporabljati pri otrocih in mladostnikih, starih od 2 do 18 let.
English: You should not use this medicine during breast-feeding, as it is unknown whether this medicine passes into the breast milk.
Slovenian: Tega zdravila ne uporabljajte med dojenjem, ker ni znano ali zdravilo prehaja v materino mleko.
English: They are typically mild to moderate in severity, and usually do not require discontinuation of treatment.
Slovenian: Običajno so blagi do zmerni po resnosti, zaradi njih pa običajno ni treba prekiniti zdravljenja.
English: Tell your doctor if you consume alcohol regularly as this could affect your treatment with this medicine.
Slovenian: Svojemu zdravniku povejte, če redno uživate alkohol, saj lahko to vpliva na vaše zdravljenje s tem zdravilom.
English: Bradycardia and hypotension
Slovenian: Bradikardija in hipotenzija
English: The studies were conducted in 553 randomised subjects aged 18 years and older who were treated once daily for 4 weeks with either Mirvaso or vehicle.
Slovenian: Študije so opravili pri 553 naključno izbranih osebah, starih 18 let in več, ki so bile 4 tedne zdravljene enkrat na dan z zdravilom Mirvaso ali z vehiklom.
English: If you miss a daily dose, your redness will not be reduced for that day.
Slovenian: Če boste izpustili dnevni odmerek, se rdečina tisti dan ne bo zmanjšala.
English: The results from a long term open label study in 449 patients, with continuous treatment for up to one year, confirmed that chronic use of Mirvaso is safe and effective.
Slovenian: Rezultati dolgoročne odprte študije pri 449 bolnikih z neprekinjenim zdravljenjem do enega leta so pokazali, da je dolgotrajna uporaba zdravila Mirvaso varna in učinkovita.
English: Important: Mirvaso is intended for adults and only for use on the skin of the face.
Slovenian: Pomembno: Zdravilo Mirvaso je namenjeno za odrasle in le za kožo na obrazu.
English: Distribution The protein binding of brimonidine has not been studied.
Slovenian: Porazdelitev Vezave brimonidina na beljakovine niso preučili.
English: 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).
Slovenian: Varnostni pomisleki v zvezi s sistemsko absorpcijo brimonidina so se pojavili tudi pri starostni skupini od 2 do 12 let (glejte poglavje 4.9).
English: Such worsening of redness usually develops within the first 2 weeks of treatment with Mirvaso.
Slovenian: Takšno poslabšanje pordelosti se običajno pojavi v prvih 2 tednih zdravljenja z zdravilom Mirvaso.
English: Do not use a double dose to make up for a forgotten dose and continue your treatment as prescribed.
Slovenian: Ne uporabite dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek in nadaljujte z zdravljenjem kot vam je bilo predpisano.
English: Please contact your doctor, who will advise you on what action to take.
Slovenian: V tem primeru se posvetujte z zdravnikom, ki vam bo svetoval, kako ukrepati.
English: The experience of use of Mirvaso in patients aged above 65 years is limited (see also section 4.8).
Slovenian: Izkušnje z uporabo zdravila Mirvaso pri bolnikih nad 65 let so omejene (glejte tudi poglavje 4.8).
English: Most of the cases were observed within the first 2 weeks of starting the treatment (see section 4.8).
Slovenian: V večini primerov se je to zgodilo v prvih 2 tednih zdravljenja (glejte poglavje 4.8.
English: The pump is child-resistant again.
Slovenian: Črpalka je ponovno za otroke varna.
English: Any increase in the daily amount applied above 5 pea sized amounts and/or increase in frequency of daily application of the medicinal product should be avoided, since the safety of higher daily doses or repeated daily application has not been assessed.
Slovenian: DrugoVsakršno zvečanje dnevne nanesene količine nad 5 grahovih zrn in/ali povečano pogostnost dnevnih nanosov zdravila je treba preprečiti, saj varnosti višjih dnevnih odmerkov ali ponavljajočih se dnevnih nanosov niso ocenili.
English: - in children below 2 years of age, as they may be at greater risk of side effects from any of the medicine absorbed through the skin.
Slovenian: - pri otrocih, starih manj kot 2 leti, ki jih neželeni učinki katerega koli zdravila, ki se absorbira skozi kožo, lahko bolj ogrožajo.
English: If anyone, especially a child, accidentally swallows Mirvaso, they may have serious side effects and need to be treated in a hospital.
Slovenian: Če kdor koli, zlasti otrok, po nesreči zaužije zdravilo Mirvaso, ima to lahko za posledico resne neželene učinke, kar zahteva zdravljenje v bolnišnici.
English: Mirvaso may also cause the following other side effects:
Slovenian: Zdravilo Mirvaso lahko povzroči tudi katere od naslednjih drugih neželenih učinkov:
English: Manufacturer Laboratoires Galderma Z.I.
Slovenian: Laboratoires Galderma Z.I.
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.
Slovenian: Celokupna pogostnost neželenih učinkov za to študijo je navedena v Preglednici 1 zgoraj, njihova pogostnost pa je največja v prvih 29 dneh uporabe.
English: Before the first use, prime the pump by pressing down several times until the medicine is idispensed onto your fingertip.
Slovenian: Pred prvo uporabo črpalko pripravite tako, da jo večkrat pritisnete navzdol, dokler si zdravila ne iztisnete na konico prsta.
English: Please contact your doctor before stopping your treatment, so that he could advice a replacement treatment as appropriate.
Slovenian: Posvetujte se z zdravnikom, preden prenehati z zdravljenjem, da vam bo svetoval o ustrezni menjavi zdravljenja..
English: Mirvaso works on a daily basis, starting with the first day of treatment.
Slovenian: Zdravilo Mirvaso deluje na dnevni osnovi od prvega dne zdravljenja dalje.
English: The most commonly reported adverse reactions are erythema, pruritus, flushing and skin burning sensation, all occurring in 1.2 to 3.3% of patients in clinical studies.
Slovenian: Neželeni učinki zdravila, o katerih so najpogosteje poročali, so eritem, pruritus, vročinski valovi in občutek skelenja na koži, ki se vsi pojavijo pri 1,2 do 3,3 % bolnikov v kliničnih študijah.
English: Do not use this medicine on other parts of your body, especially moist body surfaces, e.g. your eyes, mouth, nose or vagina.
Slovenian: Tega zdravila ne uporabljajte na drugih delih telesa, še posebej na vlažnih delih telesa, npr. očeh, ustih, nosu ali nožnici.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2014
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. februar 2014 Datum zadnje obnove: 22. novembra 2018
English: In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued.
Slovenian: V primeru hudega draženja ali kontaktne alergije je treba zdravljenje s tem zdravilom prekiniti.
English: Galderma Laboratorium GmbH Toulouser Allee 19a-23a D-40211 Düsseldorf Germany
Slovenian: Galderma Laboratorium GmbH Toulouser Allee 19a-23a D-40211 Düsseldorf Nemčija
English: The amount of gel can then be increased gradually based on tolerability and patient response.
Slovenian: Količina gela se lahko postopoma povečuje glede na prenašanje in bolnikov odziv.
English: During the first week, start the treatment with a small amount of gel (a pea-sized amount) as explained by your doctor or nurse.
Slovenian: Prvi teden začnite zdravljenje z majhno količino gela (v velikosti grahovega zrna), kot sta vam pojasnila zdravnik ali medicinska sestra.
English: Spread it smoothly and evenly as a very thin layer as directed by your doctor or nurse.
Slovenian: Razmažite ga gladko in enakomerno ter v tanki plasti, kot sta vam naročila zdravnik ali medicinska sestra.
English: If any of the above applies to you, talk to your doctor since this medicine may not be suitable for you.
Slovenian: Če kaj od naštetega velja za vas, se posvetujte z zdravnikom, saj to zdravilo morda ni primerno za vas.
English: Daily reductions in erythema for the first month of use (as measured with the CEA and PSA scales) were similar to those observed in the controlled trials, and those reductions were achievable for up to 12 months with no apparent loss of effect over time.
Slovenian: Dnevna zmanjševanja eritema pri prvem mesecu uporabe (kot je bilo izmerjeno po lestvici SEA in PSA) so bila podobna tistim, opaženih pri kontrolnih preskušanjih, in ta zmanjšanja so bila dosežena za obdobje do 12 mesecev brez očitnih zmanjšanj učinkov v določenem času.
English: The children experienced symptoms consistent with previously reported oral overdoses of alpha2-agonist in young children.
Slovenian: Otroka sta imela simptome, ki so v skladu s prej poročanimi peroralnimi prevelikimi odmerki agonistov alfa2 pri majhnih otrocih.
English: Brimonidine may cause clinically insignificant decreases in blood pressure in some patients.
Slovenian: Brimonidin lahko pri nekaterih bolnikih povzroči klinično nepomembno znižanje krvnega tlaka.
English: The safety and efficacy of Mirvaso in children and adolescents aged less than 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Mirvaso pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: Brimonidine is a highly selective alpha2-adrenergic receptor agonist that is 1000-fold more selective for the alpha2-adrenergic receptor than the alpha1-adrenergic receptor.
Slovenian: Brimonidin je zelo selektiven agonist alfa2 adrenergičnih receptorjev, ki je 1.000-krat bolj selektiven za alfa2 adrenergične receptorje, kot za alfa1 adrenergične receptorje.
English: There are no or limited amount of data from the use of brimonidine in pregnant women.
Slovenian: Podatkov o uporabi brimonidina pri nosečnicah ni oziroma so omejeni.
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.
Slovenian: Velikosti pakiranj: 1 tuba z 2 g, 10 g ali 30 g; 1 črpalka s 30 g. Na trgu morda ni vseh navedenih pakiranj.
English: The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.
Slovenian: Treba je pomisliti na možnost aditivnega ali potencirajočega učinka z depresorji centralnega živčnega sistema (alkohol, barbiturati, opiati, sedativi ali anestetiki).
English: Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
Slovenian: Zdravljenje peroralno zaužitega prevelikega odmerka vključuje podporno in simptomatsko terapijo; ohranjati je treba prehodne dihalne poti.
English: Treatment should be initiated with a small amount of gel and the dose increased gradually, based on tolerability and response to treatment (see section 4.2).
Slovenian: Zdravljenje se mora začeti z majhno količino gela, odmerek pa je treba na podlagi prenašanja in odziva na zdravljenje postopoma povečevati (glejte poglavje 4.2).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Mirvaso in all subsets of the paediatric population in treatment of rosacea (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Mirvaso za vse podskupine pediatrične populacije za zdravljenje rozacee (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Mirvaso should not be applied on irritated skin (including following laser therapy) or open wounds.
Slovenian: Zdravilo Mirvaso se ne sme nanašati na razdraženo kožo (vključno po laserskem zdravljenju) ali odprte rane.
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).
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov), o njih pa so poročali pri uporabi zdravila Mirvaso, bodisi v kliničnih študijah ali v obdobju po začetku trženja zdravila (oznčeni z zvezdico (*) v preglednici 1).
English: To close the pump, place the cap back on the pump.
Slovenian: Črpalko zaprete tako, da zaporko namestite nazaj na črpalko.
English: Post-marketing cases of bradycardia, hypotension (including orthostatic hypotension) and dizziness have been reported, some of which required hospitalisation.
Slovenian: Iz obdobja trženja zdravila so poročali o primerih bradikardije, hipotenzije (vključno z ortostatsko hipotenzijo) in omotice, od katerih so nekateri zahtevali hospitalizacijo.
English: If any of the above applies to you, or if you are unsure, talk to your doctor.
Slovenian: Če kaj od navedenega velja za vas ali če niste prepričani, se posvetujte z zdravnikom.
English: Treatment should be initiated with a smaller amount of gel (less than the maximum) for at least one week.
Slovenian: Zdravljenje se mora začeti z manjšo količino gela (manjšo od največje), kar mora trajati vsaj en teden.
English: Mirvaso should not be applied close to the eyes.
Slovenian: Zdravila Mirvaso se ne sme nanašati blizu očes.
English: Biotransformation Brimonidine is extensively metabolised by the liver.
Slovenian: Biotransformacija Brimonidin se obširno presnavlja v jetrih.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription for renewable delivery.
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je na obnovljiv recept.
English: It is supplied in tubes containing 2, 10 or 30 grams of gel or in airless pump system containing 30 g of gel.
Slovenian: Na voljo je v tubah, ki vsebujejo 2, 10 ali 30 gramov gela, ali v sistemu z brezzračno črpalko, ki vsebuje 30 gramov gela.
English: One application per 24 hours, at any time suitable for the patient, for as long as facial erythema is present.
Slovenian: En nanos vsakih 24 ur ob času, ki je primeren za bolnika, dokler je prisoten obrazni eritem.
English: Use of Mirvaso when taking these medicines may result in a fall in blood pressure.
Slovenian: Uporaba zdravila Mirvaso sočasno z jemanjem teh zdravil povzroči padec krvnega tlaka.
English: Caution is therefore advised when using medicinal products such as anti-hypertensives and/or cardiac glycosides concomitantly with brimonidine.
Slovenian: Zato je pri uporabi zdravil, kot so antihipertenzivi in/ali srčni glikozidi, sočasno z brimonidinom potrebna previdnost.
English: It is unknown whether brimonidine/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se brimonidin/presnovki izločajo v materino mleko.
English: Should any gel get onto these areas, wash them immediately with plenty of water.
Slovenian: Če zdravilo pride na katerega izmed navedenih predelov, ga takoj sperite z obilo vode.
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.
Slovenian: Za noben neželen učinek ni bilo ugotovljeno, da bi se sčasoma njegova pogostnost povečevala, prav tako pa za dolgotrajno uporabo zdravila Mirvaso ni bilo ugotovljeno povečano tveganje za pojav katerega koli specifičnega tipa neželenih učinkov.
English: Then pull the cap off.
Slovenian: Nato zaporko snemite.
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.
Slovenian: Rdečino obraza zaradi rozacee povzroči velik pretok krvi v kožo obraza, kar je posledica razširjenih (dilatiranih) majhnih krvnih žilic v koži.
English: Talk to your doctor or pharmacist, before using Mirvaso especially if: - the skin of your face is irritated or has open wounds.
Slovenian: Pred začetkom uporabe zdravila Mirvaso se posvetujte z zdravnikom ali farmacevtom, posebej če: - je vaša koža na obrazu razdražena ali ima odprte rane.
English: Other medicines and Mirvaso
Slovenian: Druga zdravila in zdravilo Mirvaso
English: If this occurs, you should discard the excess gel so as not to apply more than the recommended dose.
Slovenian: Če pride do tega, zavzrite odvečni gel in ne nanašajte količine, ki presega priporočeni odmerek.
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).
Slovenian: Pomembno je, da je bolnik opozorjen, da ne preseže priporočenega največjega odmerka (5 grahovih zrn) in pogostnosti uporabe (enkrat na dan).
English: Elimination Urinary excretion is the major route of elimination of brimonidine and its metabolites.
Slovenian: Izločanje Glavna pot izločanja brimonidina in njegovih presnovkov je z urinom.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za farmakovigilanco, ki je naveden v Prilogi V.
English: What you need to know before you use Mirvaso
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Mirvaso
English: Do not apply any other skin medicines or cosmetics immediately before the daily application of Mirvaso.
Slovenian: Na kožo ne nanašajte drugih zdravil ali kozmetičnih izdelkov tik po vsakodnevnem nanosu zdravila Mirvaso.
English: Note: when the cap is removed, the pump is not child-resistant.
Slovenian: Opomba: ko zaporko snamete, črpalka ni za otroke varna.
English: The absorption of brimonidine from Mirvaso was evaluated in a clinical study in 24 adult subjects with facial erythema of rosacea.
Slovenian: Absorpcijo brimonidina iz zdravila Mirvaso so ocenili v klinični študiji pri 24 odraslih osebah z obraznim eritemom zaradi rozacee.
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).
Slovenian: osebe s stopnjo 4 po CEA ali PSA), ki predstavlja 26 % naključno izbranih oseb, so bili rezultati primarnega opazovanega dogodka na 29. dan podobni rezultatom, ki so jih opazili pri celotni populaciji (glejte preglednico 3), in so bili statistično pomembni za obe študiji (p = 0,003).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because these medicines could affect your treatment with Mirvaso or Mirvaso could affect your treatment with these medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo, saj lahko ta zdravila vplivajo na zdravilo Mirvaso ali pa zdravilo Mirvaso vpliva na zdravljenje s temi zdravili.
English: Pharmacotherapeutic group: Other dermatological preparations, Other dermatologicals, ATC code: D11AX21.
Slovenian: Farmakoterapevtska skupina: Druga zdravila za zdravljenje bolezni kože in podkožnega tkiva, druga dermatološka zdravila, oznaka ATC: D11AX21
English: You must avoid the eyes, eyelids, lips, mouth, and the inside of the nose.
Slovenian: Izognite se predelu oči, vek, ustnic, ust in notranjosti nosnic.
English: * Adverse reactions reported from post-marketing data.
Slovenian: *neželeni učinki iz podatkov iz obdobja trženja zdravila
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
Slovenian: CEA: Klinična ocena eritema: 0=Čista koža brez znakov eritema, 1=Skoraj čista koža; blaga rdečina, 2=Blagi eritem; definitivna rdečina, 3=Zmerni eritem + znatna rdečina in 4=Hud eritem + močna rdečina
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.
Slovenian: Po ponavljajočem se dermalnem nanosu zdravila Mirvaso na kožo obraza niso opazili kopičenja zdravila v plazmi v času trajanja zdravljenja: najvišja povprečna (± standardna deviacija) koncentracija v plazmi (Cmax) je bila 46 ± 62 pg/ml, površina pod krivuljo koncentracije v odvisnosti od časa od 0 do 24 ur (AUC0-24h) pa 417 ± 264 pg.h/ml.
English: Cutaneous facial application of a highly selective alpha2-adrenergic receptor agonist reduces erythema through direct cutaneous vasoconstriction.
Slovenian: Dermalni obrazni nanos visoko selektivnega agonista alfa2 adrenergičnega receptorja zmanjša eritem z neposredno dermalno vazokonstrikcijo.
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.
Slovenian: Če razvijete kontaktno alergijo (npr. alergijsko rekcijo, izpuščaj) ali redko angioedem (resna alergijska reakcija, po navadi z otekanjem obraza, ust ali jezika), prenehajte uporabljati zdravilo Mirvaso in takoj poiščite zdravniško pomoč.
English: Some cases involved application of Mirvaso following laser procedures (see section 4.4).
Slovenian: Pri nekaterih primerih so zdravilo Mirvaso uporabljali po laserskih posegih (glejte poglavje 4.4).
English: On Day 1 of the study, all subjects received 1 drop of the 0.2% eye drops solution in each eye, every 8 hours over a 24-hour period (3 doses in total).
Slovenian: Prvi dan študije so vse osebe prejele 1 kapljico 0,2-odstotne raztopine kapljic za oko v vsako oko vsakih 8 ur v obdobju 24 ur (skupno 3 odmerke).
English: In case of worsening or unexpected redness, discontinue the treatment and contact your doctor.
Slovenian: V primeru poslabšanja ali nepričakovane pordelosti, prekinite zdravljenje in se posvetujte z zdravnikom.
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).
Slovenian: Pomembno je, da zdravljenje začnete z majhno količino, ki jo postopoma povečujete, vendar ne presežete največjega odmerka 1 gram (približno 5 grahovih zrn).
English: Before you restart the treatment with Mirvaso, test it on a small area of the face on a day when you can stay at home.
Slovenian: Pred nadaljevanjem zdravljenja z zdravilom Mirvaso opravite poskusni nanos na majhnem predelu obraza, ko lahko ostanete doma.